ISO 13485 — medical quality system registration

UL full time assessors deliver value, consistency and confidence for both your business and your customers

A quality management system is critical to ensure your medical product will be manufactured to your specifications for safe intended use every time. And for medical devices, in most cases, it is a regulatory requirement as well. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system. As an accredited registrar under ISO 17021 we certify you against ISO 13485, UL wants you to succeed, both as a quality professional and as a medical business. We employ full time, experienced auditors who can add real business value to your operation and work with you until your action requests are resolved. Our team includes full time auditors located around the world, in your time zone who can speak your manufacturer’s local language. And with UL, you can schedule integrated audits of your management system to take advantage of the similar requirements synergy among your various management system needs, including ISO 13485, ISO 14971, Canada CMDCAS, EU Notified Body, Brazil INMETRO and more.

ISO 13485, 2016 Version – Key Dates and Information

In 2016, ISO 13485 was revised after more than a decade.  Typically, the Accrediting Bodies will allow a 3-year transition, so we expect the last day of recognition of ISO 13485:2003 to be the last day of February 2019.  Before transitioning, it is also important for manufacturers to note any regulatory bodies that will require and/or recognize the 2016 version of the standard.

The 2016 version requires a lot more emphasis on risk management and embedding risk management into the quality system processes.  There is also a increased expectation for documentation.  The revisions are so comprehensive that it may be a challenge for a manufacturer to continue to maintain registrations to both ISO 9001 and ISO 13485.  Contact UL for more information or refer to the resources on this page.

UL is currently an Accredited Registrar and is offering registration to ISO 13485:2016.

The UL ISO 13485 service portfolio

  • Preliminary evaluation — A practice or audit of your site to determine your readiness for a registration audit. You will receive a written report including a list of any non-conformities found.
  • Registration assessment — Typically scheduled two to four months after your preliminary evaluation. At the conclusion of the registration assessment, your UL audit team will advise you of its recommendation and present a written non-conformity report before leaving the site.
  • Continuous assessment — Conducted after registration to measure your continued conformance to the ISO 13485 standard.
  • Triennial (recertification) assessment — Recertification assessment to begin a new 3-year cycle of registration.
  • Internal audits and training — For manufacturers who do not have certification with UL, UL experienced auditors can conduct your internal audits and training. Once UL auditors provide internal audits and/or training, the manufacturer must wait 2 years until UL can be its certification body. UL also offers ISO 13485 training courses through UL Knowledge Services.

The UL advantage

UL’s experienced and dedicated full time auditing team works closely with our customers to collaborate for compliance.

  • A culture of Partner versus Provider – UL’s technical team will work with you to meet deadlines and internal needs. We engage with our customers regularly to work through the standard requirements and demonstrate compliance.
  • Integrated assessments – UL experienced audit staff are typically qualified in multiple regulatory schemes and can reduce your overall audit burden by combining multiple audits into one, including UL NRTL Follow up, CMDCAS, MDSAP, Notified Body for EU and Brazil INMETRO.
  • Easy transfers – UL will recognize your existing accredited registration and pick up where your previous registrar left off. An experienced technical expert will provide direct guidance throughout the transfer process so your company can continue to sell in critical markets.
  • Full Time staff – UL auditors are full time employees, delivering consistent service and limiting the amount of retraining required to become familiar with your systems and locations. You also have direct access to our technical team to help you respond to challenging situations.
  • Trust and Confidence – Our team helps your business comply by applying the requirements properly
  • Single partner for Canada – UL has the breadth of services to provide both your testing and certification for global regulatory requirements including Software, EMC, Safety, Usability, Home Health, Risk management and more.

Our credentials

Our ISO 13485 program is accredited by SCC and UKAS. UL remains current with existing and emerging international standards through its participation in IEC SC62A, IEC SC62, GHTF, CMDCAS Registration Body Forum group, NB:MED and IAF ISO 13485 MDCAS Working Group.

Impartiality statement

UL places the utmost importance on the integrity and impartiality of its management system certification activities and the trust it conveys to its clients, their customers and the public at large. The principles inspiring this confidence include impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints. These principles are identifiable in UL’s Mission Statement. If any internal or external person or body should ever have concern of a situation that may threaten impartiality, it should immediately be brought to the attention of the UL Health Sciences General Manager through the contact information listed below. Link to program requirements.

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Contact UL Health Sciences Team direct:

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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.