November 2017 Issue 28 2017 Issue 28_1.pdf · ILAC MRA for Testing and calibration to ISO/IEC...

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Inside This Issue Signatory Status to the AFRAC MRA Extended to Include Medical Testing and Inspection 3 Communiqué to CABs on SADCAS Policy on Metrological Traceability 32 SADCAS Accredits More Facilities 4 IAF Communiqué ISO 9001 and 14001 34 Unki Mine Testing Laboratory Accredited 5 Joint ISO/IEC 17025 Communiqué 35 Zambia’s Central Veterinary Research Institute Accredited 7 The Business Benefits of Standards and Accreditation 36 SADCAS Accredits First Facility in Ghana 9 SADCAS Conducts ISO 15189 in Uganda 37 Highlights of the 8 th AFRAC General Assembly 10 Third ISO/IEC 17025 Training held in Swaziland 38 Highlights from the Joint IAF/ILAC General Assembly 16 SADCAS Undertakes its 5 th Internal Audit 39 SADCAS Publishes 9 th Annual Report 25 Training on the New ISO/IEC 17025:2017 Standard on Offer 40 Journey Towards Accreditation of Inspection Bodies under the Regulatory Domain in Zimbabwe 25 Upcoming Training Courses 41 Angola Appoints New Second NAFP 27 Training on Validation/Verification of Methods and Measurement Uncertainty 41 Accreditation in Supporting Public Policy 27 SADCAS Training Courses 42 Civil Engineering Laboratory (Pty) Ltd—Road to Accreditation 29 Status of Key Accreditation Standards and IAF/ILAC Documents 43 SADCAS Registers More Assessors 30 Diary of Upcoming Events 44 Advisory Committee for Inspection Bodies , Zimbabwe Holds 7th Meeting 30 Christmas Break 46 Systematic Review of ISO/IEC 17020:2012 32 THE PIONEER NEWSLETTER November 2017 VOLUME 9, ISSUE 28 SADCAS Scope in ILAC MRA Extended S ADCAS is proud to announce the extension of its scope in the International Laboratory Accreditation Cooperation (ILAC) Mutual Rec- ognition Arrangement to include Medical Testing to ISO 15189 and Inspection to ISO/ IEC 17020 following an extraordinary joint peer evaluation successfully held from 14 to 19 May 2017 by ILAC and the African Accreditation Cooperation (AFRAC). The decision was made by the ILAC Arrange- ment Council at its meeting held on Saturday 28 October 2017 in Vancouver, Canada and once again in a record 5 months after the evaluation. The MOU was signed during a cere- mony held in conjunction with the Joint ILAC and International Accreditation Forum (IAF) held on Sunday, 30 October 2017 in Vancouver, Canada. The SADCAS Board Chairman Mr Ste- ven Bruce Sidney who is also the ILAC Labora- tory Committee Chairman was there together with Mrs Maureen P Mutasa the SADCAS CEO to receive the MOU on behalf of SADCAS. Mrs Maureen Mutasa, SADCAS CEO receiving the ILAC MRA Certificate from Mrs Merih Malmqvist Nilsson, Chairman ILAC Continued to p 2

Transcript of November 2017 Issue 28 2017 Issue 28_1.pdf · ILAC MRA for Testing and calibration to ISO/IEC...

Page 1: November 2017 Issue 28 2017 Issue 28_1.pdf · ILAC MRA for Testing and calibration to ISO/IEC 17025. the extraordinary peer evaluation for scope extension was con-ducted in May 2017

Inside This Issue

Signatory Status to the AFRAC MRA Extended to Include

Medical Testing and Inspection

3 Communiqué to CABs on SADCAS Policy on Metrological Traceability 32

SADCAS Accredits More Facilities 4 IAF Communiqué ISO 9001 and 14001 34

Unki Mine Testing Laboratory Accredited 5 Joint ISO/IEC 17025 Communiqué 35

Zambia’s Central Veterinary Research Institute Accredited 7 The Business Benefits of Standards and Accreditation 36

SADCAS Accredits First Facility in Ghana 9 SADCAS Conducts ISO 15189 in Uganda 37

Highlights of the 8th

AFRAC General Assembly 10 Third ISO/IEC 17025 Training held in Swaziland 38

Highlights from the Joint IAF/ILAC General Assembly 16 SADCAS Undertakes its 5th

Internal Audit 39

SADCAS Publishes 9th

Annual Report 25 Training on the New ISO/IEC 17025:2017 Standard on Offer 40

Journey Towards Accreditation of Inspection Bodies under the

Regulatory Domain in Zimbabwe

25 Upcoming Training Courses 41

Angola Appoints New Second NAFP 27 Training on Validation/Verification of Methods and Measurement

Uncertainty

41

Accreditation in Supporting Public Policy 27 SADCAS Training Courses 42

Civil Engineering Laboratory (Pty) Ltd—Road to Accreditation 29 Status of Key Accreditation Standards and IAF/ILAC Documents 43

SADCAS Registers More Assessors 30 Diary of Upcoming Events 44

Advisory Committee for Inspection Bodies , Zimbabwe Holds

7th Meeting

30 Christmas Break 46

Systematic Review of ISO/IEC 17020:2012 32

THE PIONEER

NEWSLETTER November 2017 VOLUME 9, ISSUE 28

SADCAS Scope in ILAC MRA Extended

S ADCAS is proud to announce the extension of its scope in the International Laboratory

Accreditation Cooperation (ILAC) Mutual Rec-ognition Arrangement to include Medical Testing to ISO 15189 and Inspection to ISO/IEC 17020 following an extraordinary joint peer evaluation successfully held from 14 to 19 May 2017 by ILAC and the African Accreditation Cooperation (AFRAC). The decision was made by the ILAC Arrange-ment Council at its meeting held on Saturday 28 October 2017 in Vancouver, Canada and once again in a record 5 months after the evaluation. The MOU was signed during a cere-mony held in conjunction with the Joint ILAC and International Accreditation Forum (IAF) held on Sunday, 30 October 2017 in Vancouver, Canada. The SADCAS Board Chairman Mr Ste-ven Bruce Sidney who is also the ILAC Labora-tory Committee Chairman was there together with Mrs Maureen P Mutasa the SADCAS CEO to receive the MOU on behalf of SADCAS.

Mrs Maureen Mutasa, SADCAS CEO receiving the ILAC MRA Certificate from Mrs Merih

Malmqvist Nilsson, Chairman ILAC

Continued to p 2

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Continued to p 3

Continued from p 1

SADCAS originally joined ILAC as an Affiliate Member in 2008. SADCAS membership was then upgraded to Associate Member in 2011 having accredited enough testing and calibration to meet the competence requirements for considera-tion as a Full member. In June 2014 SADCAS underwent a pre peer evaluation of its Testing and Calibration Laboratories Accreditation Programs to determine its readiness for peer evaluation which was subsequently undertaken in May 2015. SADCAS was originally admitted as an ILAC full member in November 2015 when she achieved signatory status in the ILAC MRA for Testing and calibration to ISO/IEC 17025. the extraordinary peer evaluation for scope extension was con-ducted in May 2017 and culminating in the achievement.

With this additional achievement the accreditation certificates issued by SADCAS for the Medical Laboratories, Inspection bodies, Testing laboratories and calibration laboratories' accreditation schemes are internationally recognized thus en-hance the acceptance of test/calibration/medical/inspection results across national borders, remove the need for repeti-tive testing/inspection of products traded internationally and in the case of medical laboratories improves patient care. In line with its value proposition SADCAS is truly delivering confidence and assuring technical competence.

SADCAS Board Chairman, Mr Steve Sidney proudly poses for a photo with Mrs Merih Malmqvist Nilsson, Chairman ILAC; and Mrs Mutasa

SADCAS Value Proposition � Delivering confidence

� Assuring competency

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S ADCAS signatory status in the African Accreditation Cooperation (AFRAC) Mutual Recognition Arrange-

ment (MRA) has been extended to include Medical Test-ing to ISO 15189 and Inspection to ISO/IEC 17020 fol-lowing an extraordinary joint AFRAC/ILAC peer evalua-tion successfully held from 14 to 19 May 2017. The deci-sion was made on 27 September 2017 by the AFRAC MRA Council, a record four (4) months after the evalua-tion. The signing ceremony was held on Friday, 29 Sep-tember during the gala dinner held to mark the end of the 2017 AFRAC annual meetings including the General Assembly meeting. SADCAS was originally admitted as an AFRAC Arrangement member for Testing and Cali-bration to ISO/IEC 17025 on 8 October 2015. AFRAC Arrangement members are accreditation bodies who have been peer evaluated under applicable AFRAC procedures and deemed to comply with the require-ment for admission as a signatory to the AFRAC MRA by the MRA Council. The awarding of the AFRAC MRA is significant especially as AFRAC waits for the international recognition from ILAC and IAF. SADCAS is a multi-economy accreditation body established to meet the accreditation needs of SADC Member States namely: Angola; Botswana; Democratic Re-public of Congo (DRC); Lesotho; Madagascar; Malawi; Mozambique; Namibia; Seychelles; Swaziland; Tanzania; Zambia; and Zimbabwe.

SADCAS is gathering the necessary competence of the management systems and product certification bodies accredita-tion schemes for which it aims to undergo peer evaluation in 2019 when SADCAS undergoes re-evaluation.

Signatory Status to the AFRAC MRA Extended to Include Medical Testing and Inspection

From left to right Mrs Maureen Mutasa, SADCAS CEO; Mr Araya Fesseha,

Chairman AFRAC and Mr Boughalmi Moez, Chairman AFRAC MRA Council

Proudly displaying the duly signed MRA Certificate from left to right: Mrs

Mutasa and Mr Moez

Proudly displaying the duly signed MRA Certificate from left to right:

Ms Jeanne Ranorovelo, SADCAS Technical Manager and Mrs Mutasa

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SADCAS Accredits More Facilities

SADCAS is proud to announce the accreditation of 7 more facilities in Botswana, DRC, Zambia, Zimbabwe and Ghana. Australian Laboratory Group, Zambia Limited is a Testing laboratory based in Chilanga, Zambia which has been ac-credited in the scope Chemical Analysis in accordance with ISO/IEC 17025. The accreditation covers the determination of Copper (Cu) in ore grade by 4 acid digestion with AAS finish; determination of gold using fire assay and AAS finish; determination of oxidized Copper Sulfide by 5% Sulfuric Acid Leach and AAS analysis; and determination of cyanide soluble Copper in ore, rocks and soils. Through this accreditation Australian Laboratory Group, Zambia Limited has been granted the unique accreditation number Test-5 0027 indicating that Australian Laboratory Group, Zambia Limited is a SADCAS accredited laboratory. Société de Surveillance Minière, Democratic Republic of Congo is a Testing laboratory based in Katanga, Democratic Republic of Congo which has been accredited in the scope Chemical Analysis in accordance with ISO/IEC 17025. The accreditation covers the analysis of total Copper, Cobalt and Zinc in minerals and concentrates in Copper and Cobalt by 4 acids digestion and determination by atomic absorption; analysis of impurity in Copper by SPARK method; and deter-mination of loss of weight in concentrates of Copper, Cobalt, Lead, Zinc and Nickel in accordance with ISO 10251. Through this accreditation the “Société de Surveillance Minière” has been granted the unique accreditation number Test-5 0028 indicating that the “Société de Surveillance Minière” is a SADCAS accredited laboratory. Lenmed Health Bokamoso Private Hospital Laboratory is a Medical Testing laboratory based in Gaborone, Botswana which has been accredited in the scopes Clinical Chemistry, Serology, Haematology, Blood Bank and Microbiology in accordance with ISO 15189: 2012. Through this accreditation Lenmed Health Bokamoso Private Hospital Laboratory has been granted the unique accredi-tation number MED 017 indicating that Lenmed Health Bokamoso Private Hospital Laboratory is a SADCAS accredited laboratory. Aga Khan Hospital Laboratory, Tanzania is a Medical Laboratory based in Dar es Salaam, Tanzania which has been accredited in the scopes of Chemistry, Clinical Chemistry, Haematology, Serology and Microbiology in accordance with ISO 15189: 2012. Through this accreditation Aga Khan Hospital Laboratory, Tanzania has been granted the unique accreditation number MED 018 indicating that Aga Khan Hospital Laboratory, Tanzania is a SADCAS accredited laboratory. 37 Military Hospital Pathology Division Laboratory is a Medical Laboratory based in Accra, Ghana which has been accredited in the scopes Chemical Pathology and Haematology in accordance with ISO 15189: 2012.

Through this accreditation 37 Military Hospital Pathology Division Laboratory has been granted the unique accreditation number MED 019 indicating that 37 Military Hospital Pathology Division Laboratory is a SADCAS accredited laboratory. National Microbiology Reference Laboratory, Zimbabwe is a Medical Laboratory based in Harare, Zimbabwe which has been accredited in the scopes of Serology and Molecular Biology in accordance with ISO 15189: 2012. Through this accreditation National Microbiology Reference Laboratory has been granted the unique accreditation num-ber MED 020 indicating that National Microbiology Reference Laboratory is a SADCAS accredited laboratory. Central Veterinary Research Institute Laboratory, Zambia is a Veterinary Diagnostic laboratory based in Lusaka, Zam-bia which has been accredited in the scope Veterinary Diagnostics in accordance with ISO/IEC 17025. The accreditation in the scope “Veterinary Diagnostics” covers Chemical, Serology and Virology.

Through this accreditation Central Veterinary Research Institute Laboratory has been granted the unique accreditation number VET 002 indicating that Central Veterinary Research Institute Laboratory is a SADCAS accredited laboratory.

