The manufacturer shall plan and implement monitoring, measurement, analysis and improvement processes to ensure the conformity of products and the conformity and effectiveness of quality systems.
The foregoing planning shall include validation of the appropriate methods including statistical techniques and the scope of application.

In order to evaluate the effectiveness of the quality management system, the manufacturer shall gather and monitor information on compliance with customer requirements.
The manufacturer shall formulate in writing the methods for collecting and using the information mentioned in the preceding paragraph.

The manufacturer shall formulate in writing procedures for receiving and processing the information as mentioned in the preceding article. Specific provisions of laws and regulations, if available, shall prevail.
The foregoing procedures shall include the aggregation of production and post-production information; the consolidated information shall be used by the manufacturer as a reference for risk management, monitoring and product conformity maintenance, and the process of product realization and improvement.

The manufacturer shall formulate in writing the procedures and deadlines for complaints handling, and the content of the procedures shall include the following matters:
1. Acceptance and record of the cases of complaint;
2. Evaluation if the case is established;
3. Investigation of the incident;
4. Matters and methods of statutory notification;
5. Treatment of the products based on investigation results;
6. Decisions on subsequent correction and content of corrective actions.
If the complaint case referred to in the preceding paragraph is found not caused by the manufacturer, the manufacturer shall provide the content of the complaint and the appropriate information obtained from the investigation to the relevant stakeholders.
The record mentioned in the first paragraph shall include the matters in all the sub-paragraphs in the same paragraph and the reasons for not having exercised incident investigation. The record shall be kept on file.

The manufacturer shall handle the reporting of adverse events of Paragraph 1 of Article 48 of the Act, the reporting and the undertaking of corrective and preventive measures of Article 49 of the Act, the notifying and recalling within a definite time of Paragraph 1 of Article 58 of the Act, and formulate the procedures for operation.
The notification, corrective and preventive measures, recall as mentioned in the preceding paragraph shall be recorded and kept on file.

The manufacturer shall perform internal audits regularly to ensure the effectiveness of the quality management system and its compliance with laws and regulations.
The manufacturer shall formulate the procedures for the audit as mentioned in the preceding paragraph, which shall include the division of powers and requirements related to the planning, execution, recording and reporting of audit results.

With regard to the content of the audit plan mentioned in the preceding Article, the manufacturer shall formulate it while taking into account the subject, content and location, as well as the relative importance of the processes in the quality management system and the results of previous audits.
The content of the preceding paragraph shall include the audit criteria, scope, frequency, method and records; the auditor shall not audit the work of their own duties.

The process, place and results of the audit shall be thoroughly recorded and kept on file.
The management of the auditee shall propose corrective measures for the non-compliance of the audit results as mentioned in the preceding paragraph and correct them in time to ensure that the non-compliances and their causes are removed.
The manufacturer shall submit verification reports on the content and results of the implementation of corrective measures.

The manufacturer shall adopt appropriate methods to monitor and measure the various processes of the quality management system.
The manufacturer shall, if the objectives of processes as mentioned in the preceding paragraph are not achieved, propose corrective measures and implement the same to ensure product compliance.

The manufacturer shall, during the product realization process, formulate in writing the monitoring and measurement procedures at appropriate stages based on the characteristics of the product, to verify the conformity of the product.
The products shall not be released unless verified in the foregoing procedure.
The execution of the procedure mentioned in the first paragraph shall be recorded, and its contents shall include the following matters:
1. The name of the person authorized to give permit of the release;
2. Evidence that the acceptance criteria are met;
3. The name of the test equipment, if any equipment is used;
4. The names of the inspectors or testers of implantable medical devices, if the devices are used.

The manufacturer shall identify and control products that do not meet the requirements to prevent unintended use or delivery.
In order to meet the requirements of the preceding paragraph, the manufacturer shall formulate in writing the definition of rights and responsibilities in the procedures of identification, recording, segmentation, evaluation, discarding, etc. of the products that do not meet the requirements of the original manufacturer.
The evaluation mentioned in the preceding paragraph shall include the decision to initiate an investigation and to notify the relevant external authorities.
The manufacturer shall record the non-conformity as mentioned in the first paragraph, the reasons for subsequent evaluation and investigation, and reasons for decisions made, and keep the record in file.

