2018 IAF MLA Annual Report Now Published
Update on the IAF Database of Accredited Certifications
GFSI Celebrates World Food Safety Day with Video Series
Videos from the 2019 IAF-ILAC Mid-Term Meetings
World Accreditation Day 2019 Video Now Available
UNIDO Publishes QP Guiding Documents
2019 IAF-ILAC Joint Mid-Term Meetings
Merger of PAC and APLAC
PAC Provides Support for ISO 13485 Training
INetQI Meets in Geneva
IAF Signs MoU with ILAC and the World Bank
IAF Signs MoU with IHAF and ILAC
IAF, ILAC and OIML Renew Tripartite MoU
Transition Rate Confirmed at 93% from IAF Members
Upcoming IAF-ILAC Meetings in Singapore
Anti-Bullying Publicly Available Specification Published
2017 IAF MLA Annual Report
Key ISO management system standard revisions published
2018 IAF-ILAC Joint Annual Meetings
Insurer publishes report into value of standards and accreditation
2018 Business Improvement Forum
ISO 9001 Certification Used as Measure in GII
April 2018 IAF MLA MC Meeting Highlights
World Accreditation Day 2018 Video Now Available
April 2018 IAF Technical Committee Meeting Highlights
2015 ISO Transition Deadline Approaching
New Global Partnership with GFSI
IAF-ILAC Communications Committees Update
World Accreditation Day 2018
Expected Outcomes of Mgmt Systems Certification
Trade Benefits of the IAF MLA
U.S. FDA Recognizes ANAB for FSMA
Joint IAF-ILAC Mid-Term Meetings
IAF Renews MoU with UNIDO and ILAC
IAF Endorses FAMI-QS Certification Scheme
IAF Signs MLA Agreement With IPC
IAF Participates in COP 23
IAF Resolution 2017-13
IAF Database of Accredited Certificates
Accredited Certification and the Supply Chain
IAF MD 20 Workshop Videos
2016 IAF MLA Annual Report
2016 ISO Survey
Engaging with the Insurance Industry
ISO 9001 and ISO 14001 Transition Deadline
IAF Welcomes New Members and MLA Signatories
Growing Public Healthcare Support by IAF
IAF Participates in DCMAS Network Meeting
Business Benefits Website
2017 IAF/ILAC Joint Annual Meetings
Strong Progress on IAF Database
The Value of Management Systems International Standards
3P-EVP - Third Party Effectiveness Verification
UNECE Trade Recommendations Reference Accreditation
IAF, ILAC and JAS-ANZ Communications Workshops
FAMI-QS Signs Agreement of Cooperation with FQSI
USEPA Rule on Formaldehyde Emission Standards
African Year of Quality Infrastructure
World Accreditation Day 2017
2017 IAF-ILAC Mid-Term Meetings
Standards and Accreditation in the Insurance Sector
UNIDO: Experience in the Market Surveillance of ISO 9001 QMS
IAF MLA Annual Report 2015
SADCAS Admitted as an Accreditation Body Member
World Bank - GFDDR Report Cites Accreditaton
World Accreditation Day - 2016
ANAB Acquires Laboratory Accreditation Bureau
ISO Survey 2014
Greater Recognition for Accreditation
Publication of ISO 9001:2015
PAC 20th Anniversary Celebrations a Great Success
Assuring Success Through Accredited Certification
BIPM Workshop on Carbon Measurements
Interview with Randy Dougherty, IAF Chair (Spanish)
World Accreditation Day 2015 Celebrations - Kenya
Making Trade Work - ILAC and IAF to host session
IAF MLA Annual Report 2014
2015 EOQ Presidential Georges Borel Awards
Second OECD meeting of International Organisations
EA Celebrating its 15th Anniversary in 2015
Boosting the trade capacity of Least Developed Countries
World Accreditation Day 2015
IAF MLA Annual Report 2013
Promoting Accreditation at the WTO Public Forum
Self-Certification Is Not a Real Thing
Specifying Accreditation in Regulation
GLOBALG.A.P. receives IAF endorsement
World Accreditation Day - June 9th 2014
Accredited certification delivers real added value
Closer Cooperation
IAF after 20 years
Study into the value of ISO 9001
World Accreditation Day 2011

Growing Public Healthcare Support by IAF and the New ISO 13485:2016

By Grant Ramaley (Dental Trade Alliance)

Every patient in the world deserves safe and effective care when they go to the doctor. Taking care of seven billion patients is a shared responsibility among tens of thousands of medical device manufacturers worldwide. Everything from gene-altering devices used to cure cancer to root canal fillings; they all play a critical role in our well-being and sometimes our survival.  

Since 1996, Medical Device Regulators and industry have been working with and refining the quality system standard ISO 13485. The purpose of each refinement is to improve healthcare worldwide. Twenty years later, more countries have adopted this standard for regulatory purposes. There is even a “Playbook” created by medical device regulators that advocates use of 13485 when developing a regulatory system. 

ISO 13485:2016 was redesigned to further target more specific risks related to medical devices, such as medical device use errors, concerns with software and more attention to the supply chain. In fact, the newer version has been expanded so that the entire supply chain is included. IAF MD9:2017 was restyled to accommodate the expanded scope. It is no wonder more regulatory authorities are asking for ISO 13485 certificates than ever before. 

The IAF has been working with Medical Device Regulators through the Asian Harmonization Working Party, which requested IAF help address certain risks posed by distributors of medical devices. Most countries import 90%-98% of their devices, many of which enter the market through distributors. The AHWP, which now includes 30 nations from Africa, Asia, Latin America and the Middle East, wrote guidance that allows use of ISO 13485 to regulate Good Distribution Practices concerning medical devices. Singapore has more than 800 medical device distributors, which can now use an IAF backed ISO 13485 certificate to help the authorities monitor that part of the supply chain.  

In turn, Medical Device Distributors can be granted as much as a 50% decrease in audit durations, since the activities for design and manufacturing are carried out elsewhere. The IAF has expanded the scope for accredited ISO 13485 certification. Parts and Suppliers can now find more value in supporting the healthcare chain using this same certification. There are new scopes for accreditation in IAF MD9:2017 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) for suppliers of “Parts and Services”, just for that purpose (see Table A1.7).

Quality Systems play a critical role in supporting patient care. International trade and international healthcare are intractably linked. The IAF Multilateral Recognition Arrangement sub-scope for ISO 13485 is becoming increasingly relevant, as credible ISO 13485 certificates are seen as critical to assisting regulators with healthcare protection.  The IAF MLA allows regulators to distinguish certificates obtained through competent, onsite quality system audits from certificates purchased using online audits. Indeed, our lives do depend on quality system ISO 13485, now more than ever. 


MEMBERS LOGIN

Email
Password
Forgot Password?



> Publications


Access and download IAF publications
Click Here>>

> IAF Members
& Signatories


Contact details for IAF members, associates and related bodies
Click Here>>

> IAF NEWSLETTER


Subscribe to email Newsletter
Click Here>>
 
 

IAF MLA - Directory - Publications - News & Events - Contact Us - FAQ - Home

© Copyright, International Accreditation Forum, Inc

Website marketing by Aim IT, Sydney
Web site design Plus 5 Media

Certified Once
Accepted Everywhere