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Unki Mine Testing Laboratory Accredited

U nki Mine Testing Laboratory have been accredited by SADCAS in the scope of Chemical analysis of floatation con-centrates. Through this accreditation Unki Mine Testing Laboratory has been granted the unique accreditation

number TEST - 5 0025 indicating that Unki Mine Testing Laboratory is now a SADCAS accredited testing laboratory for Chemical analysis of floatation concentrates. Unki Mine is the 25th testing laboratory and the 17th facility in Zimbabwe to be accredited by SADCAS. The Unki Mine certificate which was issued on 10 March 2017 is valid for 5 years and expires on 9 March 2022 and throughout which surveillance assessments will be undertaken to check continued accreditation. The certificate was handed over during a ceremony held on 15 September 2017 at the Mine Boardroom in Shurugwi, Zimbabwe. In his opening remarks the acting General Manager and Engineering Manager, Mr Abener Chauke welcomed guests and explained why the Mine embarked on accreditation mainly to meet regulatory requirements of the Reserve Bank of Zimbabwe and the Minerals Marketing Corporation of Zimbabwe and also to have confidence in the assays un-dertaken by the laboratory. He also informed the guests that right from inception the Mine which was established in 2010 had always been striving to comply with standards and was certified to ISO 9001 for quality management systems, ISO 14001 for environmental management systems and OHAS 18001 for occupational health and safety. In his remarks Mr Emmanuel Katsande the Concentrator Manager under whom the Testing Laboratory falls gave a brief outline of the journey that the testing laboratories had travelled resulting in the achievement of accreditation. Mr Raison Mapfumo who is the Quality and Technical Manager, is the Nominated Representative for Unki Mine Testing Laboratory. In her speech before the certificate handover Mrs Maureen P Mutasa, the SADCAS Chief Executive Officer noted that a number of SADC countries’ economies rely heavily on mining and mineral exploitation with Botswana, Democratic Re-public of Congo (DRC), South Africa, Namibia, Zimbabwe and Zambia in the lead. The region produces significant quan-tities of major metals and minerals and contributes 49% of platinum, 36% of gold, 50% of diamonds, 40% of chromite and 53% of vanadium to the world’s production. Mining contributes 4.3% to Zimbabwe’s GDP and employs 7% of the country’s labour force. The mining sector is a major source of foreign currency for a number of countries and Zimbabwe is no exception. She noted that most of the minerals are exported in their raw form. Given these high production rates and growing global demand for finished mineral products value addition is imperative. Mrs Mutasa said that the mining sector has the relative advantage of gaining in competitiveness at fewer costs through adapting the final production to international standards. She further said that the mineral processing sector is identified in the SADC Industrial Policy as one of the priority sectors for development. Testing Laboratories play a critical role in the mining and mineral processing sector in that they conduct mineral assays in support of exploration, research, grade control in the processing plant.

During the certificate handover ceremony

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Laboratories are also involved in environmental monitoring of mining activities. Mining companies make decisions about exploration and grading based on the data generated by these analytical laboratories. Accreditation which is the proc-ess by which an authoritative body i.e. SADCAS gives formal recognition that an organization/person is competent to carry out specific tasks involves the creation of confidence in the work carried by laboratories, certification and inspection bodies collectively known as conformity assessment bodies. Accreditation is the basis of trust amongst trading partners she said. Mrs Mutasa encouraged Unki Mine Testing Laboratory to maintain their accreditation throughout the validity period of the accreditation certificate during which SADCAS would undertake surveillance assessments annually to ensure con-tinued compliance. She also encouraged the Laboratory to

extend accreditation to the other scopes of testing. She also informed Unki Mine about the ongoing revisions of ISO/IEC 17025 which was subsequently published end of November 2017 and the agreed three year transition to the new stan-dards from date of publication of the revised version of ISO/IEC 17025.

A vote of thanks was given by Mr Jameson Dondo, the Laboratory Manager of Unki Mine Testing Laboratory. In his vote of thanks he assured SADCAS that his team would throw all their efforts into maintaining the hard achieved ac-creditation and committed to pri-oritize scope extension. The hand-over ceremony was attended by over 20 Unki Mine management and staff, representatives from the Reserve Bank of Zimbabwe Messrs TN Manika and C Marufu and Mrs A Masuku from the MMCZ. The SADCAS CEO was accompanied by the 2 National Accreditation Focal Point representatives Mrs Riyana Chibanda and Mrs Mildred Machiri and Ms Jeanne Ranorovelo, the SADCAS Technical Manager.

Unki Mine is an underground mine located in central part of Zimbabwe in the Midlands near the town of Shurugwi. It has the 3rd largest reserves of platinum after Zimplats and the Zimbabwe Mining Development Company (ZMDC) and produce 76000 ounces of platinum per year. The Mine produces a concentrate which is transported by road to the Polokwane, South Africa smelter. The Mine uses a mechanized trackless Bord-and-pillar mining method.

SADCAS delegation poses for a group photo with Unki Mine Management and staff

During the handover ceremony

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Zambia’s Central Veterinary Research Institute Accredited

T he Zambian Central Veterinary Research Institute (CVRI) laboratories have been accredited by SADCAS in the scope of chemical analysis, bacteriology and serology. The Accreditation covers various tests namely: Detection of heavy

metals in bovine serum using AAS in the scope chemical analysis; Determination of contagious Bovine Pleuro-pneumonia (CBPP) by complement fixation and competitive Elisa in the scope bacteriology; and Determination of Foot and Mouth Disease using Elisa in the scope serology. Through this accreditation the CVRI's Laboratory has been granted the unique accreditation number VET 002 indicating that CVRI's Laboratory is now a SADCAS accredited testing labora-tory. Central Veterinary Research Institute is the 2nd veterinary laboratory and the 5th facility in Zambia to be accredited by SADCAS. The CVRI certificate which was issued on 14 August 2017 is valid for 5 years and expires on 13 August 2022. During the validity of the certificate SADCAS will undertake surveillance assessments to check continued accreditation. The certificate was handed over during a ceremony held on 16 November 2017 at the CVRI Offices in the outskirts of Lusaka in Zambia. In his opening remarks the Chief Veterinary Research Officer (CVRO), Dr Paul Fandamu gave a brief overview of the CVRI outlining its organizational structure, role, main activities and achievements over the years includ-ing the production of vaccines. He then outlined the journey towards accreditation which started in 2011 and culminat-ing with accreditation in August 2017. The CVRO also informed the gathering of the intention to extend scope of ac-creditation and prioritizing those scopes where Zambia currently sends samples for testing to South Africa and Botswana due to lack of international recognition. He noted the savings that would be made if the CVRI was accredited in these tests. The Director Veterinary Services, a Department under the Ministry of Fisheries and Livestock, Dr Yona Sinkala high-lighted the significance of the accreditation achievement to the nation as a whole, the Government, the Ministry, CVRI and all its clients. In particular he highlighted the role that accreditation plays in enhancing competiveness of products and access to markets thus facilitating trade especially the export of meat and meat products, milk and milk products. He also touched on the importance of credible laboratory services in support of CVRI’s diagnostic services.

Speaking during the certificate handover cere-mony Mrs Maureen P Mutasa, the SADCAS Chief Executive Officer advised the delegates that SAD-CAS, the first multi economy accreditation body in the world is signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) for the testing/calibration/medical laboratories and in-spection bodies accreditation schemes. Signatory status in the ILAC MRA was achieved in Novem-ber 2015 for the testing and calibration pro-gramme and extended to medical and inspection recently on 28 October 2017. “With these achievements, the accreditation certificate which has been issued to CVRI is internationally recog-nized’, she said. She reiterated the importance of accreditation in enhancing the competitiveness

of goods and market access thus facilitate trade. “Accreditation contributes towards national social and economic devel-opment. Ultimately accreditation helps reduce poverty and improves the quality of our lives” she added. Mrs Mutasa then advised of the ongoing revisions of ISO/IEC 17025, the standard that CVRI have been accredited and which was subsequently published at the end of November 2017. She further informed the CVRI that ILAC had already agreed on a three year transition from date of publication of the revised version of ISO/IEC 17025 and that SADCAS will, as soon as the new standard is published, issue a transition policy which the CVRI together with all other testing laboratories ac-credited under ISO/IEC 17025 will be required to meet failing which the accreditation certificate will expire at the dead-line of the transition period.

Mrs Maureen P Mutasa handing over the certificate to Honourable Mr Michael JZ

Katambo with Dr Y Sinkala Looking on

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In his address the guest of honour, Honourable Michael JZ Katambo (Member of Parliament) and Minister of Fisheries and Livestock, congratulated the CVRI for the achievement. He acknowledged the importance of accreditation to the national economy making reference to the recently launched 7th National Development Plan which prioritizes fish and livestock for economic diversification. He noted the important role played by the CVRI and internationally recognized accreditation to this endeavour. The Minister thanked the CVRI team for their hard work and dedication towards goal achievement. He encouraged CVRI to maintain their accreditation and to extend their scope of accreditation and reiter-ated his Ministry’s continued support to the CVRI. The Minister then thanked UNIDO who supported the CVRI in their journey towards accreditation. He also thanked Mrs Mutasa for her time to attend the ceremony. A vote of thanks was given by Dr Maureen Dziva and marked the end of the ceremony. The handover ceremony was at-tended by about 30 CVRI management and staff, Government officials and the media. The SADCAS CEO was accompa-nied to the ceremony by the National Accreditation Focal Point for Zambia Mrs Charity Kasoma from the Ministry of Commerce Trade and Industry here the NAFP is housed. Prior to the ceremony the delegates went a tour of the CVRI facilities laboratories and the Vaccine producing Unit. The CVRI is responsible for providing solutions to the livestock business through innovative veterinary service. The CVRI ser-vices cover a wide range of technical disciplines including animal health, veterinary services, research, diagnostics, vector control, training, public health and epidemiology. Through its services the CVRI contributes towards safeguarding Zam-bia animal health and public health by providing timely and accurate diagnostic laboratory support. At the very core of the CVRI’s business as a veterinary diagnostic research institute testing is a key support activity. ISO/IEC 17025 is the international standard that veterinary testing laboratories have to comply with in order to be accredited.

Proudly displaying the accreditation certificate are Honourable Mr Katambo Minister of Fisheries and Livestock on the Left picture and Dr Fandamu

and Mrs Charity Kasoma NAFP – Zambia

Delivering confidence, Assuring competency

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S ADCAS is proud to announce the accreditation of 37 Military Hospital, Pathology Division Laboratory in Accra, Ghana. This is the first facility to be accredited by SADCAS in Ghana. 37 Military Hospital, Pathology Division Labora-

tory has been accredited in the following scopes: � Haematology to ISO 15189:2012 � Chemical Pathology to ISO 15189:2012. The accreditation became effective on 21 September 2017 and the facility has been granted the unique Accreditation Number MED 019. The certificate is valid for 5 years until 20 September 2022. Accreditation of medical laboratories is of paramount importance as they play a pivotal role in Healthcare. Accreditation of medical laboratories in accordance with ISO 15189:2012 provides a number of benefits: � It is a means of demonstrating competence to clients both internal and external. � It is a guarantee of accurate and reliable test results. � It improves patient care. � It strengthens community confidence in test results. � It provides continuous staff education and attracts professional reference due to accuracy and competence. The 37 Military Hospital is a specialist hospital located in Accra, Ghana. It is the largest military hospital in the Republic of Ghana after the Korle-Bu Teaching Hospital. In total, the hospital has around 400 beds. SADCAS welcomes 37 Military Hospital, Pathology Division Laboratory to the family of accredited facilities and encour-

ages other non accredited facilities to follow suit for the benefit and safety of the patients in their areas of impact.

SADCAS Accredits First Facility in Ghana

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T he African Accreditation Cooperation (AFRAC) held its 8th General Assembly meeting on 29 September 2017 at the Fairmont Nile City Hotel in Cairo, Egypt. The meeting was hosted by the Egyptian Accreditation Council (EGAC). A

number of training workshops and meetings were held before and during the week as follows: � Workshops on ISO/IEC 17011 held from 23 to 24 September 2017; ILAC A3 held on 27 September 2017; ISO/IEC

17025, ISO/IEC 17021-1:2016 and ISO/IEC 17021-3:2017 held on 28 September 2017; and MRA decision making held on 27 September 2017.

� Marketing and Communications Working Group meeting, Calibration, Testing and Certification Technical Committee Working Groups; Evaluator Working Group and MRA Documents Working Group meetings held on 25 September 2017;

� Inspections Technical Committee Working Group; Technical Committee and MRA Committee meetings held on 26 September 2017;

� MRA Council meeting held on 27 September 2017; � AFRAC Executive Committee meeting held on 28 September 2017;and � AFRAC General Assembly (GA) held on 29 September 2017. The 8th AFRAC General Assembly meeting was officially opened by Mr Hany El Delsouki on behalf of Honourable Eng. Tarek Kabil the Egyptian Minister of Trade and Industry at a ceremony held on Monday 25 September 2017 and attended by over 60 delegates from African countries mainly from accreditation bodies, regional trading blocs, international de-velopment partners such as Physikalisch - Technische Bundesanstalt (PTB) Germany, accreditation cooperation partners such as the Arab Accreditation Cooperation (ARAC).

