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Chapter Law Content

Part 3 Good Manufacturing Practices for Medical Devices
Chapter 2 Standard Mode
Section 5 Measurement, Analysis and Improvement
Article 113
Manufacturers shall plan and implement the monitoring, measurement, analysis and improvement processes needed to comply with the following:
(1) Demonstrating conformity of the product;
(2) Ensuring conformity of the quality management system;
(3) Maintaining the effectiveness of the quality management system.
The above requirement shall include determination of applicable methods, including statistical techniques, and the extent of their use.
Manufacturers shall establish and maintain documented procedures to implement and control the application of the statistical techniques.
Article 114
As one of the measurements of the performance of the quality management system, manufacturers shall monitor information relating to whether they have met customer requirements.
Manufacturers shall determine the methods for obtaining and using this information.
Manufacturers shall establish a documented procedure for a feedback system to provide early warning of quality problems and for input into the corrective and preventive action processes.
Manufacturers shall gain experience from the post-production phase in accordance with the regulations of central competent health authority, and the review of this experience shall form part of the feedback system.
Article 115
Manufacturers shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the following requirements:
(1) Conforms to the planned arrangements, to the requirements of these Regulations and to the quality management system requirements established by the manufacturers; and
(2) Is effectively implemented and maintained.
Manufacturers shall establish an audit programme, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Manufacturers shall define in a documented procedure the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records.
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
Article 116
Manufacturers shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.
The above methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.
Article 117
Manufacturers shall monitor and measure the characteristics of the product to verify that product requirements have been met.
The foregoing shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements and documented procedures.
Manufacturers shall maintain the evidence of conformity with the acceptance criteria. Records shall indicate the person(s) authorizing release of product.
Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed.
Article 118
Manufacturers shall record the identity of personnel performing any inspection or testing of active implantable medical devices and implantable medical devices.
Article 119
Manufacturers shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
Manufacturers shall deal with nonconforming product by one or more of the following ways:
(1) By taking action to eliminate the detected nonconformity;
(2) By authorizing its use, release or acceptance under concession;
(3) By taking action to preclude its original intended use or application.
Manufacturers shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. Records of the identity of the person(s) authorizing the concession shall be maintained.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained.
When nonconforming product is corrected, manufacturers shall re-verify to demonstrate conformity to the requirements.
When nonconforming product is detected after delivery or use has started, manufacturers shall take action appropriate to the effects, or potential effects, of the nonconformity.
If product needs to be reworked one or more times, manufacturers shall document the rework process in a work instruction that has undergone the same authorization and approval procedure as the original work instruction. Prior to authorization and approval of the work instruction, a determination of any adverse effect of the rework upon product shall be made and documented.
Article 120
Manufacturers shall establish documented procedures to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.
The data analyzed shall include those generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to the following:
(1) Feedback;
(2) Conformity to product requirements;
(3) Characteristics and trends of processes and products including opportunities for preventive action; and
(4) Suppliers.
Records of the results of the analysis of data shall be maintained.
Article 121
Manufacturers shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Manufacturers shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time.
Manufacturers shall maintain the records of all customer complaint investigations. If investigation determines that the activities outside the manufacturers contributed to the customer complaint, relevant information shall be exchanged between the organizations involved.
If any customer complaint is not followed by corrective and/or preventive action, manufacturers shall authorize and record the reason.
Manufacturers shall establish reporting procedures in accordance with the regulations of central competent health authority for the notification of adverse events or recall actions to the central competent health authority or its designated organization.
Article 122
Manufacturers shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.
Manufacturers shall establish a documented procedure to define each of the following requirements:
(1) Reviewing nonconformities (including customer complaints);
(2) Determining the causes of nonconformities;
(3) Evaluating the need for action to ensure that nonconformities do not recur;
(4) Determining and implementing action needed, including, if appropriate, updating documentation,
(5) Recording of the results of any investigation and of action taken; and
(6) Reviewing the corrective action taken and its effectiveness.
Article 123
Manufacturers shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
Manufacturers shall establish a documented procedure to define each of the following requirements:
(1) Determining potential nonconformities and their causes;
(2) Evaluating the need for action to prevent occurrence of nonconformities;
(3) Determining and implementing action needed;
(4) Recording of the results of any investigations and of action taken;
(5) Reviewing preventive action taken and its effectiveness.