Raad voor Accreditatie (Dutch Accreditation Council RvA) Accreditation of Reference Material Producers

Transcription

1 Raad voor Accreditatie (Dutch Accreditation Council RvA) Accreditation of Reference Material Producers Document code: RvA-T034-UK Version 4, 01 mei 2013

2 A RvA-Explanatory note describes the policy and/or the procedures of the RvA concerning a specific field of accreditation. In case the policy and/or procedures for a specific field of accreditation as described in a RvA Explanatory note, is documented by EA, ILAC or IAF, the RvA will bring its policy en procedures in line with the EA, ILAC or IAF-document. A current version of the Explanatory is available through the website of the RvA. (

3 CONTENT 1 Introduction 4 2 General accreditation issues 4 3 Requirements and others 5 4 Definition of Scope of accreditation 5 5 Changes to the previous edition 7 Annex 1: Key tasks/activities for producing a reference material and ISO Standards used to assess the technical competence of bodies producing RMs with assigned values. 8 Annex 2: Examples of scope definition 9 Dutch Accreditation Council (RvA) page 3 of 9

4 1 Introduction The RvA assesses and accredits technically competent bodies producing reference materials with assigned property values. These assessments are conducted against the requirements given in ISO Guide 34 Testing and/or calibration activities that takes place as part of the production process shall meet the appropriate requirements of ISO/IEC referred to in the specific clauses. This document is intended to provide explanation of the procedures and requirements for the accreditation of Reference Material Producers. The main issues addressed in this document are: general accreditation issues (chapter 2), an explanation of the specific requirements (chapter 3) and the definition of scopes for accreditation of Reference Material Producers (chapter 4). 2 General accreditation issues In 2012, the General Assembly of ILAC resolved (resolution GA 16.20) that accreditation of technically competent bodies producing reference materials with assigned property values will be conducted against criteria based on alone, taking in consideration that testing and/or calibration activities that takes place as part of the production process shall meet the specific requirements of ISO/IEC given in. An ILAC working group is drafting a document with requirements and guidance for the assessment and accreditation of Reference Material Producers. Currently draft 9 is made available for accreditation bodies. The current view of ILAC is that under accreditation a number of key tasks in producing a reference material, shall not be performed by subcontractors. These tasks are given in italics: - Project planning (design project and selection of subcontractors); - Material preparation; - Homogeneity/Stability testing; - Characterization of property values; - Assignment of and decision on property values; - Authorization of property values and issue of certificate for reference materials; - Handling and storage (including monitoring integrity of reference material); - Distribution and post distribution service. For all subcontracted tasks the Reference Material Producer shall ensure the technical competence of the subcontractor. The accreditation of Reference Materials Producers is processed according to the rules and procedures stated in RvA-BR002 (Policy rule Accreditation ). Registration numbers are composed of the letter P and a three digit number. The accreditation provided is not yet part of the scopes of the EA and ILAC multilateral agreements. Dutch Accreditation Council (RvA) page 4 of 9

5 In practise, the Reference Material Producer may already hold an accreditation for specific calibration/testing activities under a fixed or flexible scope. For these activities other RvA explanatory documents apply. 3 Requirements and others There are a number of different approaches a Reference Material Producer can use to generate and assign property values to its reference materials. Additionally a Reference Material Producer may choose to or need to (e.g. in the case of consensus values) use subcontractors to perform one or more of the tasks leading to the production of its reference materials. Whichever approach is taken, the Reference Material Producer is the organisation that is fully responsible for ensuring that all the activities leading to the production and the assignment of value(s) have been performed competently. Therefore RvA will assess the competence of the Reference Material Producer (and any subcontracting arrangements it uses) in accordance with and the applicable clauses of ISO/IEC 17025, ISO Guide 31 and ISO Guide 35. Calibration/ testing laboratory already complying to the requirements of ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories, shall adapt their management system in accordance with : 2009, General requirements for the competence of Reference Material Producers. Laboratories should accurately study in order to understand the discrepancies between several and ISO/IEC clauses. Annex 1 illustrates how and ISO/IEC will be used in combination to assess the technical competence of bodies producing RMs with assigned values. 4 Definition of Scope of accreditation Historically, laboratory accreditation has been based on fixed scopes of accreditation, defined in terms as precise as possible, to establish accurately and unambiguously the range of tests and calibrations covered by a laboratory s accreditation. However, in the production of reference materials, this can be considered as restrictive in that it does not readily enable new or modified measurement methods to be added to a laboratory s scope, even where competence in this general area has already been demonstrated. For the purpose of this explanatory document the phrase flexible scope is used throughout. However, this explanatory document is not restricted solely to scopes that are flexible in their entirety. It is also relevant to scopes that include a combination of fixed and flexible methods, or even for primarily fixed scopes that include one or two flexible or generic methods. Dutch Accreditation Council (RvA) page 5 of 9

