Auto-certification sounds like a contradictory term, according to the established ISO standards.

But in these times when third party certifications are not looked at as very credible and their cost keeps increasing, university management researchers are looking at auto-certification as a solution to this problem.

What these researchers do is to design very lean management systems, be they quality, environment, safety, security, and so on oriented, and try to make them work on two very basic kinds of resources:

• Computerized systems.
• Personnel.

Computerized systems include highly automated measurement systems that are monitored for performance and reliability, and are kept calibrated by third party official bodies.

Personnel are also carefully selected, according to their responsibility and authority, continually trained and monitored for performance.

Records are kept for the above resources to show performance conformity.

THE CHALLENGES
Maybe the next ISO standard developers will not allow us to see this dramatic development in management systems’ culture, but it’s something that we should not ignore.

Organizations would not require third party audits anymore, second party audits would be based on the evidence provided by the supplier, first party (internal) audits would be less time wasting and much more effective.

It’s a management system that’s already in place in the food industry, via HACCP methodologies, and in the pharmaceutical industry via GMP’s.

In contrast to the traditional third party auditing practices, where very often auditors have a very obscure view of auditee’s processes, auto-certification auditors know their organization very well, and know therefore where to point their index finger to.

Were it not for the failure of – some – accreditation bodies to secure reliable audits and for – some – registrars to look at their budgets only, the idea of auto-certification would have never been born.

But so it is, and we’ll probably have to face this business development, too.

Since one of the words of the day is go lean, organizations must demonstrate their will, their capability to go lean first, and then develop plans to hit their targets and monitor how successful they are.

Auto-certification has certainly economic and organizational benefits; but let’s not forget the Titanic anecdote.  She was said to be unsinkable and we all know what happened.

These days we all want to save money.  A joke says that in a board meeting the CEO proposes to replace the very expensive consultants with much cheaper magicians.

True reality is not too far from this.  It has happened in the past history.

FINAL THOUGHT?
Auto-certification: yes or no?  I would personally answer it depends to this question.

If I would want to sell a medical device to USA I would need FDA’s official approval, therefore my auto-certification would not suffice.

But if I want to sell the same device to a MENA (Middle East North Africa) Country,  may be my auto-certification could be accepted.

We operate in a world of standards, but not in a standardized world.