NABL 130
NABL
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES
SPECIFIC CRITERIA for
SITE TESTING AND SITE CALIBRATION LABORATORIES
ISSUE NO : 03 ISSUE DATE: 28.03.2008
AMENDMENT NO : 00 AMENDMENT DATE: --
AMENDMENT SHEET Sl
Page No.
Clause No.
Date of Amendment
Amendment made
Reasons
Signature QM
Signature Director
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National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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CONTENTS PAGE NO.
Amendment Sheet
i
Contents
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Introduction
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1.
Scope
1
2.
References
1
3.
Definitions
2
4.
Management Requirements
3
5.
Technical Requirements
5
5.1
Personnel
5
5.2
Accommodation and Environment
5
5.3
Equipment and Reference Material
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5.4
Measurement Traceability and Calibration
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5.5
Calibration and Test Methods
7
5.6
Handling of Calibration and Test Items
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5.7
Certificates and Reports
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Appendix A: Impact on the NABL accreditation process
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National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
Page No: ii
SPECIFIC CRITERIA FOR THE ACCREDITATION OF SITE TESTING AND SITE CALIBRATION LABORATORIES INTRODUCTION NABL uses as the basis for all of its accreditations (of both testing and calibration laboratories) ISO/ IEC 17025: 2005, “General Requirements for the Competence of Testing and Calibration Laboratories”. NABL has also developed “Specific Criteria” for each field of testing and calibration. Laboratories seeking accreditation in any of these fields must also meet the requirements outlined in the Specific Criteria relevant to that field. Although ISO/ IEC 17025: 2005 is applicable to on-site testing or on-site calibration, it has been recognized internationally that additional, interpretive guidance is necessary so that mutual confidence between international testing and calibration services can be sustained.
1.
SCOPE This specific criteria document describes additional accreditation requirements specifically applicable to the laboratories performing tests or calibrations on-site. Laboratories may be accredited for site testing or calibration regardless of their affiliation with an accredited “permanent laboratory”, as defined in Section 3 of this document. However, if the site testing/ calibration laboratory is legally affiliated with a “permanent laboratory”, this permanent laboratory must be NABL accredited as well.
2.
REFERENCES ISO/ IEC 17025: 2005, “General Requirements for the Competence of Testing and Calibration Laboratories”.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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3.
DEFINITIONS
3.1
Permanent Laboratory: A calibration or testing laboratory erected on a fixed location.
3.2
Organization: Company, Consultancy, Partnership or other body who does not necessarily have a permanent laboratory but who tests or calibrates the characteristics or performance of materials or products at an on-site location
3.3
Site Testing/ Calibration: Testing/ Calibration (including sampling where it forms part of the documented calibration or test procedure) performed by staff of a laboratory or organization outside the premises or grounds on which the permanent laboratory of the organization or the organization’s permanent base or headquarters is located. Site Tests or Calibrations are normally performed under two categories: ™
Site tests or calibrations performed by staff sent out on-site by an accredited, permanent laboratory
™
Site tests or calibrations performed on-site by organizations that do not have a permanent laboratory
3.4
Site: Any location where site testing or calibration takes place as defined in 3.3 above
3.5
Site Laboratory: A testing or calibration laboratory facility set up in a dedicated area onsite for the duration of the testing or calibration activities.
3.6
Mobile Laboratory: Fully equipped, self-contained, transportable testing or calibration laboratory capable of performing tests/ calibrations under controlled environmental conditions. (Note: Mobile laboratories are subject to the same terms of accreditation as a site laboratory).
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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4.
MANAGEMENT REQUIREMENTS
4.1
The Quality Manual of the permanent laboratory or organization must contain a section covering the arrangements for the site operations. This shall include: 4.1.1
an up-to-date record* of on-site laboratory locations and the purpose for which they were used, including identification of any mobile laboratories (see NOTE below)
4.1.2
details* of the specific test(s) or calibration(s) undertaken at each on-site location (see NOTE below) *
The records required in 4.1.1 and 4.1.2 may be controlled and maintained as a separate quality system document, not necessarily part of the quality manual.
4.1.3
a separate listing of those tests or calibrations that the organization is capable of performing on-site
4.1.4
details of how the quality system is applied to and incorporates site testing/ calibration (e.g, an organizational chart for the permanent laboratory showing lines of responsibility and authority for site testing/ calibration etc) as well as arrangements for the supervision of site testing or calibrations where the site is not controlled by the client but rather by a third party.
