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1、GeneralRequirementsforAccreditationof LaboratoriesPart A includes all ISO/IEC Guide 25 requirementsThis document is reproducible andthis is encouraged for accreditation purposes.January 1997GENERAL REQUIREMENTS FOR ACCREDITATION OF LABORATORIESJanuary 1997ForewordThe AMERICAN ASSOCIATION FOR LABORAT
2、ORY ACCREDITATION (A2LA) is a non-profit, nongovernmental, public service, membership organization dedicated to operating a nationwide, broad spectrum laboratory accreditation system. Accreditation is defined as a formal recognition of competence that a laboratory can perform specific tests or types
3、 of tests. Accreditation is available to any type of testing laboratory, be it in the private sector (independent or in-house) or in the government sector.A2LA was formed in 1978, as a practical and efficient organization to develop and manage a system to verify and recognize competent testing labor
4、atories. Accreditation is available for virtually all types of tests, calibrations, measurements and observations which are reproducible and properly documented.The accreditation of laboratories is offered in the following fields of testing:Biological Mechanical Acoustical & Vibration Nondestructive
5、Chemical Environmental Construction Materials Geotechnical Electrical Thermal Calibration Special programs are developed in response to user needs and may cut across more than one field of testing. If only a few tests from a second field are to be included and all testing is managed in one facility
6、under one quality system, these tests may be added to the scope of accreditation in the primary field at no charge for a second field. If there are two managers of equivalent status responsible for the testing in each field, accreditation will be necessary in both fields.Users of accredited laborato
7、ries are advised to seek the Scope(s) of Accreditation from any accredited laboratory or from A2LA. The Scope(s) of Accreditation identifies the specific tests or types of tests or calibration capability for which the laboratory is accredited.The general requirements (general criteria) for accredita
8、tion used by A2LA are from the international standard, ISO/IEC Guide 25 - 1990, General requirements for the competence of calibration and testing laboratories which follow in part A. Additional program requirements (specific criteria) for specific fields of testing (e.g. environmental) or specific
9、programs (e.g. fasteners) which are necessary to meet particular user needs (e.g. USEPA, PL 101-592: Fastener Quality Act) complement these general requirements in particular areas.In effect, A2LA accreditation attests that a laboratory has demonstrated that: a)it is competent to perform specific te
10、sts or specific types of tests; b)its quality system addresses and conforms to all elements of ISO/IEC Guide 25, is documented per Guide 25, and is fully operational; c)it conforms to any additional requirements of A2LA or specific fields of testing or programs necessary to meet particular user need
11、s.It is A2LA policy not to accredit or renew accreditation of a laboratory that fails to meet the above criteria see part B, Conditions for Accreditation and part C, Accreditation Process, sections on deficiencies, accreditation decisions and suspension or withdrawal of accreditation.F:WPMANREQGENER
12、AL.REQ012297 , PresidentGENERAL REQUIREMENTS FOR ACCREDITATIONTable of Contents PageCover Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Table of Contents . . . . .
13、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Part A. GENERAL REQUIREMENTS FOR THE COMPETENCE OF CALIBRATION AND TESTING LABORATORIES (ISO/IEC Guide 25 - 1990) with explanatory notes . . . . . . . . . . . . . . . . . . 4 Introduction by A2LA . . . . . . . . . . . . . . . . . . .
14、 . . . . . . . . . . . . . . 4 1. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15、 . 5 4. Organization and management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5. Quality system, audit and review . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 7. Accommodation and
16、 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8. Equipment and reference materials . . . . . . . . . . . . . . . . . . . . . . . . . . 20 9. Measurement traceability and calibration . . . . . . . . . . . . . . . . . . . . . . . 22 10. Calibration and test methods . . . . .
17、. . . . . . . . . . . . . . . . . . . . . . . . 25 11. Handling of calibration and test items . . . . . . . . . . . . . . . . . . . . . . . . 28 12. Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 13. Certificates and reports . . . . . . . . . . . . . . . . .
18、 . . . . . . . . . . . . . . 30 14. Sub-contracting of calibration or testing . . . . . . . . . . . . . . . . . . . . . . 33 15. Outside support and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 16. Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19、. . . . . 35Part B. CONDITIONS FOR ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Part C. ACCREDITATION PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 I. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 II. On
20、-site Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 III. Deficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 IV. Accreditation Anniversary Date . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 V. Proficiency Testing . . .
21、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 VI. Accreditation Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 VII. Annual Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 VIII. Reassessment and Renewal of Accreditation .
22、. . . . . . . . . . . . . . . . . . . . . 42 IX. Adding to the Scope of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . 42 X. Laboratory Reference to A2LA Accredited Status . . . . . . . . . . . . . . . . . . . 42 XI. Misuse of the A2LA Accreditation Logo . . . . . . . . . . . . . . .
