The ISO 9001 QMS is Changing Sept 2015 Four Key Changes

April 2015

The significant changes for ISO 9001 include, one (1) the concept of the context of the organisation. Now the context of the organisation actually sets the scene in place, which would traditionally be included in the Quality Manual. With the new revision can be done on any media. The web, notice boards, podcasts, power point presentations, anything, to show what the organisation does. It does in a sense also include capability, but also the specific areas of the organisation. This could commonly be completed and complied with, with the use of a template.

Now, it’s not so much as like a one size fits all, but it’s a template, as a prompt to trigger entries to describe the context of the organisation. For example, does your organisation do Design? Does the organisation employ people with multilingual skills or people with English not being their first language? Is there just the one customer or a few customers? Or thousands of customers? How many people there are and what sort of divisions and departments there are. The structure of the organisation. So really it sets the framework to set up the quality assurance system. So that’s one of the key changes to the ISO9001 revision.

(1.30) The second one is the removal of ‘Preventive action’ which, I guess probably a lot of people had some concerns with, even interpreting “Preventive Action” back in 2000 when the term was first introduced, if not beforehand. There was confusion to say OK, if you correct something ,the action to put into place to prevent that from happening again after an occurrence is ‘Preventive Action’.

Of course the original intent of “Preventive Action” was to prevent ‘potential’ non-conformities from occurring. So what the standards have done for the 2015 revision, is to incorporate that in as ‘Risk‘, to align with the other standards, such as the HSE standard and also the Environmental Standard 14001.

So just like within the HSE standards, which is common practice for all HSE activities, particular job Activities, there are Risk assessments completed.

In the project environment, risk assessments are common. What are the risks of the project failing? Commonly, these areas are focused on Health and Safety. The intent of the standard is to incorporate Risk in terms of Quality:

•        What are the Quality risks?

•        What are the risks for producing defects?

•        Is the system set up correctly?

•        Is there adequate training? or a

•        System with the mindset of continuous improvement?

          -        So, one (1) we have defects

          -        We have over production

          -        We have wasted time

          -        Wasted resources

          -        Waiting or

          -        Cycle times ineffective

The common seven (7) wastes, which impact on quality.

•        Compliance areas

•        Regulatory requirements

•        Industry standards or

•      Other standards specific to the product or service that your producing

So traditionally risk, in a product sense, was documented or thought out through, in line with a traditional risk assessment or in common terminology with health and safety, what’s called a Job Safety Environmental Analysis or a JSEA.

In quality, in the Automotive days, that was commonly used with an FMEA template, a Failure Mode and Effects Analysis template with, a risk score number, controls and residual risks.

So, I feel that’s probably the methodology, or the tool to use to show risks. Now some companies may actually use the complete Risk Management Framework Standard to manage their risks from the onset, with the small businesses Kure and Associates are working with, recording risks is though a JSEA template or rather than call it a JSEA, call it a JSEQA to add in the quality element.

(4.50) The Third point, area of change is in documentation and records. These have now been combined, into one term called ‘Documented Information’ and that’s either documents; plans, processes procedures etc. or records, in other words objective evidence. A record showing that an activity has been satisfactorily completed.

So documents the planning documents and records, the output documents that the planned activities have been achieved

(5.28) The 4th change is that there is no mandatory requirement for any procedures in this standard. Previously, let’s go right back to 1987, all systems and processes needed to be documented and right in through to 1994. So all systems all processes documented. Each of the 20 elements of the standard needed to have some sort of plan or policy documented describing the organisation’s approach to satisfying those specific elements and the more detail of course, in terms of procedures and work instructions, and then obviously the forms to record the objective evidence.

The revision in 2000 or was it 2008 required 6 procedures. With this new standard, there is no requirement, for even a manual. No requirements for a manual to be written to show auditors when they assess your organisation. Now a manual, of course, is useful for clients and customers and people potentially looking to buy off of you. Though you won’t be preparing those for the Standard. They will now be prepared specifically for clients or for interested stakeholders.

So no manual required and no procedures required. So if you are a small organisation for example and you are interested in achieving the certification if you have intimate knowledge of the processes of the standard and your business activities and you can demonstrate that to the auditor, and also support that knowledge and information with documented evidence on jobs that you’ve carried out, with clients, you’re covered. 

Now of course one of the areas that may be slightly different, just like traditionally 25 years ago, when the standard was first introduced, companies were already covering most of the standard in their business practices. Things like Customer Satisfaction measurement. There will need to be a way for you to show that you are measuring customer satisfaction. Now that may be through surveys, checklists or phone calls, but they’re extra, they are extra requirements to add in to your systems.

So there are four (4) key changes to the standard.