GUIDELINES FOR DESCRIBING THE ACCREDITATION SCOPES OF TESTING LABORATORIES

Transcription

1 ATS-UP03 GUIDELINES FOR DESCRIBING THE ACCREDITATION SCOPES OF TESTING LABORATORIES Reviewed by: Natalija Jovičić Zarić MSc, Quality Manager (QM) Approved by: Dejan Krnjaić PhD, Director Issue/Revision: 3/1 Date: Page: 1/9

2 Guidelines for Describing the Accreditation Scopes of Testing Laboratories ATS-UP03 1 SCOPE This document provides recommendations on how to describe the accreditation scope in case of testing laboratories. The document shall be applied when defining accreditation scopes of applicants for accreditation, while the Accreditation Body of Serbia shall apply it when performing the assessment thereof. In case of all activities performed as part of the defined accreditation scope, applicants for accreditation/accredited testing laboratories shall have documented procedures in place and they shall prove their members of the staff to be trained and competent. Hence assessment (and reassessment) of the accreditation scope is the core element of the accreditation procedure and can be defined as a set of activities that the Accreditation Body of Serbia undertakes to ensure, with appropriate level of trust, that laboratory staffs are competent and are therefore reliable providers of services falling within the defined scope. Purpose of the scope of accreditation is to: (1) define the fields of a testing laboratory s activities to be confirmed by the Accreditation Body of Serbia (ATS); (2) enable clients to gain an insight into possible tests to be performed by an accredited testing laboratory. 2 REFERENCE DOCUMENTS, DEFINITIONS AND ACRONYMS SRPS ISO/IEC 17025: 2006, General Requirements for the Competence of Testing and Calibration Laboratories; SRPS ISO/IEC 17011: 2007, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies; EA-2/05: 2001, The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing; ILAC-G18: , Guideline for the Formulation of Scopes of Accreditation for Laboratories; ATS-UP07, List of Testing/ Calibration/ Inspection/ Certification Codes/Key Words. For the purposes of these Guidelines, terms laid down in the said reference documents shall be used. 3 ELEMENTS OF THE DEFINED ACCREDITATION SCOPE OF TESTING LABORATORIES 3.1 Definition of the testing accreditation scope The scope of accreditation is an integral part of the Accreditation Certificate and it comprises a short description of accreditation scope and a detailed one. A short description of accreditation scope shall be given to present the relationship between the field of testing and test items (e.g. chemical testing of products fit for human consumption, tobacco products, paper and packaging material) in accordance with point 4.3 of these Guidelines. In case of each field of testing, a detailed description of the accreditation scope shall be described in a tabular form depending on the test item(s) and it shall be described separately, whereas it will be explained whether tests are carried out in a laboratory or in the field. It shall be defined by using the elements shown in Table 1. If tests are carried out in a laboratory, it will be necessary to Issue/Revision: 3/1 Date: Page: 2/9

3 precisely state the laboratory location(s) where the tests are carried out even when this is applicable to the names of the organisational units where the said tests are carried out. If it has been assessed that a laboratory fulfils the requirements of SRPS CEN/TS 15675, Air quality Measurement of stationary source emissions Application of EN ISO/IEC 17025:2005 to periodic measurements the following sentence shall be inserted below Table 1: The laboratory fulfils the requirements related to periodic measurements of emissions as per SRPS CEN/TS and (sampling)." Testing location: laboratory (location shall be precisely stated if the location is different from the head office location it belongs to)/ field/ in a laboratory and in the field Field of testing in relation to test item(s) Test item/ material / product Test type and/or property to be measured (test technique) Test range (where applicable) Reference document Table 1 Detailed scope of accreditation in case of testing a) Test items, i.e. test material/product to be tested (e.g. soil, drinking water, pressures vessels, etc.); b) Test types and/or properties to be measured where applicable (e.g. Shore hardness test, iron (ICP-OES) tests, thickness ultrasound tests); c) Measuring range (e.g. ( ) %); d) ; The following reference shall be made in case of: - standard methods methods developed by organisations for standardisation or other renowned institutions the methods of which are accepted in a specific technical sector. In certain cases, where necessary, in addition to the reference for a standard method, it will be necessary to provide a reference for an in-house method (as identified in the laboratory management system documents). If the column entitled Reference Document shows two or more standards for one testing, all the said standards shall be applied or, if separated by horizontal lines, they shall be used as an alternative to the said test; - methods from national technical regulation (sub-law, etc.) only in cases when a technical regulation contains a complete and detailed description of the method and other elements need to perform tests; - non-standard methods or laboratory-developed methods, standard methods used outside their intended scope, amplifications and modifications of standard methods, methods specified by equipment manufacturers. In these cases, the key that is shown in a tabular form (Table 2) most often requires an abbreviated form of the method reference (as given in the management system documents), and reference/name of the test method (e.g. ВМ 01 method is a standard ASTM D method the part of which pertaining to sampling and sample preparation was modified). Key: Reference / name of the test method Table 2 Key Issue/Revision: 3/1 Date: Page: 3/9

