ISO 13485 is derived from [[ISO 9001]]


<<tiddler [[ISO13485 - Clause 0: Introduction]]>>

<<tiddler [[ISO13485 - Clause 1 Scope]]>>

<<tiddler [[ISO13485 - Clause 2 Normative references]]>>

<<tiddler [[ISO13485 - Clause 3 Terms & definitions]]>>

<<tiddler [[ISO13485 - 4.1 General Requirements]]>>

<<tiddler [[ISO13485 - 4.2.1 General]]>>

<<tiddler [[ISO13485 - 4.2.2 Quality manual]]>>

<<tiddler [[ISO13485 - 4.2.3 Control of documents]]>>

<<tiddler [[ISO13485 - 4.2.4 Control of records Tiddler]]>>

<<tiddler [[ISO13485 - 5.1 Management commitment]]>>

<<tiddler [[ISO13485 - 5.2 Customer focus>>

<<tiddler [[ISO13485 - 5.3 Quality policy>>

<<tiddler [[ISO13485 - 5.4.1 Quality objectives>>

<<tiddler [[ISO13485 - 5.4.2 Quality management system planning>>

<<tiddler [[ISO13485 - Responsibility and authority>>

<<tiddler [[ISO13485 - 5.5.3 Internal communication>>

<<tiddler [[ISO13485 - 5.6.1 General>>

<<tiddler [[ISO13485 - 5.6.2 Review input>>

<<tiddler [[ISO13485 - 6.1 Provision of resources>>

<<tiddler [[ISO13485 - 6.2.2 Competence, awareness and training>>

<<tiddler [[ISO13485 - 6.4 Work environment>>

<<tiddler [[ISO13485 - 7.1 Planning of product realization>>

<<tiddler [[ISO13485 - 7.2.1 Determination of requirements related to the product>>

<<tiddler [[ISO13485 - 7.2.3 Customer communication>>

<<tiddler [[ISO13485 - 7.3.1 Design and development planning>>

<<tiddler [[ISO13485 - 7.3.2 Design and development input>>

<<tiddler [[ISO13485 - 7.3.3 Design and development outputs>>

<<tiddler [[ISO13485 - 7.3.4 Design and development review>>

<<tiddler [[ISO13485 - 7.3.6 Design and development validation>>

<<tiddler [[ISO13485 - 7.4.1 Purchasing process>>

<<tiddler [[ISO13485 - 7.4.2 Purchasing information>>

<<tiddler [[ISO13485 - 7.4.3 Verification of purchased product>>

<<tiddler [[ISO13485 - Control of production and service provision - 7.5.1.1 General requirements>>
bag
quality_public
created
Thu, 19 Mar 2015 19:15:41 GMT
creator
dirkjan
modified
Fri, 20 Mar 2015 01:13:51 GMT
modifier
dirkjan