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ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organisations to be more efficient and improve customer satisfaction.
The ISO Quality Management System is a ‘quality process assurance management system’ as opposed to a product certification or product quality system.
In 2015 the ISO 9001 standard was revised, and ISO 9001:2008 was replaced with ISO 9001:2015. If a business was already certified according to ISO 9001:2008, there is a GAP analysis that facilitates the conversion to ISO 9001:2015.
- If a company wishes to maintain their certification to ISO 9001, they would need to upgrade their quality management system to the new edition of the standard and seek certification to it.
- Businesses have a three-year transition period from the date of publication (September 2015) to move to the 2015 version. This means that, after the end of September 2018, a certificate to ISO 9001:2008 will no longer be valid.
With regards to the process for obtaining ISO 9001:2015 certification, the following is a summarised step-by-step guide. Ultimately, a business would need to enlist the services of a certification company to facilitate the process and obtain the certification.
The company would first need to develop and implement a quality management system based on the ISO 9001 standard before they can be audit ready. They would need a minimum of six months of stats proving effective implementation.
They would then need to select the certification body they wish to certify their system.
Factors to consider when selecting a certification body:
- What is the client’s requirement?
- Reputation of certification body.
Certification process step by step:
- Determine the advantages and the disadvantages
- Design the requirements for the processes across the entire business
- Draft the process controls and documentation to manage the quality
- Set training plans for all staff on what it means and how to implement
Book a Stage 1 audit – Also called a documentation audit.
- Does your system comply with minimum document requirements set out by the ISO 9001 standard? This determines your readiness to go for the Stage 2 audit.
- You would receive an audit report from your auditor. Any negative findings must be fixed before you would be allowed to schedule a stage 2 audit.
- When all findings are cleared you would be booked for a stage 2 audit.
The main audit (called Implementation)
- Your system is tested to see if it is working and implemented.
- Checks will be done to see if your documented procedures, policies and instructions are actually happening in your business
Approval by Certification
- The Stage 1 and Stage 2 audit report and finding reports are sent to the certification board for final approval. The certification board would then award your certification.
After selecting a certification body, that body would need to provide a quote and consultation to determine the advantages and disadvantages of the entire process; design the requirements for the process across the entire business; set training plans for all staff, and facilitate a stage 1 audit.
- The Cost involved with the first three years is roughly between R50 000 – R120 000 and payment options are available on the certification body used.
- For as long as you want to be ISO 9001 certified, there would be an ongoing cost of certification payable to the certificating body.
It is important to note that the ISO 9001:2015 process can take some months to initiate, and would include at this stage merely the drafting of the documentation, and not the assimilation of empirical data which can take months. It can be a lengthy process and there is no quick fix solution.
A company would also need to be mindful that the onerous extent of the documentation for this process normally requires a dedicated resource (person) to manage the system. This would mean that the company would in all probability have to employ someone to carry out these takes.
It is also necessary to stress the amount of training required at all levels of staff in order for the system to make any impact, as internal audits need to be done as well.
What the certification does
9001:2015 certification gives partners and customers the assurance that the company they’re working with has strict processes for ensuring its quality policies are followed throughout the organisation, and that they’ve embraced the concept of quality through continual improvement.
Will this ISO 9001 be of benefit?
Businesses should be mindful that it is a long, and often costly process, and should weigh up all potential benefits and disadvantages specific to the business before embarking on the road to 9001:2015 certification.
Should you require any further information on this subject please contact the regulatory compliance manager, Julian Pillay on 0825606625 or firstname.lastname@example.org