Part 3 Good Manufacturing Practices for Medical Devices
Chapter 2 Standard Mode
Section 1 Quality Management System
Manufacturers shall establish, implement and maintain a documented quality management system that conforms to the requirements of these Regulations.
Manufacturers shall adopt the following measures:
(1) Identifying the processes and applications needed for the quality management system;
(2) Determining the sequence and interaction for implementation of the quality management system;
(3) Determining criteria and methods needed for the quality management system to ensure effective operation and control of the processes;
(4) Ensuring the availability of resources and information necessary to support the operation and monitoring of quality management system processes;
(5) Monitoring, measuring and analyzing the processes of quality management system;
(6) Implementing actions necessary to achieve planned results of quality management system processes and maintain the effectiveness of these processes.
Where manufacturers choose to purchase from a supplier part or whole of any process that affects product conformity with quality management system requirements, the manufacturers shall ensure control over such purchased processes.
Control of such purchased processes shall be identified within the quality management system.
The quality management system documentation shall include the following:
(1) Documented statements of a quality policy and quality objectives;
(2) A quality manual;
(3) Documented procedures required by these Regulations;
(4) Documents needed by the manufacturer to ensure the effective planning, operation and control of its quality management system processes;
(5) Records required by these Regulations; and
(6) Any other documentation specified by the central competent health authority.
Where these Regulations specify that a requirement, procedure, activity or special arrangement be documented, it shall, in addition, be implemented and maintained by the manufacturers.
For each type or model of medical device, manufacturers shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
Manufacturers shall establish and maintain a quality manual, the contents of which include the following:
(1) The scope of the quality management system;
(2) The documented procedures established for the quality management system; and
(3) A description of the interaction between the processes of the quality management system.
The above quality manual shall outline the structure of the documentation used in the quality management system.
Documents required by the quality management system shall be controlled. These include but not limited to any type of documented records, which shall all be controlled according to the requirements of these Regulations.
Manufacturers shall establish a documented procedure that includes the following, to define the controls needed to:
(1) Review and approve documents for adequacy prior to issue;
(2) Review and update as necessary and re-approve documents;
(3) Ensure that changes and the current revision status of documents are identified;
(4) Ensure that applicable documents are available at points of use;
(5) Ensure that documents remain legible and readily identifiable;
(6) Identify documents of external origin and control their distribution; and
(7) Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for necessity.
Manufacturers shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions.
Manufacturers shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the manufacturers, but not less than the retention period of any resulting record, or as specified by regulatory requirements.
Manufacturers shall establish and maintain records to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable.
Manufacturers shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
Manufacturers shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the manufacturers but not less than three years from the date of product release by the manufacturers or as specified by other relevant regulatory requirements.