Manual for municipalities and stakeholders€¦ · Soil quality -- Determination of organic carbon...

ASSOCIATION „КЕ&B - UV&P” VAT.NR.: BG176245551

OPERATIONAL PROGRAMME ENVIRONMENT 2007-2013

61 PREKI PAT STR., SOFIA 1618 BULGARIA TEL./FAX:(+359 2) 857 5197

E-MAIL: [email protected]

EUROPEAN UNION EUROPEAN REGIONAL DEVELOPMENT FUND

WE INVEST IN YOUR FUTURE

PROJECT NO TA-2011-KPOS-PP-78 „TECHNICAL ASSISTANCE ON WASTE MANAGEMENT” “DEVELOPMENT OF LEGAL FRAMEWORK ON BIO-WASTE MANAGEMENT AND ESTABLISHMENT OF QUALITY ASSURANCE SYSTEM FOR COMPOST AND NATIONAL

ORGANIZATION OF QUALITY ASSURANCE FOR THE COMPOST”

Development of Legal Framework on Bio-Waste Management and Establishment

of Quality Assurance System for Compost and National Organisation of Quality

Assurance for the Compost

STAGE X Preparation of documents for accreditation

and laboratory accreditation to carry out tests of the basic parameters of compost.

Final Report – 25 October 2013 X_Guidance_Lab_v0.4-EN

mailto:[email protected]

Authors:

Florian Amlinger,

Compost – Consulting & Development, Austria

– 4 –

Table of Contents

PART A GUIDE FOR ACCREDITED LABORATORIES FOR CARRYING OUT EXTERNAL QUALITY CONTROL OF COMPOST ACCORDING TO THE ORDINANCE OF THE MINISTER OF ENVIRONMENT AND WATER ON REQUIREMENTS FOR BIOLOGICAL TREATMENT OF BIOWASTE [BIOWASTE ORDINANCE, № 335, FROM 15 OCTOBER 2013], .................................................................................................................................................. 5

MAIN REQUIREMENTS FOR EXTERNAL QUALITY CONTROL AND ANALYTICAL TESTING REGULATED IN THE BIOWASTE ORDINANCE ........ 5

ADDITIONAL REQUIREMENTS FOR SAMPLE TAKING ............................................................................................................. 9

Important definitions from the Biowaste Ordinance ......................................................................................... 9

Sampling of Compost, Stabilised MBT Output and Solid Digestate ................................................................. 10

Sampling methods for liquid or semi-liquid digestate ..................................................................................... 11

THE SAMPLING PROTOCOL .......................................................................................................................................... 11

REPEATED SAMPLING AND ANALYSES; DETERMINATION OF THE ‘ASSESSMENT VALUE’ ............................................................. 21

Important definitions of the Biowaste Ordinance ........................................................................................... 21

Repeated sampling procedures and data interpretation ................................................................................ 21

THE TEST REPORT ...................................................................................................................................................... 23

The required elements to be included in the test report ................................................................................. 23

Exemplary template for the test report according to Annex 3 point 7, Biowaste Ordinance .......................... 24

PART B ACCREDITATION PROCEDURE PURSUANT TO BS EN ISO / IEC 17025 “GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES, 2005” ....................................................... 27

APPLICATION PROCEDURE .......................................................................................................................................... 27

GUIDANCE ON IMPLEMENTING ISO/IEC 17025 ............................................................................................................. 28

– 5 –

PART A

Guide for accredited laboratories for carrying out external quality control of compost according to the

Ordinance of the Minister of Environment and Water on requirements for biological treatment of biowaste

[Biowaste Ordinance, № 335, from 15 October 2013],

Main requirements for external quality control and analytical testing regulated in the Biowaste Ordinance

Pursuant to Article 14 of the Biowaste Ordinance, the regular external quality control of COMPOST, FERMENTATION PRODUCT, ORGANIC SOIL AMENDEMENT as well as STABILISED MBT OUTPUT has to be carried out by accredited laboratories.

It includes

sampling

laboratory analyses

the issuing of the test report a

For all these elements, sampling, analytical methods and test report, the laboratory must be accredited according to BS EN ISO / IEC 17025.

The detailed rules and procedures are described in Annex 3 of the Biowaste Ordinance.

Here a short summary of the main items described in Annex 3:

Annex 3: Product testing, external quality inspection, RIEW control measures

This Annex describes the entire procedure of the obligatory external quality inspection and testing of all types of products: compost, fermentation product, organic soil amendment or stabilised MBT output. It covers the following elements:

Sampling & testing frequency during

o RECOGNITION YEAR

o REGULAR ROUTINE TESTING in follow-up years

With exceptions for capacities < 2.500 t (1x/year) and < 500 t (1x/2 years)

The Sampling method

o Compost and Stabilised MBT output: EN 12579 ‘Soil Improver and Growing Media – Sampling’ & minimum quantity of sampled portion

o Digestate: ISO 5667-13:2011: ‘Water quality -- Sampling -- Part 13: Guidance on sampling of sludge’

– 6 –

Minimum elements of the sampling protocol to be issued by the sample taker and which has to be attached to the test report

Requirements for repeated sampling and how to calculate the final assessment value (estimation of outliers, mean value, tolerances for the individual quality criteria)

Minimum elements of the test report to be issued by the accredited laboratory containing all analytical results

List of all analytical methods which are needed for quality assessment and the labelling. Here it is important to not that:

o For all laboratory methods in principle European Standards (EN) as listed in Annex 3 shall be used. But other international (ISO) or Bulgarian and well as standards from other Countries are allowed under tze following conditions:

International standards implemented by Bulgarian standards, if no EN standards have been adopted by BG standards

Bulgarian standards if neither EN nor ISO standards have been adopted by BG standards

International and national standards of other countries, if neither EN, nor ISO, nor national BG standards have been adopted in Bulgaria

The standard analytical test methods to be used are defined in Annex III, point 8 Table 3-3 of the Biowaste Ordinance.

Table 1: Standard Methods as defined in Annex 3, Biowaste Ordinance

Testing parameters Method - Standard

Sampling of solid outputs from composting and MBT

БДС EN 12579:2000 from 18 Jan 2001

Soil improvers and growing media - Sampling

Sampling of digestate БДС EN ISO 5667-13: 2011

Guidance on sampling of sludges

Sample pre-treatment БДС EN 16179:2012 10 15

Sludge, treated biowaste and soil - Guidance for sample pre-treatment; EN 16179:2010

Determination of a Quantity

БДС EN 12580:2000 from 03 Nov 2001

Soil improvers and growing media - Determination of a quantity

pH value (CaCl2) БДС EN 15933:2012 10 01

Sludge, treated biowaste and soil - Determination of pH

Electrical conductivity БДС EN 13038:2011 12 01; Soil improvers and growing media - Determination of electrical conductivity

CEN/TS 15937:2013 Sludge, treated biowaste and soil - Determination of specific electrical conductivity

Water content БДС EN 15934:2012 10 01

Sludge, treated biowaste, soil and waste - Calculation of dry matter fraction after determination of dry residue or water content

