ISO 9001 has been amended and is due to be released in
October 2008. The changes will affect all quality assured
companies and they will need to be complying with the new
regulations from their first surveillance visit after March 2009.
At face value, it looks like the the requirements are
relatively simple with a change of a word here, clarification of a
phrase there and all the Certification Bodies trotting out the party
line that "the changes are only very minor".
My point is this - the difficulty of the changes will
be different for each and every quality management system. The reason is
that different companies have met the original requirements in different
ways. Therefore, they will have to meet the changes in different ways
also.
An Example
As an example, suppose the original standard stated
"Processes should be developed to show compliance with all regulations"
and the new standard might state "Processes should be documented that
show how compliance with regulatory requirements have been met". In
company A, where the Processes have already been mapped out and written
down as part of their earlier drive towards compliance, this change in
wording will not cause a problem. However, for company B, where the
processes were discussed and agreed but not documented as part of the
earlier approval, to now map and document all of the Processes within
the business will require a significant amount of time and effort.
Additionally, there would be a focus on ensuring that enough reference
is made in the Process Maps to regulatory control points, measurable
outputs, methods of monitoring compliance, etc. If company B is not used
to dealing with Processes (rather than just graphical procedures or
flow charts - a common mistake) than compliance with the new standard
would require significant time and effort.
How can you bring your system up to date?
As ever, EQM Ltd have done all the hard work so that you don't have to.
For the many hundreds of clients that already have an EQM Ltd
Quality Management System based upon our registered and proprietary
"6PE Methodology for Production of Management Systems", we are
offering a standard upgrade package. For those hundreds of clients
that take advantage of our ongoing auditing or part-time Quality
Manager services, there is an added financial incentive because we
will undertake this consultancy work at our standard project daily
rate for them.
For prospective clients that come to us with a
Quality Management System that is based on procedures or flow charts, we
would need to carry out a visit to assess that QMS and produce a
quotation before undertaking the upgrade work. However, once agreed, we
would guarantee that compliance would be achieved by the end of the
project. Not many consultants can make such a guarantee - but we can and
we will.
However, if you want to update your quality
manual, process maps, procedures, work instructions, control point
documentation, forms, and records yourself, you're going to need our
gap analysis check list. It lists all of the actions that should be taken to ensure your compliance
to ISO 9001:2008.
