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Does an ISO certification ensure quality and safety?

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“Quality is a virtue – not everyone possesses it!”

It was not a regular day for Mr. Bose, as he sat with his nose buried in paperwork. Mr. Bose was the CEO of a chain of hospitals, and had recently set up a branch in an important part of Delhi. Endeavouring to provide the best for his customers, Mr. Bose had installed medical equipments worth crores from an ‘ISO 13485 certified company’, believing that the ISO certification would ensure quality products. Over a period of six months, all the equipments started malfunctioning one by one, which led to a lot of harassment on the part of the hospital staff as well as the patients. Then, one morning, Mr. Bose received a call from the local police, which stated that he should immediately replace all the new medical equipments, since the accreditation body that had issued the ISO certificate to the company which had supplied the equipments was apprehended by the Interpol for fraudulent practices.

In order to avoid a similar plight, it is important for everyone to look beyond a mere ISO certification mark and check the validity of an ISO certificate before we put our faith into an organization. The simplest way to check an ISO certificate in order to determine its authenticity is to ask for a copy of the certificate.

Once the copy is delivered, you must

  • Look for the name of the registrar (i.e. DNV, BSI, ABS etc.) and verify its authenticity.
  • Look for the name of an accreditation body (i.e. ANAB, ANSI, UKAS, etc.) and verify its authenticity.
  • If you see a stamp from an accreditation body, find out whether it is a member of the International Accreditation Forum. This can be verified via the following link: https://www.iaf.nu/articles/IAF_MEMBERS_SIGNATORIES/4
  • If there is a registrar name on the certificate, call the registrar directly and ask them to verify that they have issued such certificate.
  • Bear in mind that if an organization certifies Plant A, it does not mean that Plant B and C are also certified. Usually the certificate will tell you exactly which processes and locations are certified. So if you have a certificate, say for ABC Company, Delhi; that would not apply for the ABC Company in Mumbai.
  • Ensure that the certificate has not expired.

After checking, if you still feel that there’s something amiss about the company, always go with your gut feeling and investigate further. After all, it is better to be safe than sorry.

Disclaimer: The above article is curated based on limited and publicly available open source information. The views and opinions expressed therein and all data and information so provided is solely for informational purposes, to be used at the sole discretion of the reader. If you disagree with any article or any part thereof, please contact us and we will resolve the issue at the earliest. KyaBae makes no representations as to accuracy, completeness, currentness, suitability, or validity of any information and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.

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