ISO 13485 audit checklist of documentation requirements
ISO 13485 audit checklist of documentation requirements
Clause 4.2
I. General requirements
1. Does Organization have documented statements of a quality policy and quality objectives? (See 5.3, 5.4.1)
2. Does Organization have a quality manual?
3. Does Organization have the documented procedures required by ISO 9001:2000/ 13485:2003?
4. Are adequate documents in place to ensure the effective planning, operation and control of Organization’s processes?
5. Does documentation include the records required by ISO 9001:2000?
6. Are there any documents required by regulations?
7. (Verify throughout audit)
8. Can you show me a file for each type or model of medical device containing or identifying documents with product specifications and QMS requirements?
9. (Review documents to verify they define the complete manufacturing process, installation and servicing)
II. Quality manual
1. Where in the quality manual is the scope of the QMS identified, including details of and justification for exclusions and/or requirements that don’t apply?
2. Where does the quality manual contain or reference the documented procedures established for the QMS?
3. Where does the quality manual include a description of the interaction between the processes of the QMS?
4. Where does the quality manual outline the documentation structure of the QMS?
III. Control of documents
1. How are the documents required by the QMS controlled?
2. (Documents to be reviewed throughout the audit)
3. Can you show me a documented procedure that defines the controls needed for each of the following?
a) review and approve documents for adequacy prior to issue?
b) review and update as necessary and re-approve documents?
c) ensure that changes and the current revision status of documents are identified?
d) ensure that relevant versions of applicable documents are available at points of use?
e) ensure that documents remain legible and readily identifiable?
f) ensure that documents of external origin are identified and their distribution controlled?
g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
IV. Control of records
1. What records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit)
2. Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit)
3. Does Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?
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