4 3.2 Definition of accreditation scope in case of sampling In case when a testing laboratory wishes to get accredited for sampling of the method which is not a part of the test method, the scope of accreditation should be presented in a tabular form and defined by means of the scope elements (sampling item, type of sampling, reference document) in the way shown in Table 3. In the column entitled type of sampling the type of testing (and/or property to be measured) should be listed where applicable in addition to the field of testing for which the sampling is performed. Sampling Test item/material/ product Type of sampling Reference Document Table 3 Detailed scope of accreditation in case of sampling 3.3 Fields of Testing / Test Items Fields of testing: I-01 Acoustic testing and noise testing including noise caused by vibration I-02 Biological, biochemical testing I-03 Chemical (analytical) testing I-04 Clinical testing in medicine and veterinary medicine I-05 Electrical and electronic testing I-06 Electromagnetic compatibility (EMC) I-07 Environmental testing I-08 Fire testing I-09 Forensic testing I-10 Mechanical, metallographic testing I-11 Microbiological testing I-12 Non-destructive tests I-13 Physical testing I-14 Radiological testing including nuclear testing I-15 Sampling I-16 Sensory testing I-17 Other tests Issue/Revision: 3/1 Date: Page: 4/9

5 Test items: P-01 Agricultural products, including animal feed P-02 Asbestos including asbestos removal P-03 Biological testing material P-04 Chemicals, chemical products, cosmetics including fertilisers and colours P-05 Building products, materials and constructions P-06 Electrical products and equipment, telecommunications, electronics P-07 Electronic equipment, including software P-08 Industrial materials and products, including metals and composites P-09 Environmental samples (air, water, soil, waste) P-10 Fuel (gas, liquid and solid) and lubricants P-11 Furniture P-12 Glass, ceramics P-13 Machines, plants, equipment, including nuclear plants P-14 Medical devices P-15 Military equipment, including explosives and ballistics P-16 Optical equipment P-17 Paper and packaging material P-18 Personal protective equipment P-19 Pharmaceutical products P-20 Plastic and rubber products P-21 Products fit for human consumption, including food P-22 Textile, leather, fabric, yarn, clothing P-23 Tobacco products P-24 Toys, sports equipment and hobby equipment P-25 Vehicles P-26 Wood P-27 Other products 4 DOCUMENT DISTRIBUTION This document shall be used by ATS assessors and testing laboratories when preparing documentation needed for the submission of applications for accreditation. This document shall be made available to the ATS employees and shall be kept on Juatsrv server (the folder entitled Issue/Revision: 3/1 Date: Page: 5/9

6 QMS_ATS ). This document shall be made available to other ATS assessors and testing laboratories via the ATS website at 5 ANNEXES Annex 1: Model description of the accreditation scope of a testing laboratory 6 FORMS 7 ATS-UP03 DOCUMENT AMENDMENT HISTORY Issue/ Revision Issue/ Revision Date 2/ / / / Issue/Revision: 3/1 Date: Page: 6/9

