SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA

SC 1.2 - SPECIFIC CRITERIA

FOR ACCREDITATION IN THE FIELD OF
CHEMICAL TESTING
4 May 2009
(Supplementary to MS ISO/IEC 17025)

MS ISO/IEC 17025

JABATAN STANDARD MALAYSIA

Department of Standards Malaysia
 SC 1.2: SPECIFIC CRITERIA FOR ACCREDITATION IN THE FIELD OF CHEMICAL TESTING

Contents Page

1 Introduction 1
2 Scope 1
3 Terms and definitions 1
4 Management requirements
4.1 Organisation 3
4.2 Management system 3
4.3 Document control 3
4.4 Review of requests, tenders and contracts 3
4.5 Subcontracting of tests and calibrations 3
4.6 Purchasing services and supplies 3
4.7 Service to the customer 3
4.8 Complaints 3
4.9 Control of nonconforming testing and/or calibration work 3
4.10 Improvement 4
4.11 Corrective action 4
4.12 Prevention action 4
4.13 Control of records 4
4.14 Internal audits 4
4.15 Management reviews 4
5 Technical requirements
5.1 General 4
5.2 Personnel 4
5.3 Accommodation and environmental conditions 5
5.4 Test and calibration method and method validation 5
5.5 Equipment 8
5.6 Measurement traceability 8
5.7 Sampling 8
5.8 Handling of test and calibration items 8
5.9 Assuring the quality of test and calibration results 9
5.10 Reporting of results 9
Appendix 1 (Classes of test) 10
References 17

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SPECIFIC CRITERIA FOR ACCREDITATION IN THE FIELD OF CHEMICAL TESTING

NOTE: Clause numbers correspond to those in the MS ISO/IEC 17025: 2005 standard which require
elaboration.

1 Introduction

This document addresses the specific criteria for chemical testing and items that are essential or
important for the proper conduct of a test. It provides detail or add extra information to the general
stated requirements of the SAMM accreditation criteria. This document shall be read in conjunction
with MS ISO/IEC 17025:2005 standard and other relevant SAMM policies.

2 Scope

This document sets out the specific requirements a chemical testing laboratory has to meet, in
addition to the general requirements of MS ISO/IEC 17025 and relevant SAMM policies.

In addition to this document, there are Specific Technical Requirements (STR) applicable to chemical
testing laboratories working in specialised areas of testing which have their own set of unique criteria.

3 Terms and definitions

3.1 Certified reference material (CRM): Reference material, accompanied by a certificate, one or
more of whose property values are certified by a procedure, which establishes its traceability
to an accurate realization of the units in which the property values are expressed, and for
which each certified value is accompanied by an uncertainty at a stated level of confidence
(ISO Guide 30).

3.2 Equipment: For the purpose of this Specific Criteria document instruments, reference
materials, consumables and reagents are included as laboratory equipment, where applicable.

3.3 Fitness for purpose: Degree to which data produced by a measurement process enables a
user to make technically and administratively correct decision for a stated purpose (IUPAC).

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3.4 Standard method: Method that has been developed, validated, collaborated, peer reviewed,
published in international, regional and national standards or by reputable technical
organisations/regulatory body.

3.5 In-house method: Method that does not meet 3.4, such as:
• Method developed by a laboratory
• Method developed by a customer (manufacturer)
• Method developed for an industry group
• Modified standard test methods (example: change in technical requirements)
• Method from scientific publications.

3.6 Measurement uncertainty: Non-negative parameter characterising the dispersion of the

quantity values being attributed to a measurand, based on the information used (VIM 2007).

3.7 Method validation: The process of establishing the performance characteristics and limitations
of a method and the identification of the influences which may change these characteristics
and to what extent (EURACHEM Guide).

3.8 Metrological traceability: Property of a measurement results whereby the result can be related
to a reference through a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty (VIM 2007).

3.9 Performance characteristic: Functional quality that can be attributed to an analytical method.
Examples of typical performance characteristics include: selectivity, accuracy, trueness,
recovery, precision, repeatability, reproducibility, detection limit, limit of quantitation, detection
capability, ruggedness and stability (EC Directive).

3.10 Performance criteria: Requirements for a performance characteristic according to which it can
be judged that the analytical method is fit for the purpose and generates reliable results (EC
Directive).

3.11 Reference material (RM): Material or substance one or more of whose property values are
sufficiently homogeneous and well established to be used for the calibration of an apparatus,
the assessment of a measurement method, or for assigning values to materials (ISO Guide
30).