Dry matter content БДС EN 15934:2012 10 01

Sludge, treated biowaste, soil and waste - Calculation of dry matter fraction after determination of dry residue or water content

– 7 –


Loss on ignition (Organic matter content, Total organic carbon))

БДС EN 15936:2012

Sludge, treated biowaste, soil and waste - Determination of total organic carbon (TOC) by dry combustion

БДС EN 15935:2012 10 01

Sludge, treated biowaste, soil and waste - Determination of loss on ignition

ISO 14235:2002

Soil quality -- Determination of organic carbon by sulfochromic oxidation

Particle size distribution БДС EN 15428:2007: Soil improvers and growing media - Determination of particle size distribution

N (total)

(Kjeldahl N)

БДС EN 16169:2012

Sludge, treated biowaste and soil - Determination of Kjeldahl nitrogen

БДС EN 16168:2012

Sludge, treated biowaste and soil - Determination of total nitrogen using dry combustion method

NO3-N (dissolved)

NH4-N (dissolved)

Determination of extractable ammonium and nitrate nitrogen in the extract with 1 mol/dm3 KCl:

СД CEN/TS 16177:2012 Sludge, treated biowaste and soil - Extraction for the determination of extractable ammonia, nitrate and nitrite

Determination of extractable nitrogen and ammonium nitrate in aqueous extracts:

БДС EN 13652:2003

Soil improvers and growing media. Extraction of water soluble nutrients and elements

Weed seeds CEN/TS 16201:2010 Sludge, treated biowaste and soil - Determination of viable plant seeds and propagules

Plant response

БДС EN 16086-1:2011:

Soil improvers and growing media - Determination of plant response - Part 1: Pot growth test with Chinese cabbage.

Impurities CEN/TS 16202:2010

Sludge, treated biowaste and soil — Determination of impurities and stones.

This standard describes two method to determine the physical impurities > 2 mm and stones > 5 mm in soils, sludges and treated biowastes. For the purpose of this Ordinance the Dry sieving method is used applying direct analysis without washing as described in chapter 7.2 of the standard..

Heavy metals and phosphorus

– 8 –


Extraction methods БДС EN 16173:2012 10 01

Sludge, treated biowaste and soil - Digestion of nitric acid soluble fractions of elements

БДС EN 16174:2012 Sludge, treated biowaste and soil - Digestion of aqua regia soluble fractions of elements

Determination of extractables forms of heavy metals and phosphorus in the extract obtained with nitric acid / aqua regia

P (total)

K (total)

Mg (total)

CaO

S (total)

CEN/TS 16170:2012

Sludge, treated biowaste and soil - Determination of elements using inductively coupled plasma optical emission spectrometry (ICP-OES)

CEN/TS 16188:2012 Sludge, treated biowaste and soil - Determination of elements in aqua regia and nitric acid digests - Flame atomic absorption spectrometry method (FAAS)

Pb, Cd СД CEN/TS 16170:2012


СД CEN/TS 16171:2012

Sludge, treated biowaste and soil - Determination of elements using inductively coupled plasma mass spectrometry (ICP-MS)

СД CEN/TS 16172:2012

Sludge, treated biowaste and soil - Determination of elements using graphite furnace atomic absorption spectrometry (GF-AAS);

Cr, Cu, Ni, Zn СД CEN/TS 16170:2012


СД CEN/TS 16171:2012

Sludge, treated biowaste and soil - Determination of elements using inductively coupled plasma mass spectrometry (ICP-MS)

СД CEN/TS 16172:2012

Sludge, treated biowaste and soil - Determination of elements using graphite furnace atomic absorption spectrometry (GF-AAS)

СД CEN/TS 16188:2012 Sludge, treated biowaste and soil - Determination of elements in aqua regia and nitric acid digests - Flame atomic absorption spectrometry method (FAAS)

– 9 –


Hg СД CEN/TS 16172:2012

Sludge, treated biowaste and soil - Determination of elements using graphite furnace atomic absorption spectrometry (GF-AAS)

СД CEN/TS 16188:2012 Sludge, treated biowaste and soil - Determination of elements in aqua regia and nitric acid digests - Flame atomic absorption spectrometry method (FAAS)

CEN/TS 16175-1:2013 Sludge, treated biowaste and soil - Determination of mercury - Part 1: Cold-vapour atomic absorption spectrometry (CV-AAS)

CEN/TS 16175-2:2013

Sludge, treated biowaste and soil - Determination of mercury - Part 2: Cold-vapour atomic fluorescence spectrometry (CV-AFS)

PCB(7) БДС EN 16167:2012

Sludge, treated biowaste and soil - Determination of polychlorinated biphenyls (PCB) by gas chromatography with mass selective detection (GC-MS) and gas chromatography with electron-capture detection (GC-ECD)

PCDD/PCDF CEN/TS 16190:2012 Sludge, treated biowaste and soil - Determination of dioxins and furans and dioxin-like polychlorinated biphenyls by gas chromatography with high resolution mass selective detection (HR GC-MS)

PAH (16) CEN/TS 16181:2012

Sludge, treated biowaste and soil - Determination of polycyclic aromatic hydrocarbons (PAH) by gas chromatography (GC) and high performance liquid chromatography (HPLC)

Salmonellae

СД CEN/TR 15215-3:2006

Characterization of sludges - Detection and enumeration of Salmonella spp. in sludges, soils, soil improvers, growing media and biowastes - Part 3: presence/absence method by liquid enrichment in peptone-novobiocin medium followed by Rapport-Vassiliadis

E. coli CEN/TR 16193:2013

Sludge, treated biowaste and soil - Detection and enumeration of Escherichia coli

Additional requirements for sample taking

Important definitions from the Biowaste Ordinance

"Individual sample" is the amount of a sample taken from any point of sampling.

"Assessment quantity" is the minimum amount of compost batch required for sample testing of compost under the relevant standard.

"Composite sample" is the total of the individual samples which are combined into a single sample.

„Laboratory sample" is the part of a composite sample which is reduced to the quantity needed to carry out the laboratory and hygiene tests.

– 10 –

"Test Batch" is a compost batch or part of it, which is investigated in the course of external quality testing .

"Compost batch" is every single compost (row, heap, pile), produced under the same conditions and at the same time.

"Sampling point": the points, spread evenly throughout the assessment batch, from which individual samples are obtained.

Sampling of Compost, Stabilised MBT Output and Solid Digestate

The requirements of the sampling procedure are defined in Annex III, point 4 of the Biowaste Ordinance.

As indicated, the method of sampling БДС EN 12579 ‘Soil Improver and Growing Media – Sampling’.

In addition to the principles and procedures as described under БДС EN 12579, the sample taker under the surveillance of the accredited laboratory has to observe the following conditions:

The sampled portion must be in the same condition with regard to the preparation (sieving, removal of harmful substances etc.) as the associated batch, which is intended to be used or placed on the market.

This needs to be confirmed by the contracting operator or its representative.

