QMS Archives - Value Added

Internal Auditor Training Program As Per Iso 13485:2016 Standard

IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System

COURSE OUTCOMES:

a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·
d. Understanding how to meet regulatory requirements leading to increased patient safety

Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student

Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in

Last Date for Registration: 7th October 2023

For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in

IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide

On Feb. 13, 2023, 33 nations sent their medical device regulators to Riyadh, Saudi Arabia, to participate in the Global Harmonization Working Party. The GHWP is a nonprofit organization that studies and recommends ways to harmonize global medical device regulations

The IAF was asked to participate and provide an update on the IAF CertSearch database, a global database where users can search and validate the status of accredited certificates issued by a certification body that has itself been accredited by an IAF-recognized accreditation body. The IAF presentation was provided by Nigel Johnston, who developed the database.

The presentation given to the GHWP members focused attention on the use of ISO 13485 and how the IAF CertSearch database is helping regulators to verify the credibility of these certificates. Johnston’s presentation raised alarms. He noted that the IAF CertSearch team had identified 20,000 fake or fraudulent certificates in the last year alone.

Although it isn’t fully populated (the database represents about 44% of all ISO QMS certificates included in the ISO Survey), it is now mandatory that accredited certification bodies upload them. Because of this requirement, this percentage is expected to increase significantly.

Source: https://www.qualitydigest.com/inside/fda-compliance-article/iaf-certsearch-team-identifies-20000-fake-or-fraudulent-iso-qms-certs