The Basics of ISO 9001 Implementation that Everyone Should Know
ISO 9001 is perhaps the best known international standard. It relates to the setting up, monitoring, improvement, and maintenance of a quality management system. The standard is widely used alongside other standards such as ISO 14001 for environmental management and OHSAS 18001 for occupational health and safety management. It can be integrated with the existing management systems of the organisation for easier management of compliance. WWISE offers expert consulting services regarding ISO 9001 implementation and certification.
Below are the basic steps for implementing an ISO 9001 quality management system. We recommend making use of our consultants to assist you in identifying pitfalls and shortcomings. In addition to consulting services, we offer a full range of training courses since training in ISO 9001 is essential for successful implementation of the quality management system throughout the organisation. The implementation process depends on the existing system that your organisation has in place, how complicated the system is, the size of your enterprise, the industry in which you operate, and the various process in the organisation.
The very first step is to become familiar with the requirements of ISO 9001. Our consultants can also assist in this regard, and we recommend attendance of the various training courses that we present to ensure that the role players understand what the standard is about, its relevancy to their jobs, and their accountability. It is essential to involve top management throughout the entire process. This is indeed a requirement of ISO 9001. Without involvement from the executive management, the quality management effort will be in vain. Top management should define the organisation’s policy and communicate it to all the employees. The executive management should also set the quality objectives and make sure the objectives are set for every level of the organisation. In addition, the top-level managers need to make resources available for implementation of the ISO 9001-compliant Quality Management System (QMS), appoint the relevant representative to coordinate the effort, and conduct the various management reviews. Leading by example is essential and the top management should be involved in the improvement of quality.
The next step is to appoint the implementation team under leadership of the management representative to oversee the implementation process. The team should include managers and key personnel from all important functions of the organisation, including marketing, sales, production, customer service, deliveries, and quality control. The management representative should have in-depth knowledge regarding ISO 9001 and for this, we recommend the training courses available from WWISE. Following the above, it is important to commence with the ISO 9001 awareness programme throughout the organisation. You can make use of our consulting and training services in this regard to ensure that all employees understand their roles, the implications of implementation, and the importance of compliance.
ISO 9001 training is the next step to ensure that the internal auditing team understands how the auditing process works, and that the managers at all levels gain the required knowledge of ISO 9001 and of quality management. The QMS will affect every aspect in the organisation and relevant training is thus essential. The initial GAP analysis should be conducted to determine what has been done, what must be done, and where changes are needed. You can also make use of our consulting expertise in this regard. The documents in place must be reviewed to determine which activities must still be performed.
Once this is done, it is time for the development of the implementation plan. It is imperative to document this properly and to commence with the QMS documentation. Any non-conformances regarding documentation and corrections made must be recorded. Documentation should include the recording of training needed, the objective of the QMS, approvals needed, resource requirements and allocation, and the expected date of completion. The QMS is then implemented, followed by the internal audit to determine the performance of the system in line with the requirements of ISO 9001. A pre-assessment audit, followed by the formal audit, takes place and then certification follows. However, to ensure ongoing improvement and compliance, it is also necessary to implement a maintenance plan, with which we can also assist you.
The above is but a broad outline of what it entails to develop and maintain an ISO 9001-compliant quality management system and to prepare for the certification process. Become ISO 9001-compliant with the professional assistance from WWISE consultants.