Medical management system documentation
ISO 13485 specifies requirements for a Quality Management System (QMS) that can be used by organizations involved in the development of a medical device over its lifecycle. Adopting a QMS guides medical device organizations to improve their overall performance and to provide a sound basis for their sustainable development initiatives. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrate a commitment to the safety and quality of their medical device manufacturing processes.
For medical device organizations, compliance with ISO 13485 can continually improve a quality management system and support conformity assessment options that are used in different regulatory jurisdictions. Compliance with all the normative clauses in EN ISO 13485 will help the manufacturer ensure a process is in place, addressing quality management system aspects related to medical devices that are included in Article 10 and Annexes IX and XI of the Medical Device Regulation ((EU) 2017/745) and IVD Regulation ((EU) 2017/746) and existing requirements for MDD and IVD until full implementation of MDR and IVDR.
ISO 9001 defines generic QMS requirements applicable to organizations of all sizes regardless of the product being manufactured.
The ISO 13485 requirements are applicable to all medical device organizations as a basis for demonstrating and supporting compliance with applicable regulatory requirements.
UL Solutions ISO 13485 program
UL Solutions is committed to making sure our medical Quality System Registration customers are able to demonstrate compliance with the latest standards and current requirement. UL Solution’s experienced auditors will independently assess your QMS and ensure it meets ISO 13485 requirements. Obtaining ISO 13485 certification from UL Solutions helps you have confidence in the systems which manufacturer your medical devices thanks to a Notified Body with a long-standing reputation. An ISO 13485 certification might give you a competitive advantage over other medical devices manufacturers and increase the confidence of your manufacturing processes.
Why choose UL Solutions
UL Solutions is a global leader in applied safety science. Our auditors offer expert knowledge in testing, inspection and certification of medical devices. have gone through rigorous training programs and participated in continuous professional development. UL Solutions remains current with existing and emerging international standards through its participation in ISO CASCO 170XX Working Groups, IEC SC62A, IEC SC62D, IEC TC62, CLC TC62, ISO TC210 and MDSAP forums.
As a UKAS-accredited Registrar under ISO 17021, UL Solutions provides QMS registration to multiple programs. Under UKAS, we offer audits to ISO 13485 and combined audits to ISO 13485 and ISO 9001. To help you maximize time and efficiency, we offer combined ISO 13485, ISO 9001 and MDSAP audits UL-UK International Limited is an Approved Body by MHRA against the MDR 2002 (as amended) for IVD devices with expectation of expanding that scope to include medical devices in the near future (Q3 2023). With this new program, we continue to offer combined audits with all of our other offerings thus continuing to minimize the need for multiple audits.
All our auditors are full-time UL Solutions employees providing consistent audit experiences and support throughout the life of your QMS. With UL Solutions as a trusted partner and our worldwide network of technical medical device experts, we help you innovate and navigate complex regulatory requirements.
Our Regulatory auditors and assessors are part of our 15,000 mission-driven employees working in more than 40 countries to serve customers in over 100 countries. The UL Certification Marks serve as a recognized symbol of trust and reflect an unwavering commitment to advancing our safety mission.
Our QMS audit service includes:
- Registration audit —The registration audit is a two-part audit consisting of a Stage 1 readiness audit and a Stage 2 certification audit. Stage 1 is 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. The Stage 2 certification audit is typically scheduled one to six months after your Stage 1 audit. At the conclusion of the registration (Stage 2) audit, your UL Solutions audit team will advise you of their recommendation toward registration. If any nonconformities surface, the lead auditor will provide a formal non-conformity report at the audit’s closing meeting.
- 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.
Our Knowledge Solutions offerings include ISO 13485 and ISO 14971 training courses among others.
Offering registrations or certifications to:
- ISO 13485
- ISO 9001 (when combined with ISO 13485)
- ISO 14971
- IEC 62304
- Brazil INMETRO
Impartiality statement: As an ISO 17000 series accredited Certification Body, MDSAP Recognized Auditing Organization and a notified body subcontractor, we do not participate in the design, manufacture, installation or distribution of the products we certify nor do we participate in the design of quality management systems we certify and we do not provide consultancy services related to those products or services. In addition, UL Solutions does not certify quality management systems that have been designed by other companies in the UL Solutions family. We also do not link our certification activities to the activities of organizations that provide product or quality management consulting services. If you require such services please use an internet search engine to identify relevant providers.