Time and again we hear of organizations operating in highly regulated sectors, such as Food & Drugs, Aviation, Medical Devices, etc. to have major quality system breakdowns, creating hazards and risks to the population.
Contaminated food, airlines operating with disregard to maintenance mandates, unsafe drugs in the market place, unreliable automotive components leading to injuries and deaths, etc... Examples abound. While the population expects the regulatory agencies to keep them safe, these organizations are, many times, operating at substandard level with resources lacking.
While regulatory control of certain aspects of our society will always exist, since "self policing" has been demonstrated to have it's shortcomings, one could make a case that regulatory agencies could mandate organizations operating under their scrutiny to implement and attain credible certification to relevant standards.
For example, organizations operating in the food supply chain could be required to implement and attain certification to ISO 22000, Aerospace repair stations could be required to do the same against AS/EN 9110; Medical Device manufactures would go for ISO 13485 and so on.
The idea is to promote another layer of control, in addition to the regulators, already stretched thin in their resources. If the certifiers were to be kept really accountable to the stakeholders and the certificates were only granted to those organizations that really deserved, the regulators would have more confidence on the systems of the organizations they are expected to police.
Health Canada has a requirement such as this for medical device manufacturers selling in Canada, to be certified to ISO 13485 by specifically approved CB's. At least one CB has already been removed from the system.
My article on the potential deployment of AS/EN 9110 in the Aviation MR&O sector tries to make a similar point.
So, I am interested in your opinions and votes to this idea.
Contaminated food, airlines operating with disregard to maintenance mandates, unsafe drugs in the market place, unreliable automotive components leading to injuries and deaths, etc... Examples abound. While the population expects the regulatory agencies to keep them safe, these organizations are, many times, operating at substandard level with resources lacking.
While regulatory control of certain aspects of our society will always exist, since "self policing" has been demonstrated to have it's shortcomings, one could make a case that regulatory agencies could mandate organizations operating under their scrutiny to implement and attain credible certification to relevant standards.
For example, organizations operating in the food supply chain could be required to implement and attain certification to ISO 22000, Aerospace repair stations could be required to do the same against AS/EN 9110; Medical Device manufactures would go for ISO 13485 and so on.
The idea is to promote another layer of control, in addition to the regulators, already stretched thin in their resources. If the certifiers were to be kept really accountable to the stakeholders and the certificates were only granted to those organizations that really deserved, the regulators would have more confidence on the systems of the organizations they are expected to police.
Health Canada has a requirement such as this for medical device manufacturers selling in Canada, to be certified to ISO 13485 by specifically approved CB's. At least one CB has already been removed from the system.
My article on the potential deployment of AS/EN 9110 in the Aviation MR&O sector tries to make a similar point.
So, I am interested in your opinions and votes to this idea.
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