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.
Price: $200
