Scope of requirements

It is not mandatory that you have documented procedures for forming the quality policy and the quality objectives, defining the responsibility of personnel, identifying resources, or conducting management reviews. However, section 4 of the standard is titled Quality s /stem requirements and section 4.2 requires that a quality manual be prepared covering the requirements of the standard. It follows therefore that you need to address the requirements of section 4.1 in your quality manual. You have a choice of how you address the requirements providing they are documented. 

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The FDA recommends that a software requirements specification document is generated. Regulators will deem software unvalidated without predetermined and documented requirements. The scope of requirements should cover ... 

Here is a summary of the scope of requirements based on the details spelt out by lEC 61508 for phase 7 in clause 7.8.2.1... 

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