Sampling may be preferably undertaken during loading or discharge

In case of final refinement of composted materials usually the compost is screen befor offered for use or marketing. Taking samples during the screening process from a sampling portion representing a defined batch provides in principle a good representation of the entire material. Therefore, if technically feasible, this should be the preferred method.

In any case, the final, composite sample must represent the whole of the material of the sampled portion.

Therefore the detailed procedure of gaining the composite sample including number and distribution of sapling points for the incremental samples shall be noted in the sampling protocol

Batches of which the feedstock composition differs more than 20% by volume must be sampled and tested separately.

This is in principle a responsibility of the operator but if there is a clear indication by visual inspection that the sampled portion presented by the operator does not represent the type of composts or digestate otherwise produced, this should be indicated in the sampling protocol

The minimum quantity of a sampled portion is below.

Table 2: Minimum quantity of sampled portion of compost.

For composted Biowaste

Quantity of treated input material Minimum quantity of sampled portion

– 11 –

per year

< 2,000 t 50 m³

2,001-10,000 t 100 m³

> 10,000 t 150 m³

For stabilised MBT Output

For all all quantities treated per year 500 m³

Quantity the laboratory sample: For the testing of all obligatory quality criteria as defined in

Annex 2 and the parameters to be indicated in product information and labelling (Annex 5, Compost Ordinance), the quantity of the final laboratory sample shall be 15 to 20 litre.

Sampling methods for liquid or semi-liquid digestate

Sampling of digestate has to be done pursuant to БДС ISO 5667-13: 2011.

In addition to the principles and procedures as described under БДС ISO 5667-13: 2011, the sample taker under the surveillance of the accredited laboratory has to observe the following conditions:

Samples for investigation should be taken from the digestate ready for use or marketing.

Therefore the sample shall be taken from the storage tank for fermentation residues when the entire fermentation process is finished.

Digestate of which the feedstock composition differs more than 20% by volume must be sampled and tested separately.

Since separation into a liquid and a (semi) solid phase is a frequently applied practice before marketing and use of fermentation products, there are two options for the sample taking:

a. when the fermentation process has completed and the digestate is marketed directly,

or

b. after separation as liquid and/or semi-solid digestate

Each final sample sent for analysis shall be representative of the final product.

Therefore the detailed procedure of gaining the final laboratory sample including number and distribution of taking individual samples, method of mixing and homogenising etc. shall be noted in the sampling protocol

Quantity the laboratory sample: The volume of the final laboratory sample should be sufficient for all obligatory analyses. As a general rule the sample quantity should be approximately 7 to 10 litres.

The sampling protocol

The requirements for the sampling protocol are defined in Annex III, point 5 of the Biowaste Ordinance.

– 12 –

The minimum elements to be included in the sampling protocol is listed below. Further in the Annex to this document you will find an exemplary template for a standard sampling protocol including all necessary elements and information.

The sample taker shall produce a sampling protocol of each sample taken. The sampling protocol shall be included in the Test Report under Art. 14, para. 3 and shall cover at least the following elements:

Name and address of the manufacturer of the compost

Address of the facility of composting

Name of sample taker;

Name and address of the contracted laboratory which carries out the analyses;

Date of sampling;

Code(s) of the batch(es) from which the sample was taken;

Sample code;

Location, quantity (m³) and cross-section (in case of piles of solid material) of sampled lot ;

Type of material (compost, fermentation product, organic soil amendment, stabilised MBT output),

Mesh size used if screened;

Description of visual properties (homogeneity, moulds, smell);

Total processing time of sampled batch;

Description of the sampling (nr. of and distribution of sampling points; volume of individual samples; used equipment; sampling during screening etc.);

If necessary, additional comments;

Signature of the sample taker and the operator or of his authorised representative.

– 13 –

Sampling Protocol

Pursuant Annex 3, Biowaste Ordinance № 235 from 15 October 2013

Laboratory

name

ZIP town

street street no.

Sampling record Sample №

Date: Sample taker:

1. General Data

Compost Producer

surname name

ZIP town

street street no.

Firm name (if applicable) .

Contact person

If not identical with compost producer surname name

Tel. No fax No. (optional) e-mail (optional)

Composting Plant, Site of sampling Name/designation

ZIP town

street street no.

National Quality Assurance System Name/designation

ZIP town

– 14 –

2. Intended Declaration

Batch № Product Type

Compost

Organic Soil

Amendment

from

composting

Fermentation

Product

Organic Soil

Amendment from

anaerobic

digestion

Stabilised MBT

Output

Brand mark

D e t a i l e d i n t e n d e d D e c l a r a t i o n

Quality-designation Reg. 2092/91 EU Eco Label

National…..

Used feedstock categories

Manure Green waste

Bio waste from households (bio bin)

Other ABPs Category 2

ABPs Category 3

Catering waste

Former foodstuff

Other cat. 3 ABP

Sewage Sludge complying with Criteria of Table A1-3, Annex 1 Biowaste Ordinance

Foreseen areas of application

organic agriculture general landscaping (non food) reclamation of landfills, brown fields, road construction

land reclamation in agricultural Horticulture/green house Sports grounds

conventional agriculture Tree nurseries biofilter

arable land Forestry/silviculture

grass land private gardening

field vegetable Growing media constituent Marketing in bags

Remarks (Excluded areas of application (in order to determine the necessary parameters to be analysed):

ABP … Animal By-Products pursuant to Regulation (EC) № 1069/2009.

– 15 –

3. Weather conditions

°C........................................... dry rain Comment: ...........................................................

...................................................................................................................................................................................................

4. Process management (hygienisation)

Temperature protocol sanitisation phase Yes No

Temperature protocol maturing phase Yes No

Temperature protocol copy received Yes No

Remarks on temperature monitoring: ......................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

Monitoring of Process control Yes No

turning dates Yes No

regulation of forced aeration Yes No

watering Yes No

addition of feedstocks and additives Yes No

other: Yes No

Yes No

Yes No

Documentation copy received Yes No

Remarks: .................................................................................................................................................................

.................................................................................................................................................................................

Total duration of rotting covering all batches included in the final lot sampled

Remarks ...................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

– 16 –

5. Sampling within last testing period?

.......................................................................................................................................................................................

.......................................................................................................................................................................................

6. Last compost analyses

Batch-No.: № of Report: date of sample taking: report:

(1) .................................. ................................................................ .............................. .......................

.................................................................................................................................................................................................... Laboratory

7. Sampling description

Notes: ...........................................................................................................................................................................

.......................................................................................................................................................................................

length width height m³ t

Size of sampled portion --------------- Meter --------------

............................................ ........................... lot.-No. screen (mm)

Data provided

measured

Size of total compost batch

............................................ ........................... batch.-No. screen (mm)

Data provided

measured

Description of sampling (Nr. of incremental samples; Sample taking from conveyor or screen; quantity of

incremental samples; preparation of combined sample; preparation of laboratory sample; parallel samples; packaging etc.; reference to sampling standard):

.......................................................................................................................................................................................

.......................................................................................................................................................................................

.......................................................................................................................................................................................

.......................................................................................................................................................................................

.......................................................................................................................................................................................