7 Guidelines for Describing the Accreditation Scopes of Testing Laboratories ATS-UP03 Annex 1: Model description of the accreditation scope of a testing laboratory Laboratory A Testing location: laboratory Mechanical and metallographic tests, non-destructive tests of metallic materials Test item material / product 1. Welded joints 2. Metallic materials Laboratory B Types of tests and/or properties to be measured (test techniques) Charpy impact test Macroscopic and microscopic tests Measuring range (where applicable) (0 300) J SRPS EN : 1993 ISO 9016:2001 EN 1321:1996 Brinell hardness test NV EN ISO :2005 Radiographic examination by means of x and γ rays Testing location: laboratory Physical and chemical testing: water, food, feed Test item Types of tests and/or properties material / product to be measured (test techniques) 1. Water Isolation and identification of Escherichia coli and coliform Drinking water bacteria Part 1: Mineral water technique membrane-filter Isolation and identification of faecal Enterococci Part 2: membrane-filter technique 2. Food and feed Horizontal method for isolation and identification of Listeria monocytogenes - Part 2: Identification method (VIDAS) Measuring range (where applicable) SRPS ISO 5579:1997 SRPS ISO :2010 SRPS ISO :2010 SRPS EN ISO : 2010 Issue/Revision: 3/1 Date: Page: 7/9

8 Testing location: laboratory Chemical testing: food, water, toys Test item Types of tests and/or properties material / product to be measured (test techniques) 1. Food Milk and milk products Meat and meat products 2. Water Drinking water Ground water Waste water Determining the presence of sodium chloride (NaCl) (titrimetry) - in cream - in butter Determining the presence of nitrogen (titrimetry) Determining the residue levels after evaporation at 180 О С (gravimetry) Determining the presence of organic compounds deriving from gasoline (C 6 -C 10 ) (GC-FID) 3. Toys Safety of children s toys - Part 3: Migration of certain elements (ICP-OES) Measuring range (where applicable) ( )% Sub-law 1) -method VII/3 -method VII/3 ( )% SRPS ISO 937:1992 SMEWW 20th 2540C method ( )mg/l VDM 01 Pb (5,0-300)mg/kg Cd (1,0-30,0)mg/kg Cr (1,0-20)mg/kg Hg (0,05-0,8)mg/kg As (0,05-0,75)mg/kg SRPS EN 71-3:2010 Key: Sub-law 1) VDM 01 Reference / name of the test method Sub-law on the Sample Taking Methods and Chemical Analysis Methods for Milk and Milk Products ( Official Journal of the SFRY, 32/83) EPA Method 5021A, Volatile Organic Compounds in Soils and Other Solid Matrices Using Equilibrium Headspace Analysis Issue/Revision: 3/1 Date: Page: 8/9

9 Testing location: in the field* and at the laboratory Physical and chemical testing: air Test item Types of tests and/or properties material / product to be measured (test techniques) 1. Stack emission * Stationary source emissions Isolation of carbon monoxide, carbon dioxide and oxygen 2. Ambient air Determination of mass concentration of 2.5 PM fraction of suspended particles (gravimetry) *Workplace air 3. Workplace determination of particulate environment lead and lead compound particles (ICP-OES) Measuring range (where applicable) SRPS ISO 12039: 2011 (1) (1-200)µg/m 3 SRPS EN 14907:2008 SRPS ISO 8518:2007 (1) The laboratory fulfils the requirements related to periodic measurements of emissions as per SRPS CEN/TS and (sampling). Sampling Test item / material/ product 1. Stack emission Type of sampling Stationary source emissions - Manual determination of mass powdered substance level Stationary source emissions - Determination of mass gas organic substance level - Activated charcoal and solvent desorption method 2. Ambient air Sample taking to determine heavy metal content (lead, cadmium, zinc, copper) in suspended particles SRPS ISO 9096: 2010 (1) SRPS EN 13649: 2009( 1 ) Manufacturer s instruction guide ECHO PM (1) The laboratory fulfils the requirements related to periodic measurements of emissions as per SRPS CEN/TS and (sampling). Issue/Revision: 3/1 Date: Page: 9/9