Guidance for Procurement in Medical Devices & ISO 13485
Identifying suppliers in the medical device industry is not always as simple as going on the internet and searching keywords. As part of an ISO 13485 compliant Quality Management System (QMS), purchasing controls must be established to ensure that quality raw materials are going into your device and that all services directly and/or indirectly involved in the production process meet regulatory requirements.
Question 1: How are “critical” suppliers best defined?
Critical suppliers are those that provide critical components, especially those that are single-sourced. These should hold your greatest focus. Determining critical suppliers requires the creation of an effective ranking system within your supplier management program. This provides a mechanism for understanding what areas of the business are critical, and the specific components, tools, and materials necessary for manufacturing your product.
Suppliers that provide critical components, and especially those that are single-sourced, should hold your greatest focus. Creating a ranking system allows you to administer desktop audits for suppliers that are either low-to-medium on the scale, or not single-sourced. This enables you to identify and manage your critical suppliers with respect to Supplier Corrective Action Reports (SCARs) from your organization, and subsequent root-cause identification and action plan development.
Question 2: What are the core elements of an Approved Supplier List (ASL)?
Purchasing controls are established to ensure that all direct materials are purchased from suppliers that meet your specifications, requirements, and quality controls. The best way to keep track of your qualified suppliers is to maintain an ASL.
Items that you can capture on the ASL include:
- Supplier Name
- Supply Scope and Application
- Key Business Contacts
- Status of Approval (Approved, Pending, Unapproved, etc.)
- Qualification Criteria
- Supplier Certification(s)
- Monitoring Requirements/Activities
- Date of Last Review
- Date of Next Review
Question 3: What Supplier Qualification Criteria should be used when adding new suppliers to the ASL?
As required by the FDA, the level of supplier assessment should be proportionate to the level of risk associated with the medical device. The FDA is not prescriptive about the use of specific qualifications or assessments for different types of suppliers, so it’s up to your company to determine rigorousness of evaluation.
Best practice is to create a form or template that guides your company’s supplier additional/evaluation process. Leveraging input from Research & Design, Quality Assurance, and in some cases, Regulatory Affairs, it’s critical to first determine the level of risk and the requirements of a supplier, and then base your qualification plan from that information. If you have a higher-risk supplier supplying a critical component to your device, or providing a critical service to the production process, then your qualification criteria should be more involved.
Companies with ISO 13485 certification communicate a commitment to quality to both customers and regulators. In order to achieve this certification, however, organizations must establish robust supplier evaluation, selection and monitoring processes.
Glossary of Terms:
ISO 13485 – An internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements.
Desktop Audit – A desktop audit reviews the documents within the audit scope. It is referred to as a “desktop” audit because it can be performed remotely at the auditor’s desk. The documents are reviewed to ensure they are complete, correct, consistent, and current.
Quality Management System (QMS) – A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Supplier Corrective Action Reports (SCARs) – A SCAR is a report issued to the supplier based upon one or more non-conformances which requires root cause analysis of the problem; and corrective and preventive action on the supplier’s part to eliminate future non-conformances.