QA Agreements for ISO 13485:2019 and other Regulatory Compliance

Why Should You Attend:

This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements for several types of key suppliers. Quality Assurance (QA) agreements are usually more flexible than standard supplier agreements and can therefore be more detailed and easier to modify than standard supplier contracts which often require legal, as well as management approval. QA agreements with you suppliers can be the easiest way to assure both your company and auditors that you have sufficient control of your key and critical suppliers and those who supply outsourced processes. QA agreements give details of who is responsible for what between you and your supplier. Yet, because these agreements are detailed and specific to a particular supplier, they should only be used for those suppliers where they provide value. Even if your key suppliers are only from different branches of your own company, a supplier QA agreement can be an important tool to show the FDA and ISO 13485 Notified Body auditors that you have the required control of these suppliers.

Areas Covered in the Webinar:

• The types of suppliers that should have QA Agreements to assure FDA and ISO 13485:2016 compliance
• Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements
• How to create supplier QA agreements and the best way to implement them
• Definition of and requirements for Critical suppliers
• Suppliers of outsourced processes
• Supplier agreements best practices

Frequently Asked Questions:

1. Is a supplier audit and agreement required for multiple facilities of the same company?
2. Is a quality agreement required for calibration service providers?
3. What are the options when there is no supply agreement and the expectation is that the quality agreement contains this kind of information?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Management
• Regulatory Affairs
• Supply-chain Management
• Supplier Engineering
• Purchasing Management
• Supplier Auditing
• Internal Auditing
• Consultants to Medical Device Companies

Betty Lane
Founder and President, Be Quality Associates LLC

Betty Lane, has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

Topic Background:

While supplier QA Agreements have been expected by the FDA and ISO 13485 for certain supplier, under ISO 13485:2016 they are mandated for all suppliers of outsourced processes. Detailed supplier QA agreements with key suppliers, whether standalone or part of a larger supplier agreement can go a long way to providing objective evidence that will satisfy external auditors that you have of control of key product and service suppliers, as expected by both ISO 13485, the FDA, and for Canada and other countries under the Medical Device Single Audit Program (MDSAP) program.

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