A quality management system (QMS) is critical to ensure that medical products will be consistently manufactured to documented specifications so only safe devices that satisfy the intended use will be placed on the market. Medical devices, in many cases, include this as a regulatory requirement as well. With every product submission, regulatory bodies and competent authorities require proof that your product has been manufactured under a certified quality management system.
As an accredited registrar under ISO 17021, UL provides QMS registration to ISO 13485. We employ full time, experienced auditors who can add business value to your operation and work with you through the entire QMS registration process. These processes are designed to help you to succeed, both as a quality professional and as a medical business.
QMS and ISO audit services
Our ISO 13485 program is accredited by UKAS. UL remains current with existing and emerging international standards through its participation in IEC SC62A, IEC SC62, IMDRF, MDSAP forums, NB: MED and IAF ISO 13485 MDCAS Working Group.
Our team includes full time auditors located around the world, many who can speak your manufacturer’s local language. UL, also provides integrated audits of your management system to take advantage of the similar requirements synergy among your various management system needs, including ISO 13485, ISO 9001, ISO 14971, MDSAP, EU Notified Body, Brazil INMETRO, ICMED and more.
Services
- Preliminary evaluation – An audit of your site to determine your readiness for a registration audit. You will receive a written report including a list of any nonconformities found.
- Registration audit – The registration audit is a two-part audit consisting of a stage 1 readiness audit and a stage 2 certification audit. The stage 2 certification audit is typically scheduled one to six months after your stage 1 audit. At the conclusion of the registration audit, your UL audit team will advise you of their recommendation toward registration. If there are any nonconformities raised, the lead auditor will provide a formal non-conformity report at the closing meeting of the audit.
- Surveillance audit – Annual audits conducted post-registration that will measure continued conformance to the ISO 13485 standard and any additional regulatory programs.
- Triennial (recertification) audit – Recertification audits are a measure of the progress and conformity of the registered QMS over the three-year registration cycle and are used to begin a new three-year cycle of registration.
- Internal audits – Manufacturers who do not have QMS registration with UL, can use or experienced UL auditors to conduct their internal audits. If a manufacturer chooses to use UL in this capacity and then decides to use UL as its QMS registrar, there must be a span of two years, without use of UL for conducting internal audits before UL can become the registrar.
Training - UL also offers ISO 13485 and ISO 14971 training courses through UL Knowledge Services
Standards:
- ISO 17021
- ISO 13485
- ISO 9001
- ISO 14971
- MDSAP
- EU Notified Body
- Brazil INMETRO
- ICMED