BEGINNERS GUIDE TO ISO 9001 : 2000

Transcription

1 INTRODUCTION ISO 9000 is a standard for Quality Management Systems. It is a series of documents that are designed to help organisations achieve better quality of product and service. This guide is split into five sections:- ISO 9001 Requirements, including precepts. ISO 9000 group of standards History World of Certification Pro s and Con s ISO 9001 REQUIREMENTS, INCLUDING PRECEPTS Precepts Quality management systems exist to control the quality of what we deliver. They also exist to provide assurance that what we do is what we want to do. This assurance means the creation of records. Therefore a quality system will ensure that not only do we get things right but we have the records (paper or electronic) that demonstrates how good we are. It is not sufficient that we just achieve a level of adequacy in our product and service delivery. ISO 9001 desires that we have a continual level of quality improvement. If you feel that this is not possible then, at least, there should be a continuing level of endeavour to achieve improvement. We all recognise that resting on one s laurels is a dangerous thing to do. It is a very relevant principle in business that if one does not improve on what one does, then competitors will seize the opportunity from you and will offer your customers the improvements that you have failed to recognise. Continual improvement is therefore a key principle of ISO Processes are what your business performs. They are the individual tasks and actions necessary in order to deliver what the customer wants. ISO 9001 advocates a process approach to quality. By this, it means that if you control all of the individual tasks and actions to the appropriate level then the linked group of business activities will result in customer satisfaction. Process control means :- (i) (ii) (iii) identification of what starts a process off i.e. the inputs the actual activities undertaken i.e. the process the process results i.e. the outputs, If considered together with appropriate checks and criteria, an adequately controlled process will result. One process leads to another, and if we know that what has gone before is OK, then it enables what we do to be done with greater confidence and with less problems. This means that the next in line from us (the internal customer), has a decent quality input to work with. Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 1 (G)19

2 Requirements The ISO 9001 requirements are categorised into 5 key areas: General requirements including documentation Management responsibility Resource management Product realisation Measurement, analysis and improvement. General requirements including documentation This section of the standard sets the targets for identifying the processes within the organisation and for determining the sequence and interaction of the processes. Most organisations do this with a series of flow charts. Whilst this has become fairly standard practice there is no requirement for flow charts to be used. One should therefore be careful about following mind sets. Only use a flowchart if it is the right technique for you. Documentation is required to demonstrate that a quality system exists and is implemented. As a minimum the documentation required is a Manual, six procedures (these may be combined to less than six documents if appropriate for you), and a set of records that demonstrate that you have conformed to ISO 9001, and product and service requirements. As a general guide, it is best to target the production of a minimum number of documents when setting up a quality system. Every piece of paper requires time and effort to produce and this will eat into an organisation s profits and ability to be effective. If you propose to produce a document that does not provide an essential control, or an essential record required by ISI 9001or does not assist in the production of the product or service, then it is probably not necessary. Management Responsibility This section addresses the need to have top management committed to ISO If people at the top do not give it their all then it is unlikely that the rest of the staff will adhere to the principles of ISO Special attention is given to Customer Focus, the need for a Quality Policy that reflects the needs of customers, your own organisation and ISO Management Responsibility includes the need to plan for quality and the need to define individuals responsibility and authorities. There is a requirement for a Management Representative for quality issues. This person is not responsible for quality, (everyone is) but is charged with ensuring that the processes for quality are in place and for reporting to top management and for quality awareness throughout the organisation. Finally this section requires a Management Review of quality. This usually means a meeting but the standard des not actually require that a meeting is held. A review, by the top management is required to address audits, customer feedback, process and product conformity actions, changes and improvement opportunities. There must be a record of these reviews. Reviews are held in order to achieve an output in terms of improvements to product, processes and management system. Resource Management Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 2 (G)19

3 Management of resources is essential for the sustainability of any organisation. ISO 9001 focuses on the human resource, infrastructure and work environment. This section basically requires that resources are adequate for the task required of them Staff should have the right number of skills and demonstrate the appropriate competence level. There should be records of training and competence. The work environment should be appropriate to the product or service and should not offer any hazards to either quality or safety. Product Realisation Product realisation is a posh term for producing the product or service. It is within this area of the quality management system that one would expect the quality controls for the product and service to be applied. Typically these are inspections and checks but also include the planning activity necessary for the producing the product, customer related processes such as delivery and post delivery aspects and consideration of any legal or statutory requirements that may apply to what you do. Communication is important and the organisation has to ensure that the arrangements for communicating with customers are understood by all employees and that customer feedback gets to those who need to review it. This section also includes all of the processes for Design. These include the arrangement s for defining inputs and outputs (customer needs and proposed specifications to meet those needs), design reviews (to identify problems and to evaluate the design project progress), design verification (to ensure that outputs meet inputs), design validation (to ensure that product meets requirements or intended use) and activities necessary to control changes to design. Purchasing is also an element of product realisation and includes the evaluation of potential suppliers to make sure that they are good enough for your organisation to use. This also addresses the arrangements for validating incoming supplies. The provision of product or a service is only possible usually after several processes have been applied. This section of the standard requires appropriate controls and processes are in place to achieve this. There are several ancillary aspects also included such as the care of customer property, preservation of the product both in store and in transit and the need to properly identify packages. Finally, if a product or service is quantified via measurement then confidence must exist in the equipment that you use to do the measurement with. Arrangements will have to be in place to check (i.e. calibrate), this equipment against appropriate standards (traceable to National Standards if necessary) so that the product characteristics are known and quantifiable within the right limits. Measurement, analysis and improvement. This final section of the standard ensures that things get better and better. It requires that the product is checked, the processes are checked and the management system is checked. These checks are conducted via inspection, measurement, data gathering and review. Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 3 (G)19

