There is a lot of myths and a perception surrounding the implementation of ISO 9001.
ISO 9001 means having a Quality Management System in place containing a set of Policies, Procedures, Work Instructions/Standard Operating Procedures (if necessary), and supporting documentation that contributes to ensuring your business processes function optimally and efficiently and prevent unnecessary non-conformities, i.e. reworks, scrap, customer complaints, etc.
The main purpose of a Quality Management System and ISO 9001 is to do things consistently and to have all the necessary controls in place in your processes to ensure nothing can go wrong that can affect the customer, i.e. enhancing customer satisfaction.
Unfortunately, implementing ISO 9001 and a Quality Management System is a time-consuming exercise and requires input from various parties.
Therefore, ISO 9001 is not a “plug-and-play” system or “software programme” that can merely be installed and used, and then a business can become certified. It is probably one of the most misunderstood perceptions about ISO 9001.
At best, it takes approximately 8-12 months minimum to implement ISO 9001 and become certified.
This process entails several phases such as:
• Documenting the Quality Management System, i.e. Policies, Procedures, Work Instructions/Standard Operating Procedures (if necessary), and supporting documentation,
• Implementing and Training the personnel throughout all the processes,
• Generating records using the Quality Management System over a minimum period of 3 months,
• Conducting Internal Audits on the Quality Management System to determine if it was effectively implemented and is maintained accordingly,
• Addressing the non-conformities (findings) raised during the Internal Audit and, if needed, depending on the nature of the non-conformities (findings), either recommend certification or schedule another round of Internal Audits,
• Schedule the Certification Audit with a reputable accredited Certification Body.
In isolated instances, the implementation of a Quality Management System and becoming certified may happen within 6 months, but this is where the customer has already documented some of the requirements of a Quality Management System and it simply needs to be tweaked and where records have already been partially generated. This is normally done by performing a Gap Analysis to identify any gaps that may halter compliance. Once a Gap Analysis was conducted, the gaps need to be addressed and the normal process, as explained above, still needs to be followed whereby records need to be generated over 3 months, Internal audits need to be conducted, Non-conformities (Findings) need to be addressed and, after that, Certification can be scheduled.
What should also be taken into consideration is that the Non-conformities (Findings) raised by the Certification Body (if any) should also be addressed and submitted after which everything must go through an approval process with the Certification Body itself.
Therefore, to summarise, implementing a Quality Management System and ISO 9001 must be thoroughly planned and enough time should be allocated for implementation and certification. Also, when implementing a Quality Management System and ISO 9001, consider involving suitable experts, like 9001 Consult (Pty) Ltd. to assist you with the process to ensure it is done correctly from the beginning.
We are ready to assist.