The 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 Practices” (cGMP). This regulation applies to medical device manufacturers and importers of devices intended for “human use”. Compliance with this regulation is required from any organization that manufactures or imports such devices into the USA.

Lakewood, CO October 14, 2009 -- A new article by quality and environmental management systems expert Mark Kaganov discussing ways to simplify cGMP and ISO 13485 quality management system documentation for medical device manufacturers is now available from Quality Works. In the article, Kaganov discusses an approach that allows organizations to improve compliance with the requirements and reduce the number of documents in the quality management system (QMS).

To establish an integrated cGMP and ISO 13485 QMS, an organization may use approaches outlined in the ISO 10013 Standard, Guidelines for Developing Quality Manuals. Among other suggestions, this standard gives an example of a documentation structure that can be used for QSR and ISO 13485 quality management systems. While the standard suggests using a three-level structure, most organizations implement four-level documentation structures to include quality records, as required by both QSR Subpart M – Records and ISO 13485, element 4.2.4. A typical four-level documentation structure includes: Quality Manual, Procedures, Instructions, and Records.

While four-level documentation structure is widely used, an organization may choose to include in the structure the quality policy, as the policy, among other commitments, defines the regulations and standards that a company intends to comply with. If an organization chooses to use this approach, its QMS will have five levels: Quality Policy, Quality Manual, Procedures, Instructions, and Records

Quality Policy - QSR, section 820.20 (a) and ISO 13485, element 5.3 require the establishment of a quality policy. To satisfy these requirements an organization may develop a quality policy that meets requirements of both QSR and ISO 13485 standards. While QSR requires a quality policy to only include a commitment to quality and be “…understood, implemented, and maintained at all levels of the organization”, ISO 13485 requirements are somewhat broader. Therefore, an organization should adhere to the requirements of ISO 13485.

Integrated 21 CFR 820– ISO 13485 Quality Manual - While Good Manufacturing Practices do not specifically require the establishment of a quality manual, Section 820.186 requires a manufacturer to establish a quality system record that: “…shall include or refer to the location of procedures and the documentation of activities required by [the QSR].” This definition very closely resembles requirements for a quality manual for an ISO 13485 compliant QMS. ISO 13485 2003, element 4.2.2 requires a quality manual to include:

1 - The scope of the QMS;
2 - Details of and justification for any exclusion or non-application;
3 - The documented QMS procedures or references to them;
4 - A description or interaction between the processes of the QMS; and
5 - An outline of the structure of the documentation used in the QMS.

The scope of the QMS is usually located in the corresponding section of the quality manual. It simply states which activities an organization performs within the scope of its certification. For example: “My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications”. If an organization does not perform some of the processes required by ISO 13485, clause 7, such as design or manufacture, this fact, with justification, is documented in the exclusions section of the manual. When an organization has defined the scope and exclusions, it should describe used processes and references to the corresponding procedures. For example, if Section 820.5, Quality System, requires that:

“Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.”, the manual will state:

"QW Medical, LLC. Has established and maintains a quality management system that is appropriate for the specific medical device(s) designed and manufactured, and that meets the requirements of 21 CFR 820 QSR and ISO 13485 standard in accordance with this Quality Manual.”

Interaction between the processes may be documented in a number of ways. Some companies choose to define interaction of the top-level processes by using variations of Figure 1 in the ISO 9001 2008 standard. Combining such a diagram with references to procedures within the manual will, to a particular degree, define interactions between the processes. For more detailed process interaction matrix, check out Author’s paper in Quality Progress Magazine or his Process Interaction Matrix article on the Quality-Works Website.

The last requirement of the element 4.2.2 of ISO 13485 requires to outline the structure of the documentation. Very often companies define their structures in the documentation management section of the manual or through references to supporting procedures within the text of the quality manual.

According to Matthew Lowe, Vice President - Medical Devices for MasterControl, Inc. “Quality Works’ approach to optimizing quality management systems, in combination with current automation technologies like the MasterControl suite of software tools, is the new efficient path to compliance, faster product-to-market intervals and a healthier bottom line in life sciences and other regulated industries.”

About Quality Works:

Quality Works is the one-stop-shop for information, documentation sets, training, auditing and consulting in the areas of ISO 9001, ISO 13485, ISO 14001 and AS9100 quality and environmental management systems. It is an international authority on management systems and has published a number of authoritative publications and documentation systems. Quality Works approaches management system issues from a non-technology background and talks to client's management in their own language. Its customer base spans the Americas, Europe, the Middle East and Asia. More information on services and products provided worldwide by Quality Works is available at http://www.quality-works.com.

Contact:
Mark Kaganov
Director of Operations
Quality Works
303-985-7942

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