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IAF/ILAC Template for comments – Certification of Multiple Sites Date: 2007-05-17 Document: IAF-GM-07-012 (NCD Z:200X)

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Comment (justification for change) by the MB Proposed change by the MB Convener observationson each comment submitted

CAI No comment.

CNAS No comment

EMA No comment

INMETRO No comment

JAS-ANZ No comment.

MAURITAS No comment

OLAS OLAS has no particular comment to propose on this document.

SANAS No comment.

Standards Malaysia

No comment

COFRAC Whole document

ed This document is an “IAF normative and informative criteria…” I remember we had a rather long discussion in the IAF TC in march 2007 on the way to designate this kind of document, and “guidance” had not been selected to be appropriate; then it is preferable not to refer to “guidance” in the document

Replace “guidance” by “document” wherever it appears

Agreed. "guidance" replaced with "document" or "criteria" as appropriate

FINAS All ge Certification of multiple sites especially the sampling procedure is one of the most misused guides by the CBs. Also the clients expect sampling to be used in any situation where the company has activities on more than one site. The restriction for use of sampling, although in a way stated in 3.1.6, should be further clarified.

To collect all the conditions for multi site procedure and where sampling can be applied, which are now separated in the document, into one paragraph and maybe partly reformulate to make the conditions more clear.

Nice idea. However, this is a minimum change document and resources are not currently available to carry out the proposed exercise.

1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.

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IQNet All All te Document lacks clarity and distinction between requirements for multi-site certification [irrespective of whether sampling is employed] and requirements for auditing by sampling.

This recommended text may be included for definitions of multi-sites and certification documents

.

The proposal mixes definitions and requirements. Standards writing protocol prevents meeting this proposal although I have sympathy with it. That is why the definitions and explanatory requirements have been separated.

ANAB ge Paragraphs edited to reflect the recent understanding that ‘certified once-accepted everywhere’ applies only where there is an MLA for the framework standard and the specific conformity assessment standard or scheme.

Accreditation reduces risk for business and its customers by assuring them that accredited bodies are competent to carry out the work they undertake within their scope of accreditation. Accreditation bodies which are members of the International Accreditation Forum, Inc. (IAF) are required to comply with appropriate international standards and to require the bodies they accredit to comply with appropriate international standards and IAF Guidance normative criteria to for the consistent application of those standards.

Accreditations granted by Accreditation body members of the IAF Multilateral Recognition Arrangement (MLA) , based on have regular surveillance to assure the equivalence of their accreditation programs. , allows companies and persons with an accredited conformity assessment certificate in one part of the world to have that certificate recognized everywhere else in the world.

Incorporated


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Therefore certificates in the field of management systems, products, services, persons or other similar programs of conformity assessment issued by bodies accredited by members of the IAF MLA are relied upon in international trade.

An organization or person with a certificate of conformity to a specific standard or scheme that is accredited by an IAF MLA signatory accreditation body for that standard or scheme can be recognized everywhere else in the world thereby facilitating international trade.

SCC Page 2 ge The three paragraphs on accreditation should be harmonized for all documents. These three paragraphs are different from the once reproduced in the IAF Normative Criteria for Advanced Surveillance and Recertification Procedures

Harmonize Agreed. Propose this task fall to IAF TC convenor to ensure harmonization

ANAB Page 4 First sentence after the Title

ed For consistent wording with the normative criteria for transfers

This document provides normative criteria for the consistent application of…

Agreed

JAB Page 4 Title in the text (P.4)

te Should be consistent with the title on the cover page IAF Normative and Informative Criteria for the Certification of Multiple Sites Based on Sampling

Reference to "informative" deleted – although clearly the document is both normative AND informative

JAB Page 4 1st paragraph in the text

te Although ISO/IEC 17021 is applicable to all types of management systems, this document is not the case, which should be clarified.

This document provides criteria on Clause 9.1.5. of ISO/IEC 17021:2006 and covers criteria on certification of multiple sites

Disagree. The intention is to widen the use of this document, although there are several standards for which the




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(p.4) previously provided in IAF GD2: 2005, Annex 3 and IAF GD6:2006, clause G.5.3.5 – G.5.3.6. This means that this document is intended for only Quality Management System (QMS) and Environmental Managements System (EMS), in which IAF members have had experience of accredited certification of multiple sites based on sampling. For other management systems, relevant standards may provide specific requirements for multiple sites (e.g. ISO/IEC 27006 for ISMS, ISO 22003 for FSMS).

sampling technique cannot be applied. It is based on GD2 and GD6 – but several management system standards can follow the same principles.

HKAS Title Page4 ed The title on page 4 is :

“IAF Normative and Informative Criteria for the Certification of Multiple Sites Based on Sampling”

It cannot be normative and informative.

