In Clause 4.4, the standard asked you to develop your overall QMS processes ISO is assuming, here, that you will have to take a second swing at this, but at the operational level. Limiting our discussion to 8.1 for the purposes of this article, however, we see the list is prescribing some ideas on what you should be thinking about when developing the “operational” processes. You’ll likely have to bite both of them at the same time. The thinking is that the list of 8.1 should happen at a higher level, with the list in 8.5.1 applying only after a given job is taken and underway, but I think this view is limiting. Suffice it to say, you may want to carefully read both clauses (8.1 and 8.5.1) and decide when and where to apply their lengthy bulleted lists of requirements. I’ve written at length about how this clause is confusing to many, and often overlaps with clause 8.5.1, which we will discuss later. The first is 8.1, called “Operational Planning and Control.” This section is the largest of the entire standard, so we need to delve into each sub-clause separately. Clause 8 gets down into more of the day-to-day, nuts and bolts of operationof the QMS, now that it’s been planned and launched. Clauses 4, 5, 6 and 7 of ISO 9001:2015 dealt with higher-level planning and structure of the QMS, and assume that you are using the standard to devise it as well as structure key elements of your company.
0 kommentar(er)
