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ANSI/ISO/ASQ Q9001:2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Quality Management Systems - Requirements

Available format(s)

Hardcopy , PDF

Superseded date

15-09-2018

Superseded by

ASQ/ANSI/ISO 9001:2015

Language(s)

English

Published date

15-11-2008

€155.24
Excluding VAT

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

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.

Committee
TC 176
DocumentType
Standard
Pages
33
PublisherName
American Society of Quality Control
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
BS EN ISO 9001:2015 Identical
EN ISO 9001:2015 Identical

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

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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