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 reservations about how its been written, e.g. Clause 8.1 has a good degree of cross-over with 8.5.1 when you get down to it. So when you get to the looking at the bullet lists you can decide (as I recommend in continuous processing environments) that actually you deal with both at the same time. ISO’s thinking was that 8.1 is a slightly higher level than 8.5.1, that 8.1 is a general approach to ‘operational planning and control’ and 8.5.1 is how you’re going to control things once you have a specific job to do. Useful if you run a batch style process, not so much if you do the same thing all day. Batch processing use 8.5.1, continuous process maybe consider combining the two, especially when doing an audit, saves time and frustration for all concerned I assure you.

Anyway limiting this guidance to 8.1 then, you should recall clause 4.4 again which asked you to develop your overall QMS processes. Assuming you went into enough detail at 4.4 then you’ve just saved yourself a ton of time and work, if not well ISO have given you another go at considering the processes invovled in your day-to-day operational activities.

The inference of 8.1 is to use a Quality Plan, not a requirement and to be honest QP’s have been out of favour for quite some time. Never-the-less with the move toward niche markets and mass customisation QP’s are definitely making a resurgence. From an auditing perspective, QP’s will make the audit a whole lot easier for all, quicker too.

8.1 is asking you to effectively consider the following clauses up-front, 8.2 requirements, 8.3 design, 8.4 purchasing, 8.5 production, 8.6 release of products and 8.7 control of non-conforming products. The documentation it requires you to keep is so that you can be confident things went as planned and you can demonstrate conformity.

QMS Guidance Pt. 6.2 – ISO 9001 Cl. 8.2

This is another clause where ISO have got creative with clause titles and detail. This clause used to be called ‘contract review’ but is now called ‘review of products and services’ and is effectively about how you take and deal with customer orders. The reason for the change can only be explained by saying that not all customer requirements arise because of a contract situation and ISO wanted to include all customer requirements.

Sub-Clause 8.2.1

Just in case you need it ISO have taken the opportunity to remind you to communicate with your customers. Its a handy way of checking that you are communicating with customers and provides a list of ways in which you can do this.

Sub-Clause 8.2.2 & 8.2.3

The standard is telling you to determine what your customer wants from you and to review them to make sure you can deliver what the customer wants in terms of products and services. The standard splits the process up but the split seems needless. The clauses can prove a massive help where you have over enthusiastic sales people making promises they haven’t the faintest idea if they can be delivered on (from my own experience this is a very real difficulty).

Most people have a clear understanding that you’ll figure out what the customer wants and if you can deliver after your customer has asked, the standard suggests you do this before the customer has asked. So what it really means is you understand what your customer wants, when they want it for and any other criteria maybe not necessarily mentioned and then you over-lay with other requirements like statutory, regulatory, capacity, capability etc and then you review the whole lot.

For some customers they may issue a purchase order (PO) and some may give you a more detailed contract. I’ve been involved in some contracts that run into 100’s of pages. What these clauses require you to do is read it all and understand it all, there are no short-cuts. The risk of failure to do this is your customer will sue you for breach at some point in the future, so yes I’m saying this clause is an important one.

As far as documentation is concerned the standard only requires you to document the results of the review and any new requirements as may come along. My advice is document as much as you can and keep it all, this way you’ll have a complete time-line and documentary evidence to fall back on at any time you feel you need to go back and check what you’re aiming to do.

Sub-Clause 8.2.4

This clause simply asks that when customer orders have been changed after you’ve agreed to complete them that you have a formal system in place to address this. The changes are not just those needed by the customer but they also include any changes you may have to make such as materials being out of stock or you’re going to miss the delivery deadline.

And just to be sure, communicate with your customer (remember 8.2.1) including whether you can deliver on the changed requirements and if you need a change this may (should) include asking for permission to make the change.

The Take-Aways

Take-Away # 1 – by taking the time to consider all of the other sub-clauses you should end-up with an operational plan that leaves no room for surprises and reduces significantly the risk of non-conformity

Take-Away # 2 – you’ll be fully aware of what’s to be measured and when meaning you’ll know in plenty of time when things start to deviate so you can correct course, avoiding costly errors

Take-Away # 3 – if you do choose to develop QP’s you’ll find you have a tool for control, training and a trigger for communication activities

Take-Away # 4 – if you can put together a ‘house style’ set of rules for customer communications this can prove a big help, particularly with new hires

Take-Away # 5 – having a very robust method for ‘contract review’ will serve you well, not only in understanding the needs of your customer, whether you can deliver on those needs but also to protect your organisation from legal proceedings should things go wrong. It’s well worth drawing-up a ‘contract review’ checklist as an aid-memoir for those employees you rely on to do the reviews.

Take-Away # 6 – link your understanding of customer requirements to internal communications (7.4) and you have a really robust system of communications both internally and externally and if you do this well then the days of someone in production screaming “why on earth did we ever make the promise to deliver on that date!” should be a thing of the past.

Take-Away # 7 – a method for how you’re going to deal with the uncertainty of change either driven by your customer or because of internal need will mean you’re best placed to respond and (hopefully at least) be able to respond and if its not possible then you have a method of communication internally and externally.

Philip Dawson MBA | Organisational Consultant | Systems Thinker | Excellence Enthusiast

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