Management System Assessment

Overview

A UL management systems assessment provides an independent, holistic analysis of how a company's processes, practices, and policies support its mission and vision. We can help businesses create a competitive advantage with actionable insight into a company's inner workings and, if needed, best-practice guidance to further fine tune management systems performance.

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.
Definition

Management systems assessment provides third party audits of processes and systems that support a business.

Benefits

UL provides expert assessment of a company's system to identify issues before they become problems and validates the system is functioning according to the standards.

Our auditors are assessed by global accreditation bodies for consistency and conformity with industry and registration bodies' standards.


DELIVERABLES

Certificate to submit to global regulatory bodies and certification bodies


APPLICABLE STANDARDS

ISO 9001 Internationally agreed to standards for management guidelines to achieve customer satisfaction »
ISO 13485 Requirements for design and manufacture of medical devices »
ISO 14971 Standards for requirements for a risk management system for medical devices »
ISO 62304 Requirement for development of medical software and medical devices »

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