Delete “and Informative” from the title. Agreed

KAB Title ed Need to unify title

IAF Normative Criteria for ~

IAF Normative and Informative Criteria for~

IAF Normative Criteria for the certification of Multiple Sites Based on Sampling

Agreed. Reference to "informative" deleted – although clearly the document is both normative AND informative

SWEDAC Title ED Not correct references: G.5.3.5- G5.3.6 G5.3.6- G5.3.13 Agreed, but G.5.3.5 included as it defines "site"

UKAS 0 0.1Line 4

te Insert “across all the sites listed” after relevant standard

Agreed

DAR/ TGA 0 0.2 ge This Guidance document distinguishes between “procedures” and “documented procedures” (see

0.2 should read: “... a certification body shall put into operation appropriate documented

Agreed. Documented procedures




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clause 4.2.1). From that, procedures need not to be documented in the CRB. The Guidance document should be reviewed accordingly.

procedures for sampling the sites at the initial audit and subsequent surveillance and recertification audits.”

referred to throughout

KAB 0 0.27th line

Change to criteria

This guidance addresses the conditions~

This Criteria addresses the conditions~ Agreed. Have used criteria or document as appropriate throughout

DAR/ TGA 0 0.3 te Multiple site organizations shall be ruled under similar processes, activities and products.

“The criteria in this document do not apply to the audits of organizations that have multi-sites where fundamental dissimilar processes, activities or products are used or produced at the different sites.”

Not agreed. Similar processes may be used to produce different products. An MS audit is of a process, not a product.

IQNet 0. 0.31st sentence

te This particular statement has been surrounded by much controversy. Suggest a better explanation of dissimilar processes.

We recommend to include definition of dissimilar processes in section 1 “Definitions”

1.6 Dissimilar processes

Dissimilar processes are the processes which are based on different technologies and produce different products.

Not agreed. See above. Similar argument applies. Dissimilar processes is self explanatory. They may be based on different technologies, which may or may not produce different products.

UKAS 0 0.3Line 3

te Combinations of sites may have similar processes Amend line 3 to read

at the different sites or a combination of sites,

Agreed

COFRAC 0 0.4 ed grammar Replace “under condition they are” by “under condition it is”

Agreed

UKAS 0 0.4Line6

te Refer to the confidence in the management system …same level of confidence in the conformity of management system across all the sites listed, can be obtained

Agreed

JAB 1 1.1 te Consistency with 17021. The term organization is used to designate any company or other client organization

Not agreed. "client organization" only used in ISO/IEC 17021 where there is




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owning a management system subject to audit and certification.

the possibility of confusion

COFRAC 1 1.2 ed For clarification and consistency with the following text

Replace “A site is a location where a client carries out work or a service” by “A site is a permanent location where a client carries out activities (work or a service)

Agreed

DAR/ TGA 1 1.2 ed The Guidance document should not divide between “organization” and “client”

A site is a location where an organization carries out work or service.

Agreed

COFRAC 1 1.3 ed For clarification and consistency with the following text

Replace “to perform specific work for a finite period of time and which will not become permanent site” by “to perform specific activity for a finite period of time and which will not become a site

Partially agreed. Consistent with 1.2 as drafted, but amended to include "service"

HKAS 1 1.3 te Who sets up a temporary site is irrelevant. It may be set up by a party other than the certified organisation. The definition for “temporary site” in the draft document is different from that in GD2:2005.

Use the definition in GD2:2005:

“A temporary site is a location other than the sites/locations identified in the certification document where activities, within the scope of certification, are implemented for a defined period of time. These sites could range from major project management sites to minor service/installation sites.”

GD2 is now obsolete and therefore no need to make us of an old definition

COFRAC 2 ge For clarity make a fusion of § 2 with the corresponding §1 subparagraphs, in one § entitled “definitions”

Merge 2.1 with 1.2, 2.2 with 1.3, and 2.3 with 1.5

Standards writing protocol prevents meeting this proposal

JAB 2 te Do we need to say ‘explanatory’ requirements? EXPLANATORY REQUIREMENTS Unchanged. Clear as drafted

COFRAC 2.1 2.1.2 ed For harmonisation Replace “certification/registration” by Agreed. Complete




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“certification”

JAB 2.1 2.1.2 te - For consistency with 17021, certification/registration should be certification.

- Examples would be appreciated to justify ‘special cases.’

Where it is not practicable to define a location (e.g. for services), the coverage of the certification/registration should take into account the organization’s headquarters activities as well as delivery of its services. Where relevant, in special cases (e.g. ………………..), the Certification Body may decide that the certification/registration audit will be carried out only where the organization delivers its services. In such cases all the interfaces with its central office shall be identified and audited.

Agreed. All references to certification/registration amended to certification

Example can be inserted if provided.

OAA 2.1 2.1.2 ED The term registration is no longer use. Where it is not practicable to define a location (e.g. for services), the coverage of the certification should take into account the organization’s headquarters activities as well as delivery of its services. Where relevant, in special cases, the certification body may decide that the certification audit will be carried out only where the organization delivers its services. In such cases all the interfaces with its central office shall be identified and audited

Agreed. Complete

IQNet 2.2 2.2.1Second Sentence

te Disagree with this statement. What if a site is temporary for 1, 2, 3 years etc. Temporary sites should be managed by the CB and it should be the CB’s/Client decision as to whether a temporary site is included on a certificate

Delete this sentence and replace with:

They may be however included within the scope of a multi-site certification subject to agreement between Certification Body and

Good idea. Agreed




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client.

