9001 Council - Information and advice to facilitate your ISO 9001 implementation.

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Maintaining ISO 9001 certification

It is important to recognize that an ISO 9001 quality management system needs to be alive and constantly evolving.

ISO 9001:2008 includes “continuous improvement” as one of its requirements, and “continuous improvement” not only refers to a company's products and services but to the ISO 9001 quality management system itself.


Achieving continuous improvement

Achieving continuous improvement is incorporated in ISO 9001:2008. All your company needs to do is to completely follow its ISO 9001 quality management system, and continuous improvement will be a natural consequence.

The following processes of the ISO 9001 quality management system will help your company continuously improve:

Goals and Metrics: setting goals on various levels and using metrics to measure performance.

Customer Feedback: measuring what customers think about the company and its products or services.

Internal Audits: periodical evaluating if the company still meets all ISO 9001 requirements.

Corrective Action: systematical identification of underlying causes of existing problems and then correcting these causes.

Preventive Action: systematical search for potential problems and correcting their underlying causes before the problems can occur.

Management Review: management's periodical review of key business indicators and planning of improvement initiatives.


TIP:

We recommend keeping all employees involved in the ISO 9001 quality management system. A great idea is to periodically send tips to all employees.


Revising the ISO 9001 documentation

Revising the quality manual and quality procedures should be a normal part of the ever-improving ISO 9001 quality management system.

These revisions can reach from small corrections to a total makeover of the entire ISO 9001 documentation. If you find your company's ISO 9001 quality management system to be bureaucratic and cumbersome, if you find your employees feeling negative about ISO 9001, and if you need to spend excessive time preparing for each audit, then your ISO 9001 QMS has plenty of opportunities for improvement and you should consider a complete makeover.


Failure of an ISO 9001 quality management system

Far too many ISO 9001 quality management systems fail. The reasons for these failures are almost always the same - and they can be easily avoided.

A quite common indicator that a company's ISO 9001 QMS is heading towards failure is a majority of employees complaining about ISO 9001. Most complaints are about excessive bureaucracy, much paperwork and extra work before audits. At the same time, those employees feel that there are no benefits to ISO 9001.

These problems are not the fault of ISO 9001 – these problems result from the way the ISO 9001 quality management system was implemented!

Typical Problem #1: Management Attitude and Purpose
If management desires to implement ISO 9001 solely for marketing reasons or due to customer requirements, the resulting ISO 9001 quality management system will often lack the all-important internal improvement component. It is possible to pretend (and fool even an experienced auditor) to have an effective ISO 9001 quality management system in place, but the costs due to bureaucracy and efficiency could be huge.

Typical Problem #2: ISO 9001 Implementation by Consultants
Frequently management decides to hire ISO 9000 consultants that are tasked with the implementation of ISO 9001. These ISO 9000 consultants promise to write a quality manual, quality procedures and other documents; in many cases, they also provide ISO 9001 implementation training. Typical problems with this approach are:

The ISO 9000 consultant is unfamiliar with the business, the company and its culture. The resulting ISO 9001 quality management system does not fit the company.

The ISO 9000 consultant tries to justify his high fees by setting up an overly complicated and convoluted ISO 9001 quality management system.

The ISO 9000 consultant does not adjust to the particular company and sets up a his usual “one-size-fits-all” ISO 9001 system. However, these “standard” systems are often geared towards large corporations, and they are often far too bureaucratic and labor intensive for small and medium size companies.

The ISO 9000 consultant is not flexible. Instead of creatively molding the ISO 9001 quality management system to fit the realities of the company, the ISO 9000 consultant tries to mold the entire company to fit his “one-size-fits-all” approach.


Typical Problem #3: ISO 9001 Management Representative without Power
Executive management of some companies erroneously consider the ISO 9001 quality management system to be a documentation task rather than the implementation of an improved and systematic management style. A consequence of this misconception is the appointment of an ISO 9001 Management Representative without the power to make real changes. In such a situation, it is very common to find an increasingly disenchanted ISO 9001 Management Representative who is desperately trying to improve the company while top management pays mere lip service to their ISO 9001 quality management system.

Typical Problem #4: Insufficient Resources
Unless a company's overall performance is well above average, the implementation of ISO 9001 usually requires significant resources: the ISO 9001 Management Representative needs to be trained, top management needs to learn about the concept of ISO 9001 and its benefits, a quality manual, quality procedures and other ISO 9001 documentation needs to be written, work processes throughout the company need to be analyzed and streamlined, employees need to be trained, etc. It is crucial to the success of the ISO 9001 implementation that management allocates enough time, as well as financial resources (for example, for employee training, for templates for the ISO 9001 documentation, or for internal audits and auditor training, etc).

Typical Problem #5: Lack of Improvement
It is a common misconception that an ISO 9001 quality management system needs to be implemented, certified and that's it. In reality, the ISO 9001 quality management system must constantly evolve as the company changes, as the market conditions change, as products change, as technologies improve and as the competition moves forward.

Typical Problem #6: Making it Too Complicated
ISO 9001 does not need to be complicated! In fact, the easier to follow and the easier to understand the quality manual and other ISO 9001 documentation, the better the ISO 9001 QMS! There are countless possible causes for overly complicated and overly bureaucratic ISO 9001 quality management systems, including the problems mentioned above, including inflexible auditors, including bad examples, including bad documentation templates, and including bad training.

TIP:

It is interesting to note that the described problems are a direct consequence of management action and management attitude towards ISO 9001, rather than the often blamed employee resistance to ISO 9001. Ensuring that top management buys into the benefits of ISO 9001 and that top management remains actively involved in ISO 9001 will dramatically improve any ISO 9001 QMS. An executive overview by a competent trainer or online course prior to the start of the ISO 9001 implementation is, therefore, highly recommended.

TIP:

Implementing ISO 9001 by a company insider as opposed to an external consultant is not only cheaper but it will also result in a more efficient ISO 9001 quality management system. We recommend appointing as ISO 9001 Management Representative a manager who has sufficient authority to make internal changes, providing this individual with training in the ISO 9001:2008 standard (there are many good public and online classes available), giving this individual the resources to purchase a set of good documentation templates, and ensuring that all functions in the company allocate enough time to work with the ISO 9001 Management Representative.

TIP:

Choose your ISO 9001 registrar carefully! We recommend that you compare different ISO 9001 registrars and pay particular attention towards auditor background (for example, some may consider former military auditors to be rigid and inflexible in their interpretation of the ISO 9001:2008 standard) and towards their attitude towards sharing ideas (in order to ensure objectivity, auditors are not allowed to consult; however, some registrars permit their auditors to share their experience).