Management system implementation such as FDA QSR which can be effectively manage through to use of ISO 13485, as it is proven to assist in the prevention, elimination, reduction and/or mitigation (PERM) of defective products [a safe and effective product]. Inspection and testing provide information and pursues conversion to knowledge through actions that can be taken to correct cause of  problems and further prevention of others. Identifying and solving process and product relating to no conformance is a QSR requirement (quality system requirements) regulation.

    Consideration must be given when and for invoking legal and regulatory requirements, in the U.S. from HIPAA and Sarbanes-Oxley, QSR and from other world regions such as Therapeutic Devices, MDD, Health Canada, and regions of Asia Pacific. FDA requires that medical devices have been designed, validated, produced and maintain safe and effective CYBERSECURITY measures.

Design (820.30)

Each organization is to establish and maintain controls for design through procedures for class III or class II device, minimum. Class I devices subject to design controls are devices automated with computer software and the following specific devices:

    It is encouraged that the review of design should comprise of an interdisciplinary team. This team reviews, evaluates, and documents the requirements of the components, device, and process design. It is from data established during this homologation phase that all other activities such as, purchasing, processing, and testing, derive. Development and validation data are also useful in cases of regulatory or product liability actions to show that the design and manufacturing processes were planned and properly validated, reviewed, and documented thus providing, if ever needed, where needing for prudence (jurisprudence). For verification and validation, two key words need be addressed, these are competence and impartiality.

Some of the many reasons for implementation of a formal management system for quality is assisting to manage legal obligations such as 21 CFR Part 803, Medical Device Reporting (MDR), and product liability. MDR requires manufacturers of medical devices to report to FDA certain adverse events that they receive from any source. Product liability actions (see prudence in previous paragraph) are often the result of design, labeling, and/or manufacturing.

Purchases (820.50)

There must be a protocol for identifying, evaluating, selecting and inclusion into a database of approve sources for purchasing deriving from design. The specifications are device master record (DMR) specification document or DMR drawing or procedure.

The organization must establish and maintain procedures to ensure control of purchases. The  suppliers, contractors, and consultants based on their ability to meet the established specifications must be assess.

Labeling and information content is an important issue of the design and production practices from purchase to use (see 21 CFR Part 801 and 809 -- other related/relevant part 807, 814 and 820.30).

Process Control (Subpart G, CFR 820)

The organization must develop methods and practices for development and implementation of processes and related equipment. For processes such as welding, moulding, lyophilizing, sterilizing, and packaging/sealing where the output cannot be fully verified until after use, the qualification should include a full validation of the processes performed by competent personnel. Prior o implementation, these methods and practices need be developed, evaluated, validated as necessary and documented.

Adverse effects within processing and where necessary, procedures have to be developed, implemented, and monitored to control product and process characteristics. Quality system personnel should participate in the timely (i.e., early) development of special controls, test or inspection methods, or training programs. Acceptance methods must be developed for measurement of outgoing product quality.

Management is Responsible (820.20)

QSR 820.20, one of the most important responsibilities of management is to establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organizations. This means each organization must establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. QSR requires that each manufacturer must establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the GMP QSR. To meet these regulatory requirements, manufacturers are required to provide adequate resources, including the assignment of trained personnel for management, performance of work, and assessment activities, including internal quality audits.

The rest is verbatim ISO 9001:2000 (Sections 4 and 5).

The organization must establish how the requirements for quality will be met [820.20(d)]. Each manufacturer must establish a management system through procedures and instructions, among other documents, see also 820.20(e).

Documentation and Control (820.40)

21 CFR 11 comes of age for records to exist in electronic state, yet documentation of the management system remains through procedures with demonstrable evidence in electronic media. A manifest with indications that management recognizes the need for a quality system in order to assure quality products and regulatory conformance. Many manufacturers, accomplish this documentation commitment through: a management policy; assignment of responsibilities and authorities; and general statements and actions such as employee training that define goals of the quality system; concurrent with procedure and documents to support the managerial system. And QSR (as well, implicitly, ISO 13485) requires that the organization maintains records such as:

  • design history files,
  • device master records,
  • device history records,
  • maintenance schedules and records,
  • complaint files and failed device/component files,
  • audit reports,
  • distribution records, and
  • personnel training records.

