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ISO 13485 Audits for Medical Device Companies

Medical device manufacturers are required to regularly conduct an audit of their ISO 13485 compliant quality management system. Emergo conducts these fully independent quality system reviews for companies that are already ISO 13485 certified as well as for firms about to undergo their initial ISO 13485 certification audit by a Notified Body or Registrar.

Emergo provides the following ISO 13485 auditor services:

These ISO 13485 audits help determine the actual status of your current quality management system and processes:

  • Off-site review of your current QA/RA documentation prior to your on-site ISO 13485 audit by a Notified Body or Registrar
  • Systematic and independent process audit to determine conformity or nonconformity of your Quality Management System to ISO 13485:2003 requirements
  • Review of your internal documentation to verify that requirements have been addressed
  • Actual verification of ISO 13485 audit requirements through review of objective evidence
  • Physical verification of compliance via interviews and fact-based observations to confirm quality system requirements
  • Evaluation of current special controls or validated processes; knowledgeable in various processes such as sterilization, clean-rooms, or software systems

Additional ISO 13485 Audit Services

You can also contract Emergo to conduct targeted ISO 13485 process audits in which we focus on specific areas where noncompliance issues have occurred, or on areas your internal auditors cannot audit due to conflicts of interest.

Emergo also provides on-site ISO 13485 auditor training in order for clients to effectively audit their own quality systems. Our training is classroom-based and teaches your employees how to become ISO 13485 internal auditors to ensure proper functioning of your QMS. Key topics of the training include why ISO audits are required, planning an internal audit, as well as conduct and performance issues related to ISO 13485 internal audits.

Please contact us for more information on our ISO 13485 auditing services.

Ask us for detailed information about ISO 13485 auditing services.

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Common questions:

What is the deadline for transitioning to ISO 13485:2016?
Notified Bodies will not issue ISO 13485:2003 certificates after March 2018. Therefore, companies that obtain ISO 13485:2003 by January 1, 2017, for example, will only have a certificate that’s valid until March 2019. After this date, companies must obtain certification under ISO 13485:2016.