› 13485:2003 Quality Manual

Does anyone have a template of the 13485:2003 Quality Manual that I could look at?

Comments

qdigest 8/14/2001

Since ISO 9001:2000 encourages organization to use the process approach model in developing and maintaining a quality management system, I would recommend that, if at all possible, develop a single QMS that covers all your operations. As a result, the scope will capture the processes involved in the design and development of the software, relevant production processes and sales and post-sale servicing activities, plus your customer communication and customer satisfaction processes, etc.

The benefit is that, even though there are different operations in different locations, your organization's personnel will share a comprehensive QMS but with individualized procedures for the sales, design, production and corporate management personnel.

Keep in mind that setting the scope of the QMS and pursuing ISO 9001:2000 registration/certification are two different things and that the scope has nothing to do with how registration is pursued. I am assuming that your organization's facilities are not already registered to ISO 9001/2:1994.

What I would recommend is that you consider selecting a registrar that has accredited operations in both the UK and the US, with auditors qualified to assess your organization's processes who are based close to those operations (e.g., software and TickIT experience in Manchester). Having separate certificates for each location is only recommended if the operations in each location cannot be covered by a single, comprehensive QMS because of the cultures involved.

If a single certificate of registration were to be issued, then which should be assessed first is simply a matter of preference, although some auditors may prefer to work through an organization a certain way. In choosing a registrar, ask which locations should be assessed first or if they should be done simultaneously. The registrar's ability to do all locations at the same time will depend largely on timing, since different types of auditors will be needed in different locations and may not all be available the same week or such.

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