View source for ISO13485:2003

ISO 13485 is derived from [[ISO 9001|ISO 9001]]


{{:ISO13485 - Clause 0: Introduction}}

{{:ISO13485 - Clause 1 Scope}}

{{:ISO13485 - Clause 2 Normative references}}

{{:ISO13485 - Clause 3 Terms & definitions}}

{{:ISO13485 - 4.1 General Requirements}}

{{:ISO13485 - 4.2.1 General}}

{{:ISO13485 - 4.2.2 Quality manual}}

{{:ISO13485 - 4.2.3 Control of documents}}

{{:ISO13485 - 4.2.4 Control of records Tiddler}}

{{:ISO13485 - 5.1 Management commitment}}

{{:ISO13485 - 5.2 Customer focus}}

{{:ISO13485 - 5.3 Quality policy}}

{{:ISO13485 - 5.4.1 Quality objectives}}

{{:ISO13485 - 5.4.2 Quality management system planning}}

{{:ISO13485 - Responsibility and authority}}

{{:ISO13485 - 5.5.3 Internal communication}}

{{:ISO13485 - 5.6.1 General}}

{{:ISO13485 - 5.6.2 Review input}}

{{:ISO13485 - 6.1 Provision of resources}}

{{:ISO13485 - 6.2.2 Competence, awareness and training}}

{{:ISO13485 - 6.4 Work environment}}

{{:ISO13485 - 7.1 Planning of product realization}}

{{:ISO13485 - 7.2.1 Determination of requirements related to the product}}

{{:ISO13485 - 7.2.3 Customer communication}}

{{:ISO13485 - 7.3.1 Design and development planning}}

{{:ISO13485 - 7.3.2 Design and development input}}

{{:ISO13485 - 7.3.3 Design and development outputs}}

{{:ISO13485 - 7.3.4 Design and development review}}

{{:ISO13485 - 7.3.6 Design and development validation}}

{{:ISO13485 - 7.4.1 Purchasing process}}

{{:ISO13485 - 7.4.2 Purchasing information}}

{{:ISO13485 - 7.4.3 Verification of purchased product}}

{{:ISO13485 - Control of production and service provision - 7.5.1.1 General requirements>>}}
[[Category:quality]]