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3.12 Validation: Confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use are fulfilled (ISO 9000: 2000).

3.13 Verification: Confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled (ISO 9000: 2000).

4 Management requirements

4.1 Organisation
As in MS ISO/IEC 17025:2005.

4.2 Management system

As in MS ISO/IEC 17025:2005.

4.3 Document control

As in MS ISO/IEC 17025:2005.

4.4 Review of requests, tenders and contract

As in MS ISO/IEC 17025:2005.

4.5 Subcontracting of test and calibration

The reporting of subcontracted tests shall follow the requirement of SAMM Policy 3: Policy on
The Use of SAMM Accreditation Symbol or Reference to SAMM Accreditation - Issue 3, 28
February 2007 (refer to clause 8 of the SP 3 document).

4.6 Purchasing services and supplies

As in MS ISO/IEC 17025:2005.

4.7 Service to the customer

As in MS ISO/IEC 17025:2005.

4.8 Complaints
As in MS ISO/IEC 17025:2005.

4.9 Control of nonconforming testing and/or calibration work

As in MS ISO/IEC 17025:2005.

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4.10 Improvements
As in MS ISO/IEC 17025:2005.

4.11 Corrective action

As in MS ISO/IEC 17025:2005.

4.12 Preventive action

As in MS ISO/IEC 17025:2005.

4.13 Control of records

Data generated by equipment affecting the test result shall be retained to provide evidence for
traceability.

4.14 Internal audit

As in MS ISO/IEC 17025:2005.

4.15 Management reviews

As in MS ISO/IEC 17025:2005.

5 Technical requirements

5.1 General
As in MS ISO/IEC 17025:2005.

5.2 Personnel

5.2.1 Signatory
Test reports of any chemical composition or specifications of any substances or product
consumed or used by, or intended for the consumption or use of, public or any section thereof,
shall be signed by
a) registered chemist; or
b) registered pharmacist and the chemical analysis that he gives or provides, or certifies
or declares in writing the result of, is for the purpose of determining the composition or
specifications of a food, medical or pharmaceutical substance or product, including
cosmetics and toiletry, or any part of component thereof; or

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c) employee working under the supervision of a registered chemist or registered

pharmacist and gives or provides, or certifies or declares in writing the result of, the
chemical analysis for the purpose and in the course of his employment and, in case of
an employee working under the supervision of a registered pharmacist, the chemical
analysis is for the purpose of determining the composition or specifications of a food,
medical, or pharmaceutical substance or product, including cosmetics and toiletry, or
any part of component thereof; or
d) gazetted officer under relevant act, directives or regulations.
Notwithstanding the above the signatory shall meet the requirements of SAMM Policy 6:
Requirements for SAMM Approved Signatory - Issue 4, 30 August 2008.

Recommended format for signing the certificate of analysis (COA) is as follow:

i) The signatory for 5.2.1 (a) should include name, function and IKM membership
number.
ii) The signatory for 5.2.1 (b) should include name, function and registered pharmacist
number.
iii) The signatory for 5.2.1 (c) should include name and function of the employee and must
also be counter-signed by the same registered chemist/registered pharmacist giving
his/her name, function and the IKM membership number/registered pharmacist
number (refer to IKM circular number 2/2008).
iv) The signatory for 5.2.1 (d) should include name, function and gazetted designation.
Note: Signatory approval is for specific classes of test/s and product/s (refer to Appendix 1).

5.2.1.1 The competency of personnel performing specific tests shall be demonstrated by the ability to
achieve performance characteristics of the tests or perform successfully in suitable proficiency
testing programmes as listed in SAMM Policy 4: Policy on Proficiency Testing Requirements
for SAMM Laboratories - Issue 2, 28 February 2007 (refer to clause 4.2 of the SP 4
document).

5.3 Accommodation and environmental conditions

As in MS ISO/IEC 17025:2005.

5.4 Test methods and method validation

5.4.1 General
The following IUPAC terminology should be used in presenting test procedures:
Laboratory sample: Primary material delivered to the laboratory.

