My company is a National Sales Unit of a global group, operating in the United Kingdom. All national sales companies have up until now operated documented quality management systems (or "business systems", as we prefer to call them) based on local processes and procedures under the umbrella of ISO 9001:2000. The challenge now is to synchronize the various systems with the Division Management System - also ISO 9001:2000. There will be only one quality policy for the whole group, but everyone works to the standard in different ways. I am tasked with carrying out a gap analysis for synchronizing my company with the group processes and procedures. I would very much appreciate any input into the suggested report format and content (keywords) for such an analysis, and hints and tips on the scope and depth of coverage. I have carried out a number of searches of the forums and found many useful titbits, but nothing that addresses my question directly: gap analysis report format and content, structure, scope and depth of coverage.

Many thanks,

//Roger

I would suggest a matrix with several columns. The column headings would be ISO Requirement Site1 Method Site2 Method ... Comments/Risks/Suggestions. That way you could compare side-by-side the practices of the different sites and select what might be considered best practices.

I like the idea of a matrix - I would need to amplify the concept because Division call their processes by different names and there is overlap among processes, functions, operations, etc.

//Rog

I had the task of harmonizing 3 QMS into 1 due to mergers and acquistions. From a global perspective, we have global standards that were called Process Descriptions, and Work Descriptions. For example, the Process Descriptions are your Corp Policies that describe how the organization addresses the ISO standards. Each division would them map the applicable Procress Descriptions to their QMS and adopt it by creating their own SOP to explain the how the QMS system addresses the ISO standards as well as any applicable regulations. Work Descriptions would be adopted as Work Instructions with the what/when/who/how details.

To assist me with my project, I created an Excel spreadsheet that listed the applicable sections of the various regulations (ISO 9001, ISO 13485, QSR, MDD and CMDR), each individual clause, any procedure (SOP or WI that mapped to that clause) and which business divisions/sites. I had to identify what clauses were applicable to our mgmt system and to what business divisions (ie., one division is a Sales & Service and did not have Design controls). I used either color and/or italics to distinguish differences and explain with rationale under a comments column.

I like the idea of a matrix - I would need to amplify the concept because Division call their processes by different names and there is overlap among processes, functions, operations, etc.

//Rog

Hi Roger,

I've attached a copy of a checklist that you can modify to suit your purpose. I hope it helps.

Your document is really excellent - thanks Howste. Underpinning the group approach are ideas from the books "Good to Great" (Collins); "The Toyota Way" (Liker), and "The Momentum Effect" (Larreche) - together with a good dose of process mapping aided by Microsoft Visio.

Thank you for helping me.

//Roger