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ISO 13485 Audits for Medical Device Companies

ANSWERED ON THIS PAGE:

  • What are the benefits of a third-party internal ISO 13485 audit?
  • What are the key elements of an internal audit?
  • How can our quality team learn to conduct regular ISO 13485 audits?

Medical device manufacturers are required to perform regular audits of their ISO 13485 compliant Quality Management System (QMS). Internal audits support the safety and effectiveness objectives of the products they sell and ensure that an adequate, effective quality system is established and maintained. Your quality staff can perform these audits, but a professional, third-party auditor is more objective when assessing the status of your QMS and processes.

Emergo conducts fully independent quality system reviews for companies with ISO 13485 certification, and for firms approaching their initial ISO 13485 certification audits by a Notified Body or Registrar.

Emergo provides the following ISO 13485 auditor services:

An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to ensure that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.

An ISO 13485 audit includes:

  • An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
  • A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements
  • A review of your internal and external documentation to verify requirements have been addressed.
  • An actual verification of ISO 13485 audit requirements through a review of the objective evidence.
  • A physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met.
  • An evaluation of current special controls and validated processes. Emergo consultants are knowledgeable in various processes such as sterilization, clean rooms, or software systems.

Additional ISO 13485 audit services

Emergo conducts targeted ISO 13485 process audits in which we focus on specific areas where noncompliance issues have occurred, as well as areas that your internal auditors cannot audit due to conflicts of interest.

Emergo also provides on-site ISO 13485 auditor training to help clients learn how to effectively audit their own quality systems. Our training is classroom-based and teaches your employees how to measure your compliance with ISO 13485 and ensure proper functioning of your QMS. Key topics of the training include:

  • why ISO audits are required,
  • planning an internal audit,
  • and performance/conduct issues related to ISO 13485 internal audits.

Emergo’s QMS Consultants bring practical, real-world experience to each ISO 13485 audit. We can help you pass your Notified Body audit and comply with quality regulations worldwide.

Ask us for detailed information about ISO 13485 auditing services.

Learn about the process, costs and timelines.

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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 valid certificate until March 2019. After this date, companies must obtain certification to ISO 13485:2016.

When should we start the transition to ISO 13485:2016?
As soon as possible. Notified Bodies will be in high demand as the deadline gets closer due to an industry surge of audit requests. Also, European regulators will pressure Notified Bodies to perform stricter (more time-consuming) audits that exhibit control of manufacturers' suppliers and processes. Also, the number of Notified Bodies available for audits will get smaller as new requirements force some to close their doors. If you delay the audit process, you may find yourself at the end of a very long line.

How long does it take to complete an ISO 13485 audit?
The time needed to complete the audit varies based on the size and complexity of your organization. Emergo suggests that companies allow at least 3 ½ days to complete the inspection process, with up two days spent on-site.

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.

 

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.