ISO 9001 - Practical, Simple and Effective
Looking for simple information on ISO 9001? It's here.
So what is ISO 9001?
ISO 9001, is the international standard for a quality management system. It states elements that your system must have, with the aims of getting consistent quality in your services or products, improving and satisfying your customers.
Often just referred to as 9001, the standard is mostly just a list of statements (clauses) that say what you must do. These are known as 'requirements'. Requirements are set out for:
- Leadership: the person/people who own or lead the company. They must know the business 'context', and their customers (and any 'interested parties' if relevant) - what they want, need and expect. They have to ensure the focus remains on your customers, demonstrate leadership and commitment to their quality system, and be responsible for its results. When planning, they must consider all these issues. They must assign suitable responsibilities and authorities.
- Your system as a whole: to create, operate and maintain a suitable system, using the process approach. If you don't know what a 'process approach' means, see the short video below. Top management must set the quality policy and objectives, and make sure that suitable planning is done, for their management system as well as your products or services. Risks and opportunities are to be considered.
- Support and infrastructure so that these enable the organisation to achieve what it plans to do. Includes having competent people, suitable plant, tools and equipment (if needed by your business), also documenting and maintaining key information.
- Operations: using suitable processes to do whatever you do, from 'designing' it (if applicable) all the way through developing/making it to supply or delivery. You must know what your customers want, supply it, have suitable controls in place, and thus make sure your customers get what was agreed. Includes controlling nonconformity (anything that doesn't meet all specifications, whether failures of products, services or processes).
- Improvement: reviewing your performance, and improving what you do. You need suitable methods to assess performance of your system, your services/products and your processes. You must collect and use suitable information for this assessment, so you can figure out if you are doing what you planned, and if you need to improve. It includes using internal audits and corrective action to fix weaknesses in your system and avoid 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 must do:
- Know what your customers want.
- Supply 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 needed.
- Ensure people are competent for the work they do.
See what I mean about good practice and common sense?
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 must meet all the requirements. You demonstrate this at a formal audit to an external auditor. Note it's an audit of your management system, not your financials, and it must be done by a properly accredited certifier, often called your external auditor. Sorry about all these terms, but my field has a few!
Then you get your certificate - assuming of course you pass, never a problem for our clients. You are then called ISO 9001 certified, or said to have ISO 9001 certification or be registered to ISO 9001. Different terms, but they all mean the same thing.
Some myths around 9001
Myth: It's only for large businesses.
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: Again, nope.
Many service businesses are certified, including architects, engineers, consulting firms of many kinds, importers, distributors and retailers. Around 40% of certifications are now held by service businesses. The current Standard (2015 version) has finally explicitly recognised this, by referring throughout to 'products or services'. Before then, it only ever 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. I do refer mostly to companies in this web site because it's shorter to write, but you don't have to be a commercial business to become certified or improve your management system by using the Standard.
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.
One 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, medium or large and in any field. You can use it to improve your system, regardless 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.
Sure, you must have some things documented, 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