DAR/ TGA 2.3 2.3.1Second item

te The multi site approach shall be restricted to companies producing similar products – even if certification is limited to the sales network.

Add: “Manufacturing companies producing similar products with a network of sales offices (this guidance would apply to the sales network)”.

Not agreed. The sales process could be similar for different products

INAB 2.3 2.3.1 Ed Consistency of style Semi-colons after each bullet All commas etc removed from lists

JAB 2.3 2.3.1 te - As well as continuous surveillance, reference to internal audits would be necessary.

- Normally the central office will require the sites to implement corrective actions rather than the central office’s direct implementation at the site.

A multi-site organization need not be a unique legal entity, but all sites shall have a legal or contractual link with the central office of the organization and be subject to a common management system, which is laid down, established and subject to continuous surveillance and internal audits by the central office. This means that the central office has rights to require that the sites implement corrective actions when needed in any site. Where applicable this should be set out in the contract between the central office and the sites.

Agreed

JAB 2.3 2.3.12nd bullet

te We agreed to change the term from ‘guidance.’ Manufacturing companies with a network of sales offices (this document guidance would apply to the sales network),

Agreed. Complete

UKAS 2.3 2.3.1Line 6

te Delete the contract, these may not exist between sites

Add - a formal agreement Agreed

ANAB 3 te Additional wording is needed to clarify that this is criteria for determining the eligibility of an organization for sampling

3. Eligibility criteria for the organization

Change to “3. Criteria for determining the

Agreed




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eligibility of the organization for sampling”

ANAB 3 3.1.1 te As this relates to the certificate and not to eligibility, it better fits in section 4.4

Relocate 3.1.1 to 4.4.1 and renumber the subsequent clauses of this section

After relocation of the clause to 4.4.1, renumber the clauses in section 4.4

Agreed

COFRAC 3 3.1.1 ed For harmonisation Replace “registration” by “certification” Agreed. Complete

HKAS 3 3.1.1,

4.0.1

Note under 4.4.6

ed This “Normative Criteria” is not “guidance”. Replace the word “guidance” with “document”.


Inmetro 3 3.1.1Last line

This document is intended to be a “Normative criteria”, however the term “guidance” appears on this item

“... in this normative criteria”. Agreed. "guidance" replaced with "document" or "criteria" as appropriate

JAB 3 3.1.1 te We agreed to change the term from ‘guidance.’ Certification documents can be issued covering multiple sites provided that each site included in the scope of registration has either been individually audited by the certification body or audited using the sample approach outlined in this document guidance.


OAA 3 3.1.1 ED The term registration is no longer use. Certification documents can be issued covering multiple sites provided that each site included in the scope of certification has either been individually audited by the certification body or audited using the sample approach outlined in this guidance.

Agreed. Complete




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SCC 3 3.1.14 te “in accordance with the audit standard” may create confusion as the audit standard is often ISO 19011. This does not seem to be intent of this statement.

Replace “audit standard” by “ the standard under audit”

Agreed. See JAB note

COFRAC 3 3.1.2 te For clarity and harmonisation for the implementation of the document

After first sentence add “If it is not the case, the processes shall be categorised by the CB in groups on similar processes and the multi-site sampling realized on each group”

Interesting concept and worth trying.

DAR/ TGA 3 3.1.2 te Products and activities shall be included. Add: The activities and products provided from or produced at site have to be similar.

Disagree. Processes is used in preference to activities and these have to be similar. Products may be different.

INAB 3 3.1.2 Ge To ensure sites performing fewer but more important processes are audited.

providing that the site(s) which conduct the most processes, or critical processes, are subject to full audit.

Agreed

IQNet 3 3.1.24.1.3

te Many multinationals, particularly in the semi-conductor business, conduct their manufacturing using many linked locations which do not have the same processes (e.g. Wafer fab in USA, Assembly in Far East). These are often candidates for multi-site although technically locations are carrying out different (but linked) processes.

This has an effect on two areas:

3.1.2 / 4.1.3

or businesses which conduct their business through linked processes taking place in different locations.

5 Sampling

Where processes in each location are not similar but are linked, the sampling, each year, shall include at least one example of each process conducted by the organisation.

Interesting concept and worth trying.

UKAS 3 3.1.2Line 4

ed Reword ---providing that all the sites that conduct the substantial processes are subject to full audit

See INAB comment above. May be several sites conducting substantial processes which could be sampled




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DAR/ TGA 3 3.1.3 ed Wording of the first sentence is not unclear. The organization’s management system shall be centrally administered under a centrally controlled plan and be subject to central management review.

I find the original clearer than the proposal

EGAC 3 3.1.3 ge The organization’s management system shall under a centrally controlled and administered plan and be subject to central management review. All the relevant sites (including the central administration function) shall be subject to the organization’s internal audit program and have been audited in accordance with that program prior to the certification body starting its audit.

