Organization and Responsibilities
Review the organization chart, responsible personnel, and division of responsibilities between the Marketing Authorization Holder and manufacturing sites in Japan and overseas.
Preparing for QMS Conformity Assessment in Japan
For QMS conformity assessment, it is important not only that quality manuals and procedures exist, but also that the device under application is manufactured and controlled under the established quality system and that implementation records can be verified.
From an early stage, compare the approval or certification application with the actual manufacturing sites, manufacturing processes, quality documents, and records.
Align Documents, Actual Operations, and Records
QMS conformity assessment confirms compliance with Japan's QMS Ministerial Ordinance and that the subject product is appropriately manufactured and quality-controlled under that quality system.
Even when a quality system based on ISO 13485 is in operation, it is necessary to confirm how the responsibilities of the Japanese Marketing Authorization Holder (MAH), the subject product, the manufacturing sites, and the manufacturing processes relate to each other.
Rather than preparing procedures alone, be ready to explain:
- Who is responsible
- Which procedure is followed
- Which records are retained
- How the process relates to the product under application
First Confirm the Scope of the Assessment
Preparation for QMS conformity assessment requires confirmation not only of the product under application, but also the product group, manufacturing sites, manufacturing processes, and existing QMS conformity certificates.
Key items to confirm include:
- Product group to which the product under application belongs
- Marketing Authorization Holder (MAH)
- Manufacturing sites in Japan and overseas
- Design facilities
- Principal assembly facilities
- Sterilization facilities
- Processes performed at each manufacturing site
- Outsourced processes
- Existing QMS conformity certificates
- Previous QMS conformity assessment history
Ensure that names and assigned processes are consistent across the application form, manufacturing-site registration, and quality documentation.
Main Documents to Review Before Submission
Manufacturing-Site Information
Organize names, addresses, registration information, assigned processes, outsourcing relationships, and related information.
Quality System
Review the quality manual, document control, record control, training, internal audits, management review, and related procedures and records.
Product and Manufacturing Processes
Review product specifications, manufacturing processes, critical processes, inspections, validation, storage, and release controls.
Changes, Nonconformities, and CAPA
For design changes, process changes, nonconformities, and corrective and preventive actions, review both the procedures and implementation records.
Linkage with Post-Market Activities
Confirm that complaints, device problems, recalls, and safety information are appropriately fed back into the quality system and CAPA.
Previous Assessment and Audit Records
When using previous QMS conformity assessments, ISO 13485 certification, MDSAP reports, or similar records, confirm their scope and relationship to the current application.
Required submission documents vary depending on the application, type of assessment, manufacturing sites, and previous assessment history. Check the latest guidance from PMDA or the relevant Registered Certification Body at the time of application.
From Application Preparation to Post-Assessment Management
- 01
Confirm the Scope of the Assessment
Confirm the product under application, product group, manufacturing sites, manufacturing processes, and Marketing Authorization Holder.
- 02
Cross-Check the Application and QMS
Confirm that the manufacturing methods, manufacturing sites, and specifications described in the application are consistent with the actual quality documents and records.
- 03
Prepare the Submission Documents
Confirm document versions, effective dates, scope, and cross-references among the required materials.
- 04
Respond to Inquiries
Understand the intent of each question and link the response text to the relevant supporting evidence.
- 05
Address Findings
Explain the cause, corrective action, implementation records, recurrence-prevention measures, and effectiveness checks consistently.
- 06
Maintain the Post-Assessment State
Confirm the scope and validity period of the QMS conformity certificate and continue operating the QMS in preparation for changes and renewal.
Common Points Overlooked in QMS Conformity Assessment
- Manufacturing-site names or assigned processes differ between the application and QMS documentation
- Procedures exist, but training or implementation records are insufficient
- Responsibilities between overseas manufacturing sites and the Japanese side are unclear
- Product-specification or process changes are not reflected in quality documents
- CAPA ends with corrective action, with insufficient root-cause analysis or effectiveness checks
- The scope of existing QMS conformity certificates or MDSAP reports has not been confirmed
MK Consulting's QMS Conformity Assessment Support
Organizing the Assessment Scope
We review the product under application, product group, manufacturing sites, processes, and existing QMS conformity certificates.
Reviewing Submission Documents
We review consistency between the application content and quality documents, required materials, and traceability of records.
Responding to Inquiries and Findings
We organize inquiry responses, supporting evidence, corrective-action plans, and implementation records so that they remain consistent.
For support with QMS conformity assessment and approval application coordination, see Approval, Certification & Notification Support.
Related Services
Frequently Asked Questions
Does ISO 13485 Certification Eliminate the Need for QMS Conformity Assessment?
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No. Whether QMS conformity assessment is required is not determined solely by the presence of ISO 13485 certification. The relationship to Japan's regulatory system, the product under application, manufacturing sites, and manufacturing processes must be confirmed.
Are Overseas Manufacturing Sites Also Within the Scope?
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For overseas manufacturing sites involved in the manufacture of the subject product, confirm the assigned processes, registration information, quality documentation, and relationship with the Japanese Marketing Authorization Holder.
Can MDSAP Reports Be Used?
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They may be usable in some cases. Confirm the manufacturing sites covered, audit scope, report content, and the latest handling requirements at the time of application.
Can the Approval Application and QMS Conformity Assessment Be Prepared Separately?
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The procedures are separate, but the manufacturing methods, manufacturing sites, and specifications in the application must be consistent with the QMS documentation. It is important to review them in parallel from an early stage.
Contact Us About QMS Conformity Assessment
Share the application product, relevant manufacturing sites and current QMS readiness.
Contact us about QMS conformity assessment