Highlights of the 8th AFRAC General Assembly

From left to right: Dr Ali Elbireer, CEO of ASLM; Representative of IHAF, Mr Hany El Desouki, Executive Director of EGAC ;

Mr Araya Fesseha, AFRAC Chair

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The Executive Director of EGAC Mr Hany El Desouki wel-comed delegates to the 8th AFRAC Annual meetings and thanked the AFRAC for the opportunity afforded to EGAC to host once again this special event in Egypt highlighting EGAC role in the establishment of AFRAC and EGAC partici-pation in other regional accreditation co operations such as the Arab Cooperation in Accreditation (ARAC) and the Euro-pean Accreditation (EA) and the reasons of participation in these fora. He noted the many opportunities the continent of Africa has and highlighted the need for a good Quality infrastructure to facilitate trade and take advantage of the huge opportunities presented. In his remarks Mr Araya Fesseha, the Chairman of AFRAC noted that Africa as a conti-nent was lagging behind quality issues even though civiliza-tion started on the continent citing the pyramids as a symbol of civilization. He then outlined the efforts and achievements of AFRAC over the years and in particular the progress made towards international recognition, and the collaborations and developments under the Pan African Quality Infrastruc-

ture whose activities are fully aligned to the Africa Union’s priority areas for economic development. He noted the poor participation by African countries in AFRAC the one stop shop for accreditation issues and called upon the Honourable Minister to assist in the membership drive. He then thanked Egypt for hosting the 8th AFRAC General Assembly meeting and PTB Germany and other cooperating partners for the support provided to AFRAC thus far. In his presentation on the United Arab Emirates' initiative on the International Halal Accreditation Forum (IHAF), the rep-resentative of IHAF highlighted the size of halal trade worldwide which is now estimated to be US$ 2 trillion and poised to grow further. "85% of meat used in Arab countries is from outside the region most of which are not Moslem hence the need for assurance" he said. He noted that both the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) do not take care of Islamic principles in accreditation hence the establishment of IHAF. Already 20 countries have signed up to IHAF. He then invited AFRAC members to consider joining IHAF a matter

which was discussed during the week of meetings and is under consideration by AFRAC.

Delegates at the 8th

AFRAC GA opening ceremony Mrs Mutasa with Mr Ron Josias CEO SANAS during

Coffee /tea break after the opening ceremony

SADCAS delegation pose for a photo with ASLM representatives at the

opening ceremony of the 8th AFRAC GA

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In his remarks Dr Ali Elbireer, the CEO of the African Society for Laboratory Medicine (ASLM) outlined the role of ASLM in preparing medical laboratories to a level that accreditation bodies can accredit them. He further outlined the platforms used for this purpose i.e. the Strengthening of Laboratory Management Towards Accreditation (SLMTA) and Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), the partners involved and the achievements so far with a number of laboratories having been accredited under ISO 15189. He then called for strengthened collabora-tion amongst all the stakeholders in order to improve the health care delivery system of which the accreditation of medi-cal laboratories is a key strategy. In the speech read on his behalf by Mr Hany Delsouki, Honourable Eng. Tarek Kabil the Egyptian Minister of Trade and Industry welcomed all delegates to Egypt and noted the importance of accreditation in economic integration and trade facilitation. He outlined his Ministry's initiatives in the accreditation arena including the restructuring of Quality Infra-structure in Egypt and the trade agreements that Egypt had signed highlighting the importance and role of accreditation in each one of the trade agreements. A number of training workshops were held in conjunction with the 8th AFRAC GA starting with the workshop on ISO/IEC 17011 held from 23 to 24 September 2017 and attended by over 38 participants from EGAC, KENAS, MAURITAS, NINAS, TUNAC, SANAS and SADCAS as well as observers from ECOWAS. The workshop which was designed to highlight the requirements of the new edition of ISO/IEC 17011 the key accreditation standard that accreditation bodies have to com-ply with for international recognition was very ably facilitated by Mrs Susan Munyiri Ochieng, Acting Chief Executive Offi-cer, KENAS (Kenya) and a member of ISO CASCO WG 42. The training workshop was highly interactive with exercises interspaced throughout the 2 days of workshop allowing for exchange of information on implementation of the new edition amongst developed and emerging accreditation bodies from Africa.

Delegates at the ISO/IEC 17011 training Workshop

Attentive participants at the ILAC A 3 Workshop ISO/IEC 17025 Workshop

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This was followed by a workshop on ILAC A3 which was held on 27 September 2017 and very ably facilitated by Mr Mah-moud Eltayeb. The objective of the workshop which was attended by 36 participants was to inform accreditation bodies on how to use A3 in undertaking a self- evaluation and to report on performance of the accreditation bodies. The facili-tator walked participants through all the 3 parts starting with the introduction, the report template and steps in the evaluation process of the new version of ILAC IAF A3 which is due to be published shortly. Group work was undertaken on the various clauses of the standard 4.5, 5, 6.2, 7.7, 7.13 and 9.7, where participants were required to indicate what goes into the self -evaluation report. This workshop was very useful and will no doubt assist in the preparation of the self evaluation report which forms the basis of any peer evaluation process. The training workshop on MRA decision making was held on 27 September 2017 and facilitated by Mr Moez Boulghami the AFRAC MRA Committee and Council Chairman. In his presentation on the MRA decision making process, Mr Moez Boughalmi outlined the terms of reference (TORs) and competence requirements of the MRA Committee and Council, composition, importance of confidentiality declarations, the decision making process and the timelines thereof as out-lined in MR 001. The last workshops were held on 28 September 2017 starting in the morning with a half day training workshop on ISO/IEC 17025 facilitated by Mr Pilot Masunga of Botswana Bureau of Standards (BOBS) who walked participants through the ISO/IEC FDIS 17025: General requirements for the competence of testing and calibration laboratories, highlighting the changes in the new edition of the standard which was subsequently published by end of November 2017. In the after-noon a workshop to update delegates on the new editions of ISO/IEC 17021-2:2016: Conformity assessment - Require-ments for bodies providing audit and certification of management systems Part 2: Competence requirements for audit-ing and certification of environmental management systems and ISO/IEC 17021-3:2017: Conformity assessment - Re-quirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems was held on facilitated by Dr Hazan Sharaf El Din.

The Technical Committee Working Groups for testing, calibration and certification, MRA Committee Docu-ments Working Group and Marketing and Communica-tions Committee met on 25 September 2017 followed by the Inspection Working Group, Technical Committee (TC) and MRA Committee on 26 September 2017 with the MRA Council meeting being held on 27 September 2017. Following the retirement of Mr Sammy Milgo, the Tech-nical Committee meeting was chaired by Mr Mpho Phaloane the Vice Chair who was subsequently elected Chair at the General Assembly the next day. The TC was attended by 9 participants from TUNAC, SANAS, KENAS, SADCAS, ENAO, EGAC, ARAC, BOBS, NINAS and one observer Mr Prags Govender the SANAS Board Chair-man. The meeting reviewed the progress made on the 2016 work plan and developed the 2017 work plan which includes the strengthening liaison with other PAQI technical committees and developing guidance on remote assessments and flexible scopes requirements now elaborated on in the upcoming new version of ISO/IEC 17011 and, continuing with awareness raising and development support activities. The TC passed a total of 8 resolutions of which 2 were tabled to the EXCO and one to the GA for noting. Mr Michael Ta-lam of KENAS (Kenya) was appointed as the Certification Working Group. The Marketing and Communications Working Group (MCWG) meeting which was chaired by Mrs Susan Munyiri KENAS (Kenya) was attended by 14 delegates, 5 of whom are officially registered as members. The meeting revised the MCWG TORs to align them with voting requirements, and discussed comments from the EXCO on the AFRAC MRA brochure and updated the AFRAC Evolution presentation. Some time was also spend reviewing progress on the 2016 work plan and noting the accomplished activities such as the published and elaborate Corporate Identity /brand manual, published and branded 2017 to 2021 AFRAC Strategic Plan and Newsletter published biannually since 2015. Finally the 2017 MCC

Inspection WG meeting in session from left to right: Mr Lawson Hechelli:

ECOWAS, Mr Phaloane SANAS and Ms J Ranorovelo SADCAS

Technical Manager

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work plan was developed and subsequently approved by the EXCO and includes activities such as aligning A 004 with the TORs of the MCC, set up social media, prepare a brochure on Accreditation: Facilitating trade, branding the AFRAC Code of ethics as well as finalizing the stakeholder engagement list. Dr Lawrena Okoro was appointed the editor of the AFRAC Newsletter for 2018. The MCC passed 8 resolutions which were tabled before the EXCO. The MRA Committee meeting which was chaired by Mr Boulghami was attended by 10 members, one observer and Mr Chua the IAF/ILAC Peer evaluator who was witnessing the AFRAC decision making process as part of the evaluation of AFRAC and the Secretariat. The meeting reviewed progress in implementation of the 2016 work plan and noted that 3 peer evaluations for SADCAS, EGAC and SANAS undertaken in May, July and August 2017 with the TUNAC evaluation scheduled to be held in November 2017. The MRA committee also noted and discussed the progress with the MAURITAS pre peer evaluation. It was noted that Mr Adel Reik (EGAC) and Mrs Susan Munyiri Ochieng (KENAS) were qualified as peer evaluators during the year. So far AFRAC had registered 3 Lead evaluators and 10 evaluators. A register of the com-bined SADCA/AFRAC/ARAC pool of evaluators was prepared and various MRA documents were reviewed and confirmed/revised then published during the year. The meeting noted the progress with the evaluation of AFRAC as regions, with the office evaluation and clearance of findings completed, witnessing of evaluations of EGAC and SANAS also completed wand findings raised cleared and witnessing of decision making underway at these meetings. Sometime was then spent on reviewing the Task Force reports and recommendations on the SADCAS extraordinary peer evaluation for scope ex-tension to medical and inspection and KENAS peer evaluation of 2016 for recognition of its testing, calibration, medical testing, inspection and management systems (QMS/EMS/FSMS) accreditation programmes for which a positive recom-mendation was made to the MRA Council for decision on 27 September 2017 after the training workshop on decision making. The MRA Committee set up the team to undertake the internal audit of AFRAC in 2018 which comprises of Mr Mahmoud Eltaib and a trainee evaluator. Some time was spent discussing ways to improve the management of the MRA process clearly identifying the objectives and outcomes and key performance indicators all of which will go into the AFRAC service charter. The MRA committee 2018 work plan developed contained activities such as peer evaluations of TUNAC and MAURITAS, mentoring and qualification of trainee evaluator and ongoing revisions and publication of some of the MRA documents as identified by the MRA documents Working group which is Chaired by Mrs Maureen Mutasa the SADCAS CEO. The MRA Committee passed 15 resolutions whilst the MRA council passed 6 resolutions some of which were tabled at the 8th GA.

The Committee meetings were fol-lowed by the 8th AFRAC GA Meeting during which a total of 31 resolu-tions were adopted. In his report to the General Assembly the AFRAC Chairman, Mr Araya Fesseha re-viewed the achievements of the 2012 to 2016 Strategic Plan which were all on target as especially in working towards international rec-ognition of AFRAC as region, num-ber of qualified and registered evaluators, expansion of the AFRAC MRA scope, technical cooperation with other region, membership drive and increasing awareness on AFRAC. Some activities such as introduction of AFRAC fees which are critical to-wards AFRAC sustenance were on

hand pending registration of AFRAC and has been carried over into the EXCO 2018 work plan. As at the time of the GA AFRAC had 6 Arrangement members, 1 full member, 2 associate members and 6 stakeholder members. On the Pan Afri-can Quality Infrastructure of which accreditation is one of the main pillars, the Chair informed the meeting about the activities undertaken and planned to celebrate the Africa year of quality including the logo and tagline which were in-cluded in WAD celebrations. He then thanked all the cooperating partners especially PTB Germany and South African department of Trade and Industry for their continued support.

From Left to right: Mrs Mutasa AFRAC Vice Chair, Mr Fesseha AFRAC Chair and Mrs Yolanda Vinni-

combe AFRAC Secretariat

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He noted the limited accreditation market in Africa and called upon countries to develop technical assistance projects to develop the conformity assessment infrastructure. He further noted the limited scope of measurement traceability within some African States and encouraged countries to develop their quality infrastructure accordingly and to structure them along the value chains for the prioritized economic development sectors. The GA received the reports of the MRA Com-mittee and Technical Committee and approved their respective 2018 work plans as presented by the respective commit-tees Chairmen. The GA also approved the financial statements for the year ending 31 December 2016 and the 2018 budget as presented. Various reports were presented to the General Assembly by PTB Germany, IAAC, APLAC, ILAC, IAF, PAC, ARSO, SADCA, ARAC and PAQI. The GA re-elected Mrs Maureen P Mutasa, the Chief Executive Officer of SADCAS as the AFRAC Vice Chair and re - elected Mr Moez Boughalmi (TUNAC) as Chairman of the MRA Committee and Mr Mpho Phaloane Senior Manager, SANAS as the Chairman of the Technical Committee for terms of office in accordance with the AFRAC Bylaws. The GA thanked EGAC under the patronage of His Excellency Eng. Tarek Kabil, Minister of Trade and In-dustry for hosting the 8th AFRAC GA and for officially opening the meetings. The newly admitted members of AFRAC including SADCAS whose scope of recognition was extended to include medical testing (ISO 15189) and inspection (ISO/IEC 17020). The Arrangement members all signed their respective MOU as commitment to abide with AFRAC by laws and the various members’ obligations at a gala dinner held whilst cruising along the Nile River to mark the end of the GA meeting on 30 September 2017. Once again the AFRAC GA was a success and great progress was made as evidenced from the achievements of the 2012 to 2016 strategic plan. The 9th AFRAC Annual meeting will be held at a venue still to be confirmed. SADCAS is very grate-ful to PTB Germany for sponsoring the SADCAS delegation to the 8th AFRAC General Assembly meetings.

