| ISO 13485:2016 Section | Document Section |
|---|---|
| 7.4 | All |
Overview
This SOP outlines the processes and requirements for purchasing goods and services by the organization. It covers the initial evaluation of suppliers, budget approval, and ongoing supplier oversight. The aim is to ensure that only high-quality goods and services are procured to support the production of high-quality products for customers.
| Process Owner | \ |
| Key Performance Indicators | \ |
General Guidelines
1.1 Supplier Qualification
Goods and services that could affect the quality of the organization’s medical devices must only be sourced from qualified suppliers.
Initial evaluation of suppliers is conducted using the Supplier Evaluation Checklist.
1.2 Qualified Supplier List
Suppliers identified as critical after initial evaluation are added to the List of Qualified Suppliers. This list also serves to document ongoing supplier oversight and the current evaluation status of each supplier.
1.3 Classifying Supplier Criticality
A supplier is deemed critical if:
- The goods or services provided could directly impact the safety of the organization’s medical devices; OR
- The goods or services could directly affect the performance of the organization’s medical devices; OR
- The goods or services could impact the regulatory compliance of the medical devices; OR
- The organization cannot produce its medical devices without the supplier’s goods or services; AND
- No alternative supplier can provide similar goods or services.
If a supplier’s impact on safety, performance, or regulatory compliance is indirect, the QMO will evaluate the supplier’s criticality case-by-case based on their effect on product safety and performance.
Suppliers not meeting these criteria are considered non-critical.
1.4 Supplier Evaluation Process
Suppliers are assessed using the following categories:
| Quality of Products/Services | Assessed by the frequency of nonconforming purchases and reported issues, factoring in delivery performance. |
| Timeliness / Punctuality | Assessed based on instances of delayed deliveries. |
| Cooperation | Evaluated based on responsiveness to follow-up inquiries and handling of complaints. |
| Payment Terms | Assessed by comparing pricing, discounts, payment terms, late fees, and return policies to other suppliers. |
Each category is rated as follows:
- 0: Unacceptable
- 1: Moderate
- 2: Good
- 3: Excellent
An average score is derived from all categories, with the quality category having double weight. The final score leads to the following outcomes:
- Average score of 2-3: Supplier is approved.
- Average score of 1-2: Supplier is conditionally approved with required oversight (see section 2.5).
- Average score of 0-1: Supplier is blocked and cannot be approved.
Process Steps
2.1 Initial Regulatory Review
Employees must verify that potential purchases align with the organization’s quality standards.
The first step is to check if the supplier is listed in the List of Qualified Suppliers. If so, the process continues to step 2.3.
If the supplier is blocked in the List of Qualified Suppliers, an alternative supplier must be found.
For suppliers not in the list, employees must seek regulatory approval from the QMO. The QMO assesses the supplier’s criticality according to the criteria in section 1.3. If a supplier is deemed non-critical, the process moves to step 2.3 without further evaluation.
If the supplier is neither listed nor deemed non-critical, the QMO conducts an initial supplier evaluation.
| Participants | Purchasing employee QMO |
| Input | Preliminary regulatory review List of Qualified Suppliers Supplier Checklist |
| Output | Regulatory purchase approval or: Initial supplier evaluation needed |
2.2 Initial Supplier Evaluation
The QMO performs the initial evaluation using the Supplier Checklist and may request additional information from the supplier. Only the QMO has the authority to approve critical suppliers.
If a critical supplier passes the evaluation, they are added to the List of Qualified Suppliers and the process proceeds. Depending on the supplier’s criticality, the QMO may implement further monitoring measures, documented in the supplier list.
If the supplier fails the evaluation, they are added to the List of Qualified Suppliers as blocked, meaning no purchase can be made and an alternative supplier must be identified.
Blocked suppliers may be re-evaluated through this process step.
| Participants | QMO |
| Input | Purchase requirement List of Qualified Suppliers |
| Output | Completed evaluation Updated List of Qualified Suppliers Approval or block decision |
2.3 Budget Approval
The employee requests budget approval from their supervisor. The supervisor reviews the costs against the budget and either approves or denies the request. If approved, the employee can proceed to place the order.
| Participants | Purchasing employee Supervisor |
| Input | Regulatory approval documentation |
| Output | Approved budget documentation Order placed |
2.4 Verification of Goods/Services
The purchasing employee ensures the received goods/services match the order and meet the expected quality standards.
If goods/services are substandard or non-conforming, the QMO is informed to record the issue and update supplier evaluation if needed. Complaints are issued to the supplier, and defective items are returned where applicable.
Invoices and receipts are documented and archived.
| Participants | Purchasing employee QMO |
| Input | Received goods/services |
| Output | Complaint records archived (if applicable) Updated Qualified Suppliers list (if necessary) Processed invoices |
2.5 Supplier Monitoring
NOTE: For class II or higher, an annual re-evaluation must occur before the Management Review.
The QMO may implement the following monitoring activities:
- Supplier Certification: Suppliers may need to provide valid, current certifications as evidence of quality system effectiveness. These are stored in the organization’s QM records and checked annually.
- Quality Assurance Agreement (QAA): Suppliers may be asked to sign a QAA to commit to quality assurance practices.
- Supplier Audits: Audits or site visits can be requested if prior records are insufficient. The QMO conducts these audits, preparing an audit plan and report per the organization’s internal auditing process. A continuous audit program may also be established.
2.5.1 Ongoing Supplier Monitoring
Supplier evaluations are updated with each new purchase and at least annually. Surveillance measures are carried out as needed and documented in the List of Qualified Suppliers.
New supplier information may trigger an update to their evaluation. If a supplier’s status drops, the QMO can initiate corrective actions, further surveillance, or block the supplier if there is a major decline in quality. A CAPA is required if there is a one-grade drop as per section 1.3.
| Participants | QMO |
| Input | New supplier data |
| Output | Updated List of Qualified Suppliers |
2.5.2 Annual Supplier Review
At least once a year, the QMO reviews all relevant data (including public information like complaints, ratings, and certifications) to update the status of suppliers on the Qualified Suppliers List.
If the supplier’s evaluation drops, the QMO can choose corrective measures such as opening a CAPA, enhancing surveillance, or blocking the supplier. A CAPA is mandatory if the evaluation drops by one grade as per section 1.4.
| Participants | QMO |
| Input | Supplier records List of Qualified Suppliers |
| Output | Updated List of Qualified Suppliers |