It is important to recognize that an ISO 9001 quality management system needs to be alive and constantly evolving.
ISO 9001:2015 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 is incorporated in ISO 9001:2015. 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.
Revising the ISO 9001 procedures and other documents should be a normal part of the ever-improving 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 easily be 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 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 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 its cost 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 the ISO 9001 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 their high fees by setting up an overly complicated and convoluted ISO 9001 quality management system.
The ISO 9000 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 midsize 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 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 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, ISO 9001 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 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.
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.
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 9001:2015 standard (there are many good public and online courses 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.