8th

AFRAC GA in session

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Highlights from the Joint IAF/ILAC General Assembly

T he 2017 joint annual meetings of the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) were held at the Sheraton Vancouver Wall Centre Hotel in Vancouver, Canada from 21

October to 31 October 2017. A total of 350 delegates attended the meetings with the following economies from the Africa region attending the meetings: AFRAC and ARAC represented by some members of the regional cooperations’ executive members; 15 SADC countries represented by SADCA; and accreditation bodies ALGERAC (Algeria); EGAC (Egypt); ENAO (Ethiopia); KENAS (Kenya); NINAS (Nigeria); MLSCN Accreditation Service (Nigeria); SADCAS (13 SADC Member States); SANAS (South Africa); SEMAC (Morocco) and TUNAC (Tunisia). The meetings started with a series of IAF Working Groups meetings followed by ILAC and IAF Committee meetings which were held in parallel. The ILAC and IAF General Assemblies and the joint ILAC/IAF General Assembly were held during the last 3 days of the meeting from 28 to 30 October. This year marked the beginning of a new approach to the hosting of IAF ILAC meetings where the meetings are managed by conference organizers who liaise directly with the IAF and ILAC Secretariats.

Four organizations including the Foundation FSSC 22000 were admitted to the IAF Memorandum of Understanding (MoU) since the 2016 annual meetings held in New Delhi, India. The Arab Accreditation Cooperation (ARAC) was admit-ted as a regional accreditation group IAF MLA Signatory in the main scope: Management Systems Certification – ISO/IEC 17021-1; sub-scope: Level 4: ISO/TS 22003; Sub-Scopes: Level 5: ISO 22000; ISO 9001, ISO 14001. Four (4) accreditation bodies were admitted as MLA signatories for the various main scopes of Management Systems, Product and Personnel certification bodies including KENAS (Kenya) which was admitted in the Main Scope: Management Systems Certification – ISO/IEC 17021-1; Sub-Scope Level 4: ISO/TS 22003; Sub-Scopes Level 5: ISO 22000, ISO 9001, ISO 14001. Five accredi-tation bodies had their scope extended to the various main scopes of Management Systems (ISO 9001, ISO 14001, ISO /TS 22003 and ISO 27006, Product and Personnel certification bodies. This brought the total membership of the IAF to 106 comprised of 81 accreditation body members, 19 Associate members and 6 regional group members.

Membership and Signatories

ILAC General Assembly meeting in session

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On the other hand, ILAC admitted one organization into the Affiliate membership category and 3 accreditation bodies into the Associate membership category. At the same time and in accordance with section 5.7 (b) of the ILAC Bylaws membership was terminated for 2 stakeholders and one affiliate members due to non - payment of fees. The Arab Ac-creditation Cooperation (ARAC) was admitted as a regional accreditation group signatory to the ILAC MRA for the ac-creditation of calibration (ISO/IEC 17025), testing (ISO/IEC 17025), medical testing (ISO 15189) and inspection (ISO/IEC 17020). A total of 12 new signatories were admitted to the ILAC MRA including: ALGERAC (Algeria) in the scope calibra-tion (ISO/IEC 17025), testing (ISO/IEC 17025) and inspection (ISO/IEC 17020); ENAO (Ethiopia) in the scope Testing (ISO 15189 and ISO/IEC 17025, KENAS (Kenya) in the scope Testing (ISO/IEC 17025), Calibration (ISO/IEC 17025), Testing Medical (ISO 15189) and Inspection (ISO/IEC 17020 and SADCAS whose signatory status in the ILAC MRA was extended to include Testing - Medical (ISO 15189) and Inspection (IO/IEC 17020) whilst EGAC (Egypt) was readmitted following a re- evaluation conducted in February 2017. The signatory status of the Papua New Guinea Laboratory Accreditation Scheme, PNGLAS to the ILAC MRA for the accreditation of testing laboratories in accordance with ISO/IEC 17025 was suspended on 14 August 2017 at the request of PNGLAS for temporary voluntary suspension to the APLAC MRA Council. This brought the total membership of the ILAC to 142 from 119 different economies worldwide comprised of: 97 Full Members (signatories to the ILAC MRA) representing 100 economies; 11 Associates representing 11 economies; 11 Affili-ates representing 15 economies; 24 Stakeholders form 16 economies; and 6 Regional Cooperation Bodies. Over 57,000 laboratories and almost 8,800 inspection bodies are accredited by the ILAC Full Members (signatories to the ILAC MRA).

The IAF General Assembly acting on the recommendation of the Technical Committee endorsed the following: ISO 9001:2015 and ISO 14001:2015 - The IAF General Assembly, acting on the recommendation of the Technical Com-mittee, resolved that at the end of the transition period, 15 September 2018, all ISO 9001:2008 and ISO 14001:2004 certi-fications shall expire or be withdrawn. As of 15 March 2018, CABs shall conduct all ISO 9001 and ISO 14001 initial, sur-veillance, and recertification audits to the new versions (ISO 9001:2015 and ISO 14001:2015). The outcomes of such au-dits shall be considered by the CAB for further decision on accredited certifications to ISO 9001:2008 and ISO 14001:2004 as deemed appropriate.

IAF General Assembly meeting in session

Transition periods

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Based on a survey done by the IAF it was noted that around only 25% of certified clients have transitioned to the 2015 versions of ISO 9001 and ISO 14001 or which the transition deadline is 15 September 2017. It is estimated that there are over 1.5 million certificates out there which if transition deadlines are not met would negatively affect the market. Thus the IAF came up with this resolution mainly to push the certification bodies to in turn push their clients to transition in time. In order to ensure that the resolution is well understood and avoid any misunderstandings, the members requested that a communiqué be issued to explain the resolution. To this end IAF issued a Communiqué entitled Important Infor-mation to Certification Bodies regarding transition to ISO 9001 and ISO 14001. The resolution and Communiqué were circulated to all Management Systems Certification Bodies under process by SADCAS and those that have expressed in-terest in accreditation by SADCAS as well as to assessors on the Management Systems Certification Bodies Accreditation Programme.

Mrs Maureen Mutasa, SADCAS CEO and Board Chairman receiving the

ILAC MRA Certificate from Mrs Merih Malmqvist Nilsson, Chairman

ILAC

Mrs Susan Munyiri Ochieng Acting CEO KENAS receiving the ILAC MRA

Certificate from Mrs Merih Malmqvist Nilsson, Chairman ILAC with

KENAS Management and Board representative

Mr Hany Delsouki Executive Director EGAC receiving the ILAC MRA Cer-

tificate from Mrs Merih Malmqvist Nilsson, Chairman ILAC

Mr Araya Fesseha, ENAO CEO receiving the ILAC MRA Certificate from

Mrs Merih Malmqvist Nilsson, Chairman ILAC

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Transitional Arrangement for the revision of ISO 50001:2011 - The IAF General Assembly, acting on the recommen-dation of the Technical Committee, resolved that the transitional arrangement for the revision of ISO 50001:2011 Energy Management Systems – Requirements with guidance for use, be three years from the date of publication of the revised standard. All ISO 50001:2011 certifications shall expire or be withdrawn at the end of the transition period. Within this transition timeline: � ABs shall be ready to carry out transition assessments for ISO 50001:2018 within 6 months from the date of publica-

tion of the revised standard. � CABs shall complete the transition with ABs for ISO 50001:2018 within 18 months from the date of publication of

the revised standard. � CABs shall cease conducting audits, including initial, surveillance and recertification to the ISO 50001:2011 18

months from the date of publication of the revised standard. The outcomes of such audits to the revision of ISO 50001:2011 shall be considered by the CAB for further decision on accredited certifications to ISO 50001:2011 as deemed appropriate.

Transitional Arrangement for the revision of ISO 14064-1:2006 and 14064-2:2006 - The General Assembly, acting on the recommendation of the Technical Committee, resolved that the Transitional Arrangement for the Revision of ISO 14064-1:2006 Greenhouse gases -- Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals, and ISO 14064-2:2006 Greenhouse gases -- Part 2: Specification with guidance at the project level for quantification, monitoring and reporting of greenhouse gas emission reductions or removal enhancements be three years from the date of publication of the revised standard.

Mr Mahmoud Eltayeb, Chairman of ARAC receiving the ILAC MRA Certificate from Mrs Merih Malmqvist ilsson, Chairman ILAC

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Within this transition timeline:

� ABs shall be ready to carry out transition assessment for ISO 14064-1:2018 and ISO 14064-2:2018 within 6 months from the date of publication of the revised standard. Note: If there is an exception to the above, the AB shall justify the exception based on valid reasons.

� CABs shall complete the transition with ABs for ISO 14064-1:2018 and ISO 14064-2:2018 within 3 years from the date of publication of the revised standard.

Transitional Arrangement for the revision of ISO 22000:2005 - The General Assembly, acting on the recommenda-tion of the Technical Committee, resolved that the period for transitioning of accredited certifications to the next revi-sion of ISO 22000:2005 Food safety management systems -- Requirements for any organization in the food chain be three years from the date of publication. Transitional Arrangements for the revision of ISO/IEC TS 17021-3:2013 to ISO/IEC 17021-3:2017 - The General Assembly, acting on the recommendation of the Technical Committee, resolved that the transition period for ISO/IEC 17021-3:2017 Conformity assessment — Requirements for bodies providing audit and certification of management sys-tems — Part 3: Competence requirements for auditing and certification of quality management systems, be two years from the date of publication of the revised standard (i.e. 31 March 2019). Endorsement of ISO/IEC 20000-6: 2017 and ISO/IEC 20000-1: 2011 as Normative Documents and Transitional Arrangement - The General Assembly, acting on the recommendation of the Technical Committee, resolved to endorse ISO/IEC 20000-6:2017 Information technology – Service management – Part 6: Requirements for bodies providing audit and certification of service management systems and ISO/IEC 20000-1:2011 Information technology – Service manage-ment - Part 1: Service management system requirements as normative documents. Certification to ISO 31000:2009, Risk management – Principles and guidelines - The General Assembly, acting on the recommendation of the Technical Committee, resolved that there will not be any accredited certification to ISO 31000:2009, Risk management – Principles and guidelines (publication date 13 November 2009). ISO 31000 explicitly states that it is not intended or appropriate for certification, and any certification would be a misuse of the standard. Therefore CABs are strongly urged not to promote or provide certification to ISO 31000 and ABs and CABs are requested to report any misuse or need for certification to the ISO Secretariat Implementation of transition to ISO/IEC 17011:2017 - The Joint General Assembly endorsed the recommendation of the Joint Executive Committee, to ensure JGA Delhi Resolution 1 – Transition to ISO/IEC 17011:2017 is fully implemented, that all peer evaluation activities carried out from 1 July 2018 will use ISO/IEC 17011:2017 as the requirements docu-ment. Details of this transition plan are described in the document entitled “ISO/IEC 17011:2017 Transition Plan” dated 29 October 2017.

The ILAC IC meeting was held on 24 October 2017 and attended by 60 delegates. Since the mid-term meetings, the Guidance on expressing inspection scopes in accreditation documents was aligned with the revision of ISO/IEC 17011 with the clean version of the draft being considered at the Vancouver meeting during which some discussions were held on multisite location inspection bodies. No substantive changes were made to the draft except changes to references and the IC agreed that document goes out for 60 days ILAC comment. Although ILAC G 27: Guidance on measurements performed as part of an inspection which was developed by Working Group 4 was published in June 2017, discussions were held in Vancouver on the pro-posal by the EA Inspection Committee to clarify or delete Clause 2.3 of the guidance document which was said to be in contradiction with ILAC P 15, ISO/IEC 17020 and ILAC P8: Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories and Inspection Bodies, the lat-ter of which is under revision. A lengthy discussion followed after which a series of questions were raised to the ARC to clarify the requirements of Clause 9 of ILAC P8. Once answers are provided by the ARC, the IC will then review the validity of the relevant statements in ILAC P15 and ILAC G27 at the mid-term meetings to be held in April 2018.

ILAC Inspection Committee (IC)

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Working Group (WG) 5 which is developing a guidance document for accreditation of bodies performing NDT activities presented the results of the survey that was undertaken to determine whether or not to continue with the drafting of the document. Both AIC and IC members voted positively to continue with the preparations with the docu-ment in order to finalize and publish it. It was therefore agreed that the document be circulated for 30 days comment by IC and AIC members. The IC noted that following the publication of IAF MD 20: Generic Competence for AB Assessors: Application to ISO/IEC 17011 the ILAC-IAF Joint Executive Committee has assigned the IAF ILAC A-series Task Force Group to develop a common ILAC/IAF document on general assessor competencies. The mandate includes the provision that the document shall be based on the requirements in ISO/IEC 17011: 2017. The Task Force Group will include 12 people representing the regions and the IAF and ILAC Committees of which the ILAC IC is represented by the Chair who had already participated at the TFG’s 1st meeting. The intention is that the new document shall replace both ILAC G11 and IAF MD 20. The ILAC IC also noted that the ILAC AIC is setting up a WG for sampling and of which ILAC IC appointed Mr Geoff Hallam Chair of WG 3 to represent it.

Brief reports were presented by the various regions’ representatives with Mrs Maureen Mutasa, SADCAS CEO presenting the SADCA report and Mrs Linda Grundlingh Accreditation Manager SANAS presenting the AFRAC report after which an outline of the ILAC IC workshop on impartiality was made.

Following a definition of impartiality as outlined in Clause 3.8 of ISO IEC 170120 and explanations of Clauses 4.1.1 to 4.1.5 which deal with impartiality, and the relationship between impartiality and independence and clarification of Type A, B and C, the workshop participants were split into 9 Groups and assigned a number of impartiality live cases gathered from the various accreditation bodies. The groups then presented their findings. In general there was a common under-standing of the concepts amongst the Groups. There were detailed discussions of the requirements of the standard which will no doubt help align the interpretations of the standard requirements on impartiality and how to determine the Type of the inspection body. The workshop was so useful that some accreditation bodies even committed to repro-duce the workshop amongst their assessors so as to contribute towards the harmonization of the standard requirements. All the workshop materials will be used by SADCAS for training purposes.

