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Weekly UpdatesThis checklist is for managers involved with the implementation of a Quality Management System (QMS) within their organisation, based on ISO 9000, within their organisation and describes the processes involved.
Most quality initiatives are aimed at increasing customer satisfaction and involve many elements in the process, such as training, "getting it right first time", empowerment, performance measurement, continuous improvement and managing change. The ISO 9000 series of standards provides a model with which organisations can build a QMS to create cohesion and integration of a group of initiatives that might otherwise be approached in isolation from each other. Having developed a system based on ISO 9000, it is then possible to obtain registration through a nationally recognised accreditation body.
Definition
ISO 9000 provides the a framework for an organisation to develop a QMS to suit its own individual situation regardless of the end product, be it tangible (manufactured) intangible (service) or a combination of both. It provides guidelines for good management practice that identify the basic disciplines, specifying the criteria by which processes can be examined to ensure that products and or services meet customers' expectations. The standard also gives a guide to measuring the effectiveness of the QMS QMS and making use of these those measures to continually improve both products and services.
Advantages of ISO 9000
* Presents an opportunity for fully integrating organisational improvement management systems.
* Provides an increased awareness of customers' needs and expectations.
* Improves processes by examining what you do and how you do it.
* Provides a means of simplifying processes and reducing costs.
* Promotes a positive approach to getting things right first time.
* Gives your organisation internationally recognised accreditation.
Disadvantages of ISO 9000
* Time consuming to set up.
* Initial cost (but so is the cost of getting things wrong).
* Staff may need convincing that it is not a bureaucratic process.
Action Checklist
1. Buy and read the standard and relevant guidelines
The ISO 9000 series of standards outline the requirements for a QMS. ISO 9000 defines the terms and vocabulary used; ISO 9001 gives the full specification for a QMS, and ISO 9004 outlines the continual improvement process. The standard allows organisations to tailor some of the requirements to suit their circumstances. They are allowed to omit parts of the Product Realisation section if it is not appropriate to the organisation or the product or service, or is not required by customers. All other sections of the standard are mandatory. Any reason for exclusion must be clearly defined and qualified within the Quality Manual.
2. Gain top management commitment
The standard places responsibility on senior management to manage the QMS. They must understand their customers' needs at a strategic level and be able to translate this into policies and set objectives to meet these needs. They must also make sure that there are clear paths of communication throughout the organisation, and that all staff are aware of customers' needs. There is a requirement for senior management to regularly review the effectiveness of the QMS system.
3. Decide how the organisation will be registered and select an registration assessment body
It is possible for just part of the organisation to apply for registration. If there is just a single site, then consider if all departments are to be accredited; if multi-site, then all sites must apply individually. Be careful to adopt a unified approach across the organisation, working within the guidelines of ISO 9000. It is better for diverse sites to work together to register, irrespective of the end product.
One of the first tasks will be to select an assessment body even though registration is at the end of the process. The United Kingdom Accreditation Service (UKAS) provides information on suitable accreditation bodies for your specific industry sectors. It is advisable to select one an accreditation body approved by UKAS,. and to have the development process and the accreditation assessment carried out by separate bodies, rather than by the same one.
4. Appoint a management representative
The management representative will be a member of the organisation's management who is given the overall day-to-day responsibility for the administration of the QMS. The appointee must be a member of the organisation's own staff and not an outside consultant. He or she also provides the link with the assessment body both during and between assessment visits.
5. Decide if outside help is required
Depending on the resources and knowledge available within your organisation you may wish to employ outside help. Some trade organisations are able to provide assistance in this matter. There are also many organisations providing training courses in ISO 9000 and quality management techniques. Employing outside help will add to the cost of registration but it that must be balanced with the benefits and expertise provided.
6. Involve staff
It is vital to gain the commitment of all staff. Some staff may see the standard as bureaucratic, or as a threat to their working practices or as drawing attention to individuals when a mistake is made. It is important to allay any such fears and to emphasise that the aim is to improve the quality of the end product or service through a simplification and rationalisation of processes, and that every member of staff has an important contribution to make.
7. Interpret the requirements
There are eight sections in ISO 90011, each with a number of sub-sections. The first three are for definition only, the remaining five are operational.
8. Write a quality policy
A quality policy is the foundation upon which all quality activities are based. It is a mission statement and it must originate from top senior management. The quality policy should be kept simple, to enable it to be understood by all staff whilst confirming the requirement of the standard, its objectives and goals for quality, including the requirement to meet customer expectations and needs.
9. Draw up a quality plan
A quality plan is a useful tool on which to timetable, build and chart progress, allocate resources and define responsibilities for action. During the process, all involved should meet and review progress at regular intervals to enable the impetus to be maintained. Care must be exercised in providing a realistic timetable.
10. Document the QMS
Having decided how you are to implement the standard, the next step is to map the system out. ISO 9001 requires a quality manual and operational procedures to be written. The manual should show the interaction of processes within the organisation, and mapping them provides a key to understanding the organisational flow and ultimately where improvements can be made. One method is to graphically represent processes using some form of flowchart, clearly showing the relationships and flow of work. Remember that any process will have three stages--input, operation and output.
ISO 9001 allows you to record the QMS in any medium you choose providing there is clear evidence of control to prevent unauthorised changes. Whilst developing the QMS, take into account existing systems, how thhey contribute to the aims of your QMS, and the competency of staff involved in carrying out the processes.
11. Establish performance indicators
A framework must be established to measure the effectiveness of the QMS. Select realistic and measurable indicators, such as the length of time taken to answer a customer query, output rates and reject quantities. Define how indicators are to be measured and set targets to be achieved. Monitor performance against targets on a regular basis.
12. Use complaints positively
Establish or enhance your existing complaints system by treating each complaint, be it from external or internal sources, as an indicator of the need for improvement. Positive action is required to correct the fault (short-term) and prevent it happening again (longer term). Keep the complainant informed of progress.
13. Review the system
After a reasonable time after commencing the project, start to review the system by establishing an audit programme. A quality audit is a key review tool, and looks at what is done in relation to the standard, in terms of organisational processes and procedures. Audit non-conformities not only point out deviations from the agreed procedure but may also indicate areas for further tweaking. Examine and action any trends in the number and type of non-conformities.
14. Get ready for assessment
When you are satisfied that the QMS has begun achieving the goals and objectives set in the quality policy, and when there has been sufficient time to obtain sufficient documentary records, then it is time to be assessed. Some assessment bodies offer a pre-assessment visit to enable potential discrepancies to be addressed beforehand. If this is not viable, then conduct an independent audit of the whole system. It is possible that a first audit may highlight a number of discrepancies, most probably of a minor nature, but each one having the potential to prevent successful registration. Only when you are satisfied that the QMS is performing as you and the standard require, then arrange for the assessment visit.
15. Assessment
This will be exhaustive in nature, and may well last two or three days, so be prepared to devote time solely to the assessment team. Assessments start with an opening meeting where the assessors explain what they are looking for and the actions they will take if discrepancies are found.
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