Audit work documents

[NdumisoN]

Hi All.

I'm currently creating documentation for us to conduct internal audits, can you please help with this question?

Internal audit work documents, are they a requirement to have and approve in ISO 13485?

 

[Jean_B]

No.

 

[Enghabashy]

*You should refer to the audit procedure or process , the main docs. formats could be : 1-NC report , 2-audit report which should reflect audit scope, criteria "it's prefer for integrating ISO 9001 & ISO 13485 to reduce doc. generation " ,3-audit schedule " should covering all Dept. /Sec. at least 1 as frequency audit each year for each Dept., the schedule should be outlined according to the previous audit results , the importance & complexity of audited activities " 4- audit plan / program which can integrate or separate of audit check lists ,

*it's more useful also if check lists are covering the integrated company processes & integrated requirements of both standards , this reduce time , auditors tasks & make audits as more effective & comprehensive ;

*the findings in audit reports & NC reports can indicate 2 referenced clauses numbers ; it’s more effective tool to reduce the duplication of reports & the relevant checklists.



*the above documents should reflect audit findings “NCs if found , Observation/recommendations if your system could accept that , the causes of NCs * the causes of NCs should be initiated by audited / process owner ,the necessary corrections , corrective actions ,Follow-up & verification of the actions taken should be documented & kept also

*don’t forget to review all of above according to the relevant clauses of ISO 9001 –Cl. 9.2 & ISO 13485- Cl. 8.2.4 & all your company management system elements /processes .

 

[Zero_yield]

I'd take a look at 8.2.4 (and 4.2.5). You definitely need a record of the audit including conclusions, areas audited, CAPAs / follow-up activities, etc. Those records need to be readily identifiable, retrievable, and retained on a defined frequency (dependent on the lifetime of the product).

Do you need to keep every napkin an auditor scribbled on during an audit? No.