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A quality manual is a high-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy-level position of your management in the area of quality management system (QMS) and compliance with applicable regulations. There are two definitions of what a quality manual for an ISO 13485 QMS should be:

A quality manual is a high-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy-level position of your management in the area of quality management system (QMS) and compliance with applicable regulations. There are two definitions of what a quality manual for an ISO 13485 QMS should be:

Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS should be: