For products subject to the EU directives on medical devices, manufacturers must implement ISO 13485 as a harmonized standard. The seminar explains the requirements in this standard, but also covers the related information in the associated technical report. ISO/TR 14969:2004, entitled Medical devices – Quality management systems – Guidance on the application of ISO 13485:2003, explains the standard. It provides guidance to assist in the development, implementation, and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for medical devices and related services.

The GHTF document provides an overall framework for the supplier management process, independent of the particular QMS. The seminar covers the six general principles introduced in the guidance and includes implementation approaches.

• Planning
• Selection of potential suppliers
• Supplier evaluation and acceptance
• Finalization of controls
• Delivery, measurement, and monitoring
• Feedback and communication

Why should you attend:
As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers. As the supply chain becomes longer and more diverse, the methods of control become more difficult and the expectations of regulators become more stringent.

The best approach implements specific actions:

• Create clear requirements for supplier
• Evaluate potential suppliers against the criteria
• Create cross-functional multi-discipline teams that remain active beyond the selection process

Areas Covered in the Session:

• The FDA's medical device regulations for supplier control
• Evaluation of suppliers
• Evaluation and selection
• Type and extent of control
• Records
• Purchasing data
• Requirements
• Change control agreements
• Control of purchasing data
• Items from the preamble
• The role of ISO 9001
• Performing suitable acceptance activities
• Approaches when audits are not practical
• Purchased or otherwise received – regardless of payment
• Sister facilities and corporate services
• ISO 13485:2003 purchasing requirements
• The purchasing process
• Evaluation and selection
• Type and extent of control
• Records
• Purchasing information
• Approval of product, procedures, processes, and equipment
• Qualification of personnel
• QMS requirements
• Verification of purchased product
• Inspection and other activities
• Verification at the supplier’s site
• Items from ISO/TR 14969:2004
• Supplier evaluation methods
• Examples of purchasing information
• Verification approaches
• GHTF Guidance
• Planning
• Identifying risks
• Establishing controls
• Selecting potential suppliers
• Business capability
• Operational capability
• Identification of potential suppliers
• Supplier evaluation and selection
• Establish criteria
• Evaluate potential suppliers
• An acceptable supplier
• Complete the control measures
• Supplier agreements
• Controls for second and lower tiers
• Delivery, measurement, and monitoring
• Monitor supplier performance
• Initiate correction, if necessary
• Initiate corrective action when appropriate
• Feedback and correspondence
  • Positive and negative feedback
  • Corrective action communication

Who Will Benefit:
This seminar is designed for all employees involved in supply management. In particular, it is aimed at cross-functional multi-discipline teams who manage supplies or commodities. This typically includes:

• Purchasing Managers
• Purchasing Professionals
• Quality Managers
• Quality Engineers
• Manufacturing Engineers
• Design Engineers
• Supplier Quality Engineers