ISO 13485 Certification Process

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  • Step 1:  Obtain a copy of ISO 13485 
    • Identify the basic requirements of ISO 13485 and how they apply to your business.  The guidelines are written specifically for the medical device industry but under a generic framework to accommodate the needs of different medical device manufacturers. 
  • Step 2:  Analyze the quality management system in place against the requirements of ISO 13485
    • Once you are familiar with the basic requirements of ISO 13485 you will have an understanding of where your company stands in comparison to the broad structure.
  • Step 3:  Fill any gaps 
  • Step 4: Select a competent registrar  
    • SQA provides experienced and knowledgeable Registrars with extensive experience in certifying companies to the ISO 13485 standard.  Our customer service focused staff will guide you through the entire certification process and provide you with all the necessary tools and checklists to complete your ISO 13485 certification.

Call SQA today to discuss your ISO 13485 auditor needs. You also can transfer your certification to SQA. Contact us at 330.762.4231

  • Step 5:  Have the registrar perform a pre-assessment of the quality management system (optional)
    • Although this is an optional step, this can be an extremely beneficial step in receiving ISO 13485 certification.  An accredited third party company, such as SQA-visits your company, reviews your current quality management system, and makes recommendations for the official audit. 
  • Step 6: Schedule and execute a stage-1 audit  (Official Step)
    • This is an official step in the audit process and a very informative session with your business and your SQA Auditory.  SQA will provide a review of documentation, internal audit results, management review results, process indicators and customer feedback. 
  • Step 7:  Schedule and execute a Stage-2 audit (Certification audit)
    • This is a detailed audit in which SQA will dig deeper in to your Quality Management System and focus on system effectiveness.  To accomplish this certification SQA will look at all production shifts and provide a more detailed review and audit report.
  • Step 8: Follow certification; move in to maintenance and improvement mode.
    • Following certification, your company will move into maintenance and improvement mode.  This is accomplished with active involvement of top management officials.  Your SQA registrar will monitor progress through annual surveillance audits and a complete system re-certification will be required every three years.

SQA has a proven track record of ethical business practices.  Our competent and experienced auditors provide a high level of customer service.  Contact us at 330.762.4231 to receive additional information for ISO 13485 certification