The company’s top management reviews the company’s Quality Management System at planned intervals to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the company. The management reviews are planned and carried out taking into consideration: the status of actions from previous management reviews; changes in external and internal issues that are relevant to the Quality Management System; information on the performance and effectiveness of the Quality Management System, including trends in: customer satisfaction and feedback from relevant interested parties; the extent to which Quality Objectives have been met; process performance in conforming products and services; non-conformities and corrective actions; monitoring and measurement results; audit results; the performance of external providers; the adequacy of resources; the effectiveness of actions taken to address risks and opportunities [see 6.1]; opportunities for improvement. Deep breath. The standard goes on to say.
The outputs of the management review include decisions and actions related to opportunities for improvement; any need for changes to the quality managed system; resource needs. The company retains documented information as evidence of the results of management reviews.
I sort of wished they had just stopped after the first paragraph instead of treating us like the unlearned swill the ISO crowd think we are. And here it is again; The company’s top management reviews the company’s Quality Management System at planned intervals to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the company. Noice.
But let’s get very specific from the outset. The technical committee has defined what the input are. What the outputs are and then tells us to keep records. Enough said. Just do it.
And in doing so let’s just make sure we don’t make the usual mistakes by confusing the word ‘review’. It’s a collection of data that is examined by top management to determine the effectiveness of the management system. How you do it is up to you. Just never forget the input/output requirements and you really can’t go wrong. Do it as a report. Do it as a separate meeting. Do it as a sub committee. Do it as part of another meeting. Just do it. And do it to the frequency you have determined is the right thing for you. External auditors like to see to see at least annually, some will accept every two years, most would love to see biannual or even quarterly, so don’t be bullied and be confident in the frequency you want.
While the standard does not require a procedure, we always write a procedure around this clause. It takes the ambiguity out of the rules. Especially the format, protocols, structure, the quorum (or at least the defined minimum) so that you are in control of your determinations of effectiveness.
We normally recommend stand alone meetings, with standing agendas, formal minutes and plenty of tabled attachments. However, we do use reports, sub committees and sub-set topics as part of other meetings. The choice still remains with you. And if it doesn’t work, PDCA.