ISO 13485 supplier assessment: template, checklist and example
An ISO 13485 supplier assessment is the documented decision that a supplier is suitable to deliver parts, materials or services that affect your product. The standard therefore asks for criteria, an assessment before the first delivery, and a re-assessment. The requirements are in clause 7.4 of the standard (purchasing). You can find the official text at ISO . For the wider requirements, also read ISO 13485 requirements and the audit process, where the auditor checks critical suppliers.
A supplier assessment is not a questionnaire you fill in once. It is a decision, backed by evidence, that you take again when the situation changes.
What does the standard require from your supplier management?
Under clause 7.4, you must assess and select suppliers based on their ability to deliver products that meet your requirements. You also record how you monitor their performance and when you re-assess them. That broadly involves three parts:
- Set criteria in advance: what makes a supplier suitable, and how do you weigh those points?
- Assess and decide: a record of who was assessed, with what result, and who made the decision.
- Purchasing data and verification: the purchase order contains the right requirements, for example an agreement that the supplier reports changes in advance. You check received products where needed.
An auditor mainly checks whether you distinguish between suppliers that affect the product and suppliers that do not. That classification is the starting point of the template below.
Step 1: set the supplier’s risk class
Not every supplier needs the same attention. A supplier of office paper needs a lighter assessment than a supplier of sterile packaging material. Use three classes:
| Class | Description | Example | Assessment |
|---|---|---|---|
| A (critical) | Supplies a part or service that directly affects product quality | Supplier of a sensor in the device | Full assessment, audit, quality agreements |
| B (important) | Indirectly affects the process or the packaging | Supplier of calibration services | Questionnaire plus supporting evidence |
| C (other) | No direct effect on the product | Office supplies | Simple registration |
You set the class by looking at what the supplier provides and what goes wrong if they deliver faulty goods. Record that reasoning in your procedure.
Template: the supplier assessment
You can copy the template below into a spreadsheet or QMS tool. Each row is a criterion. Give a score or a yes/no for each criterion, and add the evidence.
| Criterion | Question | Evidence to request | Weighting |
|---|---|---|---|
| Quality system | Does the supplier have a documented quality system? | Certificate or QMS description | High |
| Product specification | Can the supplier meet your specification? | Specification sheet, sample test | High |
| Traceability | Can the supplier trace batches or lots back? | Example of a batch record | High |
| Changes | Does the supplier report product changes in advance? | Agreement or contract | High |
| Complaints and nonconformities | How does the supplier handle complaints and nonconformities? | Procedure and an example of how one was handled | Medium |
| Lead time and capacity | Can the supplier meet the volumes and deadlines? | References, capacity overview | Medium |
| Financial stability | Is the supplier financially healthy enough for a long-term relationship? | Annual accounts or credit information | Low to medium |
For a class A supplier, complete every row. For a class C supplier, a short registration is usually enough.
Step 2: ask for the right evidence
A supplier who says they are ISO 9001 certified has not yet proven that they meet your requirements. Ask for the document that shows it. Also check that the certificate covers the right scope. This is the same logic as for the certificate of your own organisation.
For critical suppliers, an on-site audit is often the better choice. A document can be good, but the shop floor shows the difference.
Example: a supplier of sterile packaging
Fictional example. A manufacturer of an infusion pump selects a new supplier for sterile packaging. The packaging affects product sterilisation, so the supplier is class A.
| Item | Finding | Action |
|---|---|---|
| Certificate | ISO 13485 in place, scope covers the production site | Accepted, copy filed in the supplier file |
| Specification | Sample test passes on seal integrity, not on storage strength | Additional test agreed with the customer |
| Traceability | Batch numbers are readable on the box, not on the bag | Agreement made on labelling |
| Changes | Supplier wants to change the raw material without prior notice | Contractual notification duty added |
| Decision | Approved under conditions | Re-assessment after six months |
The conditions in this table are exactly what the auditor will want to see later: a decision, an action, and a re-assessment.
Step 3: record the decision and the conditions
Make the decision visible
For each supplier, write down the class, the assessment date, the assessor, the result and the validity period. A decision without a name and date does not count.
Set the agreements in the contract
Record the duty to report changes, requirements for traceability and the right to an audit. Many problems arise because these were not in the contract.
Plan the re-assessment
You re-assess critical suppliers regularly. The frequency depends on the class and on performance over the past year. Record the frequency in your procedure.
Handle supplier nonconformities
A rejected delivery or a complaint about a supplier goes to your CAPA process (corrective and preventive action). The supplier receives a formal notice, and the cause is investigated.
Common mistakes in supplier assessment
- Treating all suppliers equally. This takes a lot of time, and the critical suppliers still get too little attention.
- Only asking for a certificate. The certificate does not show whether the supplier can deliver your product properly.
- No re-assessment. A supplier that was good five years ago may work differently now.
- Purchasing assesses itself. The person who manages the supplier should not make the decision alone. Quality should be involved.
- No trace of changes. If the supplier changes its raw material, that must be in your file.
A good QMS tool can help you set up this system, but the content of the assessment remains your responsibility.