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ISO 13485, ISO 9001, FDA 21 CFR 820 Quality Manual






ISO 13485 - ISO 13485, ISO 9001, FDA 21 CFR 820 Quality Manual










Food and Drug Administration (FDA) has established and maintains Part 820 – Quality System Regulation (QSR), also known as 21 CFR 820 or “Current good manufacturing practice” (CGMP). This regulation applies to medical device manufacturers or importers of devices intended for “human use”. Compliance with this regulation is expected from any organization that manufactures or imports such devices into the USA. Among other requirements, QSR prescribes establishment and maintenance of a number of documented procedures. A typical approach to establishing documentation systems is by means of developing a suitable structure to include quality policy, quality manual, procedures, instructions, etc. This approach documents hierarchy and relationship of documents within the system, allowing users to easily locate information they need.

While QSR does not specifically require establishment of a quality manual, Section 820.186 requires a manufacturer to establish a quality system record that includes “…or refer to the location of procedures and the documentation of activities required by [the QSR].” This definition very closely resembles requirements for or intent of a quality manual for ISO 13485 compliant quality management system. Since almost all medical device manufacturers dealing with the US market comply with both, FDA QSR and ISO 13485 standard, it is a good idea to include requirements of both, QSR and ISO 13485 into your integrated quality manual.

This set includes:
- ISO 13485 / ISO 9001 / QSR Integrated Quality Manual,
- 21 CFR 820 / ISO 13485 Checklist, and
- Quality Policy

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