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Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce the entire finished device under the manufacturer’s brand name. In all of these instances, it is ultimately the manufacturer’s (specification developer’s) responsibility, not the outsourced supplier, to ensure that the devices meet all specifications.

To meet this responsibility, a manufacturer should build an effective and compliant supplier management program based on the purchasing control requirements of 21 CFR 820 and/or ISO 13485. The supplier management program ought to include processes for the evaluation of suppliers and generation of purchasing data and specifications.

QA Consulting recommends these five strategies to help avoid common mistakes when managing outsourced suppliers:

1. Incorporate risk management – Use a risk-based approach for supplier evaluations. For example, the supplier of a critical, custom component may require an on-site audit once per year, while the supplier of a non-critical, off-the- shelf component may only require a desk audit every one to three years.

2. Continue to monitor approved suppliers – Supplier management should not end once a supplier is added to the Approved Supplier List (ASL). Continue to monitor supplier performance while utilizing the supplier, using tools such as auditing or trending.

3. Establish quality agreements – Quality agreements should be implemented with outsourced suppliers when planning for production, and should include the quality requirements and a notification system for product changes, as detailed in the next two items.

4. Define quality requirements, in addition to product specifications – Quality requirements are critical when generating purchasing specifications and should be agreed upon with the supplier up front. Examples of quality requirements include, producing products to meet applicable standards, such as ISO 11607, or the use of a specific classification of clean room.

5. Implement a notification system for changes – When changes are made to a product/process by an outsourced supplier, it is up to the specification developer to assess the impact on the finished device. It is important to establish a change notification method with the supplier before the outsourcing begins. This can be especially critical for off-the- shelf components, in which the specification developer has limited input or control.

If you need assistance implementing a supplier management system or managing your outsourced suppliers, please call 512-328- 9404 or contact us at You can also read QA Consulting’s articles on a variety of quality and regulatory topics here.