Understanding “Implementation Guidelines” in the Revised QMS Ordinance
Introduction
On March 26, 2021, the Ministry of Health, Labour and Welfare (MHLW) in Japan promulgated the “Ordinance Partially Amending the Ordinance on Standards for the Manufacture Control and Quality Control of Medical Devices and In Vitro Diagnostic Devices” (Reiwa 3, MHLW Ordinance No. 60). This amendment was designed to harmonize with ISO 13485:2016 while further strengthening the quality management systems of Japan’s medical device industry. Although the revised ordinance came into force on March 26, 2021, a transitional period of three years was established. By March 26, 2024 (three years after the enforcement date of the revised ordinance), all medical device manufacturers and sellers must comply with the new QMS Ordinance.
Definition and Significance of “Implementation Guidelines”
The concept of “implementation guidelines” (実施要領), which appears frequently throughout the various provisions of the revised QMS Ordinance, is one of the key features of this amendment. But what exactly are these “implementation guidelines”?
Their purpose is to replace the previously vague “arrangements” or general “agreements” with more concrete and detailed “implementation guidelines,” thereby making the execution of the relevant work more reliable and transparent. This change is not merely a substitution of terminology but reflects an intentional quality improvement in the quality management systems required of medical device manufacturers.
Article 5, Paragraph 2 of the QMS Ordinance (Requirements for Quality Management Supervision Systems) explicitly states:
Manufacturers and sellers shall establish, implement, and maintain all requirements, procedures, activities, and implementation guidelines that are required to be documented under this ordinance.
In response to this requirement, the Ministry of Health, Labour and Welfare provides detailed commentary in its line-by-line explanation (Yakusei-hatsu 0326 No. 10), as follows:
(4) The “implementation guidelines” referred to in Paragraph 2 mean the matters that are operationally necessary for the quality management supervision system (i.e., QMS) and that are documented in addition to the quality management supervision system standards document (i.e., the quality manual) and its procedures when required by the requirements or procedures, including special arrangements and agreements.
In other words, the revised ordinance stipulates that in order to achieve effective quality management, detailed and concrete implementation guidelines are necessary, not merely standard procedures.
Why Implementation Guidelines Are Necessary
Conventional standard operating procedures (SOPs) typically define general guidelines and standardized processes. However, in the practical execution of medical device manufacturing and inspection, these standard procedures alone are frequently insufficient to ensure appropriate manufacturing control and quality management. Therefore, the creation of implementation guidelines that are more detailed and specific than procedures has become necessary.
The importance of implementation guidelines is particularly heightened when outsourcing. For example, the mere existence of “arrangements” or “agreements” between a manufacturer and a contract manufacturer does not guarantee that the requested work will be executed appropriately. Through detailed implementation guidelines, specific operational procedures, quality standards, recording methods, and troubleshooting protocols must be clearly defined, establishing common understanding between the contracting manufacturer and the contract manufacturer.
Areas Where the Revised QMS Ordinance Explicitly Requires “Implementation Guidelines”
The revised GMP Ordinance explicitly requires the development of “implementation guidelines” for the following six important areas:
1. Implementation Guidelines for the Management of Contaminated Products
- QMS Ordinance Article 25-2, Paragraph 1
- ISO 13485:2016 Reference: Section 6.4.2
Implementation guidelines must define specific procedures for the identification, isolation, evaluation, and disposition of contaminated products. When manufacturing line contamination is discovered, it is critical to document the response flow, methods for identifying potentially affected products, and criteria for recall decisions in detail.
2. Implementation Guidelines for Information Exchange
- QMS Ordinance Article 29, Paragraph 1
- ISO 13485:2016 Reference: Section 7.2.3
These guidelines establish the method, frequency, and documentation of quality information, risk information, and safety information exchange between manufacturers and manufacturing sites, as well as between relevant departments. As supply chain management becomes increasingly complex, particularly for globally operating enterprises, multilingual support and information standardization across multiple facilities have become critical challenges.
3. Implementation Guidelines for Design and Development Review
- QMS Ordinance Article 33, Paragraph 1
- ISO 13485:2016 Reference: Section 7.3.5
These guidelines define the specific methods, evaluation criteria, approval authorities, and documentation procedures for design reviews at various stages of development, including concept design, detailed design, and prototype stages.
4. Implementation Guidelines for Design and Development Verification
- QMS Ordinance Article 34, Paragraph 1
- ISO 13485:2016 Reference: Section 7.3.6
These guidelines specify the concrete methods, test items, acceptance criteria, and documentation management for verification activities that confirm that the design specifications meet the requirements.
5. Implementation Guidelines for Design and Development Validation
- QMS Ordinance Article 35, Paragraph 1
- ISO 13485:2016 Reference: Section 7.3.7
These guidelines define the methods for conducting validation activities that confirm the final product meets specifications and requirements under actual conditions of use. For medical devices that include software, implementation guidelines based on cybersecurity assessments (such as those based on IEC 62304 or IEC 81001-5-1) and usability engineering evaluations (based on IEC 62366-1) are particularly important.
6. Implementation Guidelines for Product Monitoring and Measurement
- QMS Ordinance Article 58, Paragraph 2
- ISO 13485:2016 Reference: Section 8.2.6
These guidelines establish procedures for post-market product quality monitoring, periodic measurement, detection and reporting of defects, and data analysis methods. In the era of digitalization, implementation guidelines for product use data collection, analysis, and traceability are becoming especially critical.
Implementation Considerations
When developing implementation guidelines, the following considerations are necessary:
Adequacy of Documentation
Implementation guidelines should not be merely checklists but must explicitly specify concrete procedures, decision criteria, and responsible parties. The use of diagrams, flowcharts, and visual aids is effective in ensuring that personnel at all levels can understand the guidelines.
Management of Outsourced Activities
Contract manufacturers, testing laboratories, design development firms, and other outsourced partners must either apply the manufacturer’s implementation guidelines or implement equivalent or superior guidelines agreed upon mutually. Based on ISO 13485:2016, Section 8.4 (Control of Externally Provided Processes, Products and Services), the process of establishing outsourcing relationships should include steps for sharing implementation guidelines and confirming understanding.
Continuous Improvement
Implementation guidelines must be reviewed and improved periodically in response to changes in regulatory requirements, the publication of new international standards, and updates to industry best practices. Particularly urgent is the updating of implementation guidelines to address future digitalization and artificial intelligence applications in manufacturing and quality management.
Multilingual and Multi-Site Adaptation
For enterprises operating globally, the development of implementation guidelines adapted to the regulatory requirements of each region is necessary. For example, preparation of implementation guidelines responding to the EU Medical Device Regulation (MDR), UK Medical Device Regulations, and various other national requirements is essential.
Conclusion
The introduction of “implementation guidelines” in the revised QMS Ordinance represents an important step toward evolving the quality management systems of medical device manufacturers to become more detailed, transparent, and operationally feasible. By replacing previously vague “arrangements” and “agreements” with detailed and concrete “implementation guidelines,” manufacturers can achieve truly robust quality management systems.
As the March 26, 2024 transitional period comes to an end, or has already passed, enterprises must conduct detailed analyses of their business processes and verify that they have established and maintained appropriate implementation guidelines for each of the six areas mentioned above and other relevant business functions. This is not merely a compliance exercise but represents an essential and important investment in ensuring patient safety as a medical device manufacturer.