23、. . . . . . . . . 43 XII. Adverse Accreditation Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 XIII. Suspension of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 XIV. Withdrawal of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24、 45 XV. Appeals Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 XVI. Confidentiality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 XVII. Conflict of Interest Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Diagram of the
25、Accreditation Process . . . . . . . . . . . . . . . . . . . . . . . . 48 Diagram of the Appeals Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 49PART AGENERAL REQUIREMENTS FOR THE COMPETENCE OF CALIBRATIONAND TESTING LABORATORIES (ISO/IEC Guide 25-1990)WITH EXPLANATORY NOTESIntroducti
26、on by A2LAAll laboratories accredited by the American Association for Laboratory Accreditation (A2LA) are required to comply with ISO/IEC Guide 25 - 1990, General requirements for the competence of calibration and testing laboratories, unless there is some unusual circumstance in the laboratory whic
27、h might make compliance with a specific provision not appropriate. In this Guide attention is paid to the activities of both calibration and testing laboratories and account is taken of other requirements for laboratory competence such as those laid down in the OECD Code of Good Laboratory Practice
28、(GLP) and the ISO 9000 series of quality assurance standards.According to the Guides own Introduction (paragraph 7), laboratories meeting the requirements of this Guide comply, for calibration and testing activities, with the relevant requirements of the ISO 9000 series of standards, including those
29、 of the model described in ISO 9002 when they are acting as suppliers producing calibration and test results.For laboratories engaged in specific fields of testing such as the chemical (toxicology) field (see for example the OECD Code of Good Laboratory Practice) or the environmental field, these re
30、quirements may need amplification with specific criteria which include additional requirements.The text that follows, including the NOTES, come directly from Guide 25 (in gothic print). A2LA Explanatory Notes (sections in italics) are interpretative guidance on particular requirements in the text. T
31、hese explanatory notes are not to be interpreted as additional requirements. Guide 25 covers both calibration and testing laboratories, so the pairing of calibration and test is frequently repeated. In this context, test laboratories should ignore the word calibration (with the exception of section
32、9) and calibration laboratories should ignore the word test.1. Scope1.1 This Guide sets out the general requirements in accordance with which a laboratory has to demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations or tests.1.2 Additional requiremen
33、ts and information which have to be disclosed for assessing competence or for determining compliance with other criteria may be specified by the organization or authority granting the recognition (or approval), depending upon the specific character of the task of the laboratory.1.3 This Guide is for
34、 use by calibration and testing laboratories in the development and implementation of their quality systems. It may also be used by accreditation bodies, certification bodies and others concerned with the competence of laboratories.2. ReferencesISO/IEC Guide 2: 1986, General terms and their definiti
35、ons concerning standardization and related activitiesInternational vocabulary of basic and general terms in metrology (VIM): 1984, issued by BIPM, IEC, ISO, and OIMLISO 8402:1986, Quality - VocabularyISO 9000:1987, Quality management and quality assurance standards - Guidelines for selection and use
36、ISO 9001:1987, Quality systems - Model for quality assurance in design/development, production, installation and servicingISO 9002:1987, Quality systems - Model for quality assurance in production and installation3. DefinitionsThe relevant definitions from ISO/IEC Guide 2, ISO 8402 and the Internati
37、onal vocabulary of basic and general terms in metrology (VIM) are applicable, the most relevant being quoted below together with further definitions applicable for the purposes of this Guide.3.1 laboratory: Body that calibrates and/or tests.NOTES:1. In cases where a laboratory forms part of an organ
38、ization that carries out other activities besides calibration and testing, the term laboratory refers only to those parts of that organization that are involved in the calibration and testing process.2. As used herein, the term laboratory refers to a body that carries out calibration or testing - at
39、 or from a permanent location, - at or from a temporary facility, or - in or from a mobile facility.3.2 testing laboratory: Laboratory that performs tests. ISO/IEC Guide 2 - 12.43.3 calibration laboratory: Laboratory that performs calibrations.3.4 calibration: The set of operations which establish,
40、under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a measurand.NOTES:1. The results of a calibration permits the estimation of errors of indication of
41、the measuring instrument, measuring system or material measure, or the assignment of values to marks on arbitrary scales.2. A calibration may also determine other metrological properties.3. The result of a calibration may be recorded in a document, sometimes called a calibration certificate or a cal
42、ibration report.4. The result of a calibration is sometimes expressed as a calibration factor, or as a series of calibration factors in the form of a calibration curve. VIM - 6.133.5 test: A technical operation that consists of the determination of one or more characteristics or performance of a giv
43、en product, material, equipment, organism, physical phenomenon, process or service according to a specified procedure.NOTE - The result of a test is normally recorded in a document sometimes called a test report or a test certificate. ISO/IEC Guide 2 - 12.1, amended 3.6 calibration method: Defined t
44、echnical procedure for performing a calibration.3.7 test method: Defined technical procedure for performing a test.3.8 verification: Confirmation by examination and provision of evidence that specified requirements have been met.NOTE - In connection with the management of measuring equipment, verifi
45、cation provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation or specification peculiar to the management of
46、 the measuring equipment.The result of verification leads to a decision either to restore in service, to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed shall be kept on the measuring instruments individual record.3.9 quality system: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. ISO 8402 - 3.8, without the notes3.10 quality manual: A document stating the quality policy, quality system and quality practices o