The Committee has a total of 13 WGs which have liaison roles in major international bodies for input into AIC work. The Committee has a total of 181 members. Working Group 8 on ISO/IEC 17025 has been contributing to the revision of

ILAC IC meeting in session ILAC IC workshop – Group work

ILAC IC Workshop

ILAC Accreditation Committee

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ISO/IEC 17025 and has a number of documents under it such as ILAC G 8: Guidelines on reporting on compliance, G 17: Introducing the concept of uncertainty of measurement in testing in association with the application of the standard ISO/IEC 17025, G 19: Modules in forensic science process, G 24: Guidelines for the determination of calibration intervals of measuring instruments and P9: ILAC Policy for participation in proficiency testing activities. Working Group 6 on ISO 15189 has ILAC G 26: Guidance for the implementation of a medical laboratory accreditation system. The Working Group drafted a position paper on the revision of ISO 15189 which some members would like to see being extended to other activities such as medical imaging. The WG also noted the development of a standard for Bio banking. Working Group 3 on ISO/IEC 17034 established a Task Force to work with the Working Group 4 who are revising ILAC G 18: Guidelines for the formulation of Scopes of accreditation for laboratories. Working Group 2 on metrology is responsi-ble for ILAC P 10 and P14 and is working on introducing the decision rule. A resolution was passed by the ILAC General Assembly following recommendation by the AIC to withdraw ILAC P13: Application of 17011 for the accreditation of PT providers.

A Certificate of Appreciation was presented to Ileana Martinez the Chair of the ARC in absentia following her retirement from NAVLAP. A new chair was therefore elected. The draft document on extraordinary events which had been circu-lated for comment amongst members early this year was placed on hold in April 2017 pending alignment to revised ISO/IEC 17011. The document will now be circulated to members for a 60 day comment. ILAC P8 guidelines for the use of the accreditation symbols is currently being revised and was circulated to ARC members for comment. More work is needed to take the documents forward and taking into account the comments received from ARC members. On revision of ILAC G 21: Cross frontier accreditation a draft has been produced which will be circulated to the WG for review.

Confirmed the Terms of Reference of the LC and agreed to reduce the fee to AUSD 500 per year. Presentations were made to the LC by the ILAC Chair and Committee Chairs during the Vancouver meetings. Discussions were also held on the contributions of the LC to ILAC, harmonization and consistency with concerns being raised by some on the need for further harmonization. Results on the survey undertaken by the LC are being analyzed. Around 1600 laboratories were invited to participate in the survey with 422 responding i.e. 25% response rate and with 35 countries from both develop-ing countries and developed countries participating in the survey.

In his report to the Joint General assemblies of IAF and ILAC The Chairman of the ILAC MCC and IAF CMC informed members that the Public sector assurance site now contains over 254 case studies, 74 research papers and 41 supporting materials representing a good spread across sectors including adventure tourism, medical marijuana, lifeguard compe-tence etc. The Business Benefits website in now up and running. The Business benefits site www.business-benefits.org is a website jointly developed by the International Accreditation Forum (IAF), ILAC, International Organization for Stan-dards (ISO), Independent International Organization for Certification (IIOC), and International Certification Network (IQNet), that showcases benefits of standards and accreditation through case studies, research papers, and supporting materials. The examples published on the site, cite tangible financial data to evidence the cost savings achieved whether through resource efficiency or meeting regulation at lower cost, the value of accessing new markets, or savings achieved through recognition from organizations such as insurers, regulators or purchasers. The site contains case studies from multinationals such as IBM, Chrysler, and Hitachi to national companies such as Aberdare Cables and Pretoria Portland Cement Company. Both the ILAC and IAF continue to witness increasing number of followers on social media platforms with 1489 twitter followers. The theme for 2018 World Accreditation day is Accreditation: Delivering a safe world. For the commemorations a video on the theme and a joint statement from the IAF and Chairs will be available in January 2018.

ILAC Arrangement Committee (ARC)

ILAC Laboratory Committee (LC)

ILAC Marketing and Communications Committee and the IAF Communications and Marketing Committee

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This was followed by a presentation of the report on the results of the survey of needs undertaken by ILAC IAF JDSC. The report was presented by Liliane Somma the ILAC Co Chair of JDSC. According to the survey results of which only 16 res-ponses out of 97 emails circulated were received, the most common need was for funding of attendance to IAF and ILAC meetings followed by training on key accreditation standards and peer evaluator training. Projects varied from funding of Advisory Committee meetings, attendance to regional and international meetings to development of new accreditation schemes and strengthening capability of regional structures. Presentations were then made by the various regions’ representatives on projects that were underway in the regions with Mrs Maureen P Mutasa in her capacity as SADCA Executive Committee member and AFRAC Vice Chairman making presentation on SADCA and AFRAC projects undertaken and underway in the past 2 years and also projects identified for future funding. From all the presentation it was noted that some projects were common amongst the regions and that such projects could in fact be pooled to-gether at International level so as to optimize resources. A Task Force was therefore established to look at such projects and of which Mrs Mutasa is a member. A proposal for communicating meetings outcome through information technol-ogy, online training and for receiving and responding to queries on accreditation was presented for consideration by the JDSC. The afternoon session of the meeting was spent on training on ISO/IEC FDIS 17011. The highly interactive training was conducted by Barbara Belzer.

The revisions of ILAC/IAF A1 on evaluation of a regional group, ILAC/IAF A2 on evaluation of single accreditation body, ILAC/IAF A3 on reporting on the performance of an accreditation body and ILAC/IAF A6: Approval process for A series documents will all go for a 30 day ballot and are expected to be published early in next year. The A Series JWG is now co-chaired by Maribel Lopez from Mexico and Dr Thomas Facklam from Germany with Mr Moslem Barak from ARAC as the Secretary. The KWG noted the need to revise ILAC /IAF A5 but agreed to wait until feedback has been received on the implementation of the new edition of ISO/IEC 17011. A Joint Task Force Group (JTFG) was established to revise IAF ILAC documents on assessor competence with the idea of establishing common competence requirements.

The Joint ILAC/IAF General Assemblies was held on 29 October 2017 during which 4 resolutions were passed. Various reports were presented by international organizations. In his presentation the Vice President of the IEC Mr Ulrich Spin-dler outlined the various IEC conformity assessment schemes operated by the IEC namely the IECEE CB Scheme; IECEE CB-FCS: Production line compliance which is an extension of the IECEE CB Scheme and includes factory surveillance and re-testing which ensure that the overall production line is constantly compliant with the initial testing/certification. IECE X - IEC Scheme a system for certification of equipment for use in explosive atmospheres; IECQ - IEC Quality Assessment Sys-tem for Electronic Components (IECQ) which assures quality in the electronics industry; and the IECRE Renewable energy sectors which involves certification of equipment used in Renewable Energy Applications. This scheme aims to facilitate international trade in equipment and services for use in renewable energy sectors while maintaining the required level of safety. He then highlighted the importance of mutual recognition based on peer assessments of competence in ensuring a harmonized approach. The IEC has issued more than 1 million certificates on all its schemes. In his presentation the new ISO Secretary General Mr Sergio Mujica outlined the importance of standards for economic development and protection of the public and environment. He informed the meeting about the 6 strategic directions of the ISO 5 year strategic plan. He then outlined the activities of ISO CASCO which serves as the link between ISO and ILAC and IAF. This was followed by a presentation by Dr Bernado Calzadilla Sarmiento UNIDO Director Trade and Investment who outlined the importance of standardization, accreditation and metrology in the achievement of SDG 9 on industry, innovation and infrastructure. He also reported on the activities of the DCMAS including the agreement on the definition of quality infrastructure and quality policy. He also informed the meeting about the development by UNIDO of a step by step tool for the implementation of a quality infrastructure. He then informed on the work that UNIDO is undertaking in the accreditation arena including the survey of readiness for accreditation in the SADC region where UNIDO is working with the NLA of South Africa with the intention of packaging a project to assist laboratories to work towards accredita-tion. A total of 805 laboratories are involved in the survey. UNIDO is also working with NINAS (Nigeria) and ARAC in its journey towards signatory status as a region which was achieved at the 2017 annual meetings and presented at the Joint

A Series JWG

ILAC/IAF Joint General Assemblies

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Continued from p 23

Invitation to Register as SADCAS Assessors

The Southern African Development Community Accreditation Service (SADCAS) invites qualified assessors to be regis-

tered as SADCAS assessors for its testing/calibration/medical laboratories, and certification (management systems/

product)/ inspection bodies’ accreditation programmes. SADCAS’ strategy over the next few years is to grow its pool of

assessors so as to cover the anticipated scopes of accreditation, and the geographical and language diversity in the

SADC region of which 13 Member States are serviced by SADCAS.

Assessors are experts from the public and private sectors as well as from technical institutions/associations who have

been trained, qualified and registered as assessors by an accreditation body.

SADCAS will review and evaluate all applications to ensure that the assessors have the prerequisite qualifications, tech-

nical knowledge and experience required by SADCAS.

Applications shall be addressed to:

Ms Jeanne F Ranorovelo

Technical Manager

P Bag 00320

IAF/ILAC meeting. The ITU and WTO reports were taken as read as there were no representatives at the 2017 annual meetings

Mr Peter Kronvall (SWEDAC, Sweden) was elected as Director Representing High Income Economies for an initial three-year term. Mr Marcus Long (IIOC) was elected as Director Representing CAB Association Members for an initial three-year term. Ms Sheronda Jeffries (QuEST Forum) will complete her first term as Director Representing Industry and User Asso-ciation Members at the 2018 General Assembly Meeting. Mr Xiao Jianhua (CNAS, China) will complete his first term as IAF Chair at the 2018 General Assembly Meeting. Mr Emanuele Riva (ACCREDIA, Italy) will complete his first term as IAF Vice-Chair at the 2018 General Assembly Meeting. Mr Randy Dougherty (ANAB, USA) will complete his first term as IAF Treasurer at the 2018 General Assembly Meeting.

No elections were held at the ILAC General Assembly as the Directors are still serving their terms of office. The 2017 ILAC/IAF meetings were once again a good opportunity for networking, sharing experiences and keeping up to date with accreditation developments worldwide. The meetings provided an invaluable opportunity to enhance collabo-rations and strengthen the credibility of accreditations worldwide. Many thanks to ILAC and IAF for sponsoring SADCAS Chief Executive Officer’s attendance to these very important meetings. The 2018 ILAC/IAF Annual meetings will be held in Singapore in October.

Election of Directors IAF

Election of Directors ILAC

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Continued to p 26

T he SADCAS Board of Directors approved the 9th annual report covering the period beginning 1 April 2016 to 31 March 2017 for publication on

the 23rd of November 2017. The Annual Report contains detailed information on SADCAS’s performance (financial and non-financial), progress and activi-ties for 2016/17, the final year of the second five year strategic plan covering the period 2012-2017.

The CEO in her report provides a summary of the achievements in the follow-ing key result areas that were agreed to for the financial year: � Consolidate, streamline and enhance delivery of accreditation service to

the target population; � Enhance global acceptance of SADC products and services; � Effectively promote and market the benefits and importance of accredi-

tation and SADCAS services; � Strengthen NAFPs Effectiveness; and � Grow the company’s own generated revenue and develop SADCAS into a

sustainable and dynamic organization at the cutting edge of accreditation service deliver. The annual report is available on the SADCAS website on http://www.sadcas.org/annual-reports

SADCAS Publishes 9th Annual Report

Journey Towards Accreditation of Inspection Bodies under the Regulatory Domain in Zimbabwe

[In the words of Mr John Mutswatiwa former Chief Inspector of Factories]

I ndependent Inspection Authorities in terms of the Zimbabwe Factories & Works Act Chapter14:08 or Inspection Bodies in terms of ISO/IEC 17020 require approval of the

Chief Inspector of Factories in order for them to inspect industrial Boilers and Pressure-Vessels in Zimbabwe. The International Standard ISO/IEC 17020 contains requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. The Factories Inspectorate through the then late Chief and his deputy sold this noble standard to stakeholders. The consultations of the standard with stakeholders took a long time before it was adopted. The former Chief Inspector of Factories, Mr John Mutswatiwa was sent by National Social Security Authority (NSSA) of Zimbabwe to Mauritius in 2004 to attend a labour inspection workshop which saw a seed in the accreditation of Independent Inspection Authorities in Zimbabwe. On his return, he then convinced the then late Chief Inspector Mr Newton P Mutubuki that accreditation of Independent Inspection Authorities in line with SAZS/ISO/IEC 17020:2001 was the way to go as a country. The former Chief Inspector

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Continued from p 25

Mr Mutswatiwa was given the task to run with the project. Several stakeholder meetings were held where the idea was extensively discussed and finally adopted. The stakeholders agreed that Independent Inspection Authorities will start the process of accreditation by December 2004. The deadline was not met and the late Chief Inspector never lived to see the resolution implemented. The former Chief Inspector and Independent Inspection Authorities agreed on a new date, end of December 2010. On the first of January 2011 all Independent Inspection Authorities that had not taken a step towards accreditation were prohibited from carrying out inspection services. The Southern African Development Community Services (SADCAS) Chief Executive Officer Mrs Maureen Mutasa and SANAS experts held several meetings in 2011 with Mr John Mutswatiwa to understand the implementation process and how they can be part of it. These meetings gave birth to the first draft MOU between Factories and Works former Chief Inspector Mr John Mutswatiwa and Southern African Development Community Services (SADCAS) Chief Executive Mrs Maureen Mutasa. The agreement needed the involvement of the Ministry of Labour and Social Welfare hence the late Mr Rodgers Dhli-wayo the Director of Occupational Safety and Health in National Social Security Authority (NSSA) was brought in to fa-cilitate the MOU. The MOU between NSSA and SADCAS was consequently signed on the 21st of November 2012 in Ha-rare. The SADCAS Advisory Committee was established soon after and it developed a Technical Requirement Document SAD-CAS TR 05 which was accepted by Mr Mutswatiwa on behalf of the Regulator for use during the Accreditation process. The former Chief Inspector appointed Mr Gilbert Mhangwa former Principal Inspector of Factories on secondment to SADCAS as a Regulatory Technical Expert in their Assessment Team. To this end, five Inspection Bodies have been suc-cessfully accredited in Zimbabwe. The former Chief Inspector attended the ISO regional conformity assessment training workshop on Inspection practices based on ISO/IEC 17020:2012 in December 2013; Nairobi (Kenya) to enhance his knowledge on the standard. Mr John Mutswatiwa while acquiring experience in the inspectorate job, he went up the ranks to become the Chief In-spector of Factories in Zimbabwe. He officially left the National Social Security Authority (NSSA) on the 31st of July 2017 on voluntary retrenchment after serving the Factories Inspectorate for 36 years. The SADCAS Management and staff profoundly appreciate Mr John Mutswatiwa’s dedication and commitment in achiev-ing the Accreditation of Inspection Bodies in Zimbabwe and wish him success in his current and future engagements. SADCAS also extends its appreciation to all the stakeholders who supported Mr John Mutswatiwa throughout his journey to success.

