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Regulatory and QMS Technical File Templates

Quality Manual Template

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Quality Manual Template

Quality Manual is a summary document of an organization’s quality management system. This template is prepared as per clause 4.2.2. of ISO 13485:2016. The quality manual template contains: 

  • Detailed statement of the scope of the organization’s QMS 
  • Exclusions and non-applicability with justification
  • Reference to applicable and relevant procedures
  • Structure of the document (in the form of a diagram of the pyramid)

Our fully written quality manual is approximately 45 pages and is specifically for early-stage medical device companies and is audit-ready and written by highly experienced professionals. Click below to get a preview of this template. 

Quality Manual Template:

Price: $200

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