.......................................................................................................................................................................................

.......................................................................................................................................................................................

Sampled lot, designated unequivocally? Yes No

– 17 –

8. Description of the sampled portion or batch

Site/plant compartment: ................................................ Size: .................................................................... m²

Date of Batch SET-UP: .................................................. Batch composition: yes no

Batch composition (%age of input materials): .....................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

No. of batches on the site compartment: .............................................................................................................

Pre-treatment of sampled lot

Screening / mesh size: ............................................ mm

Magnetic separator: yes no Wind separator: yes no

Notes / Observations

Odour: very strong strong medium slight non

Moisture: very dry dry humid very humid wet

Impurities: very high amount high amount medium few non

Mould/fungi: very high amount high amount medium few non

Homogeneity: very good good medium low cannot be sampled

Coverage: covered partly covered not covered

Notes: .......................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

– 18 –

9. Site drawing of sampled compost batches and portions

– 19 –

10. Photographs of the sa pled portion and the site where the sample was taken

– 20 –

11. Final notes

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

.................................................................................................................................................................................

12. Signatures

Date:

Sample Taker: Responsible PERSON Of the facility

Repeated sampling and analyses; determination of the ‘assessment value’

The requirements for repeated sampling are defined in Annex III, point 6 of the Biowaste Ordinance.

Important definitions of the Biowaste Ordinance

"Assessment value" is the mean of a number of individual measurement values of a parameter.

"Individual measurement value": the result of a single determination of a parameter.

Repeated sampling procedures and data interpretation

For statistical reasons and due to repeatability of analytical results usually achieved in matrices like compost and sludge like materials the Biowaste ordinance requires repeated sampling of the sampled portion if a certain percentage of the limit value is exceeded in order to verify the achieved test result.

This should not be mixed up with standard procedures of repeated measurements of laboratory test samples in order to assess the accuracy of the extraction or value detection procedure.

Here, the parallel testing starts with a repeated sampling from a sampled portion or lot taking the necessary individual samples and preparing the composed sample and the final laboratory sample as desribed in БДС EN 12579 (solid samples) and БДС ISO 5667-13: 2011 (liquid and semi-liquid samples) respectively.

Routine sample preparation and the entire analytical procedure are repeated for each of the single laboratory samples.

In principle the maximum number of repeated samples for determination of the assessment value is 6.

The specific requirements have been set for:

Inorganic contaminants (heavy metals)

o cadmium, chromium, copper, nickel, mercury, lead and zinc

Impurities

Plant response

Maximum particle size

Organic contaminants (to be analysed only in Stabilised MBT Output)

o PAH(16), PCB(7), PCDD/PCDF

Table 3: Procedure for the determination of the assessment value in case of repated sampling

Requirements:

Parameter group 1 Parameter group 2

Cadmium, chromium, copper, nickel, mercury, lead, zinc

Impurities

Plant response

Maximum particle size

PAH(16), PCB(7), PCDD/PCDF

Repeated sampling and tests are required if:

90% 80%

Maximum number of parallel samples taken and analysed:

6 6

Maximum number of outliers that may be eliminated:

2 2

Maximum percentage individual measurement values may exceed the respective limit value:

30% 30%

Determination of the assessment value:

Mean value of individual measurement values after elimination of maximum 2 outliers

In the case of "organic matter" and "electrical conductivity" the repeated sampling procedure was not applied.

For those paraeters, each individual measured value must comply with the relevant limit value.

The test report

The required elements to be included in the test report

The minimum elements as defined in Annex III, point 7 of the Biowaste Ordinance are listed below.

Below you will find an exemplary template for a standard test report including all necessary elements and information.

The Test Report issued by the accredited laboratory shall contain the following elements:

Operator data (name, address, ID, contact person);

The sampling protocol;

Details of the sample taker;

Information about the reception of sample;

A compilation of the analytical test results containing: the sample designation (code), the internal laboratory sample code and, if applicable, the parallel samples taken; the individual test results, the assessment value, the deviation and possible elimination of outliers for all parameters tested;

Indication in case of significant deviation from the standard analytical methods used

Confirmation that all available information has been taken into account, there are no signs of feedstock used that is not permitted in general or for the proposed application area (art. 16, para. 1, item 2);

Date of issuing the report;

Signature of the accredited laboratory.

Exemplary template for the test report according to Annex 3 point 7, Biowaste Ordinance

Test report [pursuant to Annex 3, Ordinance № 335, from 15 October 2013]

Report №:

General Information:

Contractor/Plant of the Testing

Name/address of plant operator:

Telephone:

Mobile:

Fax:

Name of responsible contact person: Email

Laboratory, sample taking and sample data:

Main raw materials and additives used for producing the sampled batch: Batch code:

Company of sample taker:

Name of sample taker: Telephone:

Date of sampling: Sampling protocol №: Sample code:

Name/location of laboratory:

Date of sample reception: Lab code of the sample

Laboratory №: Name of responsible lab person: Tel./Fax:

Email:

Product Type:

Compost

Organic Soil

Amendment from

composting

Fermentation

Product

Organic Soil

Amendment from

anaerobic digestion

Stabilised MBT

Output

Repeated sampling and determination of the assessment values:

In order to verify the the assessment value repeated sampling and analyses based on in compliance with Annex 3 Biowaste Ordinance was carried

YES NO

If YES, number of repeated samples taken and analysed:

If YES, for the following parameters were analysed in the repeated samples:

Test Results

Physical parameters Assessment

Value

Plant nutrients Assessment

Value

1. Maximum particle size mm 8. Nitrogen total (N) % DM

2. Water content % FM 9 Nitrate NO3-N (dissolved) % DM

3. Dry matter content % FM 10 Ammonia NH4-N (dissolved) % DM

4. Loss on ignition % DM 11. Phosphate total (P2O5) % DM

5. Total organic carbon % DM 12. Potassium total (K2O) % DM

6. Total impurities > 2 mm (including glass, metals, plastics)

% DM 13. Magnesium total (Mg2O) % DM

7. Stones > 5 mm % DM 14. Sulphur total (S) % DM

Biological parameters Soil improvement

15.. Plant response/Germination (rel.)