SADCAS offers accreditation schemes for:

� Calibration laboratories in accordance with ISO/IEC 17025;

� Testing laboratories in accordance with ISO/IEC 17025;

� Medical laboratories in accordance with ISO 15189;

� Management systems certification bodies in accordance with ISO/IEC 17021;

� Product certification bodies in accordance with ISO/IEC 17065;Personnel certification bodies

in accordance with ISO/IEC 17024; and

� Inspection bodies in accordance with ISO/IEC 17020.

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Angola Appoints New Second NAFP

O n 25 September 2017, The Ministry of Industry in Angola appointed Mrs Claudia Tamu de Lima Clemente Carvalho Simoes as the 2nd National Accreditation Focal Point (NAFP). Mrs Claudia

Simoes is the Deputy General Manager at the Angolan Accreditation Institute. Ms Simoes is a Petro-leum Engineer and she replaces Mrs Perola Agnela Isaac da Silva Neto who served as the 2nd NAFP – Angola from October 2016.

Accreditation in Supporting Public Policy

T he international accreditation organizations ILAC and IAF together with ISO and the Independent International Or-ganization for Certification (IIOC) have established a website www.publicsectorassurance.org to showcase different

global examples where accreditation has been used to support public policy efforts. From assisting forensic science in the UK, to effective voluntary programmes in the US, to improving the delivery of food safety in Australia, to protecting consumers in the safety of products in the Gulf Coast Countries, to supporting sustainable animal health in Botswana, the site demonstrates real examples where public policy is being delivered using accreditation.

Each topic contains case studies of how governments and regulators have used accredited conformity assessment, plus independent published research and supporting information.

A link to the public sector assurance site is provided on the SADCAS website www.sadcas.org under the window on links.

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Civil Engineering Laboratory (Pty) Ltd—Road to Accreditation

A ccreditation was first introduced to Civil Engineering Laboratory (Pty) Ltd (previously called Geotechnical Engineer-ing Laboratory (Pty) Ltd) by Lesotho Department of Standards of the Ministry of Trade and Industry. This was done

through a workshop held at Victoria Hotel on the 24th November, 2006. This subject was of interest to Civil Engineering Laboratory as it had lost a three and half million Maluti (equivalent to RSA Rand) contract because it was not accredited. Since then Civil Engineering Laboratory has taken accreditation seri-ously and participated in several plenary meetings organized by the Department of Standards. From these meetings, Lesotho Federation of Laboratories (LFL) was formed. Lesotho Federation of Laboratories organized several accreditation activities for laboratories among which World Ac-creditation Day was taken as an annual activity. Civil Engineering Laboratory has made presentations annually during World Accreditation Day celebrations. Today the Civil Engineering Laboratory Chief Executive Officer is the chair of LFL and he is much aware of the accreditation activities in Lesotho.

Since 2006 Civil Engineering Laboratory has been working on its Quality Manual and this was only completed in 2015. On the 31st August, 2015 Civil Engineering Laboratory submitted its application for accreditation to SANAS. The first document review Report from SANAS was received on the 19th October, 2015 and the Laboratory started working on the document review report comments from SANAS on the 16th November, 2015. On completion on incorporating com-ments from SANAS into the Quality Manual, the application was re-submitted to SANAS on the 29th September, 2016. A second document review report from SANAS was received on the 5th June, 2017. On the 16th October, 2017 the Laboratory submitted its application for accreditation by SADCAS as the Laboratory is based in Lesotho one of the countries serviced by SADCAS. The laboratory is now currently busy polishing-up the docu-ments. Once this exercise is completed a re-submission will be made. Through all these years of working on accreditation, the Laboratory has experienced the challenges with staff turn-over; cash flow; infrastructure; lack of internal auditors. The laboratory is however working hard to address the aforemen-tioned challenges and is continuously improving its Quality Manual, Implementing its Quality Management System at a reasonable rate, participating in Proficiency Testing Schemes organized by National Laboratory Association of South Africa and performing Inter-Laboratory Comparisons. The road to accreditation thus far has been a difficult one to walk, but now the laboratory’s engines are at full throttle. It will be the first and a pioneering laboratory that will no doubt pave way for the rest of the laboratories in Lesotho.

[This article was compiled by Mr Tšoeu Mokaloba Chief Executive Officer of Civil Engineering Laboratory (Pty) Ltd]

Laboratory technicians at work

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SADCAS Registers More Assessors

B etween August 2017 up to 30 September 2017, SADCAS registered 4 assessors.

� SADCAS has registered Ms Varsah Gungoa as Technical Assessor. She holds a Bachelor of Science degree in chemis-try and microbiology and Master of Science degree in chemistry. She is from Mauritius and speak both language French and English. She is registered under the Testing Laboratories Accreditation Programme in the scopes of mi-crobiology, chemistry, biology and environment tests.

Mrs Gungoa has worked in the implementation of ISO/IEC 17025 and has an expertise in chemistry and microbiol-ogy water testing, pollution monitoring. She has undertaken assessments on behalf of the Mauritius Accreditation Service (MAURITAS).

� SADCAS has registered Mr Gilbert Mhangwa as Technical Assessor. He holds a Bachelor of Technology (Honours)

degree in industrial and manufacturing engineering, Master of Science degree in safety, health and environmental management and in business administration. He is registered under the Inspection Bodies Accreditation Programme in the scope of Pressure Vessels and Boilers.

Prior to his registration as Technical Assessor, Mr Mhangwa was one the Technical Experts appointed by the Na-tional Social Security Authority (NSSA) under the Ministry of Occupational Health and Safety who participated in the SADCAS assessments for inspection bodies in Zimbabwe form 2012.

� SADCAS has registered Mr Collen Ndamba as technical Assessor. He holds a Bachelor of Medical Sciences and he is

registered under the Medical Laboratories Accreditation Programme in the scope of Chemistry.

Mr Ndamba is working at Bamalete Lutheran Hospital in Botswana. He followed the Technical Assessor course at the South African National Accreditation System (SANAS) and was referred to SADCAS for the mentoring stage which was successfully arranged by SADCAS.

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Continued to p 31

Laboratory Manager Eng. Awattif A. Abdulrasoul

T he 7th meeting of the SADCAS Advisory Committee for Inspection in Zimbabwe was held on 13 September 2017 at the Standards Association of Zimbabwe Boardroom in Harare, Zimbabwe. The meeting was chaired by Eng. Ngoni

Chirinda and attended by 44 members from inspection bodies, regulators, users, academic institutions and lifting equip-ment manufacturers and inspectors. The purpose of the meeting was to provide updates on developments at SADCAS and in the ILAC Inspection Committee; to set a Working Group to develop criteria for the accreditation of inspection bodies that perform inspection of lifting equipment; consider other scopes for the accreditation of inspection bodies and to review the proposed amendments to TR 05. Updates on Developments at SADCAS In the update on developments in SADCAS, Mrs Maureen Mutasa the SADCAS CEO highlighted that SADCAS was well on its way towards signatory status in the AFRAC and ILAC MRA for inspection (ISO/IEC 17020) and medical testing (ISO 15189) having undergone an extraordinary peer evaluation in May 2017 with all the witnessing being carried out in Zimbabwe. She took the opportunity to thank all the witnessed inspection bodies namely Standards Association of Zimbabwe (SAZ) Engineering Division’s Inspection Unit and Gammatec Inspection Ser-vices for their cooperation and arrangements made. She then informed the meeting that the final report on the evalua-tion had been issued following the clearance of all the findings raised and that the case was now under decision by both AFRAC and ILAC. She shared with the meeting the results of the customer satisfaction survey undertaken during the 2016/17 of which 94% rated overall SADCAS services from good to excellent with 78% rating from very good to excel-lent. One complaint on assessor behaviour/performance was received during the period under review bringing the cu-mulative number of complaints handled to 6 by 31 March 2017. The SADCAS CEO then presented the objectives and key strategies for the 2017/18 financial year and the achievements thus far in the year. Regarding funding of SASCAS the CEO informed the meeting that the Governments of SADC Member States serviced by SADCAS agreed in principle to meet the operational budget deficit for the 2017 to 2022 period amounting to US$ 2.38 million based on the formula which takes into account the country’ accreditation clientele base. Developments in ILAC Inspection Committee – The meeting was informed of the review undertaken by the ILAC In-spection Committee of ISO/IEC DIS 17011 and noted the key changes that affected the accreditation of inspection activi-ties such as the inclusion of Clause 7.9.6 on flexible scopes, changes introduced on Qualification of personnel and the requirements on the extent of assessment which now requires that all sites be assessed whereas previously this was not the case. The meeting was also informed that the revised version now goes into more detail about remote assessments for which a guidance documents may be required. On the review of ISO/IEC DIS 17025 the meeting was informed that the standard now includes options A and B for the management system aspects and that the wording used in the revi-sion is the same as that used in ISO/IEC 17020 and that the scope of the standard had been extended to include sam-pling as standalone activity. The clause on PT has been elaborated on and that there were no major changes on trace-ability, validation and monitoring. The meeting was also advised of progress with the systematic review ISO/IEC 17020:2012 at ISO with SAZ having circulated the review ballot to the Zimbabwe National Mirror Committee on 1 Sep-tember 2017. Regarding documents under development by the ILAC IC the AC was updated on the Guidance on ex-pressing inspection scopes in accreditation documents whose text will be aligned to the revised ISO/IEC 17011 to be published by end of the year and for whish an FDIS has already been circulated. The Guidance on measurements per-formed as part of an inspection process was circulated for ballot and 96% of the members voted yes following which the after review of comments raised the document was published as ILAC G 26 in June 2017 and is available from the ILAC website. Regarding the development of a document on Accreditation of bodies performing NDT activities, a lot of ques-tions were raised during the April 2017 meeting of the ILAC IC on whether to go ahead with the drafting of this docu-ment with majority agreeing to go ahead with the preparation of a guidance document. The Working Group was then requested to put the final touches to the prepared draft and to circulate it to ILAC IC and AIC members for comment. A survey was also undertaken to determine the level of interest in the document and in summary the membership do not think that ILAC should, under normal circumstances, develop sector specific guidance, but that in this particular case it should go ahead and develop guidance. The plan now is for the WG to meet in Vancouver and make the final prepara-tions to make possible circulation of the document. The 12th meeting of the ILAC IC will be held on 24 October 2017 in

Advisory Committee for Inspection Bodies, Zimbabwe Holds 7th Meeting

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Continued from p 30

Vancouver, Canada. A one day workshop will also be held to discuss a number of unclear issues in the standard based on the results of the survey on Impartiality undertaken in 2016.

Advisory Committee meeting in session

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Continued to p 33

Continued from p 31

Accreditation Scopes - The accreditation in the scope “Lifting Equipment” has been subject of discussion by the Advi-sory Committee since 2015. The National Social Security Authority (NSSA) representative informed the meeting about the progress on the development of regulations on lifting equipment. A Working Group was therefore established dur-ing the meeting and drawn from the extended AC and tasked to develop the criteria for consideration at the next AC meeting. The Working group is chaired by Mr Zimondi, Managing Director of NDT Solutions. In an ensuing presentation on the application of ISO/IEC 17020, the SADCAS CEO exposed the inspection bodies to the many scopes of application of the standard and encouraged accredited inspection bodies to think outside the box for business extension beyond boilers and pressure vessels under the Factories and Works Act. Review of SADCAS TR 05 - During the previous AC meeting held on 14 September 2016, a proposal was made to revise SADCAS TR 05 in order to substantiate the design verification engineer function whether or not it can be accredited as a stand-alone inspection activity. The Working Group that prepared the document was therefore tasked to review the document and make proposals to the AC. Following a thorough review of the WG recommendations the meeting agreed not to revise TR 05 as the AC does not foresee DVE being accredited to ISO/IEC 17020 as a standalone inspection activ-ity.

