There are two main approaches that can be used: one is ISO9000 and the other is Total Quality Management (TQM). There are significant differences between these and the arguments for and against can be forceful. In the authors view, the best Quality Management System is achieved by a combination of the two where the framework of ISO9000 is used to support and maintain the best practices developed by TQM. In this approach, the TQM philosophy and tools are used to develop the processes, systems and people within the organisation, and ISO9000 is used to provide the control and regulation of this change which is needed to ensure that processes are reproducible and meet business requirements.
The objective of ISO9000 is to ensure control and reproducibility of an organisations systems and processes. It is derived from the MoD Standard 05/21, first published about 15 years ago.
In implementation, practices and procedures are standardised and documented to comply with the standard. Periodic auditing is then used to ensure compliance with the standard. Frequently, external auditors and consultants are used to assist with or define this task.
There is no guarantee the delivered product or service will meet the quality requirements of the customer, or that the documented processes will define the best way of operating a process or working method..
Despite this, ISO9000 provides a useful framework for evaluating an organisations quality management system and prompting questions about how things are being done. It provides the opportunity for detailed examination of the critical processes, working methods and practices and provides data which will allow continuous process improvement to occur
Achieving certification should be more than a paperwork exercise and it can be used as a "vehicle for change" to achieve Total Quality.
In the UK, company's are increasingly using ISO9000 certification for marketing advantage. A recent report by BDO consultants indicated that 68% of UK applicants sought certification for this reason - not to improve quality. This contrasts with USA where about 65% of companies seed certification to improve quality
Basic philosophy is "Say what you do, do what you say, show that it works". All processes that affect the quality of delivered service or product must be defined and documented. At all times these documented procedures must be obeyed and this will be verified at audits.
The standard defines the following twenty components of a Quality Management System:
Are those responsible for maintenance and application of the standard clearly identified, together with their responsibilities ?
Do you have a Quality Manual which identifies the Procedures and Work Instructions required to support the companies Quality standards ?
How do you verify that you have the skills and resources to provide the service or product that you have agreed to supply to a customer ?
How are customers needs translated from specification through to design, manufacture and supply ?
Do people have the current and correct documented information that is required for then to do their tasks to the repeatability and accuracy required ?
Do your suppliers understand your cost, delivery and quality specifications and are you able to assure that they can and are consistently meeting your these specifications and requirements ?
Is the effectiveness, and conformance to your documented Quality system verified by regular audits and are the results of these audits reviewed with management so that any corrective actions are implemented and verified ?
Are any products or materials supplied by the customer safeguarded against damage while in your care ?
Does your process capability meet your stated quality and performance requirements and are all activities that affect the quality of the supplied product or service clearly identified and controlled ?
Is product quality safeguarded until customer acceptance ?
Are procedures for servicing your product adequately defined and effective ?
Is sufficient inspection and testing used to ensure that all material meets the acceptance requirements of the next production stage or process and is any non-compliant material clearly segregated ?
Is the accuracy and reliability of your equipment maintained within calibration appropriate to your measurement tolerances ?
Is the status of each item (good and bad) be positively identified at each stage of your processes ?
Are different product types clearly identified and segregated and can your final product be traced back through each step ofyour processes ?
Is any non conforming product isolated to prevent it being supplied to customers ?
When the quality system fails and customer complaints or process/product problems result, are the causes of these analysed and corrective action applied and validated ?
Are all operational documents and records available, legible and retained for a clearly specified period ?
Note that operational documents are those documents that directly affect the operation of the quality management system and product quality. Examples are customer complaint files, test results, run charts, circuit diagrams etc.
Is everyone in your organisation effectively trained to do the tasks expected of them ?
Have all areas needing statistical methods been identified and are the appropriate statistical techniques in use ?
In the UK, the value of the standard has been frequently criticised, especially by small businesses.
The main criticism of the standard is that it is bureaucratic, expensive to implement and maintain and does nothing to reduce costs.
Such benefits that the standard provides in improving Quality may be limited for small companies which are well managed and have informal but effective quality systems.
