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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. 11 - A simple overview guide to ISO 9001 Clause 9.2 Internal Auditing

QMS Guidance Pt. 11 – ISO 9001 Clause 9.2

Here we are then, you’ve done the planning parts in clauses 4 through 7, then done the doing part in clause 8, now we’re into the second of three sub-parts of the checking phase of how you run your QMS.

Clause 9.2 is all about Internal Auditing sometimes called first-party audits which are conducted by the organisation or by someone on behalf of the…

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…

Your Business New Solutions -New problem situations require new solutions. Blow up your old business model and remake leveraging the constraints.

So tell me, I have a business but I need some new solutions

So, just for context, I’m writing this post in a rural Derbyshire village in the UK where my neighbours are generally speaking observing the 2m physical distancing rules and wandering into shops wearing face masks in an attempt not to spread Covid-19. The reality so far as I know in my home village, there has been no cases of…

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. 14

QMS Guidance Pt. 14 – Documents Required and Others

ISO 9001: 2015 has changed and in theory at least simplified the way it required information to be documented. Out is the old split of ‘procedures’ and ‘records’. In is ‘documented information’ which covers both!

Confusing possibly so I’m offering you an overview of whats explicitly required, whats in essence implied and what I as your…

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…

QMS Guidance Pt. 5 - Design and Development of Products and Services form a significant part of organisational service offerings having its own clause in ISO 9001

QMS Guidance Pt. 5 – ISO 9001 Clause 8.3

Yes you read the header right, I’m going out of line with the standard again. Clause 8.3 is called ‘Design and Development of Products and Services’ and is a bit of an enigma.

Right from the 1987 version to the 2015 version the standard referred to products, and then in 2015 decided to add services into the mix. The effect being – well, confusion.…

QMS Guidance Pt. 4 - An eye opening overview of ISO 9001 Clause 7, Support in an easy to read and digest format.

QMS Guidance Pt. 4 – ISO 9001 Clause 7 – Support

So what does a clause called ‘Support’ really mean then?

The answer is that this clause is really about resources and what ISO expects you to do and provide as a minimum to support your QMS.

Clause 7.1

This first sub-clause is divided up into 6 parts and sets out what ISO expect you to provide when the organisation is able to do so, but…

Quality is; The Quality is 100 is a random list of what Quality is and represents. Quality is Excellence in Experience!

Quality is Excellence!

I offer you a range of random thoughts and idea’s on what Quality is, emphasising that Quality is Excellence of Experience. It is not just the characteristics of a product or the designed in functions of a service provided but those hidden and non-linear aspects of the overall process experienced.

The Quality is 100

Quality is Hello spoken with meaning

Quality is…

QMS Guidance Pt. 3 When planning a QMS its important to set objectives, have a plan for how to achieve them and what you're going to do if there's a change.

QMS Guidance Pt. 3 – ISO 9001 Clause 6

So far I’ve covered Clause 4 about Understanding the Context of the Organisation and Clause 5 which concerns itself with Leadership. Now I turn to Clause 6 which is all about the high-level ‘Planning’ processes. Later in the standard I’ll deal with the operational planning processes, but for now I’m dealing with the kind of planning that needs to be done…

5 Levels of Improvement: There is 2 types of improvement, breakthrough and continuous. Breakthrough working across value streams and continuous by the work team or individual.

5 Levels of Improvement, from Individual to Supply Chain

Organisations that aspire to improve their processes need to be able to organise how they are going to go about the improvement so thay can be assured the improvement will be what they want and intended. Typically they may choose to follow a Kaizan or Lean process which involves 5 levels at which the organisation can approach the…

QMS Guidance Pt. 2 Leadership in relation to Quality Management affects all of the operational areas ensuring the QMS is resources, people assigned and authorities given.

QMS Guidance Pt. 2 – ISO 9001 Clause 5

Clause 5 is all about Leadership and with the exception of Policy, is really a very difficult clause to approach from a ‘prepare to be audited’ perspective. My advice, prepare the Policy and forget about being audited, concentrate instead on the Senior Management Team’s (SMT) intentions if you want to use the standard as a model for how to run your…

Lord Krishna Teaches - 4 Well-being guidance tips to help with isolation, distancing and self worth.

Krishna teaches Arjuna how to navigate the mind

The story of how Lord Krishna teaches his disciple Arjuna how to navigate his mind is part of the Hindu text The Bhagavad Gita. In these times of lock-down and the new Covid-19 illness with all of the associated mental challenges these bring the story helps to illustrate 4 metal well-being practices that could be beneficial to all. The story…