The organization’s management system shall be under a centrally controlled and administered plan and be subject to central management review. All the relevant sites (including the central administration function) shall be subject to the organization’s internal audit program and have been audited in accordance with that program prior to starting of the certification body’s audit.

Agreed. Different text

INAB 3 3.1.3 Ed Typographical error Shall be under Agreed

Inmetro 3 3.1.3First line

It seems as though the verb “be” is missing “... system shall be under ....” Agreed

UKAS 3 3.1.3Line 1

ed ---shall be under--- Agreed

UKAS 3 3.1.3Line 4

ed ----internal audit programme and all shall have

Agreed

DAR/ TGA 3 3.1.4 ed It should be clear that the “audit standard” is the management system standard.

“It shall be demonstrated that the central office of the organization has established a management system in accordance with a related management system standard and the whole organization meets the requirements described in the standard. Internal audit report have to be available for

Agreed. Simpler text used




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the CB prior to the audit.”

JAB 3 3.1.4 te ‘Audit standard’ could be misunderstood to mean 19011.

It shall be demonstrated that the central office of the organization has established a management system in accordance with the relevant management system requirements audit standard …

Agreed. Amended

EGAC 3 3.1.5 ge The organization should demonstrate its ability to collect and analyse data (including but not limited to the items listed below) from all sites including the central office and its authority and ability to initiate organizational change if required:

The organization should demonstrate its ability to collect and analyse data (including but not limited to the items listed below) from all sites including the central office and also demonstrate its authority and ability to initiate organizational change if required:

Agreed

EGAC 3 3.1.5Last bullet point

ge Differing legal requirements. (Different or changing) legal requirements. Agreed

JAB 3 3.1.5 ed Add EMS as abbreviation, which would be more familiar (as used in 5.1.4).

Changes to aspects and associated impacts for environmental management systems (EMS) and

Agreed

JAB 3 3.1.63.1.7

te These clauses should be stated much earlier in the text.

Suggest to move 3.1.6 - 3.1.7 to 1.5 or Notes to 1.5.

Not agreed. In the section on eligibility as drafted.

DAR/ TGA 3 3.1.7 ed Delete AS in the brackets or mention also the documents of the other sectors ..(AS 9100 series)...

..(9100 series)… Not agreed. Referring to "AS" aids clarity.

INAB 3 3.1.7 Ge Where specific rules apply, option provided by “should” shouldn’t be available

Shall take precedence Agreed

IQNet 3 3.1.72nd

te Delete reference to these two schemes. Not appropriate for this document

Not agreed. Use of examples aids understanding.




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OAA 3 3.1.7 ED The sectors schemes mentioned should only work as examples.

Not all management systems standards are suitable for consideration for multi-site certification. Specific rules apply for some sector schemes, for example those including automotive (TS 16949) and Aerospace (AS 9100 series) and the requirements of such schemes should take precedence.

Agreed

PCA 3 3.1.7 ge The specific requirements of ISO 22000 and ISO 27001 was not taken into account .

Specific rules apply for some sector schemes including automotive (TS 16949), Aerospace (AS 9100 series), FSMS (ISO 22000) and ISMS (ISO 27001) and the requirements of such schemes should take precedence.

Noted. However, they are only examples which can never be exhaustive

UKAS 3 3.1.7 te Multi site sampling for OHSAS is not appropriate Insert new sentence at end of paragraph. Multi site sampling for health and safety management systems cannot be applied where processes, buildings, facilities, local factors (eg transport, public contact etc) storage are very likely to be variable for each site.

Noted. However, need to avoid specifying too much for specific schemes. Text amended to reflect the intention relating to local variations

DAR/ TGA 3 3.1.8 ge See comment to 0.2. Certification bodies should have documented procedures ...

Agreed

SCC 3 3.1.8 te Change to Shall Certification bodies shall have procedures to restrict….

Not agreed. A CB shall have procedures for what it does, not what it does not do

UKAS 3 3.1.8Line 1

ed Delete site, replace with “such” Agreed




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UKAS 3 3.1.84th bullet

Delete which replace with “that” Agreed

Inmetro 4 4.0.1Second line


“... set out in this normative criteria...” Agreed. "guidance" replaced with "document" or "criteria" as appropriate

IQNet 4 4.011st sentence

te Do not agree with statement. The obligation should be for the certification body to obtain the relevant information from the organization to determine if the organization meets the criteria and to inform the organization as to the audit approach and reasoning behind the approach.

The certification body shall obtain information from the organization about the way they structured and operate and make decision on compliance of the organisation with any of the criteria set out in this guidance and the relevant audit standards before starting the audit process. The Certification body and should not proceed if any of the criteria are not met

Agree in principle only. However, CB must provide information to the client. Clause amended slightly.

JAB 4 4.0.1 te ‘Audit standard’ could be misunderstood to mean 19011.

