Acquiring ISO 13485 certification and its benefits

ISO 13485 is an international quality management system (QMS) standard for medical devices. It specifies the requirements for conducting quality management and production control for medical devices.

Business operators that comply with these requirements and acquire ISO 13485 certification are able to establish the basis for compliance with the QMS medical device requirements of many countries and regions, including Japan.

SunFlare provides consulting services that are optimized to the individual circumstances of business operators wishing to acquire ISO 13485 certification.

Workflow for acquiring ISO 13485 certification

Workflow for acquiring ISO 13485 certification

Consulting services provided by SunFlare

ISO 13485 requirements

We hold lectures on the requirements for clients wishing to acquire ISO 13485 certification. As part of these lectures, we:

  • Explain ISO 13485 requirements based on the target market
    • Explain ISO 13485 requirements assuming application of the Medical Device Single Audit Program(MDSAP) in Japan, the US, the EU, or any other part of the world
  • Analyze differences between ISO 13485, ISO 9001, the QMS Ordinance, etc.
  • Analyze differences between ISO 13485:2003 and ISO 13485:2016
  • Discuss risk management (ISO 14971)

Strategic decisions

We assist clients in preparing for and examining their objectives for acquiring certification. As part of this assistance, we:

  • Provide advice on identifying the organizational scope and processes subject to certification and the scope of acquisition
  • Plan timelines and identify "to dos" for the acquisition of ISO 13485 certification
  • Define the relationship with the currently used quality management system (QMS)
  • Identify countries and regions where regulatory compliance is necessary and identify additional requirements in each country and region
  • Provide advice on selecting a certification body based on the client's policies and strategies for launching its product
  • Assist in the selection of a certification body

Client compliance with requirements

We analyze the client's current QMS to determine whether it complies with the ISO 13485 requirements. As part of this analysis, we:

  • Check whethe the client's current QMS complies with the ISO 13485 requirements and identify nonconformities and additional requirements to be satisfied
  • Review and provide feedback on documents related to the client's current QMS
  • Hold associated consulting sessions

QMS development and documents

We assist in establishing a quality management system (QMS) based on the ISO 13485 requirements. As part of this assistance, we:

  • Provide samples of various procedure manuals and report forms (quality manuals, standard/procedural documents, record formats, etc.)
  • Draft QMS documents based on an analysis of nonconformities or provide advice on revisions to QMS documents made by the client
  • Provide consulting services related to risk management for medical devices (for details, please see Compliance with standards during design development)

QMS operation

We assist in operating a PDCA cycle for a QMS. As part of this assistance, we:

  • Provide training programs for internal auditors and issue completion certificates
  • Accompany internal auditors in their audits, verify their observations and provide advice
  • Assist in incorporating management review results into a QMS and implementing operational improvements
  • Perform simulated examinations and provide support in resolving nonconformities