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CE Marking, Health & Safety . . .
Risk Management, Product Safety . . .

Many businesses have subscribed, often unknowingly, to unregistered assessment companies for ISO9001 certification and obtained little more than a low value certificate which can lead to a loss of credibility in the eyes of potential customers who better understand the process of accreditation.

  • The BS EN ISO9000 series of standards has been the topic of more discussions than most other standards combined. Now there is only ISO9001 which can be certificated.
  • Many businesses have implemented the standard due to client pressure or because of benchmarking with their competitors.
  • Benefits of implementing the ISO 9001 can be considerable, in particular the opportunity to ensure company systems are working and delivering the proof that product and service provided meets the requirements of the business and the expectations of the customer.
  • Many European Directives covering products require Quality Systems to underpin the “CE” Mark.

There are, however, several organisations that appear to devalue the intent of the standard.

Some organisations will offer you “certification within short periods” but at what benefit?

It is these companies, in the writers opinion, who have contributed to the vitriolic comments that abound about ISO9001. Their minimal involvement with the Business and standard approach to a generic documented system where little other than the name of the client appears to have changed since it was last issued, has little real benefit.  This in turn gives other European Countries the view that UK certification is often of minimal value.

The non-accredited certificates have pitfalls:

  • Certificates not accepted by Client.
  • Does not always meet regulatory requirements for “CE” Marking
  • Detrimental if known by customers that you have used a Company that sells “off the shelf”.
  • Minimal or no effect on internal improvements and systems.
  • Cannot underwrite CE marking.

With EU Directives expanding into more areas, more materials and products require CE marking supported by a third p[arty audit. This can only be carried out by an EU Notified Body.

If any ISO9001 system is not already supported by an IAF supported certificate it is possible that the Notified Body will not accept any existing system and the company will have to produce a new system to meet the requirements. This could double the cost.

Additionally why have two bodies assessing the system when CE is required when one would suffice? The Notified Body can usually assess all requirements.

The recent implementation of the Construction Products Directive is already having an effect. With structural steelwork subject to factory audits by a notified body expecting companies to already have an accredited ISO9001 system in place to speed up assessment. Some are having to upgrade existing systems and consider changes to assessment bodies.

Other areas include Medical Devices to ISO13485, some machinery to Annex IV of the Machinery Directive, etc. These all require Notified Body input.

The true mark of success is to be certificated by an organisation themselves registered. The IAF (International Accreditation Form) regulates the assessment bodies and sets Global certification requirements.

There is no guarantee that any non-accredited Assessment company will meet these requirements. In the UK UKAS is the IAF regulated body but this does not mean that UKAS is the only body in the UK There is mutual recognition between IAF registered assessment bodies. This enables the display of both an ISO9001 logo and logo for the assessment body. There is a growing trend to also show IAF on the certificates.

There are many assessment companies in the UK including SGS, Lloyds, ISOQAR with UKAS accreditation but also some bodies under JAS-ANZ (Australia and New Zealand), RvA (The Netherlands), ANAB (USA)  for full list see  http://goo.gl/lAZX12

IAF organisation Rules do not permit the Assessment body to produce procedures as well as carry out the assessment, there will naturally be a conflict of interest.

Contact Atlantic Bridge if you need any help with the issues discussed in this blog.