This manual is used as a template in developing your ISO 13485:2016 Quality Management System. This Quality Manual is designed for ISO 13485 and can accommodate the FDA Quality System Regulation (21 CFR 820).

The basic additions for the Quality System Regulation are highlighted in yellow and the applicable part of the regulation is indicated.

For example, in section 3.0 of the manual, the QSR 820.3 bb notation refers to part 820.3 Definitions; and in section 4.2 of the manual, the reference to QSR 820.30.j indicates a requirement in part 820.30 Design controls.

• Methods and systems used in the development and operation of the QMS vary widely from company to company.
• The blue text and suggestions displayed in the manual are intended to offer some options and to highlight the areas that need attention / update / replacement.
• Review the text and suggestions and at a minimum replace or update them to reflect the unique / customized information of your quality system requirements.
• Delete the blue text after each task is completed.
• Use replace function – enter “Your Company” in find space, enter your company name in replace space – system should make changes throughout the entire document.
• Additional details and instructions in the use of the QMD-002 manual template are included in a separate file “QMS-Template-Instructions”.