U.S. flag An official website of the United States government
  1. Home
  2. Page 14
  1. Home
Guide to Inspections of Medical Device Manufacturers
December 1997

[Previous Page] [Table Of Contents] [Next Page]

2. Quality System Requirements - 21 CFR 820.5 and 21 CFR 820.20

All manufacturers of medical devices are required to establish and implement a quality system tailored to the device manufactured. Each manufacturer must prepare and implement all activities, including but not necessarily limited to the applicable requirements of the QS/GMP, that are necessary to assure the finished device, the design process, the manufacturing process, and all related procedures conform to approved specifications.

The term "quality system" as specified in the GMP encompasses all activities previously referred to as "quality assurance" which were necessary to assure the finished device meets its predetermined design specifications.

This includes assuring manufacturing processes are controlled and adequate for their intended use, documentation is controlled and maintained, equipment is calibrated, inspected, tested, etc. Some manufacturers may use the terms "quality control" or "GMP Control" or "quality assurance" instead of quality system. It doesn't matter what term is used as long as the quality system concept is understood and implemented. Historically, "quality control" has meant inspection and test which, although the primary mechanisms for detecting defects, only set aside nonconforming product and do not prevent the deficiency which caused the defect. Quality assurance activities are intended to prevent the production of non-conforming products and include quality control activities. A quality system applies to the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. The GMP is based on this umbrella concept of a quality system and is designed to prevent the design or production of nonconforming product. A manufacturer's implementation of the QS/GMP is implementation of a quality system.

One aspect of a quality system is that it will identify, recommend, or provide solutions for quality problems and verify their implementation, as stated in 21 CFR 820.100.

Trend analysis is a method of complying with this QS/GMP requirement. Process and product accept/reject data collected by the firm through their documented systems, along with the complaint system, can be used in identifying conditions or situations which might not be apparent, or may be dismissed as isolated incidents. Once identified, measures can then be implemented to control or eliminate their recurrence.

Investigators should not make general FDA 483 observations that a manufacturer does not have a quality assurance system. If an adequate response is expected from the manufacturer the charge must be more specific and point out the controls that are missing or believed inadequate.

The firm must have a written quality policy. Management with executive responsibility (has the authority to establish and make changes to the company quality policy) must assure the policy is understood and implemented at all levels of their organization. The policy does not need to be extensive. Some of the best policies are only one to two sentences in length. Personnel are not required to be able to recite the policy but they should be familiar with it and know where to obtain it.

The firm's organizational structure must be adequate to ensure devices are designed and manufactured in accordance with the QS/GMP. The organizational structure should ensure the technical, administrative, and human factors functions affecting the quality of a device are controlled. These functions may involve hardware, software, processed materials or services. All such control should be towards the reduction, elimination, or ideally, the prevention of quality nonconformities.

Manufacturers must assure personnel involved in managing, performing or assessing work affecting quality have the necessary independence and authority to perform those tasks. Organizational freedom or independence does not necessarily require a stand-alone group. However, the responsibility, authority and independence should be sufficient to attain the firm's stated quality objectives.

Adequate resources must be available for the quality system to assure the firm's stated quality objectives can be achieved. Resources include monetary, supplies, etc. as well as personnel resources.

The firm must appoint a management representative who is responsible for ensuring the quality system is effectively established and maintained and who will report on its performance to management with executive responsibility for review. Management with executive responsibility is required to periodically review the quality system for suitability and effectiveness. The review shall measure the firm's quality system against the QS/GMP and the firm's own stated quality objectives as defined in their quality policy. Both the appointment and the reviews must be documented.

There must be written procedures for conducting these reviews. As stated under Quality Audit above, these procedures can be inspected and the firm must certify in writing, if requested, that the firm has complied with this QS/GMP requirement.

The firm must have a written quality plan that defines the relevant design and manufacturing quality practices, resources and activities and how they intend to meet their quality requirements. In addition, written quality system procedures and instructions are required.

[Previous Page] [Table Of Contents] [Next Page]

Return to: Page Top | Inspection Start

Back to Top