Part 3 Good Manufacturing Practices for Medical Devices
Chapter 2 Standard Mode
Section 2 Management Responsibility
Top management shall be committed to the development and implementation of the quality management system and maintain its effectiveness by providing the following evidence:
(1) Communicating internally within the manufacturer on the importance of meeting customer as well as statutory and regulatory requirements concerning the safety and performance of the medical device;
(2) Establishing the quality policy;
(3) Establishing the quality objectives;
(4) Conducting management reviews; and
(5) Ensuring the availability of resources.
Top management shall ensure that customer requirements are determined and are met.
Top management shall ensure that quality policy includes the following:
(1) Purpose that is appropriate for and conforms to the manufacturer;
(2) Commitment to comply with requirements and to maintain the effectiveness of the quality management system;
(3) Framework provided for establishing and reviewing quality objectives;
(4) Communication and understanding achieved within the manufacturer’s organization; and
(5) Review of the suitability of quality policy.
Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the manufacturer. The quality objectives shall be measurable and consistent with the quality policy.
Top management shall ensure the following:
(1) The planning of the quality management system is carried out in order to meet the quality objectives, as well as the requirements of Article 63; and
(2) The integrity of the quality management system is maintained when changes are made to the quality management system.
Top management shall establish a documented procedure to ensure that responsibilities and authorities are defined, documented and communicated internally within the manufacturer.
Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.
Manufacturers shall nominate responsible persons for activities related to monitoring experience from the post-production stage and reporting adverse events.
Top management shall appoint a member of the management who, irrespective of other responsibilities, shall have responsibility and authority that include the following:
(1) Implementing and maintaining processes needed for the quality management system;
(2) Reporting to top management on the performance of the quality management system and any need for improvement;
(3) Promoting manufacturer’s awareness of regulatory and customer requirements; and
(4) Ensuring the safety and effectiveness of manufactured medical devices.
The above responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
Top management shall establish appropriate processes for communicating the effectiveness of the quality management system.
Top management shall review the manufacturer’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
The input to management review shall include the following information:
(1) Results of audits;
(2) Customer feedback;
(3) Process performance and product conformity;
(4) Status of preventive and corrective actions;
(5) Follow-up actions from previous management reviews;
(6) Changes that could affect the quality management system;
(7) Recommendations for improvement; and
(8) New or revised regulatory requirements.
The output from the management review shall include any decisions and actions related to the following:
(1) Improvements to the effectiveness of the quality management system and its processes;
(2) Improvement of product related to customer requirements;
(3) Resource needs.