![iso 13485 bsi iso 13485 bsi](http://www.precisionedge.com/wp-content/uploads/2017/09/BSI-Assurance-Mark-ISO-13485-KEYB.png)
![iso 13485 bsi iso 13485 bsi](https://www.oxebridge.com/emma/wp-content/uploads/2018/02/bardlogo.jpg)
#Iso 13485 bsi iso#
Manufacturers with products on the market in Canada cannot wait until 29 February 2019 to transition to the ISO 13485:2016 certificate. Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. The operational phase of this program is scheduled to begin in January 2017. BSI was the first auditing organization authorized during the Pilot Phase. CMDCAS auditing organizations were eligible to apply for authorization under the MDSAP program during the pilot phase. Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot, finishing December 2016. The MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
![iso 13485 bsi iso 13485 bsi](https://www.emergobyul.com/sites/default/files/file/iso-9001-2008-page-1.png)
Medical Device Single Audit Program (MDSAP) We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.” Gary Slack, Senior VP, Global Healthcare Solutions, BSI said: “ISO 13485 is the world’s leading Medical Device standard, with over 27,000 certificates globally, therefore we’re very proud to achieve accreditation from UKAS. You can find our useful tools and resources below. Under the Canadian Medical Devices Conformity Assessment System CMDCAS, only certification bodies accredited by SCC are eligible to certify medical device manufacturers’ management systems.īSI is now able to issue both UKAS and SCC accredited certificates to the latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, to its clients.Įxisting BSI Certification customers have until 28 February 2019 to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012 we recommend you start to plan your transition with urgency. To gain accredited status, BSI’s processes were independently reviewed by the United Kingdom Accreditation Service (UKAS) and the Standards Council of Canada (SCC). SCC accredits organizations that certify the management systems of medical device manufacturers.