ISO 13485 checklist for South African importers, distributors and manufacturers

How to use this checklist

For each area, ask two questions. Do we have it: is there a procedure? And could we show it: are there current records that prove the procedure is followed? The gap between the two answers is where most of the work is.

1. Document control (clause 4.2.4)

• Every procedure has an owner, a number, a revision and an approval.
• Staff can only reach the current version; superseded versions are withdrawn.
• Changes are reviewed and approved before release, and the reason is recorded.

2. Records and evidence (clause 4.2.5)

• You know which records you keep, where, for how long, and who may change them.
• Records can be found quickly, are legible, and are protected from loss.

3. Management review (clause 5.6)

• Top management reviews the system at planned intervals, with the inputs the standard lists.
• The minutes record decisions and actions, and the actions are followed up.

4. Risk management (clause 7.1, ISO 14971)

• Risk is managed across the product life cycle, with documented criteria for acceptability.
• Complaints and post-market information feed back into the risk file.

5. Supplier control (clause 7.4)

• Suppliers are evaluated and approved before use, against criteria in proportion to the risk.
• Supplier performance is monitored, and the evaluation is repeated.
• For importers and distributors this includes the foreign manufacturer and any logistics provider.

6. Product realisation (clause 7.5)

• Receiving inspection, storage, handling and distribution are controlled and recorded.
• Products can be traced by lot or serial number to the customer, so a recall can reach them.
• Storage conditions that affect the product are monitored.

7. Design and development (clause 7.3, manufacturers)

• Design inputs, outputs, reviews, verification, validation and transfer are planned and recorded.
• Design changes are controlled. Importers and distributors that do no design can usually justify excluding this clause in the Quality Manual.

8. Internal audit (clause 8.2.4)

• There is an audit programme that covers the whole system over a planned cycle.
• Auditors do not audit their own work, findings are recorded, and actions are closed on time.

9. CAPA (clauses 8.5.2 and 8.5.3)

• Nonconformities, complaints and audit findings are investigated for root cause.
• Corrective actions are recorded, carried out, and checked for effectiveness.

What changes by licence type

Every establishment needs the core system. Importers and distributors add controls for distribution and good wholesaling practice; distributors that install or service devices add installation and servicing. Manufacturers add design and development, process validation and, where it applies, sterilisation.