4 One of the most high profile of these activities is that of Auditing. This is a systematic review of the activities or processes of the organisation to obtain objective evidence that what is intended is being achieved. Often an audit will show that things have gone off course and so an audit provides the opportunity to bring things back in line or an opportunity to revise operations and make them more effective and efficient. In the general hurly-burly of business life we seldom take the time to look at what is going on unless there is a crisis to deal with. That is why auditing has so much potential for organisations. It requires that these audits are performed on a regular basis at a frequency appropriate to the subject s criticality and importance. It is one of the most worthwhile activities that can be done in the quality assurance field. Other analysis activities include customer satisfaction. This should not be interpreted as measurement of complaints or dissatisfaction but a methodical approach to ascertaining how happy customers are. This can involve surveys but they need not necessarily be conducted if sufficient other data that you deem relevant is collated and analysed. ISO 9001 requires records to be maintained for each of the five areas. It is no use just keeping records for the sake of it. These records are data that have the potential to show the weaknesses, strengths and opportunities of the organisation. The standard therefore requires that records or data relevant to processes, the system and product are analysed. One of the records subject to review is that of non-conformances. Action is required to ensure that these are corrected and records of the corrective action are required by the standard. In addition the organisation must look for potential problems and prevent them occurring. Data that could indicate a looming problem are increases in overtime, material usage, cost and time overruns. Quite often these operational difficulty aspects are precursors to quality problems and data on these present an opportunity for preventive action. ISO 9000 GROUP OF STANDARDS The key standard is ISO 9001:2000 Quality management systems Requirements. This document points out that the standard is complementary to product and service specifications and does not replace them. In terms of hierarchy therefore, it should never be the primary consideration of a commercial arrangement. The numbering system is interpreted as follows: ISO = International Organisation for Standardisation. This is based in Geneva, Switzerland 9001 = The number that is allocated to the standard : 2000 = the year in which the standard is published. Sometimes there are other letters in the standard as it appears like this: BS EN ISO :2000. These letters stand for: BS = British Standard. The document has been formally adopted as a British standard and has all the status and authority of a document issued by the British Standards Institution. EN = European Norm. This standard has been approved by the EU committee CEN and CEN members are bound to comply with the rules and regulations applicable to EN standards. In essence, this is about ensuring fair trade between member states of the European Union and means that no organisation in one EU member state can refuse trade to another in an other EU state on the basis of not meeting the appropriate standards if the Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 4 (G)19

5 standard has been normalised or adopted by CEN. Therefore an EN standard should ensure fair play for all in the standards field. Other documents in the ISO series are supplementary and are for guidance. These are:- ISO Quality management systems Guidelines for performance improvements. This document s title says it all. It provides guidance on improvement. It is structured in the same manner as ISO 9001:2000 and therefore the two documents complement each other. However ISO 9004 is only a guide and therefore may not be used as a basis for assessment or certification. ISO 9000:2000 Quality management systems Fundamentals and vocabulary. This document provides some basic material for the understanding of quality management. It describes the fundamental principles underpinning the ISO 9000 series and defines some key terms. The list of definitions however, is considered not to be as extensive as could be. ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing. This provides a structure and systematic approach to audit terms, management, conduct, reporting and follow-up. Because a lot of emphasis of quality management is in the verification and audit of quality activities this document is a significant part of the quality arena. As the name implies, it is also applicable to environmental management systems as well as quality. HISRY ISO 9000 came about because of the need for industry to have a demonstrable approach to the control of quality. In its early days it was based on a series of procedures that grew from the need to control munitions production during and following World War Two. Its first significant document was known as BS 5750 and this was later adopted by ISO in 1994 as ISO 9001 or ISO 9002 or ISO These were three similar standards but addressing organisations that (i) did everything, (ii) did everything except design, (iii) just inspected work only. There were a lot of commonalities in these three standards. In December 2000 the ISO 9001:2000 version of the standard was published. This restructured the 1994 version and thus did away with the need for a different standard for each type of enterprise. Thus we have a one size fits all standard. Of course, the needs and characteristics of individual organisations differ and therefore the response to the current version of the standard will vary a lot from one organisation to another. WORLD OF CERTIFICATION Certification has tended to dominate ISO 9001:2000. For many organisations it has become the primary reason to adopt the standard as a means of managing quality and in our opinion this is regrettable. The primary reason for adopting ISO 9001 is because of the benefits the methodical approach can bring. However, many organisations do it because of the marketing credibility it can bring or because an influential customer has demanded that all suppliers have been registered. The consequence of this is that many organisations have gone for certification just to get a badge on the wall. In many cases this has been a waste of time. Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 5 (G)19