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Sample: A portion of material selected to represent a larger body of material (see

clause 5.7 of the MS ISO/IEC 17025).
Sample handling: This refers to the manipulation to which samples are exposed during
the sampling process, from the selection from the original material
through to the disposal of all samples and test portions.
Subsample: This refers to a portion of the sample obtained by selection or division;
an individual unit of the lot taken as part of the sample or; the final unit
of multistage sampling.
Sample preparation: This describes the procedures followed to select the test portion from
the sample (or subsample) and includes: in-laboratory processing;
mixing; reducing; coning & quartering; riffling; and milling & grinding.
Test sample: The sample prepared from the laboratory sample.
Test portion: This refers to the actual material weighed or measured for the analysis.

5.4.2 Selection of methods

The laboratory shall confirm that it can achieve the performance characteristics of standard
method before introducing the tests.

5.4.5 Validation of methods

The extent to which validation/verification is to be performed by the laboratory depends on the
test method. The table below should be followed.

Test method Validation or verification Method Reference No/ID

description requirements (Example)
Method developed in the Full validation <In-house method>, <ref. no.>,
laboratory <based on xxxx book>, <technique
(sample preparation & detection,
where applicable)>
In-house Method, Ref. No. TP12,
Based on Methods of Analysis of
Soils, Plants and Waters, Liquid-
Liquid Extraction/Soxhlet/Hydrolysis,
GC/HPLC/LCMS-MS/LCMS/AAS

Method developed by a Full validation <In-house method>, <ref. no.>,

customer (manufacturer) <based on xxxx>
In-house Method, Ref. No. P11,
Based on HACH 8038

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Test method
description
Method developed for an
industry group
Standard published
method
Method published in the
scientific literature
without any performance
data
Methods published in
scientific literature
with performance data
Changes in
implementation of
previously validated
method - i.e. changes to
equipment, reagents, lab
environment or staff
Standard published
method applied to
different matrices,
different concentration
ranges, analytes or
standard published
method used for a similar
purpose but different
conditions
Issue 1, 4 May 2009
Validation or verification
requirements
In the absence of
performance characteristic,
full validation required
Confirmation of published
performance
characteristics
Confirmation of published
performance
characteristics
Full validation
Confirmation of published
performance
characteristics
Extent of validation will
vary to demonstrate
change does not have a
significant impact on
performance
characteristics
Validation is required and
the extent will vary. e.g.
having similar properties to
those of representative
matrices and analytes
Method Reference No/ID
(Example)
<Method>, <year>
JIS H 8625: 1991
AWPA A2: 2002
<Method>, <year/edition>, <section
no.>, <technique where applicable>
IOCC Page 8a-E: 1972, Soxhlet
IOCCC 105-1998
<Method>, <year/edition>, <section
no.>
ISO 8124-1:2000, Section 5
MS 678 Part I to IV: 1980
AOCS Cc 3-25:1997
ASTM F663-07, Section 4.1
APHA 4500-CN-C, 19th Edition
AOAC 972.33, 2005
BP 2007, App. XII A
DOE Method: 1995, Reference/
Alternative Method
MPOB P2.9: 2004
SMR Bulletin No.7 B6, 1992
<In-house method>, <ref. no.>,
<based on xxxx>
In-house Method, STP 1/VI, Based on
JOACS Vol. 71, No. 3 Page 299-302
<In-house method>, <ref. no.>,
<based on xxxx>
In-house Method, LWI 14-2, Based on
FDA Bulletin No.5:1998/USEPA
245.1, 1991
<In-house method>, <ref. no.
(issue/revision no.)>, <based on
xxxx>
In-house Method, Ref. No. TP12
(revision no 2), Based on Methods of
Analysis of Soils, Plants and Waters
<In-house method>, <ref. no.>,
<based on xxxx>
In-house Method, STP 4.5-1, Based
on AOCS Cc 3-25:1997
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Test method Validation or verification Method Reference No/ID

description requirements (Example)
Commercial test kits - Confirmation of published <In-house method>, <ref. no.>,
collaboratively performance <based on xxxx>
tested, third party characteristics In-house Method, LWI 14, Based on
evaluation (e.g. AOAC) ELISA Kit Method, Direct Competitive
/ Polyclonal

Validation is required if any <In-house method>, <ref. no.>,

changes are made <based on xxxx>
In-house Method, LWI 14-1, Based on
ELISA Kit Method, Direct Competitive
/ Polyclonal

Commercial test kits - no Full validation <In-house method>, <ref. no.>,

<based on xxxx>
performance data
In-house Method, LWI 10, Based on
available, incomplete or ELISA Kit Method, Direct Competitive
not applicable / Polyclonal

5.4.6 For measurement uncertainty, requirements of SAMM Policy 5: Policy on Measurement

Uncertainty Requirements for SAMM Testing Laboratories - Issue 2, 28 February 2007 shall
be met.

