【正文】 (ISO/IEC Guide 25 1990) with explanatory notes . . . . . . . . . . . . . . . . . . 4 Introduction by A2LA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4. Organization and management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5. Quality system, audit and review . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 7. Acmodation and Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8. Equipment and reference materials . . . . . . . . . . . . . . . . . . . . . . . . . . 20 9. Measurement traceability and calibration . . . . . . . . . . . . . . . . . . . . . . . 22 10. Calibration and test methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 11. Handling of calibration and test items . . . . . . . . . . . . . . . . . . . . . . . . 28 12. Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 13. Certificates and reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 14. Subcontracting of calibration or testing . . . . . . . . . . . . . . . . . . . . . . 33 15. Outside support and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 16. Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Part B. CONDITIONS FOR ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Part C. ACCREDITATION PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 I. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 II. Onsite Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 III. Deficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 IV. Accreditation Anniversary Date . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 V. Proficiency Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 VI. Accreditation Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 VII. Annual Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 VIII. Reassessment and Renewal of Accreditation . . . . . . . . . . . . . . . . . . . . . . 42 IX. Adding to the Scope of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . 42 X. Laboratory Reference to A2LA Accredited Status . . . . . . . . . . . . . . . . . . . 42 XI. Misuse of the A2LA Accreditation Logo . . . . . . . . . . . . . . . . . . . . . . . . 43 XII. Adverse Accreditation Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 XIII. Suspension of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 XIV. Withdrawal of Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 XV. Appeals Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 XVI. Confidentiality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 XVII. Conflict of Interest Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Diagram of the Accreditation Process . . . . . . . . . . . . . . . . . . . . . . . . 48 Diagram of the Appeals Process . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 PART A GENERAL REQUIREMENTS FOR THE COMPETENCE OF CALIBRATION AND TESTING LABORATORIES (ISO/IEC Guide 251990) WITH EXPLANATORY NOTESIntroduction by A2LAAll laboratories accredited by the American Association for Laboratory Accreditation (A2LA) are required to ply with ISO/IEC Guide 25 1990, General requirements for the petence of calibration and testing laboratories, unless there is some unusual circumstance in the laboratory which might make pliance 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 petence such as those laid down in the OECD Code of Good Laboratory Practice (GLP) and the ISO 9000 series of quality assurance standards.According to the Guide39。s individual record. quality system: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. [ISO 8402 , without the notes] quality manual: A document stating the quality policy, quality system and quality practices of an organization. NOTE The quality manual may call up other documentation relating to the laboratory39。 A2LA Explanatory Note: Laboratory management needs the authority to assure quality and protect integrity of results. Laboratory management needs the support of senior management reflected in adequate budget, equipment, facilities and people. Increased backlog, missed delivery dates, excessive errors, etc., are often signs of inadequate resources and/or authority. b) have arrangements to ensure that its personnel are free from any mercial, financial and other pressures which might adversely affect the quality of their work。 A2LA Explanatory Note: When there is a possibility of staff being placed under pressure by clients or other sections of the organization, reporting relationships should be established to isolate staff from this pressure. The boundaries, expectations and responsibilities of the employee in dealing with the client may need to be specified in order to maintain independence of judg