ISO 13485:2016 Consulting and Gap Analysis


  • What are the deadlines for ISO 13485:2016 certification?
  • How should we approach the transition to ISO 13485:2016?
  • What are the biggest changes in ISO 13485:2016?

ISO 13485:2016 is the most recent update to the quality system standard specifically for medical device companies. You have until March 2019 to update your current ISO 13485 certificate to the new version.

But don't panic yet. There may be many differences between ISO 13485:2003/EN ISO 13485:2012 versions and the ISO 13485:2016 version—including an increased focus on risk management, supplier controls, and feedback mechanisms–that may seem daunting. But the changes are reasonably easy to implement with Emergo's help.

Download our free white paper about the differences between ISO 13485:2003 and ISO 13485:2016.

We'll help you upgrade to ISO 13485:2016

Our expert quality system consultants have a four-part method to help you transition to ISO 13485:2016, or implement a new system:

  • Gap analysis audit - We evaluate your management system to determine your current level of compliance with ISO 13485:2016. If you already have ISO 13485 certification, you are probably 80% or more compliant with the new requirements. However, it's important to know where you stand. The gap analysis supports the development of a list of action items to adopt the new standard, also known as a quality plan.
  • Quality plan - The quality plan is a documented list of tasks your organization must accomplish to comply with ISO 13485:2016. In addition, there is more emphasis on quality planning in the new standard, so this is an excellent way to get started! Our consultants develop a detailed quality plan tailored to your company.
  • Risk-based approach - ISO 13485:2016 places much more emphasis on risk management. Our consultants evaluate your system to ensure your risk assessment and decision-making measures are as robust as possible.
  • Pre-assessment audits - If you plan to complete the work necessary to upgrade in-house, Emergo can perform a pre-assessment audit several weeks prior to your Notified Body or Registrar certification audit. We can also conduct on-site ISO 13485:2016 training for your key employees to ensure ongoing compliance.

Act soon to maintain your current ISO 13485 certification

The deadline to comply seems far into the future, but there will be a surge of companies that want to recertify in 2018 or sooner. To avoid lengthy delays or a potential lapse in your certification, plan ahead. The number of Notified Bodies continues to shrink and demand for their services will grow. Failure to transition to the new standard may result in a suspended ISO certification, which could have dire consequences for your company. Plan ahead to beat the rush, and let us help you meet the new standard.

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