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Core QMS Requirements

ISO 13485:2016 defines the requirements for a quality management system applicable to organisations throughout the supply chain for medical devices. Below is a summary of the key elements as they apply in the Vietnamese context.

Management responsibility​

Top management must:

  • Define and communicate quality policy and objectives
  • Ensure the QMS is established, implemented, and maintained
  • Appoint a Management Representative with defined authority for quality matters
  • Conduct management reviews at planned intervals

Design and development controls​

For manufacturers responsible for device design:

  • A formal design and development process with defined phases, reviews, verification, and validation
  • Design inputs (user needs, regulatory requirements) documented and controlled
  • Design outputs traceable to inputs
  • Design verification (does the device meet design inputs?) and validation (does it meet user needs?) completed before market release
  • Design transfer to manufacturing documented

Document and record control​

  • Document control procedures ensuring current versions are available at points of use
  • Obsolete documents prevented from unintended use
  • Records of QMS activities retained for specified periods (at minimum the lifetime of the device or as required by applicable regulation)
  • Records legible, identifiable, and retrievable

Purchasing and supplier controls​

  • Supplier evaluation and qualification processes
  • Purchasing requirements (specifications) defined clearly
  • Verification of purchased product/services against requirements
  • Monitoring of supplier performance

Production and process controls​

  • Controlled production conditions with documented work instructions
  • Validation of production processes where output cannot be fully verified (e.g. sterilisation, welding)
  • Equipment maintenance and calibration programmes
  • Environmental controls where applicable

Corrective and Preventive Action (CAPA)​

  • Root cause analysis of non-conformities
  • Corrective actions to eliminate causes of actual non-conformities
  • Preventive actions to eliminate causes of potential non-conformities
  • CAPA effectiveness verification
  • CAPA records available for regulatory inspection

Complaint handling​

  • Formal complaint-receiving and investigation procedure
  • Determination of whether a complaint is a reportable event (see Incident Reporting)
  • Response to complainants
  • Aggregate trend analysis

Servicing​

Where servicing of devices in the field is part of the intended purpose or a contractual obligation, service activities must be controlled and service records maintained.

Align your QMS with Decree 98/2021 post-market requirements

Your QMS procedures for complaint handling, CAPA, and change control are directly linked to your regulatory obligations under Decree 98/2021. Ensure your QMS procedures reference the applicable Vietnamese regulatory requirements and DAV notification thresholds.