The certification body shall provide information to the organization about the criteria set out in this guidance and the relevant management system requirements audit standards before starting the audit process,


INAB 4.1 4.1.2 Ed Full stop (period) missing at end of clause. Agreed

Inmetro 4.1 4.1.2Last line

The period is missing “ activities.” Agreed.

COFRAC 4.1 4.1.3 ed numbering Replace 2.1.2 by 3.1.2 Agreed. Now 3.1.1

HKAS 4.1 4.1.3 ed Incorrect cross reference “Clause 2.1.2” should be “clause 3.1.2” Agreed

JAB 4.1 4.1.3 ed - Incorrect reference See clause 3.1.2 2.1.2 for sites of which Agreed




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- Comma should be placed for readability conduct fewer, but similar processes than other sites. Only after a positive examination by the certification body that all the sites proposed for inclusion in the multi-site exercise meet the criteria, may the sampling procedure be applied to the individual sites.

EGAC 4.1 4.1.4 ed the organization shall be required to inform the certification body in advance of the sites that it wants to be included in the certification and those which are to excluded

the organization shall be required to inform the certification body in advance of the sites that it wants to be included in the certification and those which are to be excluded

Agreed

INAB 4.1 4.1.4 Ed Two full stops at end of clause – remove one. Agreed


There are two periods in the end of the sentence “.... excluded.” Agreed

JAB 4.1 4.1.4 ed - For improved clarity

- Punctuation

If information on all the sites of a service organization where the activity subject to certification is performed are not ready to be submitted for certification at the same time, the organization shall be required to inform the certification body, in advance, of the sites that it wants to be included in the certification and those which are to excluded..

Not agreed. Original is more clear than the proposal

SCC 4.1 4.1.4 and 4.4.3

ed Extra period in last sentence. Remove extra period. Agreed

DANAK 4.2 4.2.1 ed Reference to clause 2 should be clause 3 “2” to be replaced by “3”. Agreed

HKAS 4.2 4.2.1 ed Incorrect cross reference “Clause 2” should be “clause 3” Agreed

JAB 4.2 4.2.1 ed Incorrect reference … and that all the eligibility criteria for the Agreed




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organization in clause 3 2 above are met.

SCC 4.2 4.2.1 ge “where electronic documents and/or process control, and/or other electronic processes are used” may lead to confusion. Are we talking about electronic process controls or simply process controls?

Suggest using this statement: “where information management and/or process controls through electronic means are used”

Not agreed. Proposal is more confusing than the original

UKAS 4.2 4.2.1 te The rationale for CB being satisfied must be recorded

Insert new sentence at end of paragraph.

Comprehensive information shall be detailed in the stage1 audit reports including the rationale and justification for proceeding with a multi site approach.

Mostly agreed. No need to refer to stage 1, but other elements included

KAB 4.2 4.2.15th line

ed Misquote

Eligibility criteria for the organization in clause 2 above are met.

Eligibility criteria for the organization in clause 3 above are met.

Agreed

INAB 4.3 4.3.1 Ge Organisation should not have option not to review impact of NCs at other sites

Therefore the Certification Body shall require the organisation to review the ncs …

Disagree. Proposal is very negative. If an organization can improve its MS, it should be allowed to do so.

SCC 4.3 4.3.1 te Change should to shall … from auditing by the certification body, investigation shall take place to determine whether the other sites may be affected. Therefore, the certification body shall require the organization to review the …

Not agreed. Proposal is a prescriptive "how"


te Verification of corrective action --should be performed and verified.both at ---.

Agreed – but must refer to NCRs as defined in 9.1.15 (b) of ISO/IEC 17021 – not 9.1.15 (c)

EGAC 4.3 4.3.2 te 4.3.2 The certification body shall require evidence of these actions and increase its sampling frequency

This phrase needs to be further explained e.g., in a note. This note should explain how

Not agreed. Proposal is a prescriptive "how". The document should not specify




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and/or the size of sample until it is satisfied that control is re-established

this sampling frequency be increased. Examples should be given e.g., decreasing the surveillance period.

how an action is carried out.

DAR/ KBA 4.3 4.3.3 te According to 17021:06, clause 9.1.15, the certification can be denied only if a certain kind of non-conformities (see subclause b) has not been settled by verified corrections and corrective actions. In any other case, the certification must be granted if only plans for corrections/corrective actions are accepted (i.e. non-conformities are not settled yet)

At the time of the decision making process, clause 9.1.15 of ISO/IEC 17021:2006 must be applied to any single site.

See UKAS comment

IQNet 4.3 4.3.3 te This does not comply with ISO17021 which only requires a corrective action plan to be submitted and approved prior to granting of certification

At the time of the decision making process, if any site has a nonconformity and corrective action plan is not submitted and not approved, certification shall be denied to the whole network pending satisfactory corrective action.

Not agreed. CARs (majors) must be verified – reference to 17021 now included.

SCC 4.3 4.3.3 ge A definition of “network” would be useful here. Are we talking of a network in the sense of communications or multi-sites??