17. Organic matter (OM) % DM

with 25 % test substrate content % 18. Liming value (CaO) % DM

with 50 % test substrate content % 19. Electrical conductivity mS/cm

16. Viable weed seeds and plant propagules

plants/l 20. pH (CaCl2)

Hygiene parameters Assessment Value

21. Salmonellae

22. E.coli CFU/g FM

Heavy metals and organic pollutants

Heavy metals Limit Values of the Biowaste Ordinance

Compost / Fermentation product

Organic soil amendment / Stabilised MBT output

23. Cadmium (Cd) mg/kg DM 2,0 mg/kg DM 3.0 mg/kg DM

24. Chromium (Cr) mg/kg DM 100 mg/kg DM 200 mg/kg DM

25. Copper (Cu) mg/kg DM 250 mg/kg DM 400 mg/kg DM

26. Mercury (Hg) mg/kg DM 1.0 mg/kg DM 2.0 mg/kg DM

27. Nickel (Ni) mg/kg DM 80 mg/kg DM 100 mg/kg DM

28 Lead (Pb) mg/kg DM 180 mg/kg DM 250 mg/kg DM

29. Zinc (Zn) mg/kg DM 800 mg/kg DM 1200 mg/kg DM

Organic Pollutants - Stabilised MBT Output

30. PAH (16) mg/kg DM 6 mg/kg DM

31. PCB (7) mg/kg DM 0.7 mg/kg DM

32. PCDD/PCDF ng TU/kg DM 30 ng TU/kg DM

Remarks by the testing lab (Complaints, special issues, descriptions, others)

Deviation from the standard analytical methods as listed in Annex 3 Biowaste Ordinance:

NO YES (please describe which)

List of all analytical methods applied and indicate

Confirmation that based on all available information, that feedstock used is not permitted in general or for the proposed application area (art. 16, para.1, item 2 )

YES NO (please describe!)

If NO, describe:

Protocoll of repeated sampling and the determination of the ‘assessment value’

Parameter Dimen-

sion

Individual measurement values Outlier eliminated

[№ of individual measurement value]

Assessment value

[Mean of individual measurement

values] 1 2 3 4 5 6

1.

2.

3.

4.

Date of the report and signature of responsible person of the accredited laboratory: ______________ ___________________________________________

DM – Dry matter; FM – Fresh matter; ng TU – nanogram toxic units

PART B

Accreditation procedure pursuant to BS EN ISO / IEC 17025 “General Requirements for the Competence of Testing and Calibration

Laboratories, 2005”

Application Procedure

Applicant for accreditation must submit to the Executive Agency "Bulgarian Accreditation Service" the documents, listed below, in electronic format and printed in a single copy.

The documents can be found at the web page of the Accreditation service, specifically for “Testing Laboratories at: http://www.nab-bas.bg/393/documentslib/BasicInstructions/3273

1. Application template form for accreditation of testing laboratories (the form is available as annex BAS QA 2.1.1 on the internet page of the agency)

2. General information on the testing laboratory (Annex BAS QA 2.1.2);

3. Table for accordance with BS EN ISO / IEC 17025 (Annex BAS QA 2.1.3);

4. Subcontractors (Annex BAS QA 2.1.4);

5. Staff of the testing laboratory (Annex BAS QA 2.1.5);

6. Test products and properties (Annex BAS QA 2.1.6);

7. List of the used testing methods (Annex BAS QA 2.1.7);

8. Technical equipment (Annex BAS QA 2.1.8);

9. Declaration of ownership (Annex BAS QA 2.1.9);

10. Plan / drawing of the testing laboratory rooms - description. Specific requirements and documents;

11. Model of the testing report;

12. Declaration of art. 19 paragraph. 2 (Annex BAS QF 2.8);

13. Documents for the legal laboratory status - a decision for initial entry in the Commercial Register and the UIC of the legal entity / sole trader

14. Current approved organization chart of the legal entity / sole trader and the laboratory;

15. Copy of the insurance policy "liability" for the laboratory;

16. Supervised copy of the quality guidance (BS EN ISO / IEC 17025);

17. Supervised copies of other documents from the control system (BS EN ISO / IEC 17025);

18. Copy of the report / final report from an internal audit;

19. Copy of the report / minutes of the last inspection, conducted by management;

20. Information on planned and conducted interlaboratory comparisons and proficiency testing (Annex BAS QA 2.1.10).

http://www.nab-bas.bg/393/documentslib/BasicInstructions/3273

21. Document for the amount, paid for review of the submitted documents according to the Price List BAS QR 8;

22. Complete list of the documents attached to the application in accordance with paragraph 4.1.1.2 of BAS QR 2.

Guidance on implementing ISO/IEC 17025

In support of Laboratories who are aiming to achieve accreditation for carrying out the external quality control as laid down by the Biowaste Ordinance the following provides a full guidance on the accreditaiion project under BS EN ISO / IEC 17025.

This document is translated from: „Understanding and Implementing ISO/IEC 17025“ issued by Agilent Technologies, Inc. 2009.

Understanding and Implementing ISO/IEC 17025

A Primer

Dr. Ludwig Huber

Chief Advisor for Global FDA and ISO/IEC 17025 Compliance

Understanding and Implementing ISO/IEC 17025

Dr. Ludwig Huber

Chief Advisor for Global FDA and ISO/IEC 17025 Compliance

4

Preface

This primer is intended to give a brief introduction to ISO/IEC 17025: the global standard

for laboratory accreditation.

After reading this primer, laboratory managers, staff, and others who might be affected by

ISO/IEC laboratory accreditation should:

• Understand the benefits of laboratory accreditation.

• Have an overview of management and technical requirements.

• Know what steps are required to evaluate whether or not laboratory accreditation makes good business sense.

• Be familiar with implementation steps.

• Know the types of documentation required.

• Know how to prepare a laboratory for internal and external audits.

The concepts and ideas expressed in this primer are my own and do not necessarily

reflect official Agilent or LabCompliance policies.

Quality standards are quite dynamic. They are updated every couple of years. Related

implementation guidelines, as developed by international committees, are published even

more frequently. What is state-of-the art today may not be appropriate tomorrow.

A timely update of all information is important and only possible using online information tools.

Web sites with regular updates related to quality standards in laboratories include:

http://www.iso.org

The Web site of the International Organization for Standardization can be used for

ordering ISO standards and other documents.

http://www.ilac.org

The Web site of the International Laboratory Accreditation Cooperation contains guidance

documents with information on the interpretation of accreditation criteria for specific

applications.

http://www.citac.cc/

The Cooperation on International Traceability in Analytical Chemistry Web site has

downloads that are helpful for implementing ISO/IEC 17025.

http://www.labcompliance.com

Updated regularly, this Web site includes tutorials relevant to laboratory quality and

compliance issues.

Dr. Ludwig Huber

http://www.iso.org/http://www.ilac.org/http://www.citac.cc/http://www.labcompliance.com/

5

Chief Advisor for Global FDA and ISO/IEC 17025 Compliance LabCompliance

[email protected]

mailto:[email protected]

6

Contents

PREFACE ........................................................................................................................................................................................................................................ 4

MANAGEMENT SUMMARY.......................................................................................................................................................................................................... 7

MAIN BENEFITS OF CORRECTLY IMPLEMENTED ISO/IEC 17025 ........................................................................................................................................ 8

REQUIREMENTS OVERVIEW............................................................................................................................................................................................. 9

KEY STEPS TOWARDS ACCREDITATION ............................................................................................................................................................................ 10

INTRODUCTION .......................................................................................................................................................................................................................... 11

QUALITY SYSTEMS .......................................................................................................................... 12

ISO/IEC 17025 – Laboratory Quality System ................................................................................................................................................... 12

Scope and Contents of this Primer ................................................................................................................................................................... 14

MANAGEMENT REQUIREMENTS ............................................................................................................................................................................................... 15

Organization .................................................................................................................................................................................................................... 16

Management System ........................................................................................................................................................................................ 16