6 Certification is performed by Certification Bodies. They are often termed Third Party organisations or Registrars In the 1980 s there were not too many of them but there are about one hundred and twenty in the UK today. Certification bodies are split into two groups. These are accredited and un accredited. Accredited certification bodies have significant credibility because they are under the auspices of higher organisations known as Accreditation Authorities. There are two of these within the UK and are Accreditation Service for Certifying Bodies Europe) and United Kingdom Accreditation Service often referred to by their initials as ASCB(E) and UKAS. Their logos are known respectively as the Eurotick (showing a rectangle with the European stars a tick and their initials) and the Crown and Tick (showing a crown above a tick above the words Quality Management all within a square box). Un accredited certification bodies have less street credibility because they do not have any authority overlooking their activities. Often these companies are closely associated with consultancies who have a vested interest in guaranteeing the provision of quality manuals and consultancy together with a pass or ISO 9001 certificate. It is important to note that certification is a voluntary thing and that there is no requirement in law or regulation etc for organisations to be ISO 9001 certificated. Often, certification bodies, both accredited and non-accredited will allow organisations to believe that there is an impetus for certification that does not really exist and will quote government policy or statements in a misleading manner. Certification to ISO 9001 can help an organisation increase its trading position and it is for this reason that many firms become certificated. However, there is no legal requirement for an organisation to achieve it. Terminology is a thing that is often confusing in this area. The following two terms are often misused: Certification = this applies to the firm or organisation that is seeking certification. Accreditation = this applies to the certification body that issues the certificate. Typically a certification body must comply with the requirements of ISO in order to achieve accredited status. PROs AND CONs There are very few disadvantages associated with ISO 9001:2000. There are a considerable number of benefits. First the down side: The standard is very good at setting targets. These targets are general and define what is to be achieved. The standard never says how anything is to be achieved. This is because every organisation has its own approach to a topic and its own way of doing things. If it works for you then it can t be wrong. That is why the standard does not say how to do a job. It only says that a job has to be done. There are a considerable number of professional advisors, consultants and friends with experience, that are only too happy to tell you how to approach a task. It is this aspect of implementing the standard that has a considerable number of pitfalls. All too often what has worked for them does not work for Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 6 (G)19

7 you and this difference often leads people to condemn the standard rather than the approach to it. Typically, as mentioned earlier, an organisation will be encouraged to produce lots of flowcharts and then they get in a muddle with them or can t see the point? As the standard does not ask for them it can t be the standard s fault you have trouble with them. But that does not stop the standard getting the blame. Another pitfall is that too many organisations pursue ISO 9001 without actually reading the standard or even owning a copy. They will go to seminars, employ consultants and attend several training courses but, they don t actually read the standard. It might seem an all too obvious thing to say but, how do you expect to comply with a standard if you consult everyone and everything under the sun except that standard itself? ISO 9001 uses a technical dialogue and vocabulary that may be a little unfriendly to the lay person. Do persevere with it because its requirements are its real benefits. The standard may be considered as a management tool. It only requires that a few basic and commonsensical actions are conducted because these actions have been seen in the past, to really contribute to good quality and to help avoid problems. If one were to take away the over used and boring old word quality the standard would be a splendid model on which to base a growing enterprise. It is because of its requirements that the standard is such a benefit. Just reviewing your operations to see how well the requirements are met often brings to light potential weaknesses and opportunities for the business. These are the real benefits and they are the internal benefits of ISO The external benefits are that certification can enhance an organisation s street credibility. This is only of merit if the certificate awarding body is credible itself. Accreditation will help their case but there have been several high profile cases where certificated organisations have delivered poor quality products / service. CONCLUSION ISO 9001 is just one standard for managing quality. There are other standards and methods that have a contribution to make and therefore ISO 9001 is only complementary to the main product or service specification of the organisation. It defines requirements that are very useful goals for an enterprise to adopt. The structure and layout of the standard is logical and methodical. There is a bit of a circus surrounding the standard and a new profession has developed in the last couple of decades to service peoples interest in quality management, ISO 9001 and certification. A lot of damage is done through the provision of well meaning but often misleading advice especially regarding certification, accreditation and the value of certificates. People tend to read very heavy text books on the subject rather than the dozen or so pages of the standard itself. This has lead to a lot of confusion. Organisations tend to become ISO 9001 registered because of perceived commercial benefits but the real reward of implementing ISO 9001 is in the internal improvements effective implementation can bring about. END April 2003 Business Assessment Service Ltd 2003 Printed 02/05/2006 Page 7 (G)19