ISO 9001 -Quality Management System

What is at the core?

ISO 9001 - quality management system is fundamentally based on PDCA.

The aim of this methodology is to bring consistency in the management system.

"To ensure that the best mechanism that has been identified, is done repeatedly at all times by all concerned."

PDCA stands for - 

P  =  Plan

D = Do

C = Check

A = Act

Plan: 

As is obvious, to achieve the desired results, an organization is required to plan its activities. 

Planning involves identifying & aligning activities/resources in a manner that the desired result is achieved.

Yes, to plan is to get it on paper before it is to be put into practice.

This addresses the key questions like - What is to be done? Why it is to be done? How it is to be done? When it is to be done? By whom it is to be done? Where it is to be done?

To get a feel of how important planning is, think of the contrary words like haphazardly, arbitrarily, randomly, etc.

Do:

Once you have done the planning, next is the implementation/execution of that plan. Put to use the processes you have identified, the resources (man-material-machine) you have aligned.

Check:

Review what you planned & what you did. Address the gaps if you find any. May be the plan can be improved upon; may be the plan was okay but there was derailment in implementation, take note of the insights that your planning & doing must have brought up.

Act:

Now, you are required to incorporate the results back into your planning, that you must have got while checking/reviewing process.

Then act again on the revised plan & follow it up with check & act processes.

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.

Hmmm....now 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.