4.1.5
identification of approved signatories**, criteria for signatory approval and limits of signatory authority. This criteria should include an assessment of the following attributes: -
qualification and experience
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position in the overall staff structure
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familiarity with the calibration or test procedures and awareness of any limitations of these procedures
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knowledge of the procedures for recording, reporting and checking results
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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awareness of the needs for periodic re-calibration of equipment
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awareness of the requirements and conditions for NABL accreditation, particularly those related to calibration or test reports
**
An “approved signatory� is a person who is recognized by an accreditation body as competent to sign accredited-laboratory test/ calibration reports.
4.2
The relevant parts of the quality manual shall be available to the personnel on-site
4.3
Audit and review of the site laboratory’s quality control system must be conducted using similar procedures as those applied to a permanent laboratory.
4.4
The designated internal auditor shall visit site and mobile laboratories as part of the audit and review process. The audit process shall contain specific elements to assess whether on-site tests and/ or calibrations continue to comply with the requirements of the quality system. The review process shall contain specific elements to ensure suitability and effectiveness of on-site tests and/ or calibrations.
4.5
Procedures shall exist for recording and reporting all results obtained at site and shall be coordinated with the system operating in the permanent laboratory (where appropriate). Records of original observations, calculations, data transfers and checks shall be identifiable by person and date. Records shall be made in a permanent manner and maintained so that they are not obliterated by rain, humidity, spills, leaks or other environmental factors that may affect the immediate or future readability of the records. Procedures shall exist for ensuring the security and confidentiality of test/ calibration data obtained and held on-site.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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5.
TECHNICAL REQUIREMENTS
5.1
PERSONNEL
5.1.1 The permanent laboratory or organization shall have procedures for ensuring that staff performing site tests/ calibrations are properly trained and competent. Evidence of the competence of staff performing the specific on-site tests or calibrations shall be available. (This evidence should include training records, appropriate analysis of blind proficiency samples {where available} and other demonstrations of method proficiency). 5.1.2 On-site personnel not employed or sub-contracted by the permanent laboratory or organization shall not assist in the performance of accredited tests or calibrations unless adequately supervised by trained staff employed or sub-contracted by the permanent laboratory or organization. On-site personnel not employed or sub-contracted by the permanent laboratory or organization shall not perform accredited tests or calibrations, unassisted, under any circumstances.
5.2
ACCOMMODATION AND ENVIRONMENT
5.2.1 Where the environment may affect the instrumentation, the test specimen or the measurement and test data, the data shall be qualified as per the requirements of these criteria. 5.2.2 Where tests/ calibrations are undertaken in a hostile or unstable environment or in an environment that may affect the test or calibration results, there shall be procedures for monitoring these conditions and the effect of the environment on the performance of the test or calibration. This monitoring shall be documented. 5.2.3 There shall be provisions for restricting access to the site laboratory when unrestricted access could invalidate the test or calibration results.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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5.3
EQUIPMENT AND REFERENCE MATERIAL
5.3.1 There shall be procedures for operating, maintaining, storing and calibrating equipment used in site testing or calibration. Equipment maintenance and calibration records shall include the location, date and operator for all maintenance and calibration as well as details of storage between uses. 5.3.2 Appropriate checks shall be made on-site to confirm the calibration status and fitness for use of equipment before testing or calibration begins. Equipment whose performance is sensitive to movement shall be verified/ calibrated on-site. Where, the testing/ calibration equipment is not sensitive to movement, there will be no requirement of on-site check for fitness of use. In such situations, the calibration status and fitness for use shall be checked in the permanent laboratory or at the organization’s permanent base before and after site testing or calibration. If equipment is found to be unfit for use and/ or out of calibration, it shall not be used and shall be immediately withdrawn from service. The laboratory shall examine the effects of such equipment on previous tests or calibrations. 5.3.3 If equipment other than that owned by the permanent laboratory or organization is used, the provider of such equipment shall be considered as a supplier of outside services/ supplies, subject to the requirements specified in Clause 4.6 of ISO/ IEC 17025: 2005.The laboratory shall document and archive calibration certificates (where appropriate) and other relevant details of the rented equipment. Rented equipment must be inspected for damage or malfunction before each use. It is the site laboratory’s responsibility to ensure that rented equipment receives the same checks/ calibrations and other controls as laboratory-owned equipment, prior to and during use.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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5.4
MEASUREMENT TRACEABILITY AND CALIBRATION
5.4.1 When it is necessary to utilize reference standards at site, adequate measures shall be taken to ensure that the necessary calibration status is maintained during transportation and also at site. The response of such reference standards to environmental changes or other relevant parameters shall be known and documented. 5.4.2 Reference standards shall be maintained in a suitable environment at all times, such that handling, transport and storage do not invalidate their calibration status NOTE: A reference standard is a standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.