There being no other issues to discuss the meeting ended at 13:00 hours with a vote of thanks to the Chairman and to SADCAS for making arrangements for the meeting. The meeting was held at the Standards Association of Zimbabwe Headquarters in Harare, Zimbabwe.

Systematic Review of ISO/IEC 17020:2012

T he systematic review of ISO/IEC 17020:2012: Conformity assessment - Requirements for the operations of various types of bodies performing inspection has been completed with the standard being confirmed.

ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection. Up to date SADCAS has accredited 6 inspection bodies in Zimbabwe and the Democratic Republic of Congo in accor-dance with ISO/IEC 17020:2012. SADCAS is now signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) for Inspection (ISO/IEC 17020) and as such the accreditation certificates issued by SADCAS on the Inspection Bodies Accreditation Programme are internationally recognized.

T he SADCAS policy on metrological traceability is defined in the following SADCAS documents:

� Clause 6.14 of Issue 14, SADCAS PM 01: SADCAS Policy Manual; � Clause 2.1 of Issue 6, of SADCAS TR 09: Criteria for performing calibration and intermediate checks on equipment

used in accredited facilities; and � Clause 3.2.5 of Issue 13 ,SADCAS TR 02: Accreditation requirements

Communiqué to CABs on SADCAS Policy on Metrological Traceability

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Continued from p 32

According to SADCAS policy on metrological traceability equipment and instruments used by testing laboratories/medical laboratories/inspection bodies and having a significant impact on the measurements results shall be calibrated. The equipment and reference standards used by calibration laboratories and having an impact on the accuracy and va-lidity of measurements results shall be calibrated by:

a) A National Metrology Institute (NMI) whose service is suitable for the intended need and belongs to the CIPM and

are signatories to its Mutual Recognition Agreement (MRA) amongst NMIs and who have approved CMC’s within the BIPM Key Comparison Database (KCDB) which includes the range and uncertainty for each listed service.

b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement or by Regional Ar-

rangements recognized by ILAC whose service is suitable for the appropriate calibration. c) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA. The National Metrology

Institute shall have participated in the SADC Cooperation in Metrology (SADCMET), a member of the Joint Commit-tee of Regional Metrology Organizations and the BIPM (JCRB) through Intra-Africa Metrology System (AFRIMETS), to get measurement traceability. Calibration certificates issued by the NMI shall provide sufficient information regard-ing the process of calibration.

d) The acceptance of other NMIs other than those of CIPM MRA partners shall be at the discretion of the SADCAS Chief

Executive Officer after due consultations of the appropriate Advisory Committee subject to satisfactory evidence of the technical competence of the laboratory using appropriate methods as outlined in the technical procedures.

e) A calibration laboratory whose service is suitable for the intended need but not covered by the ILAC Arrangement or

by regional arrangements recognized by ILAC As defined in these documents, for options (c) and (d) appropriate evidence for the technical competence of the labora-tory and claimed metrological traceability shall include the following: � Record of calibration method validation; � Procedures for estimation of uncertainty; � Documentation for traceability of measurements; � Documentation for assuring the quality of calibration results; � Documentation for the competence of staff; � Documentation for accommodation and environmental conditions; and � Audits of the calibration laboratory. Options a) and b) above are the preferred SADCAS options for metrological traceability. Options c) and d) are only appli-cable when options a) and b) are not possible. Equipment and instruments used by testing/medical laboratories/inspection bodies and having a significant impact on the measurements results shall be calibrated. SADCAS accepts evidence of traceability as outlined above. Where trace-ability as stated above is not technically possible or reasonable or available, the testing/ medical laboratories/inspection bodies and client and other interested parties may agree to using reference materials /certified reference materials as outlined in 6.14.4 of SADCAS PM 01 Issue 14, Issue 13 of TR 02 and Issue 6 of TR 09.

SADCAS accreditation documents are available from the SADCAS website www.sadcas.org/policies_n_procedures.php This communiqué serves to inform all accredited and applicant Conformity Assessment Bodies to comply with the re-quirements on SADCAS Policy on Metrological Traceability as stipulated in the above-mentioned documents and com-pliance with will be verified by the assessors during the respective scheduled assessment of your facilities.

According to SADCAS policy on metrological traceability equipment and instruments used by testing laboratories/medical laboratories/inspection bodies and having a significant impact on the measurements results shall be calibrated. The equipment and reference standards used by calibration laboratories and having an impact on the accuracy and va-lidity of measurements results shall be calibrated by:

a) A National Metrology Institute (NMI) whose service is suitable for the intended need and belongs to the CIPM and

are signatories to its Mutual Recognition Agreement (MRA) amongst NMIs and who have approved CMC’s within the BIPM Key Comparison Database (KCDB) which includes the range and uncertainty for each listed service.

b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement or by Regional Ar-

rangements recognized by ILAC whose service is suitable for the appropriate calibration. c) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA. The National Metrology

Institute shall have participated in the SADC Cooperation in Metrology (SADCMET), a member of the Joint Commit-tee of Regional Metrology Organizations and the BIPM (JCRB) through Intra-Africa Metrology System (AFRIMETS), to get measurement traceability. Calibration certificates issued by the NMI shall provide sufficient information regard-ing the process of calibration.

d) The acceptance of other NMIs other than those of CIPM MRA partners shall be at the discretion of the SADCAS Chief

Executive Officer after due consultations of the appropriate Advisory Committee subject to satisfactory evidence of the technical competence of the laboratory using appropriate methods as outlined in the technical procedures.

e) A calibration laboratory whose service is suitable for the intended need but not covered by the ILAC Arrangement or

by regional arrangements recognized by ILAC As defined in these documents, for options (c) and (d) appropriate evidence for the technical competence of the labora-tory and claimed metrological traceability shall include the following: � Record of calibration method validation; � Procedures for estimation of uncertainty; � Documentation for traceability of measurements; � Documentation for assuring the quality of calibration results; � Documentation for the competence of staff; � Documentation for accommodation and environmental conditions; and � Audits of the calibration laboratory. Options a) and b) above are the preferred SADCAS options for metrological traceability. Options c) and d) are only appli-cable when options a) and b) are not possible. Equipment and instruments used by testing/medical laboratories/inspection bodies and having a significant impact on the measurements results shall be calibrated. SADCAS accepts evidence of traceability as outlined above. Where trace-ability as stated above is not technically possible or reasonable or available, the testing/ medical laboratories/inspection bodies and client and other interested parties may agree to using reference materials /certified reference materials as outlined in 6.14.4 of SADCAS PM 01 Issue 14, Issue 13 of TR 02 and Issue 6 of TR 09.

SADCAS accreditation documents are available from the SADCAS website www.sadcas.org/policies_n_procedures.php This communiqué serves to inform all accredited and applicant Conformity Assessment Bodies to comply with the re-quirements on SADCAS Policy on Metrological Traceability as stipulated in the above-mentioned documents and com-pliance with will be verified by the assessors during the respective scheduled assessment of your facilities.

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Important information for Certification Bodies regarding

transition to ISO 9001 and ISO 14001

A s the three-year transition for ISO 9001 and ISO 14001 moves into its final year, IAF (the global association for de-veloping the principles and practices for the conduct of conformity assessment) has passed a resolution that as of

15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and recertifi-cation audits to the new versions - ISO 9001:2015 and ISO 14001:2015. This resolution continues the efforts of IAF, its accreditation body members, stakeholder members of IAF and accredited conformity assessment bodies, to encourage those who need to upgrade to the new versions of the world’s leading management system standards. Any organisations who need to move to the new version of ISO 9001 and ISO 14001 should contact their conformity assessment body as soon as possible to make arrangements for their audit. Further information on transition can be found on ISO 9001 and ISO 14001. As noted in the joint ISO/IAF Communiqué on 15 September 2017 to mark one year to the transition deadline, the new versions of ISO 9001 and 14001 make very logical progressions from previous versions, delivering standards which ad-dress the key issues for both today and the future. The new ISO 9001 promotes enhanced leadership involvement in the

management system, introduces risk-based thinking and aligns the quality management system policy and objectives with the strategy of the organization. The changes in ISO 14001 focus on key issues such as protecting the environment improving environmental performance, lifecycle thinking and organizations’ environmental leadership.

Note that failure to achieve certification to the 2015 standard by the deadline means that your certification is no

longer valid and this may affect your ability to supply to all markets.

IAF Communiqué ISO 9001 and 14001

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Joint ISO/IEC 17025 Communiqué

A laboratory's fulfillment of the requirements of ISO/IEC 17025 means the laboratory meets

both the technical competence requirements and management system requirements that are

necessary for it to consistently deliver technically valid test results and calibrations. The

management system requirements in ISO/IEC 17025 are written in language relevant to labo-

ratory operations and operate generally in accordance with the principles of ISO 9001.

Joint ISO-ILAC-IAF

Communiqué on the

Management Systems Requirements of ISO/IEC 17025,

General Requirements for the competence of testing and

calibration laboratories

April 2017

ISO Acting Secretary General ILAC Chair IAF Chair

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The Business Benefits of Standards and Accreditation

T here are many cases where standards and accredited conformity assessment help businesses of any size and sector reduce costs, increase productivity and access new markets. They can help to:

� Build customer confidence that your products are safe and reliable � Meet regulation requirements, at a lower cost � Reduce costs across all aspects of your business � Gain market access across the world Business Benefits www.business-benefits.org is a website jointly developed by the International Accreditation Forum (IAF), ILAC, International Organization for Standards (ISO), Independent International Organisation for Certification (IIOC), and International Certification Network (IQNet), that showcases these benefits through case studies, research papers, and supporting materials. The examples published on the site cite tangible financial data to evidence the cost savings achieved whether through resource efficiency or meeting regulation at lower cost, the value of accessing new markets, or savings achieved through recognition from organisations such as insurers, regulators or purchasers. The site contains case studies from multinationals such as IBM, Chrysler, and Hitachi to national companies such as Aberdare Cables and Pretoria Portland Cement Company.

The site was launched in October at the ILAC and IAF conference in Vancouver. Additional case studies will be added in the coming months to ensure that it can be a valuable resource to promote the use of standards and accreditation to the business community. The site aims to mirror the success of Public Sector Assurance, a similar site that promotes the value of accreditation to policy makers.

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Page 37 VOLUME 9, ISSUE 28

SADCAS Conducts ISO 15189 Training in Uganda

S ADCAS recently conducted a 5-day internal auditing training course on ISO 15189 at Ridar Hotel in Mukono, Uganda from 21 to 25 August 2017. This is the first course to be conducted by SADCAS in Uganda. The training course was

sponsored by A Global Healthcare Public Foundation (AGHPF), a non-profit making organization dedicated to alleviat-ing the burden of HIV/AIDS through community Public Health in Uganda. The main objective of this training course was to train laboratory personnel on the fundamentals of internal auditing which they can then use as a means of aligning their practices to comply and satisfy the requirements of the standard. The training course was attended by twenty three (23) participants largely from government hospital laboratories as well as person-nel from non-governmental organizations (NGOs). In his welcoming remarks Professor Kilian Songwe, Regional Director of AGHPF gave a brief background of his Foundation and outlined the general public healthcare issues that they hope to tackle with the assistance of the relevant stakeholders. He also took this opportunity to introduce the SADCAS Trainer Dr Farojdeo Hemraj who in turn also gave a short account of SADCAS and the role it is playing particularly in the SADC region in the areas of accreditation, training and other related activities before commencing the course which included a 2 day practical auditing session in a laboratory.

In closing Professor Songwe expressed his and the participants gratitude to SADCAS for a course well structured and informative and also explained that they would like to train more laboratory personnel in future as they are determined to improve public healthcare services in the country. The Trainer Dr Hemraj thanked AGHPF for en-gaging SADCAS to carry out this training course in Uganda and also expressed his gratitude to the Ridar Hotel staff for their warm hospitality during his stay in Uganda and the logistical support that they offered during this training.

Training in session

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A Multi-economy Accreditation Body!!

Page 38 THE PIONEER

Third ISO/IEC 17020 Training held in Swaziland

T he third ISO/IEC 17020 Requirements, implementation and internal auditing course was held at Lugogo Sun Hotel, Ezulwini, Swaziland from 30 October to 03 November 2017. The Ministry of Commerce, Trade and Industry through

NAFP-Swaziland organized the training. A total of 25 participants/ inspectors from different government departments and municipalities attended the training. Ms Phindile Dlamini, the Chief Quality Systems Administrator in the Ministry of Industry and Commerce of Swaziland delivered the opening remarks highlighting the importance of the training to the Swaziland Government to achieve its 2022 vision of becoming a first world country. She emphasized the need by all inspection bodies to have the people, facilities, technical expertise and management systems in place in order to conduct inspections professionally and com-petently. Ms Dlamini mentioned that ISO/IEC 17020 standard specifies the general requirements for the competence of various types of inspection bodies irrespective of the sector involved. She encouraged participants to take the course seriously. Mrs Dlamini then introduced the Trainer, Mr Danmore Mabambe and wished all participants fruitful discussions during the five days. The Trainer delivered a comprehensive elaboration of the eight clauses of the ISO/IEC 17020:2012 standard. Participants were given the opportunity to ask questions on each clause for clarification with various examples given by the Trainer in reference to their respective work places. The Trainer articulated the importance of competence evaluation of personnel, facilities, traceability of measurements, environment conditions, inspection methods and procedures as vital tools of accreditation. Participants understood why the quality system require an inspection policy which is the overall intention and direction of an organization to inspection as formerly expressed by the top management. During the internal auditing part, the Trainer covered the reasons for carrying out internal audits, the audit process (including how to conduct the opening and closing meetings), positive and negative characteristics of an auditor and competence requirements for auditors. There was a lot of debate in the groups and during question and answer sessions. Participants had the opportunity to comment on other groups’ presentations. Participants also reviewed inspection policy and procedures by detailing all the activities performed at their respective work places to confirm compliance to ISO/IEC 17020. There was a lot of discussion and interaction throughput the training programme. An examination was written on the last day of the training. Judging from participants’ feedback the training went on well.

