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PAC Provides Support for ISO 13485 Training

Standards Malaysia assisted the Pacific Accreditation Cooperation (PAC) to organize a three day workshop on the Quality Management Systems (QMS) Standard for Medical Devices, ISO 13485, from 30 October - 01 November 2018. The workshop was part of an effort to assist PAC members in understanding and implementing IAF MD8:2017 Application of ISO/IEC 17011:2004 in the Field of Medical Device Quality Management Systems (ISO 13485) and IAF MD 9:2017 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485), but included nearly two days of activities relating to the inner workings of ISO 13485. The training also included representatives from Malaysia’s Ministry of Health, who noted the growing role of ISO 13485 and IAF-based accreditation in regulating medical devices.

Faridah Shahidin of Standards Malaysia and IAF representative Grant Ramaley provided the expertise and training, including practical exercises on the application of MD9. The Ministry of Health in Malaysia has been examining the IAF program for ISO 13485 for some time, and thanked PAC for “a very informative and very well organized” workshop. After receiving a full update on changes to the standard, attendees dove into how medical device risks are managed using ISO 14971 and ISO 13485.

Grant Ramaley, who led the training on the Risk Management portion of the workshop, stated: “Risk Management is really the heart and soul of ISO 13485. Without understanding how medical device risks are managed, it is impossible to appreciate the difference in the way ISO 13485 is implemented”.

The workshop moved from classroom exercises to discussions on how devices, which the breakout groups had picked, might put patients and users at risk. The class then transitioned into using design and development controls within ISO 13485 to eliminate or reduce those risks as far as possible.

Ms. Shahidin’s detailed coverage on IAF MD9 received an enthusiastic response. Her experience working for many years in the medical device industry, then as a Conformity Assessment Body auditor, and currently as an assessor for Standards Malaysia, were all put to good use. She crafted scenarios that thrilled and challenged the class.

One of the trainees stated, “Faridah taught me quite a bit through her exercises. It was particularly fun trying to untangle the impartiality scenario she came up”. Aainaa Kamilah Roslee presented on IAF MD8 on behalf of Standards Malaysia and PAC on the last day.

With more than 40 members, PAC represents one of the largest Regional Accreditation Groups amongst the IAF membership. The region also provides unique medical devices to the world. One member from a medical device company that specializes in making devices from natural rubber was on hand and praised the depth of the training workshop. Surgical gloves alone are worn billions of times each year, and most of these come from this region.

“In setting to work to create an IAF accreditation program for the medical device QMS 13485 standard, the Working Group was guided by the vision that medical devices are needed everywhere to help support and protect healthcare systems worldwide. It was an incredible privilege to participate with Faridah, Aainaa and support the training with PAC and Standards Malaysia” – Grant Ramaley.

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