2 October 2017
We must stress that an ISO 9001 Quality Management System (QMS) needs to be alive and constantly evolving.
ISO 9001:2015 includes "continuous improvement" as one of its requirements: this refers not only to a company's products and services, but also to the QMS.
Achieving continuous improvement is incorporated in ISO 9001:2015. All your company needs to do is to completely follow its ISO 9001 QMS, and continuous improvement will be a natural consequence.
The following processes of the 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.
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 procedures and other documents should be a normal part of the ever-improving Quality Management System.
These revisions can range from small corrections to a total makeover of the entire ISO 9001 documentation. If you find your company's ISO 9001 QMS 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 Quality Management System has plenty of opportunities for improvement and you should consider a complete makeover.
Far too many Quality Management Systems fail. The reasons for these failures are almost always the same - and they can easily be avoided.
A fairly common indicator that a company's QMS is heading towards failure is a majority of employees complaining about ISO 9001. Most complaints are about excessive bureaucracy and 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, but result from the way the Quality Management System has been implemented.
Typical problem #1: management attitude and purpose
If management desires to implement ISO 9001 solely for marketing reasons or due to customer demands, the resulting QMS will often lack the all-important internal improvement component. It is possible to pretend (and fool even an experienced auditor) to have an effective Quality Management System in place, but its cost due to bureaucracy and efficiency could be huge.
Typical problem #2: ISO 9001 implementation by consultants
Frequently management decides to hire consultants that are tasked with implementing ISO 9001. These consultants promise to write the ISO 9001 procedures and other documents; in many cases, they also provide implementation training. Typical problems with this approach are:
The consultant is unfamiliar with the business, the company and its culture. The resulting Quality Management System does not fit the company.
The consultant tries to justify high fees by setting up an overly complicated and convoluted QMS.
The consultant does not adjust to the individual 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 mid-size companies.
The consultant is inflexible. Instead of creatively molding the ISO 9001 Quality Management System to fit the realities of the company, the consultant tries to mold the entire company to fit his own "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 Management Representative who is desperately trying to improve the company while top management pays mere lip service to their QMS.
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, ISO 9001 procedures and documentation needs to be written, work processes throughout the company need to be analyzed and streamlined, and 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 QMS must constantly evolve as the company changes, as 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: the easier the ISO 9001 documentation is to follow and understand, the better the resulting QMS. There are countless possible causes for overly complicated and bureaucratic Quality Management Systems. This includes the problems mentioned above, along with inflexible auditors, bad examples, bad documentation templates and bad training.
It is interesting to note that the problems highlighted above are a direct consequence of management action and attitude towards ISO 9001, rather than the often-blamed employee resistance to ISO 9001 implementation. Ensuring top management buys into the benefits of ISO 9001 and remains actively involved in the Standard's implementation, will dramatically improve any Quality Management System. An executive overview by a competent trainer or online course prior to the start of the ISO 9001 implementation is, therefore, highly recommended.
Implementing ISO 9001 internally as opposed to hiring a consultant is cheaper and will result in a more efficient QMS. We recommend appointing an ISO 9001 Management Representative who is a manager within the company, with sufficient authority to make the required changes. The representative must then be trained in all aspects of the 9001 Standard (there are lots of excellent public and online courses available) and be given the resources needed to purchase a set of documentation templates. Finally, it is important to ensure all functions in the company allocate enough time to work with the representative.
Choose your ISO 9001 registrar careful. We recommend that you compare different registrars and pay particular attention to auditor background (for example, some may consider former military auditors to be rigid and inflexible in their interpretation of the 9001 Standard) and to 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 experiences).