scope:

PURPOSE

Part III provides nonmandatory guidance on approaches and methods to implement the requirements of Parts I and II. Consistent with its intent to provide nonmandatory guidance, the terms must, require, and shall are not used in statements of action in this Part. As such, alternative approaches and methods may be used to satisfy Parts I and II requirements.

APPLICABILITY

Application of this Part III guidance may be achieved by either or both of the following approaches when implementing Parts I and II requirements:

(a) as content within the QA program document to provide details relevant to an organization's activities

(b) as content in policies, protocols, instructions, and procedures that establish controls for activities affecting quality

Part III contains details of proven methods and activities to achieve compliance with Parts I and II requirements, and provides proven principles and practices that may be used to establish an efficient and cost-effective QA program. Part III reflects industry experience, proven methods of performance, technology changes and regulatory considerations, and insights into the intent of the NQA Committee in formulating Parts I and II requirements. Part III does not, however, limit the Standard user from utilizing alternate methods and activities that can be proven to provide results consistent with Parts I and II requirements.