Define “network” "of listed sites" inserted


te Ensure/re enforce nature of non conformities Insert at end of line 1 (ref ISO/IEC 17021 section 9.1.15 b)

Agreed

COFRAC 4.3 4.3.4 ed numbering Replace 3.1.4 by 4.1.4 Agreed

HKAS 4.3 4.3.4 ed Incorrect cross reference “Clause 3.1.4” should be “clause 4.1.4” Agreed

JAB 4.3 4.3.4 ed Incorrect reference Such exclusion can only be agreed in advance (See clause 4.1.4 3.1.4).

Agreed

OAA 4.3 4.3.4 TE I should be better clarify in which moment the It shall not be admissible that, in order to Resolved by change of reference as 1 MB = Member Body (enter the IAF Member acronym, e.g. RvA)2 Type of comment: ge = general te = technical ed = editorial NB Columns 1, 2, 4, 5 are compulsory.



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exclusion should be agreed. overcome the obstacle raised by the existence of a nonconformity at a single site, the organization seeks to exclude from the scope the "problematic" site during the certification process. Such exclusion can only be agreed in the contract review.

above

DANAK 4.4 4.4.2 ed Reference to the certification documents seems to be missing in the second sentence.

Underlined text to be added:

The scope or other reference on the certification documents shall make clear that the certified activities are performed by the network of sites in the list. If the certification scope of the sites is only issued as part of the general scope of the organization, its applicability to all the sites shall be clearly stated.

Agreed.

HKAS 4.4 4.4.2 te To avoid misleading scope.

The third line, “The scope or other reference on..” is incomplete.

Add at the end of clause 4.4.2 the following:“For situation mentioned in clause 4.1.4, the certification scope should indicate that the certification is for a limited number of sites.”

Replace the incomplete phrase by “The scope or other reference stated on the document..”.

Text amended more simply

INAB 4.4 4.4.2 Ed Remove ‘on’ - Typographical error The scope or other reference No. Words were missing – see below

Inmetro 4.4 4.4.2Third line

The particle “on” does not make sense on the sentence

“...or other reference shall make clear...” No. Words were missing – see below

JAB 4.4 4.4.2 ed Words missing? The scope or other reference on the documents shall make clear that …

Agreed. See below




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OAA 4.4 4.4.2 ED There are some word missing in “The scope or other reference on … shall make”

The documents shall contain the name and address of the central office of the organization and a list of all the sites to which the certification documents relate. The scope or other reference on the certification document shall make clear that the certified activities are performed by the network of sites in the list. If the certification scope of the sites is only issued as part of the general scope of the organization, its applicability to all the sites shall be clearly stated.


SCC 4.4 4.4.2 ed Second sentence seems to be missing something Other reference on what? See above


ed Delete “on” No. Words were missing – see above


There are two periods in the end of the sentence “.... documentation.” Agreed.

PCA 4.4 4.4.3Add clause after

ge The problem of contracts with all sites is not addressed. Suggestion is made to include extra point after 4.4.3

The certification body shall have legally enforceable agreement, directly or through central office, with all the sites covered by the scope of the certification as required by 5.1.2 of ISO/IEC 17021.

Not necessary. Covered by 17021 which applies in full.

SCC 4.4 4.4.3 ge A definition of “sub-certification documents would be useful.

Define “sub-certification” documents Simplified to "Certification…."

EGAC 4.4 4.4.4 ed The certification documentation will be withdrawn in its entirety, if the central office or any of the sites does not/do not fulfil the necessary criteria for the maintenance of the certification

There is no need for do not in this sentence. Agreed.




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DAR/ TGA 4.4 4.4.6 ge See comment to 0.2. The Certification bodies shall have documented procedures for the addition of new sites.

Agreed.

INAB 4.4 4.4.6Note

Ge It conflicts with clause 2.2 which state that temporary sites shall not be included.

A risk analysis should be done of processes done at temporary sites to determine their inclusion in the scope.

Leave as is but remove conflicting statement in clause 2.2

Disagree. Some temporary sites could be quasi permanent (IQnet) – eg. in existence for a year or more. Note deleted.

Inmetro 4.4 4.4.6Note


“...this normative criteria”. Note deleted

HKAS 5.1 5.1.1 te The samples selected should be representative. Replace the words “a range of different” with “a representative range of different” in the second line.

Agreed.

COFRAC 5.1 5.1.45th bullet

ed Consistency with text Replace “activities” by “processes” Agreed.

DANAK 5.1 5.1.4 te Differing legal requirements may also be criteria for selection of sites.

To be added:

Differing legal requirements

OK, but not included. List is not intended to be exhaustive "may include among others"

INAB 5.1 5.1.4 Ed Clarity (addition of commas), consistency of style (semi-colons after each bullet )

may include, among others, the following aspects

All commas etc removed

SWEDAC 5.1 5.1.4 point Significance….

ED Change wording to get the way of writing the document more harmonized

Change to: Significance and extent of environmental aspects and associated environmental impacts.

