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practical, simple and flexible ISO 9001 |
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FAQs for ISO 9001 and QualityMost Frequently Asked Questions
On ISO 9001How to...
Who does what
About quality and quality improvement
More questions, answers and articles in my e-letter Archive What is a quality system?It is a system that is used to manage (and ensure) quality in an organisation. Think of it as the system a particular business uses to design, develop or make its services or products. For a service business, it's the system you use to develop and deliver your services. If you make or manufacture widgets, it's the system you use to make them. If you sell or distribute products that other companies make, it's the system you use to source, get/buy & then sell them. For a nonprofit (eg, charity or other organisation) it's the system you use to deliver your charter or the reason you exist. Your business quality system comprises your policies, processes, procedures, people, equipment or other resources: all that is involved in producing your services or products, from planning them in the first place, through creation or design (if that applies) through development and finally delivery to your customers. But a quality management system goes beyond just 'producing service or product' to embrace how you manage your organisation, how you make sure your people are competent, that you have the right equipment, tools or whatever else you need right through to checking your results, making sure what you planned to happen in fact did happen, and doing something sensible about that if not. All the various elements work together (or should do!) to accomplish goods or services of consistent quality that meet their specifications. Do you have a business now? Have you been in business for a year or more? Are you still in business? Still have customers buying from you? If you answer yes to these questions, you already have a quality system. It may not be an 'ISO 9001 quality system' yet, but you do have a quality management system. And you probably already have some kind of QA, perhaps also some QC. What's in the Standard?The Standard itself consists of a set of specific requirements. The requirements aren't impossible, arcane or even strange. Really, they are just sheer good practice, and sound business sense. Requirements are set out in these groups:
Each requirement is numbered: there are 28 in 4 groups - more if you count all the sub clauses & details in the content. An important point: The requirements specify what must be done, but not how. The requirements are generic. And because they are, you can apply them to all kinds of businesses & organisations. But skill and experience is necessary to to apply the Standard's requirements intelligently and effectively in your particular organisation and environment. Which makes sense if you think about it, because you can't - or shouldn't! - try to apply a 'one size fits all' approach to, say: a security firm, a property development company, an automotive parts manufacturer, a food-producing business, a nonprofit professional organisation, police departments, the State Revenue Office SRO in Victoria, the USA's Federal Aviation Association or companies that develop, service or install software. On the down side, the Standard was written by a committee, and has the inherent weaknesses of multiple authorship. And the language it uses isn't always immediately accessible as must be able to be translated to/from many others. Thus, it can be difficult to understand without experience. See ISO 9001 in a Nutshell for a summary of the requirements in the Standard.
Why do ISO 9001?That's a very important question. You should have at least one good reason to do it. And just 'having the certificate' alone is definitely not a good reason - it's one of the most common mistakes. Some of the most frequent reasons given: greater client assurance, because it's the most widely known quality system model, it's internationally accepted, or to get benefits such as increased sales, improved processes, improved communication at all levels, greater business control, greater internal consistency and discipline, and reduced costs through doing things faster, better or cheaper and/or reducing errors or customer complaints. >>More about the benefits of ISO certification. Should everyone 'do ISO'? Using the Standard as a model for your own quality management system can benefit any organisation, regardless of whether or not you choose to seek external certification. If you do, then there is a cost involved, but too often people only focus on the immediate cost. Try turning that thinking around to consider the cost of not having quality. What's the real cost of business lost through failures in services or products? The cost of dissatisfied customers? Of repeating the same mistakes, duplicating work. Or of inefficient processes, when it's cheaper and more effective to do things once and get them right the first time (not the second, third or even fourth). If you really can't achieve any extra satisfaction for your customers (eg, a welfare organisation with a 'captive market') then certification may not be valuable for you. If you're not sure, ask a certifier or consultant; any reputable one should be able to advise. Can I do ISO 9001 myself?The short answer is yes, but getting ISO 9001 certification will involve time, effort and resources. You must know what the Standard says, identify your gaps, and work out how to fill them. You'll also need to know how to interpret the Standard and apply it to your business, and make all the changes needed to achieve the requiqrements. If you've never done it before, expect it to take time and effort to figure out what's involved, take longer than it would if you used a consultant, and thus also to involve cost. A possible alternative solution is to obtain and use a good DIY ISO 9001 kit. What's a certifier or registrar?They are specialised organisations who are accredited to do the formal audits and to issue certificates, provided of course the audit finds you meet all the requirements at their audit. Certifiers/registrars award the certificates: think of them as a bit like an examiner. They test (audit) your system, and then give you the certificate. They do not teach you how to do it, help prepare you or tell you how you can 'pass the audit'. In fact they can't, because this would be a conflict of interest. But good certifiers will adopt a 'business partner' approach, rather than the very old-fashioned dictatorial or inspector-like attitude. How does it happen? You choose a certifier: & sign up with them, agree on the particular Standard (eg, ISO 9001) and the scope, pay the fees, and arrange a date for audit. Are all certifiers the same? No. Contrary to widespread belief, they're not government bodies but are private companies: service providers. They all assess you against the same Standard, but of course there are differences. Choose the one you think will suit your business best. What do consultants do?Consultants give advice and help. We assess your system against the requirements, do a gap analysis to establish your current position, advise, coach you through the process and how to meet the various requirements, and prepare you for audit. We do not and can not give you the formal certificate. A good consultant can be very valuable. We can speed up the process, make it easier and more efficient, so you save time and money. We make sure you avoid the most common mistakes. A good consultant will help you get a system that suits you, not just a certificate. But ultimately only you can decide if it's worth it, because it's your company, your time and your money. Do take care selecting: How to choose a consultant. QA, QC and QMMany people think terms like QC, QA and so forth are all the same. They aren't.
The next development was QA or quality assurance. This moves beyond the end-product further 'up the line' to find and fix faults earlier in the process, and is aimed at providing confidence that requirements are, or have been, met. Note that QA includes QC at its core, but it also looks at support processes (such as training, document control, audits) to try to prevent non-conformance occurring in the first place or stop it happening again if it does. Finally, Quality Management extends beyond both of the former to embrace the management of the entire organisation in order to achieve the required quality of services or products. Hence, a quality management system. Get more information
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Quality control
or QC is where things began. At its simplest, QC has a focus on
product/service - checking your final product to make sure that it
is OK (conforms to requirements), or rejecting it as non-complying if it
doesn't. 
