1 / 9

How to a Perform Supplier Audit for the ISO 13485 Certification?

Compliancehelp Consulting LLC offers 360-degree solutions to companies seeking ISO and other QMS certifications. From implementing the ISO 13485 standards to helping companies achieve the ISO 27001 certification. They can do it all. Companies across the US rely on them for personalized training, consultation, certification, internal audit, analysis, and implementation services. Visit https://www.quality-assurance.com

compliancehelpconsulting
Download Presentation

How to a Perform Supplier Audit for the ISO 13485 Certification?

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. How to a Perform Supplier Audit for the ISO 13485 Certification?

  2. A supplier evaluation is one of the most practical ways of ensuring that obtain the correct product designed for your medical device manufacturing company. Monitoring and evaluating your suppliers will reveal the risks each supplier poses to your company. Supplier evaluations are an ongoing process where you approve, monitor, and correct your suppliers as soon as you notice failures and or errors for the ISO 13485 certification. Furthermore, you need to maintain records demonstrating the evaluation process and proving your suppliers can meet your needs. Find an easy guide on evaluating and selecting suppliers for your medical device company. ISO 13485 Standard: Supplier Management Requirements

  3. Criteria For Evaluating Suppliers for ISO 13485 Certification! The ISO 13485 standard highlights a list of criteria that help companies evaluate and select dependable suppliers. These criteria include: • Ability to satisfy your needs: Ask your supplier if they can meet your tolerances and requirements. Assess whether they comply with all legal requirements. Also, enquire if there’s a quality or analysis certificate for the product they are supplying. • Effect on quality: Evaluate how the supplied product affects your medical device manufacturing process. If the impact is extensive, you should be more mindful in selecting the correct product. If the product has little influence, the analysis approach can be less rigid. • Supplier performance: Judge if the supplier can meet your requirements on time. Question if you can they reply to queries promptly or how confident you are in their services. Also, check if the supplier has valid technical and quality certificates, such as the ISO 9001 certification or the ISO 14001 environmental management. • Risks: Check if the supplied product affects the safety and or quality of your medical devices. If it poses any safety threats to the devices’ operation or function, you should look for other suppliers before applying for the ISO 13485 certification.

  4. There are several ways to estimate the quality of your supplier. This includes asking the supplier to demonstrate their quality and or capabilities through surveys or trial orders. Or you can conduct a supplier audit. Hiring internal audit services and conducting supplier audits can provide you with valuable insight into the supplier and how they operate. The audit will compare the current operations of the supplier against their planned processes. How To Evaluate Medical Device Suppliers?

  5. How to perform supplier audits? The audit will initially review the process requirements, collect objective evidence, conduct reviews, and record them. By comparing this objective evidence to the requirements, you can determine if the supplier can meet your needs. During this process, you will need to focus on the processes critical to your company. For instance, you can ask them how they deal with nonconforming products, and how they ensure traceability or meet legal requirements.

  6. Conducting a supplier audit can significantly reduce risks while you are on the road to achieving the ISO 13485 certification. It will allow you to know if your suppliers are correct for your company or if you need to look for better options. Also, you will learn if they can improve the quality of your products or pose threats to them. So, wait no more and follow the above guidance to start your supplier evaluation. Bottom Line

  7. About The Company Compliancehelp Consulting LLC offers 360-degree solutions to companies seeking ISO and other QMS certifications. From implementing the ISO 13485 standards to helping companies achieve the ISO 27001 certification. They can do it all. Companies across the US rely on them for personalized training, consultation, certification, internal audit, analysis, and implementation services. Option Type I hope and I believe that this Template will your Time, Money and Reputation. You can simply impress your audience and add a unique zing and appeal to your Presentations.

  8. Contact Us Compliancehelp Consulting, LLC 5686 South Redwood Rd, 84123 Salt Lake City, Utah United States 877-238-5855 info@quality-assurance.com https://www.quality-assurance.com

  9. THANK YOU

More Related