#qualitysystems

QMS Guidance Pt. 13 - ISO 9001 Clause 10 - a simple guide to how to implement it and what needs to be documented. Clause 10 closes the loop on the PDCA cycle, it also infers the use of Lean 6-Sigma methodologies or similar.

QMS Guidance Pt. 13 – ISO 9001 Clause 10

So here we are, the final auditable clause and what a clause. This is the one where you as the Quality Manager or Quality Champion or even the consultant can choose to add value to the whole process. This is the ACT in the Plan, Do, Check, Act (PDCA) process advocated by ISO.

Clause 10.1

This is a completely new clause and requires you to not…

QMS Guidance Pt. 12 - ISO 9001 Clause 9.3 is about Management Review, an important aspect of how the QMS is run, risks addressed and opportunities identified

QMS Guidance Pt. 12 – ISO 9001 Cl. 9.3

Clause 9.3 conveniently tells you how to do a Management Review, that its the responsibility of the SMT to do the review and what should come out of the review. It also, via a very handy bullet list gives you an outline for an agenda for the review.

Sub-Clause 9.3.1

A general clause requiring the SMT to review the QMS at planned intervals. So you…

QMS Guidance Pt. 10 - ISO 9001: 2015 Clause 9 concerns itself with monitoring, measuring, analysis and evaluation. I offer you an overview of the clause and what it might mean to your organisation

QMS Guidance Pt. 10 – ISO 9001 Clause 9

Clause 9 is called Performance Evaluation and I’m splitting the clause up into 3 QMS Guidance notes along the lines of the sub-clauses because its such an important clause to get right.

This clause deals with a whole range of aspects to do with performance including, how and what you decide to monitor and measure, levels of customer satisfaction,…

QMS Guidance Pt. 9 - A simplified guide to ISO 9001 2015 Clauses 8.6 and 8.7 concerning the release of products and services and control of non-conforming outputs

QMS Guidance Pt. 9 – ISO 9001 Clauses 8.6 & 8.7

So to recap Clause 8 so far;

We have a high-level plan to implement the processes identified in Clause 4.4

We’ve communicated with the customer about what their needs are, reviewed them and confirmed that we can actual deliver on them

Where necessary we’ve gone through a design process where we formulated a master plan and if required a unique…

QMS Guidance Pt. 8 - A simple guide to ISO 9001 Cl. 8.5, a major clause and deals with Production and Service Provision and is further divided up into quite a number of sub-clauses

QMS Guidance Pt. 8 – ISO 9001 Clause 8.5

Clause 8.5 is an absolute beast of a clause covering ‘Production and Service Provision’ and is divided up into a number of sub-clauses each of which in its own right is important.

Sub-Clause 8.5.1

Anyone who has been following these guidance notes so far will know that this clause called ‘Control of Production and Service Provision’ could in some…

QMS Guidance Pt. 7 - QMS Guidance on how to apply ISO 9001 Clause 8.4 which is about purchasing and supplier control

QMS Guidance Pt. 7 – ISO 9001 Clause 8.4

More ISO clause title bloat, clauses 8.4.1, 8.4.2 & 8.4.3 taken together are actually titled ‘Control of externally provided processes, products and services’ or to you and me Purchasing!

Sub-Clauses 8.4.1 & 8.4.2

These two sub-clauses can effectively be dealt with as one since they are telling you about the levels of control you’ll have to…

QMS Guidance Pt.6 - ISO 9001 Clause 8.1 Operational Planning and Control - straight forward guidance on how to comply with the requirements of the standard and clause

QMS Guidance Pt. 6.1 – ISO 9001 Clause 8.1

This is the actual first part of Clause 8 ‘Operation’ and as the name suggests this is now the doing part of the standard.

Clauses 4, 5, 6 and 7 are the higher level planning and structural clauses, the rules of the game if you like. Clause 8 is the ‘nuts and bolts’ part of the QMS. Just like other parts of the standard I have some concerns or…