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Build Confidence That Your Supplier Management Process Mitigates Risk.

Medical device manufacturers, along with dental laboratories, must grasp the significance of carefully choosing their suppliers and subcontractors. This ensures that they can deliver on their commitment to customers by providing consistent quality products.  
  • Achieve good manufacturing best practices
  • Maintain your company's quality standards
  • Enhance your understanding of the suppliers and subcontractors within your network
  • Meet requirements for FDA Part 820 and ISO 13485:2016
  • Validate suppliers and subcontractors
  • Reduce nonconformance
  • Improve purchasing controls and supplier evaluation

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Schedule a meeting with us to learn more about this offer or call sales direct at 470-533-2581 or 800-330-6003. 

Safelink consulting

Get expert assistance with developing a supplier management process.

Let SafeLink be your partner in crafting a supplier management process to ensure that your supplier QMS can withstand the increasingly complex regulatory environment. If you already have an effective supplier management process in place, then SafeLink can provide supplier audits to identify and resolve any quality issues that could put the quality of your product and your company at risk. Discover more in our blog about this topic. Get a free checklist.

Supplier Management Process for Quality Standards
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QMS - Supplier Management Process

This part of a Quality Management System is intended to show how the organization:

  • Ensures the adequacy of specified purchase requirements prior to communication to the supplier.
  • Evaluates and selects suppliers based on their ability to supply products in accordance with the organization's requirements.
  • Develops criteria for selection, evaluation and re-evaluation is established
  • Records the results of evaluations and any necessary actions arising from the evaluation shall be maintained. (ISO 13485 Section 7.4.1 Purchasing Process; Part 820 Section 820.50 Purchasing Data)
  • Conducts inspection and other activities necessary for ensuring that purchased product meets specified purchase requirements (ISO 13485:2016 Section 7.4.3 Verification of purchased product; FDA Part 820 Section 820.50). 
  • Ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
  • Documents non-conforming product and the actions taken to resolve issue with supplier.
  • Determines when the organization needs to perform verification at the supplier’s premises which would notify supplier of the intended verification arrangements.
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SafeLink qms

Get expert assistance with developing an effective Quality Management System.

A well-implemented QMS is an indispensable tool to drive efficiency, compliance, and competitiveness for long-term success. A QMS - Quality Management System is the cornerstone of excellence providing a structured approach to ensure consistent quality

SafeLink Consulting offers expert assistance to help your business achieve FDA compliance and develop a highly effective quality management system. Discover more about FDA Dental Regulations.

Here's how SafeLink Consulting can assist your business

Premier provider of Safety Programs and Quality Systems

  • Risk assessments and due diligence performed by safety and quality experts
  • Effective written safety and quality programs customized for your business
  • Onsite or virtual safety consulting, training, and audits to reduce risks and assist in meeting OSHA compliance
  • OSHA Outreach Trainers, ASQ Certified Quality Auditor, and CDT on staff
  • Onsite Quality Management System development and internal audits by a Certified ASQ Auditor for product or process issues 
  • Guidance with an OSHA or FDA inspection or inquiry, compliance audits, and assistance in registering with FDA