Hello everyone.
Some time ago external audit discovered problems with process equipment - no validation protocols, no supervision, and so on. Now I have to do the audit of this equipment and part of process acc. to ISO 9001, 13485, MDD 93/42/EEC. Could you give me some advice how to do it in a comprehensive manner?
I think I should check:
- if this part of process is included on the production process chart (ISO 9001, p. 4.4.1 b)
- if there are documented requirements for the maintanence activities, including the interval of performing the maintanance activities + records from that activity (ISO 13485, p. 6.3)
- if the work environment is documented and monitored acc. to adequate procedure + records from monitoring (ISO 13485, p. 6.4.1) + records from checking the measuring equipment - f.ex. termometer, hygrometer (ISO 3485, p. 7.6)
- if the personnel performing work is competent - records from trainings (ISO 13485, p. 6.2, 6.4.1; ) and have assigned responsibilites (ISO 9001, p. 4.4.1 e)
- records from validation of the equipment: IQ, OQ, PQ (ISO 13485, p. 7.5.6)
- instruction how to operate the equipment to produce the device in conformity to requirements (ISO 13485, p. 7.5.1a)
- if the traceability of product is maintained in this process (ISO 13485, p. 7.5.9)
What do you think?
Some time ago external audit discovered problems with process equipment - no validation protocols, no supervision, and so on. Now I have to do the audit of this equipment and part of process acc. to ISO 9001, 13485, MDD 93/42/EEC. Could you give me some advice how to do it in a comprehensive manner?
I think I should check:
- if this part of process is included on the production process chart (ISO 9001, p. 4.4.1 b)
- if there are documented requirements for the maintanence activities, including the interval of performing the maintanance activities + records from that activity (ISO 13485, p. 6.3)
- if the work environment is documented and monitored acc. to adequate procedure + records from monitoring (ISO 13485, p. 6.4.1) + records from checking the measuring equipment - f.ex. termometer, hygrometer (ISO 3485, p. 7.6)
- if the personnel performing work is competent - records from trainings (ISO 13485, p. 6.2, 6.4.1; ) and have assigned responsibilites (ISO 9001, p. 4.4.1 e)
- records from validation of the equipment: IQ, OQ, PQ (ISO 13485, p. 7.5.6)
- instruction how to operate the equipment to produce the device in conformity to requirements (ISO 13485, p. 7.5.1a)
- if the traceability of product is maintained in this process (ISO 13485, p. 7.5.9)
What do you think?