We should not generate and use procedures that there is no need. An effective tool is to flow chart or process map, and analyze if the existing procedures are adequate, correct, or excessive. Process mapping is an excellent method for improving operations and the associated management system activities. And auditing is a must aspect of any effective quality management system.

Product Approval

The management system includes procedures for assuring that products such as components, packaging, labeling, manufacturing materials, and finished devices have been approved for use; and that contracted items and services are suitable [820.50, 820.80]. Likewise, the quality system shall assure that rejected items are identified and properly disposed [820.90]. Additionally, the quality system must assure that production records are reviewed before the product distribution [820.80(d)]--Records are part of the device history record.

See also PMA and 510(k) protocols.

Acceptance Activities (Subpart H, CFR 820)

QSR determines that testing and inspection is performed in accordance to planned arrangements (see 820.80, 820.181, and 820.20). Some of the methods used to accomplish this are adequate test and inspection procedures, training of test personnel, quality system audits, review of quality system records, process monitoring, and product audits (not to confuse with system audits).

Labeling, other than (Subpart K, CFR 820)

Labeling is part of the information provided to the FDA for evaluation and study prior to release. Further, the Federal Regulations allows, through 21 CFR 801.4, for the FDA to consider;

  • advertising issues,
  • manufacturer's statements,
  • knowledge that the product is offered and used for purpose for which is neither labeled or advertised, and
  • the manufacturers knowledge of facts that would give it notice that a product is to be used for purpose other than those for which the manufacturer offered it. 

These empowers the FDA to deal with fraud issues and save court time and resources.

Auditing (820.22)

QSR (Part 820.20) indicate that the organization must prepare and implement procedures to assure that the management system implement is valid and effective. Management with executive responsibility reviews audit reports as part of their review of the suitability and effectiveness of the quality management system. With the advent of electronic documents, expectations are that records and other documents be in electronic form.

Human Development and Training... Competency (820.25)

QSR requires quality awareness [see 820.25(b)]. Personnel involved in the management system must be properly trained, which shall comprise of both education and experience in accordance to the position's scope of responsibilities... and in ISO 9001:2000 awareness and competence is explicitly brought upon as a demonstrable requirement.

A management system must include an ongoing program for training and motivating personnel. Personnel should be made aware that product quality is not solely the responsibility of management. Quality is the responsibility of every collaborator. It is extremely important to understand the following with respect to typical quality-related functions.

  • Top management sets the stage and attitude for the organizations.
  • Research and development, otherwise Engineering, has primary responsibility for designing quality into the device.
  • The product is design for manufacturability and produced for repeat-ability
  • Manufacturing personnel have primary responsibility for producing devices that have the maximum level of performance that can be achieved based on the product and process as intended in the design.
  • Quality system personnel have primary responsibility for the program's management, status reports, audits, problem identification, data analysis, etc., as described in the QSR/ISO 13485.

Where necessary, employees (and contractors) are qualify (and competent) to perform and realize quality activities. Records of training and/or certification must be maintained. Personnel performing quality system functions should:

  • have sufficient, well-defined responsibilities and authority;
  • be afforded the organizational freedom to identify and evaluate quality problems;
  • be able to formulate, obtain, and recommend possible solutions for quality system problems; and,
  • verify implementation of solutions to quality problems.
  • competence is demonstrable.


FDA promulgates regulation [803] for organizations in manufacturing, distribution, servicing requiring from them to establish and maintain reports, including the designation of MDR (Medical Device Reporting) reports for serious injuries, death, or certain other adverse incidents (also under FDA see MedWatch). The basis of a management system toward quality, as required by the QSR, is to reduce the frequency of MDR reporting

Additional Information, Health care Improvement

The Institute for Health Care Improvement provides services to assist health care organizations to improve operations and reduce costs. Applying techniques through education, training, project management, investigation and research concurrent with social and technical support performance can improve.




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