• ANSI/ISO/ASQ Q9001:2008

    Current The latest, up-to-date edition.

    Quality Management Systems - Requirements

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-11-2008

    Publisher:  American Society of Quality Control

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
       1.1 General
       1.2 Application
    2 Normative references
    3 Terms and definitions
    4 Quality management system
       4.1 General requirements
       4.2 Documentation requirements
    5 Management responsibility
       5.1 Management commitment
       5.2 Customer focus
       5.3 Quality policy
       5.4 Planning
       5.5 Responsibility, authority and communication
       5.6 Management review
    6 Resource management
       6.1 Provision of resources
       6.2 Human resources
       6.3 Infrastructure
       6.4 Work environment
    7 Product realization
       7.1 Planning of product realization
       7.2 Customer-related processes
       7.3 Design and development
       7.4 Purchasing
       7.5 Production and service provision
       7.6 Control of monitoring and measuring equipment
    8 Measurement, analysis and improvement
       8.1 General
       8.2 Monitoring and measurement
       8.3 Control of nonconforming product
       8.4 Analysis of data
       8.5 Improvement
    Annex A (informative) Correspondence between ISO 9001:2008 and
                          ISO 14001:2004
    Annex B (informative) Changes between ISO 9001:2000 and
                          ISO 9001:2008
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

    General Product Information - (Show below) - (Hide below)

    Committee TC 176
    Document Type Standard
    Publisher American Society of Quality Control
    Status Current
    Supersedes

    History - (Show below) - (Hide below)

    2008 COR 1 2009 [15/07/2009]
    2008 [15/11/2008]
    2000 [13/12/2000]
    94 [01/01/1994]

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2042 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    GR 1252 CORE : ISSUE 1 QUALITY SYSTEM GENERIC REQUIREMENTS FOR HARDWARE
    ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    SAE AS 6171 : 2016 TEST METHODS STANDARD; GENERAL REQUIREMENTS, SUSPECT/COUNTERFEIT, ELECTRICAL, ELECTRONIC, AND ELECTROMECHANICAL PARTS
    ASTM F 1470 : 2018 : REDLINE Standard Practice for Fastener Sampling for Specified Mechanical Properties and Performance Inspection
    ASTM F 754 : 2008 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    ASTM C 1533 : 2015 : REDLINE Standard Guide for General Design Considerations for Hot Cell Equipment
    ASTM F 1925 : 2017 : REDLINE Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASME A17.6 : 2010 STANDARD FOR ELEVATOR SUSPENSION, COMPENSATION, AND GOVERNOR SYSTEMS
    ANSI/ASSE Z10 : 2012(R2017) OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS
    ASTM F 2042 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ASTM F 754 : 2008 : R2015 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    ASTM C 1615/C1615M : 2017 : REDLINE Standard Guide for Mechanical Drive Systems for Remote Operation in Hot Cell Facilities
    ASTM F 1716 : 1996 : R2015 Standard Guide for Transition and Performance of Marine Software Systems Maintenance
    NAVSEA T9074 BD GIB 010/0300 : 0 BASE MATERIALS FOR CRITICAL APPLICATIONS: REQUIREMENTS FOR LOW ALLOY STEEL PLATE, FORGINGS, CASTINGS, SHAPES, BARS, AND HEADS OF HY-80/100/130 AND HSLA-80/100
    ANSI/ASSE Z490.1 : 2016 CRITERIA FOR ACCEPTED PRACTICES IN SAFETY, HEALTH AND ENVIRONMENTAL TRAINING
    ASTM F 1716 : 1996 : R2008 Standard Guide for Transition and Performance of Marine Software Systems Maintenance
    ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    ASTM F 1716 : 1996 : R2002 Standard Guide for Transition and Performance of Marine Software Systems Maintenance
    NASA MSFC STD 2907 : 2006 WORKMANSHIP STANDARD FOR PRINTED WIRING BOARDS
    NASA MSFC STD 2594 : 2002 MSFC FASTENER MANAGEMENT & CONTROL PRACTICES
    EIA 557 : 2006 STATISTICAL PROCESS CONTROL SYSTEMS
    ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM C 1725 : 2017 : REDLINE Standard Guide for Hot Cell Specialized Support Equipment and Tools
    ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    AIHA Z10 : 2012 OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS
    SAE AS 9000 : 1998 AEROSPACE BASIC QUALITY SYSTEM STANDARD
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