DuncanGibbons
Involved In Discussions
I've tried to identify clear differences in requirements between ISO 13485 and AS 9100D. Below are the clauses in AS 9100D that are unique to AS 9100D and have no matching clauses in ISO 13485:
7.1.2 People
8.1.1 Operational risk management
8.1.2 Configuration management
8.1.3 Product safety
8.1.4 Prevention of counterfeit parts
8.5.1.1 Control of equipment, tools and software programs
8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification
I determined these by critically searching for similar requirements in ISO 13485. Can any confirm that these are unique to AS 9100D, or if they disagree and know of clauses/requirements in ISO 13485 that fulfil these clauses for medical?
My focus is on the "Validation and control of special processes" requirements.
7.1.2 People
8.1.1 Operational risk management
8.1.2 Configuration management
8.1.3 Product safety
8.1.4 Prevention of counterfeit parts
8.5.1.1 Control of equipment, tools and software programs
8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification
I determined these by critically searching for similar requirements in ISO 13485. Can any confirm that these are unique to AS 9100D, or if they disagree and know of clauses/requirements in ISO 13485 that fulfil these clauses for medical?
My focus is on the "Validation and control of special processes" requirements.