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Readiness for ISO 13485 — Medical Device Quality

Assess how close your business is to the requirements of ISO 13485:2016.

24 questions · ~6 min

Anonymous: we don't ask for a name, email or company details. Only the answers are kept, with nothing that identifies you, for statistics.

How to answer

Choose “Yes” only when the requirement is applied in practice and there is documentation or records. “Partly” means it is done informally or not everywhere.

4 Quality management system

4.1 Have you determined your regulatory role (manufacturer, authorised representative, importer, distributor) and the requirements that apply (e.g. MDR/IVDR)?

4.1.5–4.1.6 Are outsourced processes controlled, and is the software used in the quality system validated?

4.2.2 Is there a quality manual with the scope, the justification for any exclusions and references to the procedures?

4.2.3 Is a file kept for each medical device type or family (description, specifications, production, labelling, installation, servicing)?

4.2.4–4.2.5 Are documents and records controlled, and kept for at least the lifetime of the device and as long as regulatory requirements demand?

5 Management responsibility

5.3–5.4 Are there an approved quality policy and measurable quality objectives?

5.5 Have responsibilities and a management representative for the quality system been appointed?

5.6 Is a documented management review held at planned intervals?

6 Resource management

6.2 Has the competence of personnel been determined and documented, with training records?

6.3–6.4 Are the requirements for infrastructure, maintenance, the work environment and contamination control documented, where applicable?

7 Product realization

7.1 Is documented risk management applied throughout the product life cycle (e.g. according to ISO 14971)?

7.2 Are customer and regulatory requirements determined and reviewed, and is there communication with the authorities where required?

7.3 Are design and development controlled (inputs and outputs, reviews, verification, validation, transfer to production, changes, design file)? If this does not apply to you, choose “Not applicable”.

7.4 Are suppliers evaluated and monitored according to risk, and are purchased products verified?

7.5.1–7.5.4 Is production carried out under controlled conditions (instructions, cleanliness, batch records), and are installation and servicing controlled?

7.5.6–7.5.7 Are processes whose output cannot be verified validated (e.g. sterilisation, sealing, software)? If this does not apply to you, choose “Not applicable”.

7.5.8–7.5.9 Are products identified and traceable (with UDI where required)?

7.5.11 Is the product preserved during storage, handling and distribution?

7.6 Is monitoring and measuring equipment calibrated, with records kept?

8 Measurement, analysis and improvement

8.2.1 Is feedback gathered from the market and from production (post-market surveillance)?

8.2.2–8.2.3 Is there a procedure for handling complaints and reporting incidents to the competent authorities (vigilance)?

8.2.4 Are internal audits carried out according to a programme?

8.3 Are nonconforming products controlled before and after delivery (e.g. recalls, field safety notices)?

8.4–8.5 Is data analysed, and are corrective and preventive actions (CAPA) taken, with verification of their effectiveness?

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