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ISO 13485 Quality Manual Review

ISO 13485 Quality Manual
Quality Management System
Quality Management Procedures
ISO 13485 2003 Documentation Structure
ISO Requirements

ISO 13485  - ISO 13485 2003 Quality Manual Review

ISO 13485 Quality Manual Review

Quality Works offers complimentary ISO 13485 Quality Manual review. We provide this service to assist companies in identifying deficiencies and opportunities for improvement in their top-level documentation. This review and our suggestions will help your organization improve performance of your Quality Management System. This service will help you prepare for your ISO 13485 certification or improve your quality manual if your business is already ISO certified. Our consulting and auditing experience shows that common deficiencies of quality manuals are:  

  • Missing commitments to comply with ISO 13485 and regulatory requirements,

  • Duplicate and discrepant information throughout quality manuals,

  • Inadequate references to supporting ISO 13485 documentation and applicable regulations,

  • Insufficient definition of interaction of processes,

  • And others...

Take advantage of this complimentary confidential service. Mail us a MS Word copy of your ISO 13485 quality manual and we will reply with our comments that will help your organization improve your Quality Manual and the entire Quality Management System.

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