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How to get the best from ISO 9001 based QMS

Updated on May 12, 2012

Revitalize it before it is too late

ISO 9001 - the most misunderstood concept in Business Organizations

If we really try to find out the most misunderstood and the same time most widely implemented Management concept throughout the history of business organizations, ISO 9000 standard may be the number one in the ranking. The concept has missed the desired goals if it included significant change in the way organizations work. The concept has not yielded sustainable changes apart from bringing a superficial change in attitude towards documents, customers, offering your work to audits and revisiting your processes during audits only.

ISO 9000 based QMS is around for about three decades. The growth of certification to ISO 9000 standard has been phenomenal. Audits, MR meeting, continual improvement, CAPA, root cause analysis have become common language of organizations across the globe. It has achieved a few things; better attention to documents, the performance measures and some of the key parameters becoming common knowledge. It has brought about a commonality of language across the organizations in certain areas.

We talk about document control, management commitment, corrective actions, preventive actions, continual improvement, data analysis, organization wide objective setting but I have reasons to believe that in many organizations it is like parrots reciting the lines without really practicing these principles. Similarly despite reciting the words like data analysis, corrective actions, preventive actions the organizations fall into the same kind of problems they used to get into prior to adopting the ISO 9000 certifications. They remain almost same as before and the changes which could have been brought about are minimal.

Chances are that your ISO 9000 based QMS does not excite anyone in the organization and it has become a burden. The symptoms may appear as given below:

  • No one wants to volunteer for so called “ISO activities”
  • The dates for carrying out Management Review meetings are hard to get
  • The MR meetings are delegated by CEO to lower levels
  • ISO 9001 QMS has reduced to Surveillance Audits
  • Hectic preparations are carried out before the audit
  • CAPA is not delivering any real solution to various problems
  • The procedures are not used and surface during audits only
  • Procedures have not undergone any change for many years.
  • If strictly measured, the QMS has not delivered any significant improvement..

How to go about treating the ailments

We need a kind of surgical intervention rather than taking prescription or off the shelve medicines. The reasons for non performance of ISO is too deep rooted to be eliminated by simple medicines. We need an operation theater of knowledge with scalpel and knife in the form of the concepts which are essentially the fundamental principles from which the Standard has been sourced. We need the knowledge background to make the meaning of many steps of ISO 9000 Standard.

Essentially you are carrying a dead body of system thinking / under the illusion that there may be some value / life in it. There are no easy answers. But there are some possible reasons as I, a common man associated with Quality systems, perceive which are given below:

Missing Emotions or presence of negative emotions

Any organizational practice or activity has one important aspect- emotions. We have organizational emotions like being together in moments threatening survival, a grand dream of growing, a goal symbolizing success in market place, a challenge overcome, fighting against the odds. It is seen that ISO implementation is deprived of strong emotional component.

The best way to understand the emotional component is to see the Excellence Model which captures entire organizational working. Out of 5 enablers three are primarily emotional, Leadership, People and Policy & Strategy. All the results are around human beings- people, customer and society results.

Where is the emotional component in ISO 9001? Perhaps there is only emotional aspect associated with ISO is the fear during key activities, audits and closing meetings. How can something will succeed which only creates fear? ISO has been positioned on these lines in a vast number of organizations. It has been seen that the responsibility lies with the people who are spearheading ISO 9000 in organization and certification bodies. Both of them lack that profound knowledge. The CEO as is the truth is not keen on this another source of headache. He fails to understand that a good ISO system is a tool to reduce the sources of headaches. Human beings cannot with something which is bothering them so the procedures have been made generic and the control areas have been widened. Many organizations have one parameter for their “Actual monitoring” and another parameter for “ISO monitoring”. Our system does not inculcate the courage to face criticism and criticize ourselves. This aspect is the source of problems.

· Who is the real owner of the QMS?

The certifying body experts go on doing their job in a clinically efficient manner. They position themselves at a higher pedestal creating a distance from the users of their services. The entire thing sends a wrong message that the real owners are auditors and not the auditee.

Lack of profound knowledge among people responsible for design

Another source of problem is lack of knowledge or more appropriately “Profound Knowledge” as Deming has used. Quality performance is a direct outcome of the state of mind of employees while at work. It is foolish to see quality performance in isolation and in separation with the human beings who are supposed to implement these standards or set of prescription. The deep rooted basics of ISO 9000 is rarely understood and the result is a QMS which stops breathing after some time and survives on artificial breath injected during Surveillance audits and MR meetings.

Taking the easy path of command and control

Imagine a school teacher of nursery class. The requirement of the class is engaging children for almost three hours in a most pleasurable way where they spend their time learning many a things on the way like group formation, adjustment, sharing, developing a sense of confidence about being alone and learning through relationships. If a teacher starts focusing on these requirements she will face a great deal of challenge. She will have a tough time maintaining the order in the class and achieve the true goals of her role. What happens in real life? The easy way out which is treaded by the teachers in most of the cases is command and control. The classic example is a famous fire in a school where many children burnt to death as they refused to leave their school room as instructed by their teacher. Such was the level of fear commanded by the teacher over the class. In case of ISO also the fear element is there in varying degrees.

It is a cultural journey which is not considered

The analogy is as simple as trying to change the life style of a human being who is used to late nights and gets up just in time to catch his office, starting his days on a note of anxiety. Now someone having an influence on that human being is trying for a change in the life style.. It cannot happen with a set of documents like charting a daily routine and hanging on the wall..

Typical Implementation – QMS is separate than real activities

A typical approach is forming a group to steer the implementation of ISO based QMS. The mandate given to the group or taken by the group is essentially meeting the needs and requirements of the certifying body. The certifying body assumes a huge importance as they are going to award the certificate. It is seen that the certifying body auditors suffer from an element of limitation. They are limited by their role regarding the standards, their brief and their own understanding of the organization. The entire arrangement fails to notice the invisible but most powerful element of the organizations i.e. organizational emotions. The QMS implementation does not see the emotional component and fails to make an entry into the same. The result is the rejection of ISO QMS with varying degrees.

The informal Organization

After a while when many audits take place along with closing meetings the ISO 9001 is started to be regarded as something which is primarily a source of pain. Like most other things the good part achieved is forgotten. The good part may be a common view of the processes, metrics, and element of analysis of problems. But rather than driving the organization it limps along the organizational activities.


We need to take a hard look at the existing QMS based on ISO 9001 and may be engaging a sincere consultant to assess the health. We must remove two parallel systems and remove the fear of NCRs from the minds of people. It does not mean that people should be allowed to take things casually but instead allowing the problems or rather encouraging them to come out is a huge opportunity to fix them. We need to reposition the QMS from one which satisfies the Auditor to that which meets the needs of employees. A radical change is needed in most of the cases.


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