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If there is one international standard – of those to have been developed down the years by the International Organization for Standardization (ISO) – that you will have heard of, there’s a good chance that it will be ISO 9001.
For organisations that are serious about improving their operational processes, including achieving greater efficiency and ensuring the optimal approach to quality management, the prospect of incorporating the ISO 9001 standard could be a very attractive and useful one.
But if you don’t want to merely achieve compliance with ISO 9001, but also be certified to this standard, it will help to have a ‘cut out and keep’ checklist to guide you on this journey. So, we have detailed the essentials below.
What is ISO 9001?
When it comes to implementing an effective quality management system, or QMS, within your business’s operations, ISO 9001 is likely to be hugely useful for you.
ISO 9001 is the best-known member of the ISO 9000 family of standards. It outlines the criteria for a QMS, and any organisation can use this standard, regardless of its size or sector. Nor is that merely a claim; today, more than one million companies and organisations around the world are certified to ISO 9001.
Central to the effectiveness and reputation of ISO 9001 is a series of proven quality management principles, including a strong customer focus, the process approach, continual improvement, and the motivation and implication of top management.
ISO 9001 was revised in 2015, and continues to prove its worth in helping organisations to monitor and measure performance across their operations. This, in turn, places such company’s in the strongest possible position to keep on improving their processes and capabilities to ensure the delivery of consistently high-quality products or services.
Why should a business become ISO 9001 certified?
Hopefully, the above will have already given you a sense of why it can be such a good idea to get your organisation ISO 9001 certified. In short, it is a standard that has a proven track record of helping organisations like yours to improve their all-round performance, including through the creation of a business culture that is squarely quality-focused.
This, in turn, will help make potential customers, clients and partners more confident in doing business with you, thereby bringing your business improved sales, revenues, and growth prospects. And, as ISO 9001 is an international standard, it can even be instrumental in opening up new markets for your business around the world that may have previously seemed inaccessible.
12-step ISO 9001 checklist
So, presuming you have decided that your organisation doesn’t wish to merely comply with ISO 9001, but also achieve certification to help further demonstrate its commitment to quality management… what are the next steps? We have set them out below.
Step 1: Leadership buy-in
Given the level of commitment and effort that will be required in order to achieve ISO 9001 certification, it really will be crucial to secure ‘buy-in’ from the most senior people with your organisation. You will need to be sure precisely why you wish to pursue ISO 9001 certification as an organisation, the budget you have for this project, and the impact on your business.
Step 2: Perform a gap analysis
A ‘gap analysis’ is all about formally identifying the gaps in your organisation’s current quality management systems, and the remediation work that will be needed if you are to achieve ISO 9001 compliance. This is likely to be easier if you already carry out regular reviews of your company’s quality management processes.
Step 3: The scope
The gap analysis should produce a series of recommendations that you will then be able to refer to in your formulation of a scope of works. The scope will need to be specific, encompassing all the necessary actions, tasks, and activities to remediate gaps in your current systems, as well as the financials and anticipated timeframe for the implementation of such changes.
Step 4: Implement the QMS and create the QMS manual
An organisation’s quality management system, or QMS, effectively comprises the various mandatory policies, procedures, and processes that the business will be required to enforce, if it is to be sure of delivering quality products and services and optimising business performance.
Following on from this, there will be a need to present the QMS in the form of multiple documents, manuals, and registers.
Step 5: Internally communicate
Once you have put together a QMS policy, the next stage will be to distribute it to your wider organisation. The manner in which you communicate the new QMS throughout your organisation, as well as the commitment your leadership team has to doing so, will be crucial to your efforts to embed the QMS into your business culture.
Not only will your organisation’s existing staff need to be trained in the updated processes, but those joining your workforce should also be given your QMS policy at the onboarding stage. This will all help ensure everyone is quickly well-versed in the various requirements.
Step 6: Create an audit plan
We are now getting to the stage where your system will have been implemented, and your personnel will have had a chance to start getting accustomed to the new or altered procedures.
At this point, you will be able to put in place an audit plan. This should include arranging for internal audits encompassing all your business’s departments, so that any issues and deficiencies can be identified shortly after they emerge, and corrective actions taken.
Step 7: Identify roles and responsibilities
If your organisation is to be successful in achieving the consistently high-quality output that ISO 9001 compliance and certification can help deliver, it will need to ensure accountability. And in order to ensure accountability, your business will need to identify and assign various roles and responsibilities.
Those roles will include a ‘policy/process author’ who will have responsibility for documenting the process, as well as one or more ‘reviewers’ for various processes. ‘Approvers’ will be needed, too, to provide final sign-off once they are satisfied that a given product, service or activity has been completed to a high standard.
Step 8: Refine the QMS and implement system changes
Once you have spent several weeks carrying out internal reviews within your organisation, it is almost certain that you will have pinpointed certain areas for which further refinement is needed.
So, be sure to take the chance in the two or three months prior to your business’s external audit, to iron out problems and put in place any changes that turn out to be necessary.
Step 9: Internally audit
As the term suggests, an external audit is an audit that will be carried out not by your own in-house team, but instead by an independent certification body. It is this external audit that will be required if your company is to achieve certification to ISO 9001, rather than merely compliance.
So, to help prepare for this, take the time now to carry out one more internal audit. It will, in effect, serve as a ‘dry run’ for the external audit that will determine whether you become certified.
Step 10: Apply for stage 1 audit
With all that internal auditing done, it’s time to book your business’s external audit. It might take several weeks for you to complete the application and secure a date for the assessment, so you should be booking the stage 1 audit early enough to account for this.
Step 11: The external audit
Finally, the moment will be reached when an external auditor walks into your business’s premises, and assesses your organisation’s ISO compliance with the QMS.
To help make sure the audit goes smoothly, you should be sure to prepare the office for the auditor’s arrival, ensure documents will be available if and when needed, and have a copy of the QMS manual ready for the auditor as well.
Step 12: Once ISO 9001 certified, now what?
Presuming that at this point you have passed the audit and have secured ISO 9001 certification, you will have the right to display your certification – including on your company website – and promote the fact that you are certified to potential customers, clients, and partners.
But your work will hardly stop there. It will be necessary to continue reviewing, monitoring, measuring, evaluating, identifying, and acting upon risks so that your business’s procedures can remain optimised, and your organisation can retain its hard-won ISO 9001 certification.
Continued internal audits will also be needed, as will external audits – and if your organisation fails the latter, its certification will not be renewed going forward.
Using software to help manage compliance
Phew! As you can see from all the above, there is a lot involved in achieving ISO 9001 compliance and certification, even if it is also true that the benefits of securing certification can make your exhaustive efforts more than worthwhile.
Your organisation is also, though, likely to be greatly appreciative of access to specialised technology that can help take the hassle, stress, and inefficiency out of the process of achieving ISO 9001 compliance and subsequent certification.
To learn more about how our own Vision Pro platform could assist you in better managing your business’s efforts to comply with ISO standards such as ISO 9001, please do not hesitate to reach out to our team, by calling us today.