Meanwhile this ISO standard has developed into the ultimate benchmark for good craftsmanship relating to the quality of products and services. ISO 9001 is consequently a familiar concept in almost every industry nowadays.
The first version dates back to 1987. Every 5 to 7 years, the standard is reviewed and updated by a committee of experts, based on an international survey of users. A version of ISO 9001 was published in 1994, 2000, 2008 and the latest update dates from 2015.
Each version is an improvement on the previous ones. Nevertheless, some reservations about the standard remain, although these have been eliminated in the newer versions.
To rectify these unjustified assertions, we list the most common misconceptions and present the current situation.
1. ISO 9001 mainly involves a lot of paperwork
The first versions of ISO 9001 created a lot of ‘paperwork’ associated with mandatory procedures and supporting instructions. As feedback from users was submitted to the expert committee, the need for ‘paper’ became less and less, e.g. the number of mandatory procedures in the 2000 and 2008 versions was limited to 6. In fact, in the current 2015 version, it has actually been eliminated.
The current philosophy is: demonstrate that everyone in the organisation has the same approach to quality. Compliance with this requirement is demonstrated through interviews, or by the organisation itself through databases, completed forms, etc. rather than on the basis of regulations.
Conclusion: ISO 9001:1987 required a lot of paperwork. Since then, this requirement has been systematically reduced to the current level whereby documentation is kept to a minimum (theoretically even zero). Or: ISO 9001:1987 focused on paperwork, ISO 9001:2015 focuses on demonstrability, in any shape or form.
2. ISO 9001 is a task for the quality manager
For many quality managers, one of the objectives was and is to obtain and maintain ISO 9001 certification. This was often an uphill struggle, because cooperation between colleagues and board members was not always forthcoming. After all, ISO 9001 is a quality standard, and who else but the quality manager should manage it?
In the most recent versions of ISO 9001, this is no longer the case: there is a specific requirement in the area of leadership now. Auditors don’t ask for documents or vague statements, but want to discuss strategy, approach, objectives, means, organisation, etc. with the management.
Conclusion: with the first versions of the standard, the responsibility for obtaining and maintaining ISO 9001 certification could be assigned to the quality manager. In the current version of the standard, this is no longer the case. The entire management team is now involved. In the past, the quality manager was responsible; now it is the entire organisation.
3. ISO 9001 limits our flexibility
Other similar statements we hear include: "We can no longer put our own stamp on things", "ISO restricts our own input", "ISO dictates how we should work", etc.
With each version of the standard, the approach was: the standard determines what should be assured, but not how it should be achieved.
For example, the standard requires stakeholders in the organisation to be identified, and their demands and expectation vis-a-vis the organisation to be defined. It is obvious that this should be done, notwithstanding ISO 9001, but the standard does not specify how this should be done, i.e. organisations decide for themselves how to approach this.
The same applies to the possible risks that could impact an organisation, and which measures would be relevant to limit them, and to the opportunities and measures required to turn them into reality.
Conclusion: in many earlier versions that involved a lot of procedures and work instructions, this statement could have been correct. Today, however, this is no longer the case, since ISO 9001 never determines 'how' something should be done, but rather 'what' is meaningful and relevant for each kind of organisation in order to be successful in the long term.
4. ISO 9001 is meant for large companies, not for SMEs
This statement was also largely accurate for the initial versions of the standard, but it no longer holds true for the current version. The standard has been drafted in a generic way, which means that it is applicable to both large international companies and SMEs, and to both manufacturing and service organisations.
In fact, one trend we have noticed in recent years is that the proportion of SMEs with ISO 9001 certification is consistently increasing due to the fact that large organisations are increasingly asking/requiring their suppliers to have certification.
Conclusion: the text of the standard is drafted in general terms, and applicable to both large and small organisations, to production companies and to service organisations.
5. Implementing ISO 9001 is expensive and time-consuming
What is the cost of implementing a quality management system in accordance with ISO 9001? There is no one answer to this. It depends on the type of organisation, its maturity, the number of employees, etc.
Which costs should be taken into account? In general, this is limited to internal and external preparation time, and the cost of certification (the initial certification audit and annual follow-up audit for 3 years).
But what are the benefits? A more efficient organisation, embedding a culture of continuous improvement, higher customer satisfaction, better risk management, clear objectives and action plans to achieve them, and much more.
Does the implementation take a long time? Again, this depends on the organisation, but in general, it takes about 4 to 8 months between the decision to obtain ISO 9001 certification and actually gaining it.
Conclusion: the introduction of an ISO 9001 management system is expensive, but should be considered an investment in the future of the organisation. And which company manager would not be prepared to invest in the above-mentioned benefits?
Unfortunately, a number of persistent misconceptions remain about the usefulness of ISO 9001. Hopefully, the foregoing clarifications have convinced you to the contrary. ISO 9001 is a valuable tool that will improve your organisation in a structured manner.
Would you like further information? If so, feel free to contact our experts.