Amended. See OAA comment

SWEDAC 5.1 5.1.4 point Geographic

TE Clarification of geographical dispersion needed Change point to: Geographical dispersion, Not agreed. Separate issues




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al… including legal requirements

SWEDAC 5.1 5.1.4 TE Important point in IAF GD 6/2006 for EMS has been taken out.

Add to list: - potential interaction with sensitive environment

9th bullet amended

PCA 5.1 5.1.6Add clause after

Te The problem of time gap between visits in central office and local offices is not addressed

5.1.7 The certification body shall have procedure(s) for determining the time frame for completion audit in all the sites. The central office shall be visited first, followed by the sites in any order chosen by lead auditor.

Not agreed. Proposal too prescriptive and no argument to necessarily audit the central office first.

SWEDAC 5.1 5.1.6 TE Important point in IAF GD 6/2006 for EMS has been taken out.

Add to this clause : the surveillance program should include visits, within a reasonable time, to all sites of the organization in accordance with the certification body’s sampling method.

Not agreed. This is not sampling of sites

OAA 5.1 5.1.4 Item 8

ED Environmental Management System reference is incorrect .

Significance and extent of aspects and associated impacts for environmental management systems

Agreed, but (EMS) is retained for clarity

DAR/ TGA 5.2 5.2.1 ge See comment to 0.2. The Certification bodies shall have a documented procedure for determining..

Agreed



“... in this normative criteria”. Agreed. "guidance" replaced with "document" or "criteria" as appropriate

DAR/ TGA 5.2 5.2.2 ge Records on how the sample approach has been adapted to the company shall be available in any multi-site certification – not only restricted when the certification body’s procedures result in a smaller sample as required from the guidance.

Delete the need for records in 5.2.2 and add: “The certification body shall have records on each application of multi-site sampling justifying that it is in accordance with this guidance.”

Agreed




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Inmetro 5.2 5.2.2Second line


“...of the normative criteria set out...” Agreed. "guidance" replaced with "document" or "criteria" as appropriate

Inmetro 5.2 5.2.3Second, third and fourth paragraphs

The square root symbol is missing “ y = x “ Not understood. Square root sign appeared normal when I downloaded from IAF web-site. May be a "WORD" problem

JAB 5.2 5.2.3 te Consistency with 17021 Surveillance audit visit: …

Recertification audit: …

Agreed

JAB 5.2 5.2.3 te The letter ‘v’ is substituted for the square root. Correctly represent the square root (√) Not understood. Square root sign appeared normal when I downloaded from IAF web-site. May be a "WORD" problem


te Low to medium risk activity. This is not defined .It will be different for different management system standards.

For environment and health and safety management systems, risk is a fundamental aspect of the standard and the scope of the standard i.e low medium risk of , for example, environmental pollution or harm to an individual’s occupational health and safety

For quality management systems what is low to medium risk,? Is it of the product failing to meet the customer requirements, or are we confusing the likely impact/consequence of a product failing. Eg a

Reword as follows.

The following calculation is based on the example of a single, or series of simple production/service processes with less than fifty employees at each site. Eg ? ? ?provide typical examples…

The minimum number……….

Initial

Surveillance

Re -certification

Noted. However, brief was to produce document without significant change. The proposal re-opens the whole debate on risk. Much of the proposal is covered in clause 9.1.4 of ISO/IEC 17021

Note added to require CBs to define risks of activities




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carpet or a bridge. ( or a small switch in the new motor car) The purchaser expects both to meet the specified requirements.

For QMS and FSMS there should be no low/medium risk of the system failing, certification is confidence that the product meets customer requirements.

Many “low risk “products have very complex processes

Establish a minimum number of sites based on a single process then CB will be required to increase the sample size based on more complex operations

Add at end of 5.2.3

An increased sample size will be required where complex processes are involved.

DANAK 5.2 5.2.5 te Other relevant factors may indicate the need for increase of the sample.

Underlined text to be added in the list of factors:

Variations in working practices, e.g. shift working

Differing legal requirements

Significance and extent of aspects and associated impacts for EMS management systems

Agreed

Not a factor on sample size

Agreed

EGAC 5.2 5.2.5 te 5.2.5 The size or frequency of the sample should be increased where the certification body’s risk analysis of the activity covered by the management system subject to certification indicates special circumstances in respect of factors such as

This phrase needs to be further explained e.g., in a note. This note should explain how this sampling frequency be increased. Examples should be given e.g., decreasing the surveillance period.

Disagree. Proposal is for prescriptive "how"




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INAB 5.2 5.2.5 Ed Consistency of style Semi-colons after each bullet Agreed. All commas etc removed

DANAK 5.2 5.2.6 ed The number of National offices is missing The number to be added:

4 National offices: sample = 2: minimum 1 at random

Agreed

Inmetro 5.2 5.2.6Second line from the example

The number of “national offices” is missing “4 national offices “ Agreed

JAB 5.2 5.2.6 ed Typo (The number 4 is missing.) 4 national offices: sample=2 Agreed

OAA 5.2 5.2.6 Example

ED The number of National offices of the example is missing (4).

