|These tips help ensure you are |
following the correct processes
for successful ISO certification.
by Stuart Patch
Compass Assurance Services
A key requirement of any investment is that it adds value to your business/organisation. ISO 9001 Quality Management System (QMS) is one of the world’s most widely implemented standards, but it can be quite confusing at times. Below I break down some of the key certification requirements and give some tips to ensure you are following the correct processes for a successful certification.
Alignment to the strategic directionFor any investment to be effective and sustained within an organisation, it should be aligned to the organisation's strategic direction. This not only ensures consistency with the organisation strategy but also reduces the amount of administrative duplication through coordinated planning of activities.
Focus on the customerIt is important when designing your quality management system (QMS) that you align it with the requirements of your customers. Understanding what your customers require and the key deliverables are essential to ensuring you build and maintain an effective QMS.
LeadershipA lack of senior management commitment to your QMS guarantees it will not be effectively sustained. It is important that the right ‘tone at the top’ of the organisation is set and an ongoing active interest is taken in the success of the QMS.
This article is related to the Video: How IS0 9001:2015 Affects Life Sciences and Manufacturing.
Ownership and responsibilityJust as senior management needs to support the QMS, it is essential that this commitment is cascaded through the organisation. Making sure that ownership is created by suitably allocating responsilbility for elements of the QMS will help achieve this.
TrainingWhen allocating responsibility, ensure that staff is adequately trained, that they understand how their role fits within the QMS and the overall system goals. Through training, people can also be educated on how to be part of a continuous improvement culture, always looking at ways to improve the robustness and efficiency of the system.
Monitoring and measurementA QMS is a live system that needs to be continuously monitored to ensure that it is meeting the objectives that have been set. It is through this measurement and monitoring that the performance of the system can be measured and deviations identified. From this information corrective actions can be designed, implemented and then monitored as to their effectiveness. This monitoring and measurement will take many forms from transactional processes through to the overall system. These metrics will also form the base of reviews with leadership and become an important way to maintain leadership commitment to the system and required resources.
DocumentationProcesses and procedures need to be designed and documented as part of your QMS. Just as important, there will also need to be documentation to demonstrate that the procedures are understood and followed throughout your organisation.
AuditingHaving an independent audit process will also help improve the robustness of your QMS. This can take the form of an internal audit with your organisation's employees or carried out by external parties.
Realizing the benefits of your QMSMaintaining your QMS will add many benefits to your organization in terms of better efficiency, organization and also financial benefits (to name a few). Therefore it is important to be aware of how to get the most of these benefits. Some examples of these benefits are discussed in a prior blog.
Maintaining your certificationTo keep your certification, you will need to maintain contact with your certifying body and they will conduct surveillance audits of your system during your certification period. Companies such as Compass Assurance have a very down to earth, practical approach for doing this.
Stuart Patch is an executive trainer, business consultant and company director who specializes in the areas of financial management, risk management, project management and procurement. Stuart’s customized training services and business consulting are backed up by a extensive global career working as Finance Director for large listed organisations.