For a company of 20 - 30 employees, the owner manager can assure full control - as the organisation expands, then informal quality controls and communications may breakdown as the span of control becomes excessive - unless the Quality culture is already firmly embedded.
However, ISO9000 is often forced upon small companies as a condition of trading with larger organisations and government bodies. A 1992 estimate was that 10% of large companies were likely to demand it, and 80% of government departments. Then it is used as a marketing tool rather than one to improve quality. A recent report by BDO consultants indicated that 68% of applicants sought certification for this reason - not to improve quality. Anecdotal evidence from USA suggests that about 60-70% of companies there seek it as a means of improving quality. However, gaining ISO9000 certification can put a company 12 to 18 months ahead of its rivals and also improves the quality image of a company.
It is possible that its benefits are greater for the larger company when the problems of controlling large numbers of staff and varieties of operations require some formalisation and simplification of procedures and practices. Unfortunately, big companies tend to be bureaucratic and it is probable that their Quality Management System (QMS) will tend to follow this. The style of the QMS will be formed within this culture.
Why company's choose ISO9000
Company's choose to go for ISO9000 registration for a number of reasons, some of which are listed below:
1 For marketing advantage. Many organisations now only use contractors or suppliers that have ISO9000.
2 Because instructed to by the Parent Company.
3 As a miraculous cure-all that will save costs and increase market size with minimal effort required from the management.
4 As a means of auditing the existing operations so that problems can be exposed, defined and rectified as a step towards a Total Quality programme. Accreditation to ISO9000 can then be used to advertise the company's commitment to quality improvement.
In the author's view, the commitment to quality required for the last reason makes it the only approach that will produce successful achievement and maintenance of the standard.
ISO9000 confirms that a company has a consistent quality system. It does not guarantee that the goods and services supplied are recognised as quality by the customer. The relatively low significance of ISO9000 as a function of the company's quality is demonstrated by the fact that the US Baldridge Award gives only 4% for quality systems and the European Quality Award gives a total of 14% to the management of processes with quality systems included as only one of these processes.
Benefits of implementing a formalised quality system include the following:
1. Clear identification of the accountability and areas of responsibility of staff at all levels.
2. A clear understanding among staff of what is required of them.
3. Better control and predictability of process times.
A well designed Quality Management System also allows quicker response to changing market demands and the requirements of new legislation e.g. COSHH, EMC compliance and the new environmental standard, BS7750
According to a survey by SGS Yarsley, 10% of those businesses which gain certification recoup their costs within two years and 50% within three years. While about 7% of UK companies are wound up each year (1992 data) only 0.2% of BS5750 companies fail. Savings are made on overtime payments, administration, removal of unnecessary procedures and improved productivity.
ISO9000 allows independent evaluation of clauses, and auditing against each clause may mean missing or misunderstanding the significance of a non compliance or omission to the overall business effectiveness of the Quality Management System and the business efficiency of the organisation. If the target is to get accreditation then no real improvement to the system may have been achieved.
The value of the consultancy and certification business that has grown up around the standard has been estimated at £80m. This growth has been accompanied the emergence of some auditors and consultants of dubious quality. Over 30 bodies have now been approved by The National Accreditation Council for Certification Bodies (NACCB, among them BSI, Lloyd's and Det Norske Veritas. BSI, who publish the British version of the standard, dominate this market, certifying over 50% of those companies seeking certification.
Within the last few years, the Department of Trade and Industry
has allowed more bodies to issue certificates, without the requirement for NACCB approval.
Unless a certifying body is NACCB-accredited, then the certificate it issues is effectively worthless. NACCB accredited bodies are identified by the logo of a tick within a small rectangle surmounted by a crown.
The growth of the auditing industry has supported the belief that registered auditors are required to prepare for and maintain ISO9000 registration within an organisation. The standard does require that people are trained to maintain the standard. - if the organisation provides in house training, then this can be designed to meet specific local requirements and interpretations of the standard.
External assessors cannot be expected to understand the complexities of the business and the significance of what they find or don't find. No auditor can instruct you how to achieve define and control your QMS. However, you must be able to demonstrate that you both understand and effectively control your processes and be able to state how these are addressed in the relevant clauses of the ISO9000 framework.
