The top management of an organisation should be determined and committed to implement a quality management system. No quality initiative within an organisation can succeed without commitment from top management. Top management can demonstrate to their clients that the organisation is committed to quality through the certification and registration of the ISO 9000 standard. Top management should thus come to the realization that overall business efficiency would be improved by means of a quality management system
People are responsible for the implementation of ISO 9000. An implementation team, headed by a Service Provider and a Management Representative (MR), is to be established. The Service Provider and MR is the coordinator and is responsible for planning and overseeing the implementation of the quality management system. He is thus the link between top management and the ISO 9000 registrar. All departments within the organisation should be represented on the implementation team.
Conducting ISO 9000 awareness programs will inform all employees about the aim of a quality management system. These include the advantages offered to customers and employees, their respective responsibilities and roles within the system, and how the quality management system operates. The benefits that an organisation hopes to realize through a quality management system implementation should be emphasized through ISO 9000 awareness programs.
All personnel and all areas in an organisation are affected by a quality management system. Training regarding the quality management system should thus be provided for all employees. The quality management system implementation plan should make provision for this training. All basic concepts of quality management systems and its impact on the organisation should be covered.
A quality management system conforming to the ISO 9000 standard should be created. However, this does not preclude incorporating, adapting, or adding onto quality programs that already exists. Thus, this step basically involves comparing an organization’s existing quality management system (if there is one) with the requirements of ISO 9001:2015.
Once an organization’s quality management system has been compared with the ISO 9001:2015 standard, a documented implementation plan is used to address any non-conformances. The documented implementation plan identifies and describes processes in order to make the organization’s current quality management system in full compliance with the ISO 9000 standard.
Documentation is an area where non-conformance regarding quality management systems are very common. In order to avoid these non-conformities, documentation of a quality management system should include the following:
In order to control quality management system documentation, a documented system should be created. The creation, approval, distribution, revision, storage, and disposal of various types of documentation are thus managed. Document control systems should be as easy and simple to operate as possible. However, it should still be sufficient enough to meet the requirements of ISO 9001:2015.
In large organizations, it is best to implement the quality management system being documented as the documentation is developed. This is in stark contrast to smaller organizations, where the quality management system is implemented throughout the organisation all at once. During phased implementation, however, an evaluation can take place regarding the effectiveness of the system in different areas.
Through management review and an internal quality audit, the implementation progress is monitored to ensure that the quality management system is effective and thus conforms to the IS0 9000 standard.
The effectiveness of the installed system should be checked regularly by means of an internal quality audit. Below are some reasons for conducting an internal quality audit into a quality management system:
A management review should be conducted three to six months after quality management system implementation took place. The reasons for conducting management reviews are to ensure continuous effectiveness, adequacy, and suitability of the quality management system.
Before applying for certification, a pre-assessment audit usually takes place. Certification bodies provide a qualified but independent auditor to conduct this service. Some degree of confidence is gained before application for certification if the pre-assessment audit goes well.
A formal application for certification is made at a certification body as soon as the quality management system has been operating for a few months and has stabilized. An audit of the documents (known as an adequacy audit) is first carried out, and if it conforms to the requirements of the quality standard, it is followed by an on-site audit. A certificate is only awarded to the organisation if the certification body is satisfied with the workings of the system. However, the certificate is valid for a period of three years only, after which the certification body will carry out periodic surveillance audits.
Although an organisation gained certification, it is important to note that it has to try and improve the suitability and effectiveness of the quality management system on a continuous basis.Services | Contact us | Book a Consultation | Sitemap