The manufacturer shall impose the following treatments separately or simultaneously on unqualified products:
1. Measures to remove non-conformities;
2. Measures to prevent the use or application of substandard products mistakenly for their intended purposes;
3. Authorization of the use, release or acceptance of the product under concession.
The manufacturer adopting the treatment method in the third sub-paragraph of the preceding paragraph may do so only with sufficient valid reasons to meet the requirements of the second subparagraph of paragraph 1, Article 36, and receive the approval of the responsible personnel. The name and title of the person giving the approval shall be recorded and kept on file.

If any non-conformity is found after delivery, the manufacturer shall take appropriate measures with regard to its impact or potential impact, and shall be recorded and kept on file.
The manufacturer shall, in accordance with laws and regulations, formulate in writing the procedure for issuing advisory notices to external parties, and shall follow the said procedure.
The issuance of advisory notices shall be recorded and maintained by the manufacturer.

The manufacturer shall, in light of the possible effects of product reprocessing, formulate in writing appropriate rework procedures and have the procedures under review in accordance with the original procedure.
Reprocessed products shall be verified to ensure compliance with acceptance criteria and laws and regulations.
The implementation of rework shall be recorded and kept on file.

The manufacturer shall formulate in writing the items and analysis procedures of data collection to prove the adequacy, suitability and effectiveness of the quality management system.
The procedure mentioned in the preceding paragraph shall include implementation methods including the use of statistical techniques and selection of their scope of application.
The data of analysis mentioned in the first paragraph shall include the results from monitoring and measurement. The analysis shall provide at least the following information:
1. Customers' opinions, comments and expressions on the product, service or complaint handling process;
2. The compliance of product specifications;
3. The characteristics and trends of changes of the processes and products, and the timing of intervention for appropriate improvements;
4. Evaluation on the raw materials or services provided by suppliers;
5. Result of the audit on the manufacturer;
6. Evaluation of service reports, when necessary.
If the quality management system is found to be unsuitable, inappropriate, or ineffective through the analysis made in the preceding paragraph, the manufacturer shall take the analysis results as basis of improvements following the provisions of Articles 75, 76, and 77.
The aforementioned results of analysis shall be recorded and kept on file.

The manufacturer shall, based on its quality policies and objectives, make necessary changes to ensure and maintain the adequacy, suitability and effectiveness of the quality management system, and the safety and performance of the medical device.
The changes mentioned in the preceding paragraph shall be based on the audit results, post-marketing surveillance, data analysis, and corrective and preventive actions, and shall be implemented after the review and validation of the content of changes by the management.

The manufacturer shall take corrective actions to remove the cause of non-conformity and prevent its recurrence.
The implementation of the corrective actions mentioned in the preceding paragraph shall not be delayed for no reason, and the content of the actions shall be formulated based on the degree of influence of the non-conformity.
In order to implement the corrective action mentioned in the first paragraph, the manufacturer shall formulate in writing the procedures for completing the following items:
1. Review of non-conformities including customer complaints.
2. Judgment of reasons for non-conformities.
3. Evaluation of the adoption of corrective actions.
4. The planning, formulation and implementation of corrective actions, and the necessary updates of quality system documents.
5. Verification that corrective actions do not conflict with laws and regulations, and do not degrade the safety and performance of the medical device.
6. Review of the implementation of corrective actions and their effectiveness.
With regard to the formulation of corrective actions, the manufacturer shall record and keep the results of investigations it has performed on non-conformities and the implementation of corrective actions.

The manufacturer shall take preventive actions to remove possible causes of non-conformity and prevent its occurrence.
The aforementioned content of the preventive actions shall be based on the degree of impact of potential non-conformities.
In order to implement the preventive actions in the first paragraph, the manufacturer shall formulate in writing the procedures for completing the following items:
1. Judgment of potential non-conformities and their possible causes.
2. Evaluation of the adoption of preventive measures.
3. The planning, formulation and implementation of preventive actions, and the necessary updating of quality system documents.
4. Verification that the preventive actions are not in conflict with laws and regulations, and do not degrade the safety and performance of medical equipment;
5. Review of the implementation of preventive actions and their effectiveness.
In order to determine preventive actions, the manufacturer shall record and keep on file the results of investigations of potential non-conformities and the implementation of preventive actions.