5.4.7 Automated equipments should include audit trail features to establish full traceability of data
and user.

5.5 Equipment
As in MS ISO/IEC 17025:2005.

5.6 Measurement traceability

5.6.1 The calibration interval may be reduced or extended based on factors such as history on
stability, accuracy required and ability of staff to perform regular checks.

5.7 Sampling
As in MS ISO/IEC 17025:2005.

5.8 Handling of test and calibration items

As in MS ISO/IEC 17025:2005.

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5.9 Assuring the quality of test and calibration results

5.9.1 The level and type of quality control will depend on criticality, nature of the analysis, frequency
of analysis, batch size, degree of automation and the test difficulty and reliability. The level
adopted should be sufficient to ensure the validity of the results.

Quality control samples shall be typical sample of the test procedure.

5.10 Reporting the results

5.10.1 The laboratory should incorporate security features in test report (e.g.: by printing on security
paper, use of watermark / embossment, etc).

The form of reporting of results shall not give a wrong impression of the uncertainty of
measurement. (refer to clause 5.4.6.2 of the MS ISO/IEC 17025).

5.10.2 Certificate of analysis shall conform to the requirements of SAMM Policy 3: Policy on The Use
of SAMM Accreditation Symbol or Reference to SAMM Accreditation - Issue 3, 28 February
2007.

5.10.2j)All pages of certificate of analysis should be either signed or initialed by approved signatory
(refer to clause 5.2.1 of this SC document for the format of signing).

The laboratory shall include a statement specifying that the certificate of analysis shall only be
reproduced in full with written approval from the laboratory.

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APPENDIX 1
Classes of Test and Product

1) Adhesives (Organic Resins) and Glues

• Adhesives
• Binders
• Cement
• Glues
• Putty
• Sealant
• Others

2) Agricultural Products and Materials

• Compost
• Fertilizers and liming materials
• Fungicide formulations
• Herbicide formulations
• Oil seeds and by product (including palm kernel)
• Oil seeds and by-products
• Pesticide formulations
• Plant material
• Soils
• Stockfoods/feed meal
• Vitamins in stockfoods
• Wood and timber treatment materials
• Others

3) Biological Specimens
• Specified human specimens
• Specified veterinary specimens
• Other biological specimens

4) Cement, Concrete and Related Products

• Aggregates
• Blended cement
• Ceramics

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• Clays & soils

• Concrete
• Fibre cement
• Fly ash/clinker
• Glass
• Limestone, lime gypsum
• Masonry cement
• Mortar
• Portland cement
• Pozzolans
• Sand
• Others

5) Cosmetics & Essential oils

• Cosmetics and toiletries
• Essential oils
• Herbal-based cosmetics
• Intermediates and miscellaneous chemicals for cosmetics
• Perfumes
• Others

6) Drugs and Pharmaceuticals

• Antibiotics
• Chemicals used in compounding pharmaceuticals
• Drug intermediates and raw materials
• Enzymes
• Hormones
• Natural drugs (medicinal plant preparations)
• Pharmaceutical formulation
• Synthetic drugs
• Vaccines & sera
• Veterinary preparations (herbal & synthetic)
• Vitamins
• Others

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7) Dye & Dye Intermediates

• Dye intermediates
• Natural dyes & colouring materials
• Synthetic dyes
• Others

8) Environmental Monitoring
• Air (including stack emission and ambient monitoring)
• Industrial effluent (including palm oil & rubber effluent)
• Leachate
• Sewage water
• Soil/sediment/slugde
• Solid wastes (including municipal and industrial)
• Others

9) Explosives & Pyrotechnics

• Ammunitions
• Industrial explosives & associated material
• Pyrotechnics
• Explosives chemicals and allied materials
• Others

10) Foods
• Alcoholic beverages
• Dairy products
• Edible oils, fats and their products
• Eggs and egg products
• Essential nutrients, including vitamins
• Fish and fish products
• Flour and confectionery
• Food additives and supplements
• Honey and honey products
• Infant foods
• Meat, poultry and derived products

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• Non-alcoholic beverages
• Nuts, fruits and vegetables and derived products
• Pet foods
• Residues in foodstuffs
• Sauces, herbs, spices and condiments
• Sugars and sugar products
• Tobacco and by-products
• Other specified foods

