ISO 9001:2000
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Quality management systems — Requirements
Hardcopy , PDF
French, English, Russian, Spanish, Castilian
08-12-2000
23-11-2025
ISO 9001:2000 specifies requirements for a quality management system where an organization
- needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
- 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 regulatory requirements.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
| Committee |
ISO/TC 176/SC 2
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| EN ISO 9001:2000 | Identical |
| AS/NZS ISO 9001:2000 | Identical |
| AS/NZS ISO 9001(INT):2000 | Identical |
| HB 150(Int):2000 | Identical |
| HB 66(INT)-2000 | Identical |
| UNE-EN ISO 9001:2000 | Identical |
| JIS Q 9001:2000 | Identical |
| AS 3901-1987 | Identical |
| BS EN ISO 9001:2000 | Identical |
| AS/NZS 3905.12:1999 | Similar to |
| ISO 13408-6:2005 | Aseptic processing of health care products — Part 6: Isolator systems |
| I.S. EN ISO 11135:2014&A1:2019/LC:2019 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)<br> |
| I.S. EN ISO 11137-1:2015/A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018) |
| ANSI/AAMI/ISO 11140-3:2007(R2015) | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test. |
| ANSI/AAMI/ISO 11140-3:2007(R2025) | Sterilization of health care products— Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| ASME B16.5:2020 | Pipe Flanges and Flanged Fittings: NPS 1/2 through NPS 24, Metric/Inch Standard |
| CEI UNI EN ISO/IEC 17021-3: 2019 | Conformity assessment - Requirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems |
| I.S. EN ISO 15883-1:2009/A1:2014 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014) |
| ASME B16.47 : 2020 | Large Diameter Steel Flanges NPS 26 Through NPS 60 Metric/Inch Standard |
| ANSI/AAMI/ISO 11140-4:2007(R2015) | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration. |
| CEI UNI ISO/IEC 42001:2024 | Information technology – Artificial intelligence – Management system |
| AIAA R 099 : 2001 | RECOMMENDED PRACTICE FOR SPACE LAUNCH INTEGRATION |
| AS/NZS ISO 9001:2000 | Quality management systems - Requirements |
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