Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing over and edging nervously towards the door.
Everybody knows that ISO 9001 is a boring, necessary evil for big companies, but isn't it really just bureaucracy gone mad?
The real reason for having a quality system is to help you run your business better. If it doesn’t do that then the problem is your implementation of the standard, not ISO 9001 itself.
Small companies only need small simple quality systems, bigger companies may need a system to match. All companies are different so their processes should reflect what they do and how they do it. A quality system is there to benefit the company – it should simplify things and make life easier not harder.
There are many misunderstandings about ISO 9001, so let me lay some of those myths to rest:
1. ISO 9001 is a bureaucratic nightmare
Done badly, it can be. I have seen systems with documentation that fills metres of shelf (or shared drive) space and is mind-numbing to use! Done well, it certainly isn’t – it can be lean, easy-to-use and with minimal bureaucracy. You have a choice.
Organisational knowledge in ISO 9001:2015
2. ISO 9001 is complete nonsense and is not for 'us'
ISO 9001 gives you lots of freedom about what you do and how you do it. If it is ‘complete nonsense’ it hasn’t been implemented properly. It should be directly relevant, helpful and specific to your business; it should make things easier not harder, and should be based on how you work now not some generic business processes. But, most of all, you do need to make sure that senior management are fully behind it and are seen to be fully behind it.
3. ISO 9001 destroys creativity and innovation
It is often appropriate to allow complete freedom in some areas. ISO 9001 enables you to be as creative and innovative as you like in specific areas. But do you want a complete lack of consistency or established ways of working across your entire business? I suspect not.
4. ISO 9001 will slow us down and be very costly to operate
Done badly, this can be the case. Done well, the opposite is true. Quality and timescales are not mutually exclusive, they are opposite sides of the same coin. You can’t reduce timescales unless you eliminate defects or inefficiencies in the processes. Doing things right first time is invariably quicker and cheaper than undertaking rework or remedial measures at a later stage.
5. ISO 9001 is costly and time-consuming to put in place
It can be done quickly for a modest cost. It is possible to put in a comprehensive system in less than 6 months if it is well organised, or you could take longer to reduce the demand on people’s time. If it takes longer than a year, or needs several full time equivalent staff, then you may not be doing it as efficiently as you could.
6. ISO 9001 can be bought cheaply in a standardised, off-the-shelf form
Yes, it can, but I don’t recommend it. I believe that every company is unique and needs working practices that reflect its own business culture and market sector. If you buy a ‘shrink wrapped system’ it won’t represent the way you work and has a high probability of falling into disuse – it won’t bring the benefits that a good quality management system should.
7. ISO 9001 requires us to have hundreds of documents
No it doesn’t! You define the documents and records that you need to meet some simple and sensible business objectives.
A closer look at Document Control for ISO 9001
8. ISO 9001 requires us to have written procedures for everything
No it doesn’t! There aren't any mandatory procedures in the standard; the processes or procedures that you do decide to have can be simple and pragmatic i.e. low-bureaucracy. Companies can use basic process flowcharts to show how they work, provided via a simple, web-based system (e.g. a company Intranet), along with simple electronic forms using HTML, Wiki pages, Excel/Word, etc, where appropriate.
9. ISO 9001 doesn’t improve quality
Implemented properly it improves the consistency of activities and enables monitoring and continuous improvement of quality. By optimising processes, sharing best-practice across the company, and reducing customer complaints and re-work it also reduces cost.
10. ISO 9001 is only for large companies
It used to be the case that ISO 9001 was really for companies of perhaps 50 people or more, but since the advent of ISO 9001:2000 and succeeding versions, it can suit companies with just a handful of staff.
11. ISO 9001 requires hordes of consultants and auditors
No it doesn’t! It’s best to use a UKAS-accredited auditor to formally assess conformance but you should only see them once or twice a year. If you want some assistance and advice a business quality consultant can help you to design your system and put it in place. They can also guide you around the hazards (see above). But most of the work can be done by your own people – they are the ones who know how your business operates and they will be the day-to-day owners and users of the system. You should choose your quality management platform with this in mind.
Remember, an ISO 9001 quality management system is there to benefit your company. Unless it makes life easier, not harder, you aren’t doing it right.