Showing posts with label QUALITY MANAGEMENT SYSTEM. Show all posts
Showing posts with label QUALITY MANAGEMENT SYSTEM. Show all posts

Thursday, 8 September 2016

ISO 9001:2015 | In Plain English

As a layman would understand it, here is another attempt to know the importance of ISO 9001:2015 standard in the day to day working of an organization.

As we know, an  organization comes into being to achieve certain purposes - purposes of its own & the purposes of people/entities that get associated with it.

Additionally, an organization is nothing but a "portfolio of activities".

Hence, an organization has to manage the portfolio of activities to fulfill these purposes in order to maintain its existence.


Matter of thought:

ISO 9001 is not "saying" what you do, but, "showing" what you do.

ISO 9001 is not about "intentions", but, how you "implement the intentions".

When one studies the standard, we frequently come across the words like "identify", "determine", "establish" etc.

These words connote the meaning "to know". This means that an organization has to be conscious/awake to the fact as to what it is doing & how it is doing it.

The word "control" is also frequently mentioned in the standard. Its because you have got to have the control on any particular thing in order that you can take it in the desired direction or to the desired destination.

However, many of the companies continue to work in a haphazard manner  - not knowing where they want to go & how they want to go there. Indulging in patch works. Instead of consistently marching forward towards its purpose, the organization keeps going left & right.

Can you control an unbridled horse or a rudderless boat? Or can you manage a stampede?

ISO 9001:2015 requires you to lay down the track (the system) & make your train (the company) run on it. And it continues to do so thorough need based or periodic course corrections.

Now, what is this track or the system & how one establishes it?

The track here consists of the activities that an organization does, specifically the signification ones. Interesting thing about these activities is that they do not happen on their own. These activities happen only when men & machines act.

Hence, you have got to rein in or harness these men & machines so that each of these prove to be a step forward in the direction of your destination/goal. 

The top management at the firm, the boss, is the driver of this train & he/she has the responsibility to drive the train to its destination. And this is what ISO 9001:2015 recommends to achieve this through PDCA cycle- Plan, Do, Check & Act -

Plan: Plan the activities that you want to do. What is to be done(action), how it is to be done(concept), when it is to be done (time/sequence), by whom it is to be done (man/machine), how & when the activity/man & machine will be monitored, etc.

Do: Execute the plan by putting it into action. Get you men, material & machine rolling.

Check: Verify if your men, material & machines are operating as per the plan or not. Validate if your plan is effective, whether it is achieving the intended result or not. Do periodic reviews to know whether you are on right track or not.

Act: The feedback obtained through the "check" mechanism, be acted upon by incorporating it into your system. These are course correction activities.

Yes, though PDCA cycle, you go round & round to move forward.

Documentation Requirements:

The standard requires you to document/write down what an organization does.

This way, you make the applied concepts & actions VISIBLE which further helps in better understanding, control & management.

Thursday, 24 December 2015

ISO 9001:2015 || The New Version of QMS

The new version of ISO 9001 was released on 14 September 2015.

It has a transition period of 3 years.

ISO 9001 received its newer version after 7 years as the previous version was released in 2008 [ISO 9001:2008].

The current version, ISO 9001:2015, is expected to have a life till 2030.

Unlike ISO 9001:2008, ISO 9001:2015 is less perspective in nature.


What makes this new version different from the old version?

On the bedrock of PDCA & Process Approach, three major changes have been introduced. 

These are the change in the structure (flow) of the standard & the introduction of two new concepts - context of the organization & risk-based thinking.

The structure has been changed to make ISO 9001:2015 coherent with all other ISO standards. Its an attempt to standardize all ISO standards. This way, all ISO standards will have the same number of clauses, 1 to 10. Or we can say that the standards will have the same hierarchy.This will make it easier for client organizations to integrate multiple management standards.

The context of the organization pertains to the unique environment in which an organizations/business operates. 

This environment consists of such factors as competition, social, political, geographical, management, legal, technological, etc. These factors may have both positive as well as negative effects on a business. 

By adopting this funneled approach,  an organization will be able to identify the boundaries of its QMS & thus, it will be able to plan better for its precious & cherished QMS.

So, when a business is establishing its quality management system, it is required to understand its context & take measures to manage this environment, as far as possible, so as to consistently deliver quality products & services. 

The organization must have measures in place that will allow it to exploit the opportunities, as & when they are thrown up by the environment. Simultaneously, there must be measures in place to offset any negative impact as may be thrown up by the environment from time to time. 

Of course, this environment will be required to be reviewed periodically in the light of the measures taken  for relevance & effectiveness.

Next is risk-based thinking. A business is required to manage the risk in its operations. The requirement of preventive action of the older version, has now been replaced by risk-based thinking requirement in the new version. you need to have a "questioning mind". Maybe a skeptical mind.....

For an organization, the risk may be associated with the environment in which it is operating or its operations or its resources or its targeted market segment or its stakeholders or its manpower or the machinery & equipment used by it, etc.

Hence, the organization is required to identify all such risks, evaluate them & take measures to mitigate them.

All in all, the new version of ISO 9001 makes QMS more comprehensive in nature by making you consider a broader array of aspects that may have positive as well as negative impact on your quality management system.