11) Leather
• Natural leather
• Synthetic leather
• Others

12) Medical Devices

• Breathing apparatus and equipment
• Catheters
• Condoms
• Diagnostic instruments
• Health care and health hazard technologies
• Limbs (prostheses)
• Pacemakers
• Resuscitators
• Surgical gloves
• Surgical instruments
• Syringes
• Treatment equipment
• Others

13) Metals and Alloy

• Aluminium and aluminium alloys
• Copper and copper alloys
• Ferrous materials
• Precious metals
• Recycle waste

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• Tin, lead and their alloys

• Zinc and zinc alloys
• Others

14) Ores & Minerals

• Ferrous ores
• Minerals
• Precious metal ores
• Radioactive ores
• Trace elements for geochemical prospecting and metal recovery
• Other ores & minerals

15) Paints, Varnishes, Inks, Coatings and Allied Products

• Inks
• Lacquers
• Paints and protective coatings
• Varnishes
• Others

16) Paper, Paper Board & Wood Pulp

• Composite packing materials
• Newsprint and board packing materials
• Paper, paper board and speciality papers
• Pulp
• Others

17) Petroleum & Petroleum Products

• Bituminous materials
• Crude petroleum
• Fuels
• Lubricants
• Miscellaneous products (including hydraulic, antifreeze, additives to fuels and lubricants)
• Oil shale
• Solvents
• Others

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18) Polymers

19) Rubber
• Compounding materials
• Formulated products
• Latex
• Natural
• Synthetic
• Others

20) Soap, Detergents and Toiletries

• Soaps
• Synthetic detergents
• Wetting and emulsifying agents
• Others

21) Solvent
• Acetone
• Chloroform
• Hexane
• Petroleum ether
• Toluene
• Others

22) Textiles and Textile Products

• Carpets
• Clothing
• Fabrics
• Fibres & filaments
• Flags and decorations
• Mattresses
• Technical textiles (including geo-textiles, medical textile, automotive textiles, aircraft textiles)
• Tents
• Upholstery (Including window covering, furniture coverings and beddings)
• Yarns & chords
• Others

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23) Water
• Distilled demineralized
• Ground water
• Industrial/cooling purposes
• Mineral water
• Pharmaceutical water
• Potable and domestic
• Processed water
• Recycled water
• Reverse osmosis water
• Saline water
• Steam raising/boiler water
• Surface water
• Swimming pool and spa
• Ultrapure water
• Others

24) Workplace Environment and Hazards

• Air in confined spaces
• Asbestos fibre
• Diesel particulates
• Engine emissions
• Inhaleable dust
• Inorganic gases
• Isocyanates
• Metals and metal compounds
• Mine atmospheres
• Mine roadway dusts
• Organic vapours
• Respirable dust
• Respirable quartz
• Synthetic mineral fibre
• Welding fumes and gases
• Others

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References:

1. EC directive - European Communities Decision of 12 August 2002 Implementing Council

Directive 96/23/EC Concerning the Performance of Analytical Methods and the
Interpretation of Results. Official Journal of the European Communities, C (2002) 3044.

2. EURACHEM - Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002

Edition).

3. IUPAC - International Union of Pure and Applied Chemistry.

4. ISO Guide 30 - Terms and Definitions Used in Connection with Reference Materials.

5. ISO 9000:2000 - Quality Management Systems - Requirements.

6. VIM - International Vocabulary of Metrology - Basic and General Concepts and Associated
Terms (2007 Edition).

7. Specific Criteria for Accreditation - Chemical Testing (IANZ).

8. Specific Guidelines for Chemical Testing Laboratories (NABL).

9. CAN-P-1570 - Appendix B Guidelines for Presentation of Testing Scopes (SCC).

10. PALCAN Guidance for the Validation of Test Methods (SCC).

11. Accreditation for Chemical Laboratories (UKAS).

12. Specific Requirements for Chemical & Biological Testing Laboratories (SINGLAS).

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Acknowledgements:

1. En. Tham Kok Pheng (Chairman) STANDARDS MALAYSIA

2. Ms. Siti Norehan Ishak /

Ms. Siti Rohaya Omar (Secretariat) STANDARDS MALAYSIA

3. Dr. Koh Yew Ming ALS TECHNICHEM (M) SDN. BHD.

4. Pn. Zaiton Ariffin JABATAN KIMIA MALAYSIA

5. En. Ho Peng Hee STANDARDS MALAYSIA

6. Dr. Norhayati Moris STANDARDS MALAYSIA

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