What Is ISO 13485? The Medical Device QMS Explained

One of the most common questions medical device manufacturers ask is: what documents are required for ISO 13485? ISO 13485 documentation shows how an organisation controls quality, manages risk and keeps processes consistent. It also provides evidence that the quality management system (QMS) is implemented and monitored.

The exact documents and records depend on the organisation’s activities, products and regulatory obligations.

Why ISO 13485 documentation matters in Australia

ISO 13485:2016 is the international standard for medical device quality management systems. A QMS brings together the processes, responsibilities and records an organisation uses to maintain product quality and meet applicable requirements.

In Australia the Therapeutic Goods Administration (TGA) regulates medical devices. Manufacturers must meet the applicable regulatory requirements. This may include showing that an appropriate quality management system is in place.

Well-controlled documentation helps organisations show how their processes work during audits and regulatory assessments. It also supports traceability, risk management and consistent product quality.

Key documents required for ISO 13485

●      Quality manual
A quality manual, where maintained, describes the scope of the QMS and explains how its processes connect. It may reference the procedures used to meet applicable ISO 13485 requirements.

●      Quality policy and objectives
The quality policy sets out management’s commitment to quality and applicable regulatory requirements. Quality objectives turn that commitment into measurable goals where appropriate.

●      Medical device file
ISO 13485 requires a medical device file for each medical device type or family, as applicable. It contains or references information such as product specifications, intended use, labelling, instructions for use and relevant manufacturing procedures. Depending on the product and activities, it may also cover storage, distribution, installation and servicing.

●      Document and record control
Document control ensures that procedures, work instructions and forms are reviewed, approved and kept current. Record control ensures that required evidence remains legible, identifiable, protected and easy to retrieve.

●      Risk management records
Risk management records show how risks associated with the medical device are identified, evaluated, controlled and monitored throughout the relevant life-cycle stages.

●      Design and development records
Organisations responsible for device design must maintain applicable records covering design planning, inputs, outputs, reviews, verification, validation and design changes. The requirements depend on the organisation’s role and whether design and development controls apply.

ISO 13485 documentation checklist for Australia

Use this checklist as a starting point. Not every document applies to every organisation.

●      QMS scope and related documentation

●      Quality policy and quality objectives

●      Medical device file for each applicable device type or family

●      Document and record control procedures

●      Defined responsibilities and authorities

●      Risk management records

●      Design and development records, where applicable

●      Staff training and competence records

●      Supplier evaluation and monitoring records

●      Product identification and traceability records, where applicable

●      Calibration records for relevant monitoring and measuring equipment

●      Production and process validation records, where required

●      Product release records

●      Complaint handling and nonconforming product records

●      Corrective action records

●      Internal audit and management review records

●      Applicable regulatory reporting records

Additional records may be needed for sterilisation, installation, servicing, software validation or other processes relevant to the organisation’s activities.

Key records the QMS needs

●      Training records

●      Calibration records

●      Process validation records

●      Product release records

●      Complaint records

●      Regulatory reporting records

●      Internal audit records

●      Corrective action records

●      Design and development records

Common ISO 13485 documentation mistakes in Australia

Documentation problems often arise when records are created for an audit rather than used to manage day-to-day work.

●      Outdated procedures: staff use documents that no longer reflect approved processes.

●      Unclear responsibilities: no one is clearly assigned to maintain or approve key records.

●      Incomplete records: required activities are performed, but the evidence is missing.

●      Unnecessary paperwork: documents are maintained without a clear purpose or regular review.

●      Poor record retrieval: staff struggle to locate evidence when auditors request it.

Documents and records should reflect actual practices. If required evidence is missing, the organisation may be unable to demonstrate that the activity was completed as intended.

How ISO 13485 documentation supports TGA Compliance

A controlled QMS helps manufacturers demonstrate how they manage product quality, risk, traceability, complaints and post-market activities.

However, ISO 13485 certification does not automatically satisfy every Australian regulatory requirement. The documents you need depend on your medical device, its classification and the TGA pathway that applies to you.

Check the latest TGA requirements to make sure your documentation is complete and up to date.