Re: QMS Audit
Hi and thanks for the welcome

- i am deemed competent as an internal auditor (main area of expertise however is NC's - RC analysis and CAPA) - but now moved into a brand new industry therefore one of my initial goals is to perform a general audit of the QMS system - i havent had much exposure to this forum but it looks a great resource for information that i will duly explore......
just looking for quick tips and obvious pitfalls in the general sense
My (good, bad or indiferent) approach would be:
- review the quality manual, specifically the scope and the process interraction diagram(s); this way I can get a good understanding of what the organization doeas and a good picture of the processes employed by the organization
- follow the major product realization process(es) step by step and sample each; this way I can see and record the actual process, the process & product performance monitoring, documentation, records, employees, gages, materials, equipment & environment; I can also ensure that the interractions are as described in the quality manual
- from here I can follow up on support processes like calibration, maintenance, purchasing, training, document & record control, quality planning, engineering, NC product control, etc.
- after I review all these processes I would look at customer satisfaction and business planning ; this is the evidence of management's commitment to meet customers' requirements and meet the requirements of the standard
- after I finish reviewing all these processes I would take any questions and collected performance indicators and look at data analysis, internal audits, management review and improvement actions system for actions to address any previously identified nonconformances and opportunities; this will evidence the support and commitment from the management to implement, monitor & maintain the QMS, and to continually improve.
Note that the last two bullet points more or less reflect the requirements for an organization's quality policy. By following this approach to auditing I can get a very good picture of any organization that I can expand on as needed. If you are consulting, then use the findings to formulate your proposal to the organization; this way you will be very close to the actual amount of time and effort you have to trade for the quoted price.