To maintain a complete and viable Quality System, Quality Manual, and Quality Program the use of International, and/or National Standards is mandatory to ensure your system is compliment to consensus requirements. QAMC has programs developed to aid and assist you in developing your quality system to reach: “Intent”, “Registration”, “Compliance” and/or “Accreditation” to one or as many as necessary of the following Standards:
ISO/IEC 17025: 1999 (E)L - General requirements for the competence of testing and calibration laboratories (This requirement covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods)
ANSI/NCSL Z540-1-1994 - Calibration Laboratories and Measuring and Test Equipment – General Requirements (Written for Purchasers or Suppliers) (This Standard is specific to calibration laboratories and measuring and test equipment)
ISO 9001: 2000 - Quality management systems – Requirements (Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction)
ISO 10012-1: 1992 (E) - Quality assurance requirements for measuring equipment – Part 1 Metrological confirmation system for measuring equipment (Written for Purchasers or Suppliers) (Includes both requirements and guidance on the implementation of the requirements)
MIL-STD-45662A - Calibration Systems Requirements {Military standard containing requirements for the establishment and maintenance of a calibration system used to control the accuracy of measuring and test equipment (M&TE) and measurement standards}
ANSI/ISO/ASQC Q10011-12 (-2)(-3) - Guidelines for Auditing Quality Systems (Emphasizes the importance of quality audits as a key management tool for achieving the objectives set out in an organization’s policy)
QS 9000 3rd Edition – 1998 - Quality System Requirements (Automotive Industry) (Defines the fundamental quality system requirements for internal and external suppliers of production and service parts and materials)
10 CFR Part 21 & Part 50 Appendix B - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants including Reporting of Defects and Noncompliance
ISO/IEC Guide 25: 1990 (E) - General requirements for the competence of testing and calibration laboratories (This standard is replaced entirely by ISO/IEC 17025 and will be used only until ISO 17025 status can be obtained) (Gap analysis from Guide 25 to ISO 17025 is available upon request)
ISO 9000:2000 - Quality management systems – Fundamentals and vocabulary (Describes the fundamentals of quality management systems and specifies the terminology for quality management systems)
ISO 9004: 2000 - Quality management systems – Guidelines for performance improvements (Provides guidelines that consider both the effectiveness and efficiency of the quality management system)
ISO 10012-2: 1997 (E) - Quality assurance for measuring equipment – Part 2 Guidelines for control of measurement processes (Intended to be used as a guidance document for quality management or as a requirement document by agreement between the Supplier and the customer)
FDA GMP 820.72 - Equipment and Calibration (USFDA Quality System regulation requiring each manufacturer developing, conducting, controlling, and monitoring production processes to ensure that the end device conforms to its specifications)
ANSI/ASQC M1-1996 - Calibration Systems (Specifies general requirements for assuring the quality of calibration in accordance with established practices or objectives quality control techniques)
IAS 9000 – 1998-03 - Aerospace Basic Quality System Standard (Standardizes the quality system requirements, compliance requirements, and elimination or reduction of unique requirements of the Aerospace industry)
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