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SafeLink consulting

Build Customer Confidence Through Your Quality Management System.

It is crucial for suppliers and subcontractors of medical device materials and components to uphold the quality standards expected by their customers. SafeLink Consulting can assist in enhancing your awareness of how to be a valuable asset rather than a liability to your customers as they navigate the increasingly complex regulatory landscape. 
  • Achieve good manufacturing best practices
  • Maintain your customer's quality standards
  • Enhance understanding of your customer's supplier evaluation process
  • Meet requirements for FDA Part 820 and ISO 13485:2016
  • Become better prepared to pass a supply audit initiated by your customer
  • Reduce nonconformance
  • Gain an edge of your competitors by being an asset to your customers

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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.

SafeLink can help you be better prepared to pass a supplier/subcontractor evaluation or audit. Be ready to respond quickly to your customers’ requests for this type of information and welcome them should they request to audit your facility. If you already have an effective process in place, then SafeLink can provide supplier audits to identify and resolve any quality issues that could put the quality of your customer's product and your customer at risk. Discover more in our blog about this topic.  Get a free checklist.

Supplier/Subcontractor Auditing
Our compliance advisors are ready to help your business succeed.

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