ANSI/ISO/ASQ Q9001:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
15-09-2018
English
15-11-2008
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Superseded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 AS6171 | 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 AS9000A | Aerospace Basic Quality System Standard |
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