Document Control ............................................................................................................................................................................................. 17

Review of Requests, Tenders, and Contracts .................................................................................................................................................. 17

Subcontracting of Tests and Calibrations ........................................................................................................................................................ 17

Purchasing Services and Supplies .................................................................................................................................................. 18

Service to the Customer .................................................................................................................................................................................... 18

Complaints ......................................................................................................................................................................................................... 19

Control of Nonconforming Testing and/or Calibration Work ........................................................................................................................................ 19

Improvement ................................................................................................................................................................................................................. 19

Corrective Action ............................................................................................................................................................................................... 20

Preventive Action .............................................................................................................................................................................................. 20

Control of Records ............................................................................................................................................................................................. 21

Internal Audits ................................................................................................................................................................................................... 22

Management Reviews ...................................................................................................................................................................................... 22

TECHNICAL REQUIREMENTS ....................................................................................................................................................................................................... 23

7

General ............................................................................................................................................................................................................... 24

Personnel ........................................................................................................................................................................................................... 24

Accommodation and Environmental Conditions ........................................................................................................................................... 25

Test and Calibration Methods and Method Validation .......................................................................................................................................... 26

Equipment.......................................................................................................................................................................................................... 28

Measurement Traceability ...................................................................................................................................................................................................... 28

Sampling ............................................................................................................................................................................................................ 29

Handling Test and Calibration Items ................................................................................................................................................................ 29

Assuring the Quality of Test and Calibration Results ...................................................................................................................................... 30

Reporting of Results .......................................................................................................................................................................................... 30

8

Recommendations for Implementation ...................................................................................................................................................... 31

Organizational Structure ......................................................................................................... 33

Equipment ................................................................................................................................. 34

Documenting Specifications .................................................................................................... 34

Selecting a Vendor................................................................................................................................... 35

Installation and Documentation ............................................................................................. 35

Initial Testing for Calibration and/or Performance Verification .............................................. 35

Testing During Ongoing Use .................................................................................................... 37

Maintenance and Repair ......................................................................................................... 37

Software and Computer Systems............................................................................................ 37

Measurement Traceability .................................................................................................................... 39

Measurement Uncertainty ............................................................................................................ 42

Steps Toward

ISO/IEC 17025 Accreditation ................................................................................................................................................................ 45

Investigation ............................................................................................................................. 47

Implementation ............................................................................................................................... 48

Documentation ..................................................................................................................................................................................................... 49

Policies and Quality Manual .......................................................................................................... 52

Processes ..................................................................................................................... 52

Standard Operating Procedures (SOPs) and Work Instructions ........................................... 52

Records ...................................................................................................................................... 53

Document Control .................................................................................................................... 53

Internal and External Audits .......................................................................................................................................................................... 55

Internal Audit Schedule ............................................................................................................ 57

Audit Phases ............................................................................................................................. 57

9

Dealing with Multiple Regulations

and Quality Standards .............................................................................................................................................................................. 59

References .................................................................................................................................................................................................... 62

Glossary ...................................................................................................................................................................................................................... 63

10

Management Summary

11

Management Summary

ISO/IEC 17025 is the global quality standard for testing and calibration laboratories. It

is the basis for accreditation from an accreditation body. The current release was

published in 2005.

There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical

Requirements. Management requirements are related to the operation and effectiveness of

the quality management system within the laboratory, and this clause has similar

requirements to ISO 9001. Technical requirements address the competence of staff; testing

methodology; equipment and quality; and reporting of test and calibration results.

Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs

involved should be considered before proceeding.

Main Benefits of Correctly Implemented ISO/IEC 17025:

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides both

laboratory and business benefits such as:

• Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will

also help to get more contracts from organizations that don’t mandate accreditation, but

do give preference to accredited laboratories in competitive situations.

• Improved national and global reputation and image of the laboratory.

• Continually improving data quality and laboratory effectiveness.

• Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.

Analytical testing laboratories seeking ISO/IEC 17025 will be impacted in multiple

areas. The main difference between good analytical practices and formal accreditation is

the amount of documentation to be developed. There is no doubt that any good analytical

laboratory uses qualified analysts, checks the performance of equipment used for

testing, and validates analytical methods. However, many times the outcome of the tests

is not fully documented. ISO/IEC 17025 accreditation requires formal documentation for

nearly everything. It is similar to operating in a regulated environment – ‘what is not

documented is a rumor,’ and is viewed by assessors

as ‘not being done.’

12

The overall impact of

accreditation on an

analytical laboratory can

be best illustrated by

looking at the whole

sample/data workflow.

Figure 1 shows a typical

laboratory workflow of

samples and test data,

together with ISO/IEC

17025 requirements.

13

Requirements Overview:

ISO/IEC 17025 Requirements for Testing Laboratories

Sampling Sample Handling

Testing Test

Reports

Record Maintenance

Sampling plan

& sampling documentation

Sample identification &

protection of sample integrity

Monitoring the quality

of test results

Test conditions

& test results, with estimated

uncertainty

Ensure record integrity

& security

Compliance across all workflow steps

• Validation of analytical methods & procedures • Equipment calibration testing & maintenance • Qualification of material • Traceability

• Control of nonconforming testing • Qualification of personnel • Controlled environmental conditions • Written procedures

Compliance across the laboratory

Documentation control, corrective & preventive actions, complaint handling,

supplier & subcontractor management, non-conflicting organizational structure, internal audits

Figure 1: ISO/IEC 17025 Requirements for Testing Laboratories

Specific requirements include:

• Sampling should be performed according to a sampling plan, and all sample details should be documented.

• Samples should be uniquely identified and the sample integrity should be protected during transport and storage.

• The quality of test results should be monitored.

• Test reports should include test results as well as an estimation of the overall measurement uncertainty. The report should also include either detailed information

about the sample and test conditions, or a link to a reference document.

• Records should be properly maintained to ensure data integrity and availability.

Some requirements impact more than one workflow step:

• All analytical methods and procedures should be validated. This includes methods

14

and procedures for sampling, testing and data evaluation.

• Equipment used for sampling and testing should be calibrated, tested, and well maintained. Material such as calibration standards should be qualified and traceable to

System International (SI) units or to certified reference material.

10

• Nonconforming test results should be documented and controlled.

• People should be qualified for their assigned tasks through education, experience, or training.

• Environmental conditions such as temperature, humidity, and electromagnetic interference should be monitored and controlled.

• All routine tasks should be performed according to written procedures.

Some additional requirements impact not only sample analysis, but also the organization

of the entire laboratory:

• Specific documents should be developed and maintained, including individual policies and a quality plan.

• Known existing problems should be corrected and an action plan should be developed to avoid recurrence of the same or similar problems.

• All complaints from clients should be formally followed up.

• A formal program should be used to manage suppliers, service providers, and subcontractors.

• The organizational structure should be such that there are no conflicting interests that could impact quality.

• Compliance with ISO/IEC 17025 and internal procedures should be assessed during regular internal audits.