6 Flexible scopes of accreditation do allow a Reference Material Producer to undertake the preparations and issuing of reference material certificates, even though they may not be explicitly stated on their accreditation scope, but fall well within their reference material category. Accreditation of a flexible scope places more of the responsibility onto the laboratory itself for demonstrating that valid, fit-for-purpose activities are undertaken competently and consistently. For that the Reference Material Producer has to keep a concise summary of all the applied measurement (analytical) methods, specific properties of identified species, characterisation ranges (composition) and description of the matrix (material/ artefact). The summary shall be available to RvA at all times, for the purpose of RvA assessment logistics. The summary has to be sent to RvA in the assessment planning phase and again four weeks prior to the actual RvA assessment. Based upon the summary RvA will determine the size of the assessment and composition of the assessment team. In the scope of a Reference Material Producer and for each individual activity four items shall be included: - The first column contains the sequence number of the activity (this number is allocated by the RvA for database purposes). The RvA may decide to list the reference material category code.. - The second column specifies the matrix and or artefact for which property values have been established. This can be similar to a 'fixed scope', but more generalised descriptions as given in the examples are allowed. - The third column specifies the properties and/ or identity the species and/or characterisation ranges. For synthetic reference materials, e.g. calibration solutions and gas mixtures, it is desirable to accurately specify the identity of components in the matrix and the range, which can be flexible. For natural reference materials it is important to specify the identity in generic terms as the composition way vary from source to source. - The fourth column specifies one or more characterisation procedures which have been used in assigning property values to the reference material. These procedures are given in ISO Guide 35. In addition the applied technical procedure may be added. RvA will assess alternatives to ISO Guide 35, but will only except characterisation methods that are at least equivalent to ISO Guide 35. The characterisation procedures for assigning property values have to be assessed by RvA prior to accreditation and are as such not flexible. However the applied measurement methods (analytical methods) may be flexible, in which case RvA assesses post priory, if the Reference Material Producer and/or its subcontractors used validated methods and are competent in performing measurement on the candidate reference material. In Annex 2 an example of the scope of accreditation for Reference Material Producer is given. Dutch Accreditation Council (RvA) page 6 of 9

7 5 Changes to the previous edition In comparison with version 3 dated the following changes were made: - The results of the new the ILAC position on conducting accreditation in accordance with ISO Guide 34 alone - Update Annex I. Dutch Accreditation Council (RvA) page 7 of 9

8 Annex 1: Key tasks/activities for producing a reference material and ISO Standards used to assess the technical competence of bodies producing RMs with assigned values. Project planning Design project Select subcontractors (if needed) Material preparation Production planning Selection of material(s) Production control Control of environment Control of poor quality material Homogeneity/Stability testing Statistical plan Calibration/testing homogeneity & stability pre and post certification Characterisation of Property Values Identification of measurand Method selection Method validation Quality assurance Traceability of measurement result Uncertainty of measurement result (ISO/IEC 17025) ISO/IEC when it is necessary to check the composition of the selected materials for determining suitability ISO/IEC ISO Guide 35 ISO/IEC ISO Guide 35 Assignment of and decision on property values Data evaluation Identification of bias Statistical procedures Traceability of property value to SI/stated reference Uncertainty of property value ISO/IEC ISO Guide 35 Authorisation of property values and issue of certificate for certified RM Certification of assigned value(s) Issuing certificate in accordance with ISO Guide 31 Instructions for use Handling and storage Packaging & labelling Monitor integrity of RM during storage Monitor storage temperature & Environment Distribution Distribution Post distribution service ISO Guide 31 ISO Guide 35 ISO/IEC Dutch Accreditation Council (RvA) page 8 of 9

9 Annex 2: Examples of scope definition Nr. Matrix / Artefact Property Value(s) / Identity / Characterisation Ranges 1 Ferrous Metals Steels, Irons and Ferro Alloys 2 Non-Ferrous Metals Aluminium Alloys, Chromium, Cobalt, Copper, Lead, Magnesium, Nickel, Tin, Titanium Zirconium Base Alloys Elements Elements 3 Cements, Clays and Related Products Elements Metal oxides 4 Pure Organic Compounds Organic chemicals 5 Pure Organic Compounds Organic chemicals 6 Pure Organic Compounds Calibration solutions 7 Petroleum Products Diesel and Gasoline 8 Foodstuffs Food supplements 9 Soils, Sludges and Sediments Soils, Sludges, Sediments 10 Analysed Gases Single and Multi Component Gas Mixtures Purity (% m/m) Melting point (30-300ºC) Polychlorinated Biphenyls Sulphur (Trace to % Levels) Selenium (content and speciation) Inorganics (Trace to % Levels) ppm to % Levels CarbonMonoxide/Nitrogen Carbon Dioxide/Nitrogen Nitric Oxide/Nitrogen Propane/Air Propane/Nitrogen Methane/Air Characterisation Procedure/ Technique Measurement by a network of qualified laboratories using a variety of measurement procedures of Measurement by a network of qualified laboratories using a variety of measurement procedures of Measurement by a network of qualified laboratories using a variety of measurement procedures of Measurement by two or more independent reference measurement procedures. Methods selected from HPLC, GC-FID, GC-MS, titration Karl Fischer reference measurement procedure at an NMI laboratory by contact thermometry reference measurement procedure (GC-IDMS) and/ or measurement by a network of qualified laboratories using a variety of methods of reference measurement procedure (ICP-IDMS) reference measurement procedure (HPLC -IDMS and GC-IDMS) reference measurement procedure (ICP-IDMS) and/or measurement by a network of qualified laboratories using a variety of measurement procedures of Measurement by two or more independent reference measurement procedures. Method selected from: NDIR, NDUV, GC-FID, GC-TCD or chemiluminescence. ISO 6142 and ISO6143 Dutch Accreditation Council (RvA) page 9 of 9