WHAT TO EXPECT IN THE NEW ISO 9001:2015 (PART 1)
Disclaimer : Most of the contents here are not the 'actual/literal' text of the actual new ISO 9001:2015. It's the personal interpretation of the author.
0.1 – QMS as a strategic decision, a robust Quality Management Systems (QMS) – to help organization to improve its overall performance and forms an integral component of sustainable development. Design and implementation of QMS is influenced by the context of organization and (including) the changes.
Definition
a. Strategic– Identification of long term/overall aims and interest and means to achieve them (taking into account coping up with fundamental changes – susceptible to the surroundings (what is happening around you) – law, competition, regulations, standards, trends, new technology, innovation, Research and Development etc.)
b. Robust– a process, system able to withstand or overcome adverse conditions (defects, non-conformance, corrective action request)
c. Improve overall performance – integral component of sustainable development– no system is perfect, it should be improved and become part and parcel of company's culture to achieving excellence.
d. Designed and Implemented by the sort of industry-specific – service/product provided by the company (to achieve such purpose – goals and objectives) – customization/tailor-made (1)
The rest of the content in 0.1 also talks about culture (already covered), external factors – socio-economic conditions under which it operates) – when we talk about socio-economic conditions – it talks about how the process - impacts the general public, public perception, surroundings – possibly employment opportunity and most important – the organization must realize its financial capacity –not to do something way beyond their ability. Do something that suits the organization ONLY (2)
Also touched on QMS can differ from one organization to another(See (1) - customization)
0.2 – not much have been changed except more emphasis is given in point no. 2 – ISO 9001 – improved internal communication, better understanding and control of process – reduction in defects and waste
(the only way to do all these is to adopt principle of “no walls, no politics, no overlapping of duties, no pinpointing, no blaming culture” - so 100 points go to"Improved Internal Communication" - everything starts here....
and also point no. 4 of 0.2 – ISO 9004 which touches on configuration management; apart from other elements – quality plan, project QM, measurement process/equipment, documentation, (and again - ) financial/economic benefits of the system (See (2), Statistics etc.
Definition
Configuration Management - system engineering process for establishing and maintaining consistency of a product's (or services) performance, functional and physical attributes with its requirements, design and operational information throughout its life.
0.3– comprehensive process-approach explained in better details. What's interesting are the words “understood” and “understanding” are being used. It means that the system HAS to be understood – on company-wide basis.
There is no point making a system only to be understood by a certain 'exclusive top management level'.
How to make everyone understand?
Mind you, I'm not talking about the typical (word by word) memorizing the policy or objectives – remember UNDERSTAND is totally different than MEMORIZE....
How to make everyone understand?
Mind you, I'm not talking about the typical (word by word) memorizing the policy or objectives – remember UNDERSTAND is totally different than MEMORIZE....
- a laymen understanding – is to understand QMS in their OWN work! (refer Job Description and Responsibilities/Authorities) – if these are not clear, DON'T HOPE everyone to understand – you will receive typical provoking comments from them just like when the previous system was implemented - “This is not my job?” “Having ISO is like having NOTHING – no impact – nothing for me” - hence - they don't feel the system!
0.4 including Figure 1 and 2 talk about 'Plan-Do-Check-Act” in much more simple understanding but implementable.
0.5 Something new – Risk-Based Thinking (in fact it's partial risk management) – which I agree 100%.
Definition
Simply look back at your Management Review Meeting, Data Analysis and Continual Improvement Plan (if you have any - if you don't, then 'BIG TROUBLE') – now PROACTIVELY start identifying, assess and prioritize the risks (the effect of "uncertainty") – how do you that?
Yes, look back at frequent problems in your data?
And prioritize - put them according to order, mark them with RED, YELLOW or GREEN and discuss the solution further. You can also integrate ITP, HIRARC, SHASSIC, CONQUAS or whatever specific assessment/inspection system you have (if you have one - if you don't, then go for the normal inspection that you do - incoming, in-process and outgoing) etc. into it.
No overlapping please...let all the system be harmonized and co-exist.
Now, should you have a full (projected) Risk Management Plan before starting the operation? (Preliminary, Design, Interim and Final) – if you have the time – the answer is YES!
Project Management - Critical Path Method - justify the RED ones by thinking outside the box (outside the software) - there must be alternative ways of justifying it. Yes, I have the great CPM and the 'technical S Curve' but why is there still delay?
Just match it with your MRM Data...you'll be on the right track.
0.6– compatibility with other management systems – explained in greater details.
VERDICT?
Yes, the new ISO 9001:2015 is attempting to cover and solve ALL kinds of management and technical problems (sound kind of ambitious - don't you think?) – however, lots of cross-referencing need to be made. Act smart for a while...please
Yes, the new ISO 9001:2015 is attempting to cover and solve ALL kinds of management and technical problems (sound kind of ambitious - don't you think?) – however, lots of cross-referencing need to be made. Act smart for a while...please
(wait for Part 2)
