Frequently Asked Questions

What is a Quality System ISO 9001 ?

It is a system that is used to manage quality. ISO (the International Organization for Standardization) definition is 'the management system to direct and control an organization with regard to quality'.

Think of it as the system a particular business uses to design, develop or make products. 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 buy & sell them. Or if you are a service business, then it's the system you use to develop and deliver your services.

Your business quality system comprises your policies, processes, procedures, people, tools and equipment or other resources: all that is involved in producing your products or services, 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 product' to include how you manage yourself, making 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 youdo have a quality management system. And you probably already have some kind of QA, perhaps also some QC.

Why invest in Quality ISO 9001?

Quality is no accident, especially consistently high quality, Quality Management Systems are being developed to comply with current international directives, standards and practices.

An effective Quality Management System in your company will enhance productivity, reduce costs and increase your opportunity to garner a solid position in the market for your products and services. Companies determined to keep their competitive edge now and in future are developing through comprehensive quality management systems. Benefits of installing a quality management system are enormous.

What is a Standard ISO 9001 ?

It is a published document that sets out specifications (and sometimes procedures) intended to ensure that a something is fit for purpose and consistently performs in the way it was intended, whether a material, product, method or service.

Standards establish a common language which defines quality and establishes safety criteria. They ensure quality and consistency.  Some simple examples include:

  • Traffic light colours: globally, red = stop, amber = caution and green = go
  • Conformity in sizes of screws and threads - a nut made in Melbourne Australia, fits a bolt made in Shanghai, China
  • Containers - freight moves worldwide using standardised containers and handling technology. 

 

What's in the Standart ISO 9001?

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: 

  • General requirements -  requirements that apply throughout; including requirements to identify your processes, have and control your documentation and manage records
  • Management responsibility - requirements for the 'decision-makers'
  • Resource management - covering people, environment and infrastructure 
  • Product realization - requirements for core business activities  

An important point: The requirements specify what must be done, but not how.  
The requirements are generic.  And because it can be applied to all kinds of businesses & organisations, you need skill and experience to apply it intelligently and effectively in yourparticular organisation and environment. 
Which makes sense if you think about it, because you can't - or shouldn't! - just 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 stations, the Australian ATO, the USA's Federal Aviation Association or companies that develop, service or install software.  
 An ISO 9001 system must be both documented and auditable - that is, able to be audited.    
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: it can be difficult to understand. 

Why do ISO 9001? Why do ISO

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 mostcommon 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.

Should everyone 'do ISO'?  Not necessarily, but using it as a model for your quality system can benefit almost any organisation. 

If you decide to apply for certification, then there is a cost involved, although too often people only focus on the 'cost of quality'. 

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.

What are the principles of the ISO 9001:2000 standard?

The quality management principles of ISO 9001:2000 are aligned with the philosophy and objectives of most quality award programs.
These principles are:

  • Customer focus
  • Leadership
  • Involvement of people
  • Process approach
  • System approach to management
  • Continual improvement
  • Factual approach to decision making
  • Mutually beneficial supplier relationships
Can I do ISO 9001 myself?

Getting ISO 9001 certification does take 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. 
Do expect it to take you some time and effort to figure out what's involved, to perhaps take longer than using a consultant, and thus also to involve cost.  A potential solution is using a good DIY kit.

What's a Certifier or Registrar?

A company with the authority to issue certificates is called a certifier or registrar. They supply the external auditors. Only companies who are accredited can award certificates, provided of course they agree you meet all the requirements at their audit.

Certifiers award the certificates: think of them as a bit like an examiner. They test (audit) your system, and if it meets requirements, give you the certificate. But they don't coach you, help prepare you, or tell you how to 'pass'. In fact they can't, because this would be a conflict of interest. But good certifiers will adopt a 'business partner' approach, not a 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 help and advise. 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 certify (accredit) you.

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.

Quality Manual - what is it?

The quality manual is an important part of your 'quality documentation'.  It may be the main or even the only component. 

ISO 9001 says your system must be documented.  It also has specific requirements for you to include:

-   a quality policy - the position or approach that your organisation takes on policy
-   measurable objectives - what you plan to achieve, and how you will assess that
-   your processes / procedures - how you want things done.

You add anything else needed in your organisation, which might be anything from checklists and flowcharts to IT systems or engineering drawings. 

What does a Quality Manual look like?

Contrary to popular belief, there isn't a single acceptable format.  And it isn't possible (fortunately!) to state definitively that it must always look like this, and always have  certain exact headings.  It really depends on what is needed.   Think of a sports car, a delivery van or a SUV. 

While they're all vehicles, what's "right" in one situation won't be in another.  A smallish business might only need a single manual, whereas a large company might require many.

The manual/s can be hardcopy (paper) or softcopy: online documents like web pages, help files, even internal IT systems.  And they can be done in many ways, from easy to very hard. 

The best way of understanding the 'quality manual' is to look at a good example,  and preferably a couple. 

Exemptions or 'We Don't Do Design'

When there were separate Standards, you had to choose the applicable Standard, and then meet all its requirements.  But now, with the single Standard ISO 9001:2000, you may claim exemption from certain clauses but only in a single section: section 7. 

Also, you must provide good reasoning when you claim exemption, and your exemption must not affect your ability or responsibility to provide product/services that meet requirements, either customer or applicable regulatory ones. 

For example, if you just make the same things over and over again, and thus don't do any design-related activities, you could claim exemption for that clause (7.3) because it does not apply.  If you don't use, acquire or hold any property of your customers (7.5.4), you could exclude that clause.

But you can't just choose to opt out and exclude a clause just because you want to.  For example, an architectural practice simply could not reasonably argue that 'design' did not apply to their business activities.  A business that includes repairs of products sold under warranty, which they take back from customers to fix, could not claim exemption from 7.5.4 'customer property' and so on.