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[musbau.lasisi@gmail.com]

Requirement

Conformity Y/ N

Details

Prerequisite Program

 

 

Management Commitment

1.   Senior management ensures that the responsibilities and authorities are defined and communicated within the company

 

 

Internal Communication

1.   There is a clear communication and reporting channel between senior management and personnel.

 

 

Management Review

1.          Management review includes: o audit results o customer feedback

o process performance and product conformity o status of preventive and corrective action o follow-up action from previous management reviews o planned changes that could affect the quality system o recommendations for improvement

 

 

Quality Manual

1.     A quality manual with appropriate processes and procedures exists

 

 

Control of Documents

1. Document control procedures are in place including approval for adequacy prior to use, updates and re-approval, identification of the current version, availability, legibility
2. Records are controlled (identifies which records are needed and how long they are kept)
3. The following records are maintained as appropriate to the product (e.g. GMPs,

 

 

 

[Brendan Triplett]

Good morning,

 

Do you have a question for this or just asking for review of what you have written.  What standard are you looking for this to be measured against?  Let us know.

 

Cheers!