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Continued to p 16

Page 39 VOLUME 9, ISSUE 28

Continued to p 40

I n order to monitor the effectiveness and suitability of the SADCAS QMS and compli-

ance of its systems with ISO/IEC 17011 SAD-CAS had an internal audit was undertaken from 5 to 6 October 2017. This was the 5th Internal audit to be undertaken by SADCAS. The focus of the internal audit was on the Calibration Laboratories Accreditation Programme (CLAP) and the Testing Laboratories Accreditation Programme (TLAP) and covered clauses 4, 5, 6, 7 and 8 of ISO/IEC 17011, and ILAC Policy documents P8, P9, P10, P14 and ILAC R7. The internal audit team comprised of Mr Neville Tayler as the Team Leader, Mr Xavier Mugari responsible for testing with Mr Victor Mun-dembe covering calibration programme. A total of 9 findings were raised during the internal audit of which one is a nonconformity, 5 concerns and 3 comments. In line with AP 06: Internal audits, SADCAS will identify and propose corrective actions to address all the findings raised within a month and implement the accepted corrective action within 4 months of receiving the audit report.

SADCAS Undertakes its 5th Internal Audit

Internal Audit closing meeting on 6 October 2017

Internal Audit opening meeting on 5 October 2017

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Page 40 THE PIONEER

Continued from p 39

Speaking during the closing meeting the Audit team was very impressed with the maintenance of the system and in par-ticular the record keeping and access thereof. The SADCAS CEO thanked the team for a value adding internal audit and congratulated the SADCAS team for their efforts in maintaining the SADCAS QMS and ensuring its continued compliance with ISO/IEC 17011 and the international documents and suitability and effectiveness. This reaffirms the results of the customer satisfaction survey undertaken during the 2016/17 of which 94% rated overall SADCAS services from good to excellent with 78% rating from very good to excellent.

Internal Audit closing meeting on 6 October 2017

T he following training courses based on the New!! ISO/IEC 17025:2017 Standard now on offer

• One-day ISO/IEC 17025 Awareness

• 3-day ISO/IEC 17025 Internal Auditing

• 3-day ISO/IEC 17025 Bridging Course (to the new standard)

• 5-day ISO/IEC Requirements and Internal Auditing

Training on the NEW!! ISO/IEC 17025:2017 Standard Now on Offer

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Continued to p 16

Continued to p 30

Upcoming Training Courses

Page 41 VOLUME 9, ISSUE 28

To register for any of the above open courses please download SADCAS F 70 (b) - Training Book-ing Form from SADCAS website: http://www.sadcas.org/sadc-as-forms-english?page=2

or contact SADCAS at [email protected] for more information.

COURSE DATE(S) VENUE

COUNTRY/CITY

FEES (BWP)

FEES (USD)

ISO/IEC 17021 Requirements & Internal Auditing 29 Jan to 2 Feb 2018 Swaziland (Mbabane) (In-house) -

ISO 15189 Requirements & Internal Auditing 12 to 16 Feb 2018 Botswana (Gaborone) (In-house) -

ISO 15189 Requirements & Internal Auditing 19 to 23 Feb 2018 Botswana (Francistown) (In-house) -

ISO/IEC 17025:2017 Requirements & Internal Auditing 19 to 23 Feb 2018 Botswana (Gaborone) 8,900 -

ISO/IEC 17025:2017 Awareness 26 Feb 2018 Botswana (Gaborone) (In-house)

ISO/IEC 17025:2017 Requirements & Internal Auditing 26 to 30 Feb 2018 Zimbabwe (Harare) - 750

Method Validation and Measurement Uncertainty 26 to 30 Feb 2018 Namibia (Windhoek) 8,900 -

ISO/IEC 17025:2017 Requirements & Internal Auditing 5 to 9 March 2018 Botswana (Gaborone) (In-house) -

ISO/IEC 17025:2017 Requirements & Internal Auditing 5 to 9 March 2018 Namibia (Windhoek) 8,900 -

ISO 15189 Requirements & Internal Auditing 5 to 9 March 2018 Botswana (Gaborone) (In-house) -

Method Validation and Measurement Uncertainty 12 to 16 March 2018 Zambia (Lusaka) - 850

ISO/IEC 17025:2017 Requirements & Internal Auditing 19 to 23 March 2018 Namibia (Swakopmund) 8,900 -

ISO/IEC 17025:2017 Requirements & Internal Auditing 26 to 30 March 2018 Tanzania (Dar es Salaam) - 850

Upcoming Training Courses

Training on Validation/Verification of Methods and Measurement Uncertainty

SADCAS also offers training on Validation/Verification of Methods and measurement Uncertainty.

The objective of the Validation & Verification of Methods is to:

� Bring the participants from fundamental principles of descriptive statistics with the emphasis on hypothesis testing for the determination and verification of:

� Trueness (Bias)

� Precision

� Linearity of calibration curves

� Working Range

� Selectivity/specificity

� Ruggedness & Robustness

� Sensitivity

� Limit of Quantification

� Limit of Detection

� Create an understanding of the requirement of validation and verifi-

cation and their respective applications in terms of both ISO/IEC

17025 and ISO 15189

� Ability to design a validation or verification programme

� Remove the mystique surrounding the concept of Measurement Uncer-

tainty;

� Promote a practical methodology, based on GUM requirements to calcu-

late measurement uncertainty over the working range of the method;

� Promote acceptable forms of expression of Measurement Uncertainty

associated with any results.

The objective of Measurement Uncertainty is to:

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Page 42 THE PIONEER

T he Southern African Development Community Accreditation Service (SADCAS) provides training for conformity assessment bod-ies’ management and staff. Conformity assessment bodies (CABs) include calibration/testing laboratories, medical laboratories,

certification and inspection bodies.

SADCAS Trainers

SADCAS draws its trainers from a pool of qualified and experienced experts from the SADC region who have up to date involvement in accreditation matters be it system implementation and/or assessments.

Training Programmes

SADCAS currently offers the following accreditation training courses:

Five-Day Requirements and Internal Auditing Training Courses on the Various Key Accreditation Standards

� ISO 15189 Requirements and Internal Auditing for medical laboratories

� ISO 15189:2012 Requirements and Internal Auditing [Bridging course] for medical laboratories

� ISO/IEC 17020 Requirements and Internal Auditing for inspection bodies

� ISO/IEC 17021 Requirements and Internal Auditing for management systems certification bodies

� ISO/IEC 17025:2017 Requirements and Internal auditing for calibration/testing laboratories

The objective of the 5-day courses is to provide an insight into the respective system standard’s requirements and implementation as well as to guide CAB’s personnel on how to prepare and carry-out an internal audit so as to monitor compliance with the system standard. These courses are made relevant and practical as they include case studies and exercises that reflect the respective profes-sional disciplines. In order to objectively assess participants, an examination is written at the end of each course. Participants are also evaluated throughout the course.

Three-Day ISO/IEC 17025 International Auditing

The objective of the 3-day training course is to impart internal auditing knowledge and skills to laboratory staff. The course covers the following main topics:

Three-day ISO/IEC 17025:2017 Bridging Course to the new standard

One-day Awareness Training Courses on the Various Key Accreditation Standards

� ISO 15189 for medical laboratories

� ISO/IEC 17020 for inspection bodies

� ISO/IEC 17025 for calibration/testing laboratories

The objective of the one day awareness training courses is to create awareness on the benefits and importance of accreditation and the requirements of the respective accreditation standards. The SADCAS courses can be conducted in-house. In-house courses have the following benefits:

� You choose the venue of the course in � You choose the date of the course � Cost effective as a number of staff can be trained at the same time � Promotes team work as members have access to the same consistent information

For more details please contact SADCAS Email: [email protected]

� Introduction to Auditing � The Audit process � Reporting and corrective actions

� Auditor competence � Benefits of an auditing

SADCAS Training Courses

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Page 43 VOLUME 9, ISSUE 28

Continued to p 44

Status of Key Accreditation Standards and IAF/ILAC Documents

STANDARD STATUS

ISO/IEC 17000:2004 Conformity assessment – Vocabulary and

general principles

International standard to be revised

ISO/IEC WD 17000 Conformity assessment – Vocabulary and

general principles

Working Draft (WD) study initiated

ISO/IEC 17007:2009 Conformity assessment – Guidance for

drafting normative documents suitable for use for conformity

assessment

International standard under periodical review

ISO/IEC 17011:2017 Conformity assessment - Requirements for

accreditation bodies accrediting conformity assessment bodies

International standard published on 30 November 2017

ISO/IEC 17021-5:2014 Conformity assessment – Requirements

for bodies providing audit and certification of management

systems – Part 5 Competence requirements for auditing and

certification of asset management systems

International standard under periodical review

ISO/IEC 17021-6:2014 Conformity assessment – Conformity

assessment – Requirements for bodies providing audit and cer-

tification of management systems – Part 5 Competence re-

quirements for auditing and certification of business continuity

management systems

International standard under periodical review

ISO/IEC 17021-7:2014 Conformity assessment – Conformity

assessment – Requirements for bodies providing audit and cer-

tification of management systems – Part 5 Competence re-

quirements for auditing and certification of road traffic safety

management systems

International standard under periodical review

ISO/IEC CD 17021-10 Conformity assessment – Requirements

for bodies providing audit and certification of management

systems – Part 10: Competence requirements for auditing and

certification of occupational health and safety management

systems

CD approved for registration as Draft International Standard

ISO/IEC 17024:2012 Conformity assessment – General require-

ments for bodies operating certification of persons

International standard under periodical review

ISO/IEC 17025:2017 General requirements for the competence

of testing and calibration laboratories

International standard published on 30 November 2017.

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Continued to p 45

Continued from p 44

Diary of Upcoming Events

DATES MEETINGS VENUE

5 December 2017 SADCAS Advisory Committees Meetings for Calibration/

Testing/Medical Laboratories Accreditation Programmes/ PTB

Germany

Johannesburg, South Africa

5 December 2017 ISO/CASCO TIG Meeting Geneva, Switzerland

6 December 2017 ISO/CASCO STAR Meeting Geneva, Switzerland

STANDARD STATUS

ISO/IEC TS 17027:2014 Conformity assessment – Vocabulary

related to competence of persons used for certification of

persons

Close of review

ISO/IEC TR 17028:2017 Conformity assessment - Guidelines

and examples of a certification scheme for services

International standard published in June 2017

ISO/IEC WD 17029 Conformity assessment – General require-

ments for bodies performing validation and verification activi-

ties

Working Draft study initiated

ISO/IEC NP TR 17032 Conformity assessment - Guidelines

and examples of a certification scheme for processes

New Project approved

ISO/NP TS 17033 Conformity assessment – Ethical claims,

Labels and supporting information – Requirements

New Project approved

ISO/IEC 17065:2012 Conformity assessment - Requirements

for bodies certifying products, processes and services

International standard under periodical review

ILAC/IAF ISO/IEC 17011:2017 Transition Plan Preparation for the publication of the revised ISO/IEC 17011

Conformity assessment bodies in November 2017, IAF and ILAC

have developed a plan to ensure all accreditation bodies that

are signatories to the IAF MLA and ILAC MRA have transitioned

to ISO/IEC 17011:2017 three years from the date of publication

of the revised standard in accordance with the IAF/ILAC JGA

resolutions

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Page 45 VOLUME 9, ISSUE 28

Continued from p 44

DATES MEETINGS VENUE

31 August 2017 SADCAS FRAC Meeting Johannesburg, South Africa

6 to 7 December 2017

ISO/IEC 17011 Training Workshop for National Accreditation

Focal Points and SADCAS Staff/ SADC EU REIS Programme

Johannesburg, South Africa

7 December 2017 ISO/CASCO CPC Meeting Geneva, Switzerland

8 December 2017

11th

National Accreditation Focal Points Annual Meetings /

SADC EU REIS Programme

Johannesburg, South Africa

8 December 2017 IAF-ILAC-ISO Joint Strategic Group Meeting Geneva, Switzerland

11 to 13 December 2017 Regional training on ISO/IEC 17011: 2017 – General require-

ments for Accreditation Bodies Accrediting Conformity Assess-

ment Bodies

Nairobi, Kenya

14 December 2017 SADCAS/SANAS TPA M.29 Pretoria, South Africa

5 February 2018 SADCAS HRRC Meeting Johannesburg, South Africa

15 February 2018 SADCAS FRAC Meeting Johannesburg, South Africa

15 February 2018 SADCAS Board of Directors Johannesburg, South Africa

12 February 2018 ISO/CASCO WG 49 – Revision of ISO/IEC 17000 Geneva, Switzerland

7 March 2018 BIPM-OIML-ILAC-ISO Quadripartite Meeting Paris, France

12 to 16 March 2018 SADC TBT Meetings Pretoria, South Africa

9 to 12 April 2018 7th

International Conference of Metrology Marrakech, Morocco

Delivering confidence, Assuring competency

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Page 46 THE PIONEER

PUBLISHED BY:

SADCAS Plot 50669 Unit 2A, First Floor

Tholo Office Park, Fairgrounds

Private Bag 00320

Gaborone, Botswana

Tel: +267 3132909/ 3132910; Cell No: +267 71250042

Fax: +267 3132922

Email: [email protected]

Website: www.sadcas.org

Editors: Maureen Primrose Mutasa

Jeanne Françoise Ranorovelo

Layout & Design

Linda Dirorimwe