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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.

Management reviews must be conducted at planned intervals, typically at least annually, with documented evidence of review including: discussion of QMS effectiveness, analysis of complaints and FSCA trends, assessment of post-market surveillance data, and decisions on resource allocation for quality improvements. Management review records must be retained and made available for regulatory inspection.