Key Steps towards Accreditation:

There are eight key steps towards laboratory accreditation:

1. Management defines a project owner.

2. The project owner studies details of the standard, supporting literature, and other relevant information.

3. The project owner defines the preliminary scope of accreditation and works with laboratory professionals to prepare a list with requirements.

4. The project owner and laboratory professionals perform a gap analysis to determine the difference between the requirements and what is currently implemented in the

laboratory.

5. Based on the outcome of the gap analysis, the project owner, laboratory professionals, financing and documentation professionals, and external consultants

estimate the costs for accreditation.

6. Estimated costs are presented to management, along with incremental opportunities.

7. Management decides to proceed with accreditation.

8. The project owner leads implementation steps.

12

Introduction

13

Introduction

Companies have to continuously deliver high-quality products and/or services if they

want to be successful in the marketplace over the long term. Quality improvement has

become a key national and international business strategy. Most companies are using

quality systems as a method of assuring the consistency and conformity of products or

services to a defined set of standards or customer expectations.

Quality Systems

Several quality system standards were developed in various countries in the 1960s and

1970s. The MIL-Q-9858A was established in the United States in 1963, and the BS 5750

was established in 1979 in the United Kingdom. These are probably the two most important

standards from this era. The ISO 9000 series of quality standards was established in 1987

for implementing and maintaining a quality system. This standard is internationally

accepted and can be used as a criterion for third-party quality assessment.

ISO/IEC 17025 –

Laboratory Quality System

Laboratories play an important role in company quality systems. The ISO/IEC 17025 (1)

can be used as a standard to develop and establish a quality system for a laboratory

and also for assessment by laboratory clients or third parties. The standard can also be

used as a criterion for laboratory accreditation. Working according to global standards is

especially important for laboratories to ensure validity and global comparability of test

and calibration results. One of the goals of using global standards is to reduce the

number of tests required in national and international trading.

The first edition of the “International Standard General Requirements for the Competence

of Testing and Calibration Laboratories” was produced as a result of extensive

experience in implementing ISO/IEC Guide 25 and EN 45001; it replaced these earlier

standards in 1999. This new standard contains all the requirements that testing and

calibration laboratories have to meet if they wish to demonstrate that they operate a

management system, are technically competent, and are able to generate technically

valid results.

14

Management requirements in the first edition refer to ISO 9001:1994 and ISO 9002:1994.

These standards have been superseded by ISO 9001:2000, which made an update

of ISO/IEC 17025 necessary. In the second edition of ISO/IEC 17025, released in 2005,

clauses were amended or added only when considered necessary in the light of

ISO 9001:2000

Testing and calibration laboratories that comply with ISO/IEC 17025 will therefore also

operate in accordance with ISO 9001.

Accreditation bodies that recognize the competence of testing and calibration

laboratories use ISO/IEC 17025 as the basis for their accreditation.

ISO/IEC 17025 is divided into five clauses, two annexes, and one bibliography section:

• Clause 1: Scope The standard covers the technical activities of a laboratory as well as the management and

organizational aspects to perform the technical activities in a competent way.

• Clause 2: Normative References

• Clause 3: Terms and Definitions

• Clause 4: Management Requirements Most of the requirements are similar to those specified in the ISO Standard 9001:2000.

• Clause 5: Technical Requirements Most of the requirements come from the ISO Guide 25.

• Annex A: Cross References to ISO 9001:2000

• Annex B: Guidelines for Establishing Applications for Specific Fields

• Bibliography

The most important clauses are clause 4 and 5, describing management and technical

requirements. In addition to official requirements, these clauses also include notes with

further explanations and recommendations.

15

Scope and Contents of this Primer

Implementing a quality system such as ISO/IEC 17025 has an impact on laboratory

organization and operation. This primer will discuss some of the specific implementation

requirements, along with their implications for testing and calibration laboratories.

This primer is especially useful for chemical analytical laboratories seeking

accreditation according to an internationally recognized standard. Examples include food

testing, environmental testing, chemical testing, clinical testing, pharmaceutical testing,

and other testing laboratories. This primer will guide laboratory and QA managers and

staff through the entire process of ISO/IEC 17025 accreditation. It also helps

laboratories working under different quality systems to efficiently set up procedures for

compliance with all requirements.

Covered in this primer:

• Management requirements

• Technical requirements

• Recommendations for Implementation

• Steps toward ISO/IEC 17025 accreditation

• Documentation

• Internal and external audits

• Implementing multiple quality systems

The primer and its reference material should give a good understanding of the

importance of ISO/IEC 17025, the requirements, and the key points for implementation.

The primer is not a substitute for the standard itself and does not list all requirements.

Rather, it focuses on the most important requirements and the ones that need specific

attention, according to the opinion and interpretation of the author. The primer also does

not include tools such as sample quality manuals, operating procedures, and all the

templates that would help to quickly implement ISO/IEC 17025. These items can be

obtained as special packages that are available from service providers, for example, the

ISO/IEC 17025 Accreditation Package from LabCompliance (2).

16

Management Requirements

17

Management Requirements

Management requirements pertain to the operation and effectiveness of the quality

management system within the laboratory. The requirements are similar to ISO 9001.

This clause is divided into fifteen chapters, described below.

Organization

This chapter ensures that the roles and responsibilities of the laboratory, the

management, and key personnel are defined.

Key points:

• An organizational structure, as well as responsibilities and tasks of both management and staff should be defined.

• The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratory’s work quality. Examples include

commercial marketing or financing departments.

• A quality assurance manager should be appointed.

• All personnel should be free from any commercial or financial pressure that could adversely impact the quality of calibration and test results.

Management System

This chapter describes how to ensure that a management system is implemented,

maintained, and continually improved.

Key points:

• There should be policies, standard procedures and work instructions to ensure the quality of test results.

• There should be a quality manual with policy statements that are issued and communicated by top-level management.

• The effectiveness of the management system should be continually improved.

18

Document Control

Individual paragraphs in this chapter describe how to ensure that all documents related

to the management system are uniquely identified and created, approved, issued, and

changed following documented procedures.

Key points:

• All official documents should be authorized and controlled.

• Documents should be regularly reviewed and updated if necessary. The review frequency depends on the document itself. Typical review cycles are between one

and three years.

• Changes to documents should follow the same review process as for the development of initial documents.

Review of Requests, Tenders, and Contracts

This chapter describes how to ensure that requirements of requests, tenders and

contracts are well defined, reviewed, understood, and documented.

Key points:

• The laboratory supervisor’s review should ensure that the laboratory has the technical capability and resources to meet the requirements.

• Changes in a contract should follow the same process as the initial contract.

Subcontracting of Tests and Calibrations

This chapter describes how to ensure that tests and calibrations subcontracted to third

parties are performed according to the same quality standards as if they were done in

the subcontracting laboratory.

Key points:

• The competence of the subcontracted party should be ensured, through a documented quality system, such as ISO/IEC 17025.

• The subcontracting laboratory is responsible to the customer for the subcontractor’s work, except in the case where the customer or the regulatory body specifies which

subcontractor should be used.

