ISO 9001 has been amended and was released in December 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.

What are the changes?

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.