ISO 9001 - Practical, Simple and Effective
Want simple and clear information on ISO 9001? It's here.
What is ISO 9001?
It's the international standard for a quality management system. That means it specifies what a management system should do, be and have in order for you to achieve consistent quality(whether for services or products), keep improving and help 'enhance' the satisfaction of your customers. 'Management system' just means the system used to plan, operate and manage your business (or organisation, if you aren't a profit making business).
The Standard mostly is made up of a set of statements of what you must have or do ('requirements').
They are set out in 7 individual clauses (numbers 4-10), but it's often easier to think of them in these broad categories:
- Requirements for the leaders/owners of the organisation (called 'top management'): to know what field or context you operate in, your customers plus any other parties if relevant, what they want, need and expect, and to consider your risks and opportunities. All of these factors should be considered when planning, including setting some suitable goals/objectives
- Requirements for the system itself: to create, operate and maintain a suitable system, using the process approach. If you don't know what that is, see a short video here. Top management must demonstrate leadership and commitment, keep the focus on customers, set the quality policy and objectives, and make sure that suitable planning is done, for your products or services, but also for the management system itself.
- Support and infrastructure requirements to make sure you have what is needed to support what you do, from having competent people through plant, tools and equipment (if needed) and documenting certain information.
- Operational requirements: you must have suitable processes to do whatever you do, from design if that applies through to through developing/making/supply/delivery. You must know what your customers want, create or supply that with suitable controls in place, in order to make sure your services or products meet all requirements that apply. This includes controlling nonconformity, a term applied to stuff that doesn't meet all requirements, whether that is crappy product or failures in services.
- Assess and improve: have suitable methods to assess your performance (of the system, your services/products and your processes), using suitable data. You must decide what data you need, collect and analyse it, in order to figure out if you are doing what you planned to, achieving your objectives and also to improve what you do and how you do it. This includes using of internal audits and corrective action to fix weaknesses in your system and stop them happening again.
See my ISO 9001 requirements in a nutshell for a longer outline.
In a nutshell, the requirements of 9001 are really just good practice and common sense.
Some examples of what you have to do:
- Know what your customers want.
- Provide them with whatever you agreed (to make, design, obtain or do, product or service).
- Plan, manage and control your operations to achieve the results you want. If you don't, figure out what happened and do something about it, if need be.
- Have people who are competent for the work they do.
What's a Process?
The Standard is based around your processes. If you're not sure what they are, see this video for a quick view, especially for service businesses.
How do you get ISO 9001?
To get ISO 9001 certification (often incorrectly called 'ISO accreditation'), your quality management system has to meet all the requirements. You must show this at a formal audit that assesses this. Note this is an audit of your management system rather than your financials and must be done by a duly accredited certifier (also called external auditor). Sorry about all the alternative terms, but this field does have a few!
Then you get your certificate - assuming of course you pass, never a problem for our clients. You are then referred to as ISO 9001 certified, or to have ISO 9001 certification or be registered to ISO 9001. Several different terms, all meaning the same thing.
Some myths around 9001
Myth: It's only for large businesses.
Reality: Nope. Small businesses can get enormous benefit from using and applying the 9001 Standard, regardless of whether you choose to become certified or not.
Myth: It's only for manufacturing.
Reality: Most definitely not. It is used successfully by service businesses, including consulting firms, importers, distributors and retailers. Around 40% of certifications are now issued for services. And the 2015 version for the first time explicitly recognised this, by referring throughout to 'products or services', whereas up until then it only used the term 'products'.
Myth: It's only for commercial businesses.
Reality: wrong again. It is used successfully by many non-commercial organisations, including schools and colleges, statutory authorities including government departments, agencies, police forces, charities, churches and missions.
Myth: It dictates exactly what you have to do and how.
Reality: No (again). While ISO9001 does say what you have to do or have, it does not specify how. An example: the Standard requires you to plan what you want to achieve, organise your processes to achieve your goals, and operate, maintain, improve and control your processes to get there.
But it doesn't prescribe any specific methods or ways to do anything. That's up to you. Which is good news. You see, the vast majority of standards are very specific and highly prescriptive, but 9001 isn't. It's what's called a generic standard, meaning it can be used by any kind of business or organisation, small or large and in any field. Use it to improve what you do, irrespective of whether or not you decide to become certified.
Myth: You have to document everything you do. 'Say what you do and do what you say'.
Reality: also wrong. Yes, you do have to have some things written down, but probably far less than you think. Many people still repeating this tired old mantra are far behind the times - stuck way back in last century! The Standard has changed a lot since then, and all for the better.
What's the catch?
By far the biggest one is that someone sets up a complicated, rigid and bureaucratic system, most often because they don't know any better and think it 'has to be like this' to get the certificate for ISO 9001. That's just not true. You can do it with an intelligent quality management system, one that's simple, practical and effective. I know because I've been showing and helping people do it this way for many years now.
Doesn't everyone do that? Unfortunately, no. Some struggle with complex and bureaucratic systems, weighed down by practices and documents that are hard to understand, let alone use. Expensive to create - far worse to try and use.
How does that happen? Most often it's a lack of understanding and experience. Because you really do need knowledge and experience: pitfalls for the ignorant or unwary are many. To recognise the most frequent and see how to avoid them, get my free report on the most common mistakes with ISO 9001. Or the Youtube video for an animated version.
Why settle for less than a simple, practical and effective quality management system? So you can do what you do now, but even better, and use the power of ISO 9001 to get tangible improvements?
Author: Jane Bennett