5.5
CALIBRATION AND TEST METHODS
5.5.1 Up-to-date test/ calibration procedures (whether standard methods or internal procedures/ amplifications/ modifications) shall be available to all staff performing tests or calibrations at site. 5.5.2 Procedures shall exist for the supply and updating of test/ calibration procedures required by staff working at site. 5.5.3 Where appropriate, the uncertainty of measurement will be estimated using appropriate methods of analysis, taking into account the prevailing environmental conditions. Where it is not appropriate to determine measurement uncertainty the laboratory shall demonstrate that method performance is within the defined control limits of the reference test method. NOTE 1: The best measurement capability for site calibrations will normally be larger than that stated for the permanent laboratory. NOTE 2: The NABL Guide to the Expression of Uncertainty in Measurement NABL-141 contains internationally accepted method for determining measurement uncertainty.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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5.6
HANDLING OF CALIBRATION AND TEST ITEMS
5.6.1 Appropriate precautions shall be taken during storage, handling, transportation and preparation to prevent damage to items tested or calibrated at site.
5.7
CERTIFICATES AND REPORTS
5.7.1 Results obtained from on-site tests/ calibrations shall be identified as such on issued Certificates/ Reports, whether they form part or all of the information presented. 5.7.2 In addition to the information specified in Clause 5.10 of ISO/ IEC 17025: 2005, Certificates/ Reports shall contain the date of sampling and any other details relevant to the calibration/ test such as location of calibration/ test item. 5.7.3 All the certificates and reports shall bear NABL logo for the accredited tests/ calibrations All other clauses which are not mentioned here shall be as per ISO/ IEC 17025: 2005.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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APPENDIX A Impact on the NABL Accreditation Process 1.
Application At the time of application, the laboratory must specifically identify those tests or calibrations (and personnel involved) that are performed on-site, whether wholly or partly, including a complete description and identification of any mobile laboratory and its equipment. The laboratory must also identify themselves as an “organization” or an affiliate of a “ permanent laboratory”, as defined in section III of this document. If the site testing/ calibration laboratory is legally affiliated with a permanent laboratory, the permanent laboratory must be accredited or must apply for accreditation at the same time.
2.
On-Site Assessment The assessment, whether or not it includes the assessment of an affiliated “permanent laboratory”, shall entail an examination of the operation of the quality system at site, normally where testing/ calibration for a client is performed. It shall also entail the assessment of the testing/ calibration competency of the site test/ calibration staff, with particular emphasis on those tests/ calibrations that can only be carried out at site. The initial assessment of site testing/ calibration capabilities may involve visits to more than one site.
3.
Scope of Accreditation An accredited permanent laboratory which is also accredited for site testing/ calibration shall be issued one Scope of Accreditation specifying all tests/ calibrations within a particular field which they have been accredited to perform, both in the permanent laboratory as well as at site. However, all site tests/ calibrations shall be so noted on the Scope.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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An accredited site testing/ calibration organization (not affiliated with a permanent laboratory) shall be issued a Scope of Accreditation specifying all site test/ calibrations for which they have been accredited. The accreditation organization shall be identified on the Scope by the address of the organization’s permanent base or headquarters. If the accreditation is to include more than one mobile testing facility (not affiliated with a permanent laboratory), each mobile facility (as defined in Section II of this document) will be considered as a separate field of testing/ calibration and will be issued a separate Scope of Accreditation.
4.
Proficiency Testing Accredited field testing/ calibration laboratories shall be required to participate in relevant Proficiency Testing programmes, in accordance with NABL 163 “NABL Policies & Procedures for Inter-Laboratory Comparisons and/ or Proficiency Testing”.
National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 130 Issue No: 03
Specific Criteria for Site Testing and Site Calibration Laboratories Issue Date: 28.03.2008 Amend No: 00 Amend Date: --
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National Accreditation Board for Testing and Calibration Laboratories 3rd Floor, NISCAIR 14, Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067 Tel.: 91-11 26529718 – 20, 26526864 Fax: 91-11 26529716 Website: www.nabl-india.org