FDA Cited Multiple QMS Deficiencies at Canadian Firm Certified by BSI to ISO 13485
The FDA has cited a company with multiple QMS violations, despite holding ISO 13485 certification by BSI.
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Author: OQRI
Registrar TUV Rheinland Ordered to Pay Over $2 Million to Victims in PIP Breast Implant Scandal
Registrar TUV Rheinland has been ordered to pay over $2 million to victims in PIP breast implant scandal.
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BSI Granted CE Mark for Spinal Implants That Are Dissolving Inside Patients
Certification body BSI granted CE Mark to a company whose spinal implants are now dissolving inside patients, forcing them to undergo additional surgeries.
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ISO, World Bank Agreement Forces Standards on At-Risk Nations
ISO has renewed an agreement with the World Bank, now ensuring that the international lender will impose ISO standards on at-risk developing nations who seek financial assistance.
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New ISO 19011 Standard Strips Requirement Directing Auditors to Comply with Laws
The latest version of the ISO 19001 standard on auditing stripped out decades-old language requiring auditors to comply with the laws applicable to their audit clients.
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