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ISO 9001 - ISO 13485 - ISO 14001 Consulting

Quality Works specializes in Quality Management System (QMS) and Environmental Management System (EMS) consulting. Along with ISO 9001 and 14001, our staff specialize in medical devices and offer a wide range of services:

  • ISO 9001 QMS

  • ISO 13485 QMS

  • ISO 14001 EMS

  • FDA 21 CFR 820

  • Counsil Directive 93/42/EEC for CE marking of medical devices.

  • Canadian Medical Device Regulations (MDRs)

  • Development and implementation of a new QMS or EMS

  • Upgrade of existing systems to establish compliance with additional standards

  • Conduct second party audits, including pre-certification audits

  • Assistance in certification audits

Tell us how we can help you. Based on information you submit, we will provide you with a proposal and a firm quote similar to this example. We will develop an implementation plan for you similar to this example. Visit our ISO 9001 consulting page for more details or for a free no obligation proposal and quote, please complete our Request for Free Quote or call today.

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