19

Purchasing Services and Supplies

This chapter describes how to ensure that services and supplies delivered by third

parties do not adversely impact the quality and effectiveness of laboratory operations.

Key points:

• Suppliers should be selected and formally evaluated to ensure that services and supplies are of adequate quality.

• Records of the selection and evaluation process should be maintained.

• The quality of incoming material should be verified against predefined specifications.

Service to the Customer

This chapter describes how to ensure that the laboratory continually meets customer

requirements.

Key points:

• The laboratory should communicate with customers to clarify requests and get customer input.

• The laboratory should have a formal program to collect feedback from customers on an ongoing basis.

• The laboratory should allow customers to audit the laboratory.

20

Complaints

This chapter describes how to ensure that any customer complaints are documented,

evaluated, and adequately followed up.

Key points:

• There should be a policy and procedure for the resolution of complaints received from customers.

• Records of complaints and all steps taken when resolving the complaint should be maintained. This includes documentation of investigations and corrective actions.

Control of Nonconforming Testing and/or Calibration Work

Tests, calibrations, and other laboratory operations should conform to previously defined

specifications such as laboratory specifications or client-defined specifications. This

chapter describes how to ensure that nonconforming test and calibration results are

adequately followed up, and that corrections are initiated.

Key points:

• There should be a policy and process that come into effect when results do not conform to procedures.

• Corrective actions should be taken immediately to avoid recurrence.

• The significance of nonconforming work should be evaluated, for example, the possible impact on other testing or calibration work.

• If necessary, customers should be notified.

Improvement

This chapter describes how to ensure that the effectiveness of the management

system is continually improved.

Key points:

• Suggestions for improvements should be taken from audit reports, analysis of data, customer complaints and suggestions, corrective and preventive actions, and

management reviews.

• Suggestions should be collected over time and reviewed by management for suitable actions.

20

Corrective Action

This chapter describes how to ensure that the root cause of nonconforming work or

deviations from laboratory and management procedures are identified and that

adequate corrective actions are selected, implemented, documented, and monitored.

Key points:

• Corrective actions can be triggered through nonconforming tests or other work, customer complaints, internal or external audits, management reviews, and

observations by staff.

• Corrective actions should be selected and implemented to eliminate the specific problem and prevent recurrence of the same problem.

• As the first step in the process, the root cause of the nonconformity should be identified.

• The effectiveness of the corrective action should be monitored and evaluated.

Preventive Action

Preventive actions should be initiated when potential sources of nonconformities have

been identified. Nonconformities may be technical or related to the management system.

The objective is to reduce the likelihood of the occurrence of such potential

nonconformities.

Key points:

• There should be a procedure to identify potential sources of nonconformities and define preventive actions to prevent occurrence of these nonconformities.

• The effectiveness of the preventive action should be monitored and evaluated.

21

Control of Records

This chapter describes how to ensure that all records in a laboratory are uniquely

identified, readily available when needed, and protected against unauthorized access

for viewing or changing.

Key points:

• There should be procedures for identification, collection, indexing, storage, retrieval, and disposal of records.

• Records should be stored such that their security, confidentiality, quality and integrity are ensured throughout the required retention time.

• For technical records such as test reports of analytical measurements, original observations should be retained, along with processing parameters that will allow

tracking final results back to the original observations.

• Record format can be hard copies or electronic media. There should be procedures to protect and back-up electronic records and to prevent unauthorized access.

• Records can be corrected if there are mistakes. The original record should be crossed out, but still visible.

• When electronic record systems are used, the same principle applies. The laboratory should ensure that original records are not overwritten by the system and that

corrections are recorded together with the original records. Using a system that

prevents overwriting original records and stores changes in an electronic audit trail that

can be viewed and printed is highly recommended.

22

Internal Audits

Internal audits should verify that the laboratory complies with ISO/IEC 17025 and with

internal technical and quality procedures. Internal audits are also an excellent preparation

for external assessments and can help to continually improve the quality system.

Key points:

• The laboratory should have a procedure and a schedule for internal audits. Internal audits can either cover the whole laboratory and all elements of the quality system at

one specific period of time or can be divided into several subsections.

• The schedule should be such that each element of the quality system and each section of the laboratory are audited yearly.

• The audit program should be managed by the quality manager.

• Audit findings related to the quality of test and calibration results should be reported to customers.

• Audit follow-up activities should include corrective and preventive action plans (CAPA). The effectiveness of the plans should be monitored.

Management Reviews

Requirements in this chapter describe how to ensure the continued suitability and

effectiveness of the quality system, policies, and testing and calibration procedures.

Key points:

• There should be a schedule and procedure for periodic management reviews.

• Recommended review frequency is once a year.

• The management review should include a discussion about the outcome of recent internal audits and external assessments, corrective and preventive actions, results of

proficiency testing, customer complaints and feedback, and any recommendations for

improvements.

• Management should decide on follow-up activities. These activities should be monitored for effectiveness.

24

Technical Requirements

25

Technical Requirements

Technical requirements address the competence of staff, sampling and testing

methodology, equipment, and the quality and reporting of test and calibration results. This

clause is divided into ten chapters.

General

The technical requirements clause starts with a general chapter. This chapter’s

purpose is to make readers aware that the correctness and reliability of test and

calibration results are determined by a variety of factors.

Key points:

• The different factors impacting the quality of results should be documented. They include, for example, sampling, equipment, test methods, and environmental conditions.

• The extent to which impacting factors can contribute to the measurement uncertainty should be taken into account when developing test and calibration methods.

Personnel

Personnel probably have the highest impact on the quality of test and calibration results.

This chapter describes how to ensure that all laboratory personnel who can impact test

and calibration results are adequately qualified.

Key points:

• Only competent personnel should perform testing and calibrations. This includes part-time as well as full-time employees, as well as all management levels.

• Competence can come from education, experience, or training.

• Management should define and maintain tasks, job descriptions, and required skills for each job.

• Based on required skills and available qualifications, a training program should be developed and implemented for each employee.

26

• The effectiveness of the training should be evaluated. If the training is related to a

specific test method, the trainee can demonstrate adequate qualification through

successfully running a quality control or proficiency test sample. A statement from

the trainee such as ‘I have read through the test procedure’ is not enough.

• Management should authorize personnel to perform specific tasks, for example, to

operate specific types of instruments, to issue test reports, to interpret specific test

results, and to train or supervise other personnel.

• The date of this authorization should be recorded. The associated tasks should not

be performed before the authorization date.

Accommodation and Environmental Conditions

This chapter has been included to ensure that the calibration and test area environment

will not adversely affect the measurement accuracy. It includes five sections with

information that is mostly common sense. One clause recommends having effective

separation between neighboring areas when the activities therein are incompatible. An

example would be to separate laboratories that analyze extremely low traces of a solvent

from those which consume large quantities of the same solvent for liquid-liquid

extraction.

Key points:

• Environmental conditions should not adversely affect the required quality of tests. This means, for example, that equipment should operate within the manufacturer’s

specifications for humidity and temperature.

• The laboratory should monitor, control, and record environmental conditions. Special attention should be paid to biologic sterility

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