ISO 13485 Certification is essential in today’s marketplace. The medical device industry involves a complex spectrum of regulatory systems, national and international standards, and other requirements. Your organization has a responsibility to consistently deliver devices that are safe and effective. Certification to ISO 13485 is not only used by medical device manufacturers as the foundation to their management system, it is also used by non-medical device companies in order to gain new business opportunities within the medical device community.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. The upgrade ISO 9001:2015 is due by September 2018. Orion clients with an ISO 9001 certificate are asked to upgrade ISO 9001:2015 by July, 2018. All requirements of ISO 13485are specific to organizations providing medical devices, regardless of the type or size of the organization. For more information visit: webstore.ansi.org or www.iso.org
The ISO 13485:2016 revision was launched March 1, 2016. Orion cannot certify new clients to the ISO 13485:2003 version after March 1, 2018
and the 2003 verion certificate is no longer valid as of March 1, 2019.
Why was ISO 13485 revised? All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.
What are the key improvements? The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. ISO 13485:2016 standard and information is available at www.iso.org.
Our auditors are exceptionally qualified with excellent backgrounds and experience. It is Orion’s commitment to work together with our clients and provide them with the highest level of professionalism and satisfaction. Orion auditors are fair and thorough and treat each of our clients with respect. They are not interested in promoting bureaucracy, but in learning the distinctive ways in which a company has met the requirements of the standard.
Orion Registrar is dedicated to earning your loyalty with consistent, cost-effective service and value added auditing. With Orion, you will have confidence that your registrar hears and responds to your voice, and is flexible enough to meet the individual needs of your company. We are small enough to understand the special requirements of small businesses, yet big enough to provide the depth of skills and experience required to mentor even the largest companies as they strive to continually improve their processes. Orion personnel at all levels, do their utmost to form a partnership with our clients.
With Orion, a company may customize their certification needs. Your company may seek ISO 13485 or medical device certification separately, or you may choose to certify your integrated management system. In addition, you can choose from a six-month or annual surveillance plan. A partnership with Orion means that we can customize our service to best meet your specific needs. All of Orion’s services are fixed-fee per service and audit days are based on size and complexity of the company. There are never any hidden charges or extra fees. Travel expenses are billed at actual cost. Orion always works to provide you with the most economical options.
Orion Registrar is accredited for ISO 9001 by the ANSI-ASQ National Accreditation Board (ANAB)
Demonstrate your commitment to quality, safety, and continuous
improvement by contacting Orion Registrar today.