Skip to content

EMIS undertakes expansion of ISO credentials

EMIS Inc. to obtain ISO 13485 accreditation in support of Health Canada mandate

Edmonton, AB - 17 December 2009 – Building on the numerous ISO certificates EMIS Group already maintains, EMIS Inc. announced today that it has formally commenced the process to obtain yet another ISO certification in support of the recent Health Canada announcement that it will enforce regulations that patient management software is a Class II Medical Device, and as such, the organization requires an ISO 13485:2003 certificate to comply.

EMIS Group already holds and maintains a series of ISO certifications, including: ISO 9001:2008; 9001:2008 Tickit; 270001; and 20000. The depth and breadth of EMIS’ commitment to quality software development and support is a key aspect of it recently being awarded the inaugural Technology Supplier of the Year award from the UK IT Industry Awards.

EMIS Group has a dedicated department and staff which aid the organization in continued compliance with the complexities of adhering to the highest quality standards throughout the entire organization. This same department services the needs of EMIS Inc. in Canada. It has already helped EMIS Inc. in adoption of many of the same procedures, policies, and operating standards which support the existing ISO certificates.

“We don’t see adding 13485 as a significant hurdle for us based on the head-start we already have,” stated Ann Worthington, Director of Quality Assurance. She continued, “Given the fact that we maintain the certificates we do, 13485:2003 is not a significant challenge for EMIS Inc. to add to the portfolio.”

In August of this year, Health Canada issued notice that in the near future they will begin enforcing its policy that patient management software is a Class II Medical Device. Health Canada’s remit is entirely focused on patient safety, and EMIS applauds this move to assure that the software at the foundation of medical practice is developed in consistent and monitored ways. While the initial notice indicated a deadline for compliance of August 31, 2010, EMIS is led to believe that Health Canada may be announcing a slight extension to this timeline. Should a vendor of patient management software not be compliant by the deadline, Health Canada possesses the legal authority to force the non-compliant vendor from continued marketing of its solutions, and users of that solution to discontinue their use of the solution.

About EMIS Inc.
EMIS Inc. is the Canadian subsidiary of The EMIS Group based in Leeds, United Kingdom. EMIS Inc. launched its Canadian operations in 2005, expanding on its success as the number one provider of EMR solutions in the UK and other countries. Since this time, EMIS Inc., headquartered in Edmonton, has become recognized in Canada as one of the pre-eminent solutions able to improve the health of Canadians and the daily activities of their providers through the use of a physician-centric, clinically based electronic medical record. EMIS supports its’ corporate principals of improving the health of individual patients, and the population as a whole through advanced knowledge garnered by empowering physicians to collaborate.

For More Information Please Contact:

Emis Inc.
Ron Hughes
Director, Sales & Marketing
(866) 443-3647
ron.hughes@emis.ca