ISO 13485 -- medical quality system registration
A quality management system is critical to ensure your medical product will be manufactured to your specifications for safe intended use every time. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system.
UL is an accredited registrar under ISO 13485 with 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.
ISO 13485 drivers
- Device manufacturers seek registration to ISO 13485 to improve their internal management of medical device quality systems.
- Medical industry regulators use the ISO 13485 standard to standardize the evaluation of the quality systems of approved device manufacturers.
- Customers of medical device manufacturers such as health care providers have required device manufacturers to seek registration to ISO 13485.
- Medical device component and service providers are also experiencing increasing demand for registration to ISO 13485 from their customers.
The UL ISO 13485 service portfolio
- Program Requirements
- Preliminary evaluation -- A practice or mock 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 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.
Global marketing requirements and integrated audits
You can schedule integrated audits of your management system to take advantage of the similar requirements synergy among your various quality management system needs. Typically, these combined audits require fewer audit days than the audits required for separate systems. For example, in one audit UL can assess conformity to ISO 13485, ISO 9000, Medical Devices or In-Vitro Diagnostic directives, ISO 13485 under CMDCAS, Japan's PAL, Brazil's InMetro certification requirements, and ISO 14971 Risk Management requirements.
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.
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.
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