The cost of the initial assessment and of each subsequent surveillance audit starts at around £1000. In addition to the cost of the initial assessment, companies may also have to pay for an additional surveillance visit in the first year.
There is also a danger that ISO9000 is regarded as a prescription for Quality and that the administrators of it are experts in Quality. This is not correct - real, sustainable quality is from gut commitment to a the Total Quality philosophy. This cannot be defined in a standard, nor implemented to formal plans, or shown by winning a certificate. Furthermore, it involves all within an organisation.
Quality exists within an organisational culture - each new Quality initiative modifies that culture, incrementally reforming it as it approaches its optimum "shape".
Achieving Total Quality means a complex process of cultural and organisational change, which requires day to day commitment and action. ISO9000 can mean life as normal except for occasional audits.
A company, will tend to design and implement a Quality Management System (QMS) that mirrors its existing way of working - if it is lean and efficient then the CMS will be similar, if it is bureaucratic then the QMS will share these defects.
It could be argued that ISO9000 fits into the Quality by inspection approach and Total Quality is the Quality by assurance approach that is required for sustained competitive advantage. However, as some form of inspection is required to define what and where improvement are needed, then the two approaches are complementary.
ISO9000 milestones must be agreed by the Quality Team so that its implementation can be effectively planned and its progress monitored and publicised.
ISO9000 achieves discipline and stability and provides a good platform for the construction of a quality system and a focus for its development. Importantly, it is something defined and tangible that can be used with to achieve an objective of Total Quality.
ISO9000 and Total Quality should be used for quality improvements by using Deming's Plan-Do-Check-Action cycle as follows:
1 Find out how the existing system is working and its advantages and limitations.
2 Define what you want the new system to do.
3 Produce Total Quality procedures that define the new Quality Management System, comply with ISO9000 and are easy to maintain .
4 Ensure that these procedures are maintained and updated to keep them at the optimum way of working.
This requires special comment as enforcement of a formal QMS can freeze current practice and put a clamp on initiative - working practices must conform to the documented procedure. This conflicts with the Total Quality philosophy of continual review and improvement to processes, involving all staff - with ISO9000 any changes have to take place within an formal system.
Therefore its important that a flexible and effective documentation control system is set up, and that the amount of documentation subject to control is kept at a minimum
In some cases, the written procedures may be inaccurate so that for a task
to be completed, the procedure or part of it may need to be bypassed. Parts of
the written procedure may also be redundant. It is important that processes are
fully understood before they are documented, preferably by drawing these out
graphically as flow charts. The process operators should also be included in
the review of these processes - this gets buy in and is also a focus for
communication and barrier breaking.
The installed Quality Management System must be a living system that allows continuous revision and development. An effective system for updating and issuing documentation is required so that modified working practices and documented procedures are matched. A number of software packages are now available to promise to make this task easier and more efficient.
Total Quality is a long term goal for most companies, and unless milestones can be achieved in a reasonably short time, then people can become discouraged and give up. Achieving ISO9000 does provide a clear milestone on the journey to Total Quality. The steps to the implementation of ISO9000 should be defined, and the progress made publicised to everyone regularly. Changes to the systems will ultimately affect how people have to work and therefore they must be kept informed and able to contribute to any required changes.
As the effects of recession continue to be visible, company managers may return to their established strategies (e.g. directive management and Taylorism) rather than taking the risk of TQM - esp. as it can mean challenging the fundamental belief systems of the organisation - ( career limiting !) . If shareholders and financial institutions want quick returns on their investments, then the company may be bounced into employing short term strategies rather than those that allow a long term growth policy.
Although seeking ISO9000 certification can be seen as evidence of management commitment to Total Quality, it may also be an excuse for stopping ant future improvements - the threat of complacency may mean that a ISO9000 certified company is not supplying products or services to the Quality standards demanded by the market.
Written by Brian Hunt and published in the October / November 1995 issue of Electrotechnology. Please send any comments to firstname.lastname@example.org