Example:

1 head office: visited at each audit cycle (initial/surveillance/recertification)

4 National offices: sample = 2: minimum 1 at random

27 regional offices: sample = 6: minimum 2 at random

1700 local branches: sample = 42: minimum 11 at random.

Agreed

COFRAC 5.3 5.3.2 ed For clarity to express that the calculation of audit duration time is realised site per site, using the appropriate IAF guidance on each site. “Normally “ is not necessary, the criteria is already a “should” one

“Normally the number of man-days per site, including the central office, should be consistent with the most recently published IAF guidance calculation of man-days for the relevant standard.” By “The number of man-days per site, including the central office,

Agreed




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should be calculated using for each sit the most recently published IAF guidance for calculation of man-days for the relevant standard.”

HKAS 5.3 5.3.2 ed The document on auditor manday is not guidance Replace the word “guidance” with “criteria for”

Agreed.

SCC 5.3 5.3.2 ed Use of “man-days”. This is no longer acceptable as a term.

Please use “person days.” Disagree. Man days is common parlance worldwide and is not gender specific

DANAK 5.3 5.3.3 te Reductions is a common used possibility for certification bodies and any justification need to be recorded in order to maintain historical records, that will be present when there are change of personnel.

Text to be added:

“Reasons justifying reductions shall be recorded by the certification body. “

Agreed

DAR/ TGA 5.3 5.3.3 te Not all clauses of standard could be applied in the audit of central office – as it is the case for the local sites.

“Reductions can be applied to take into account the clauses that are not relevant to the central office and the local sites, or where there is considerable commonality of activities, products and processes at sites. However, certification body shall consider, that auditing the central office requires additional time when multi - site is applied.”

Agreed in part. Last sentence not justified

HKAS 5.3 5.3.3 te The reduction in audit time for “commonality of activities and processes at sites” has been accounted for by sampling. No further reduction should be allowed.

Delete the following from clause 5.3.3:“, or where there is considerable commonality of activities and processes at sites”

Agreed

HKAS 5.3 5.3.4New clause

te Clause 4.3.6 of GD2:2005 should be included for setting a minimum.

Insert a new clause:

5.3.4 The total time expended on initial

I do not support this clause, but it has been retained in simplified form after




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assessment and surveillance (understood as the total sum of the time spent at each site plus the central office) should never be less than that which would have been calculated for the size and complexity of the operation if all the work had been undertaken at a single site (i.e. with all the employees of the company in the same site). In most cases it will be considerably more.

objections from several parties. The last sentence is superfluous.

NAC 5.3 - Te 1. There are no man-day requirements for Multiple Sites and Temporary Sites as in GD2 and GD6.

2. The reductions for auditor time requirements are not clear.

1. It should be added man-day requirements for Multiple Sites and Temporary Sites in this IAF Normative Criteria.

2. It should be clarified for reductions for auditor time requirements.

Noted. This will be addressed in the new "stand alone " document for man day calculations

NAC 2.2 - Te There are no assessment requirements for Temporary Sites and also how to sampling as in GD2 and GD6.

It should be added and clarified. Not agreed. The calculation should be the same for any sites if they are included in the network of sites.

Late Comments

NABCB (ICL)

Cl 4.3.1 Line 3 Ed “Evaluation” is preferable to “investigation” Replace “investigation” with “evaluation” Noted but considered unnecessary

NABCB (ICL)

Cl 4.3.3 Line 1 Te Make a reference to ISO 17000 for definition of non-conformity

Add after non-conformity (refer to ISO 17000:2004)

Not agreed. Refereed back to 17021 as the relevant reference for certification

NABCB (ICL)

Cl 4.4.6 Line 2 Te Additional sites may be added as a part of enhancement of scope activities

Add after “surveillance/recertification” – “enhancement of scope”

Agreed




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NABCB (ICL)

Cl 5.1.4 Bullet point 8

Te This does not seem to be a relevant criteria for sampling of sites

Delete the bullet point Noted, but others think it is relevant

NABCB (ICL)

Cl 5.1.4 Te Add 2 new bullet points regarding differences in language, social norms etc, regulatory requirements

Add 2 bullet points – “Differences in language, work culture, social norms”

“Any differences in applicable regulatory/statutory requirements for different regions/countries

Agreed, but combined in other bullet points

NABCB (BVCI)

Cl 5.3 Entire clause

Te The document should clearly define the criteria to be used [viz. whether the mandays should be calculated individually per site and added OR should be calculated for the total cumulative manpower and distributed OR should be calculated based on the manpower in the sampled sites] for calculating the audit time. In the absence of uniform guidance, each CB will define its own criteria and hence the purpose of the guidance will be defeated.

An example shall be provided for manday calculation under all possible scenarios to avoid any misinterpretation or come out with a manday calculator like IATF has for TS scheme

Noted. However, it is considered that one example is enough. This is a minimum change document and changes have been kept to a minimum



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