ISO 9001 certification isn’t achieved overnight, but for those willing to invest the necessary time, money and resources, compliance can be very beneficial.
ISO 9001:2015 is the internationally recognised standard for quality management. The criterion of ISO 9001 certification is set out in practical, adaptable guidelines.
More than one million organisations in over 170 countries are ISO 9001 compliant. These figures clearly represent a key benefit of ISO systems, being that they can be seamlessly applied across various sectors and countries.
In the modern business landscape, there’s an extremely diverse range of companies, each with their own unique processes, needs and goals.
In many cases, an organisation will be vastly different from their competitors, let alone those operating in completely different sectors. ISO 9001 quality management systems cater for this, so regardless of your business’ size, location or field, you can improve the quality of your systems and achieve certification.
How is ISO 9001 Structured?
If you’ve decided to pursue ISO 9001 certification, or you’re looking to maintain your existing compliance with the standard, understanding its’ structure is crucial.
By building a sound comprehension of the framework itself, you can set your business up for certification success well into the future.
Making improvements you see fit and hoping for the best is a shot in the dark and, in the majority of cases, it simply doesn’t work. Your compliance efforts need to be highly targeted and precise, so that during the certification process, the time, money and resources you’re investing are well spent.
The ISO 9001 framework is an invaluable resource, guiding you in the development of quality management systems that are closely aligned with standard requirements.
ISO 9001:2015 comprises ten core clauses, each detailing a different component of what it takes to get (and stay) compliant. This amended version of the standard differs from the guidelines of ISO 9001:2008, which only had eight clauses in total. There are, however, still areas of overlap between the two, as can be seen below.
|ISO 9001:2008||ISO 9001:2015|
2. Normative References
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realisation
8. Measurement, Analysis and Improvement
2. Normative References
3. Terms and Definitions
4. Context of the Organisation
9. Performance Evaluation
It is incredibly important that you approach meeting the requirements of these clauses from the point of view of what works for you as a business. Not the other way around. Always ask yourself, how can we meet this requirement within the context of our business?
Everyone in your company has a distinct role in your business’ achievement of ISO 9001 certification, regardless of their position. Staff members need to not only be aware of this but also be provided with the required training to perform their role accordingly.
Getting your team committed to the setting up and improvement of excellent processes organisation-wide can, in the long-term, drive brilliant, maintainable results and set your business apart in the market and in the minds of customers.
The Importance of Conducting ISO 9001 Internal Audits
After successfully reaching their certification objectives, many organisations fall into the trap of taking a step back from their efforts. They’ve already become ISO 9001 certified, so they can just “set and forget” – right?
While this might be a tempting route to take, such approach can be damaging to a business’ ability to maintain long-term results. You may save time and money in the near future, but if you want to stay ISO 9001 compliant, you’ll likely encounter costs later on that outweigh your initial savings.
This is because, when quality management systems aren’t actively maintained, organisations typically need to put far more resources into staying ISO 9001 compliant down the line. Beyond this, when it comes time to review your quality management systems, if they fail to meet the standard guidelines, you risk losing your certified status.
This is just one of the many reasons why periodically conducting ISO 9001 internal audits is crucial if you want to get the most out of your ISO 9001 certification. Internal auditing is a great way to regularly monitor your company’s ongoing level of compliance, so you can promptly identify and address any areas of concern.
A key aspect of maintaining your business’ ISO 9001 certification is, of course, continually looking for opportunities to improve existing systems. ISO 9001 internal audits act as a systematic self-check mechanism, helping you identify downfalls and build a realistic, enforceable plan-of-action for improving existing quality systems.
If your organisation is looking to establish clear direction and greater conformity with ISO 9001 standard guidelines, internal auditing may be the ideal solution for you.
The Core Stages of ISO 9001 Internal Auditing
Typically, there are two key stages of an ISO 9001 internal audit:
- Document Review
- Process Review
Whether you’re conducting your internal audit in-house or outsourcing, ensuring a clear, thorough process is followed is crucial. This will, ultimately, help you make sure that no essential components of your quality management systems are overlooked.
Beyond having compliant systems in place, organisations aspiring towards becoming ISO 9001 certified need the documentation to back up their processes. Once this has been checked and confirmed by your internal auditor, they need to move onto looking at your quality management systems themselves.
The review of an organisation’s processes is the main component of an ISO 9001 internal audit, as it involves assessing their actual activities against relevant documentation and the standard guidelines. During this stage, the role of internal auditors is to pinpoint any discrepancies and ensure that, before ISO 9001 certification is granted, systems are in line with the compliance requirements.
ISO 9001 Internal Auditing: In-House vs Outsourcing
Once you’ve established that your organisation needs to conduct an ISO 9001 internal audit, the next step is determining which route to take: in-house or outsourcing.
There are, of course, benefits to each approach. Thus, your final decision will need to be based on your specific organisation’s circumstances, context and capabilities.
While hiring a dedicated internal auditor may be preferable for some companies, for others, this may simply not be a viable choice. This is primarily because of the cost associated with such option, including that of a salary and any required training. Thus, it’s typically only particularly established organisations that have the means to appoint a full-time auditor or audit team to monitor their quality management systems.
However, if you’re considering hiring one or more auditors internally, it’s important to note that they can only evaluate compliance in areas of the organisation that they haven’t been directly involved in. This means that they aren’t permitted to audit areas for which they are responsible or those where they’ve completed the work in question.
Alternatively, if this approach isn’t suited to your organisation, you may decide to outsource this service from an independent establishment. This can be preferable for many reasons, including the following:
- Unbiased Appraisal
- Outside Perspective
- Specialist Knowledge
- Cost Reduction
- Greater Staffing Flexibility
The Benefits of Conducting an ISO 9001 Internal Audit
If you’re still tossing up whether or not to complete an ISO 9001 internal audit, the following benefits are definitely worth taking into account.
An ISO 9001 internal audit can help you:
- Identify discrepancies between your existing quality management systems and the ISO 9001 standard guidelines;
- Develop a systematic, strategic action plan to address any non-conformances;
- Improve efficiencies and optimise your organisation’s allocation of resources;
- Establish systems for proactively pinpointing potential risks or threats, so that your business can avoid their detriment down the line;
- Increase accountability across all organisational levels;
- Reduce waste where possible.
Our Top Tips for Nailing Your ISO 9001 Internal Audit
Ready to get started with your ISO 9001 internal audit? Make sure you’re prepared by getting familiar with our top tips first:
1. Appoint the right auditors
Whether you appoint auditors within your organisation or seek out assistance from specialist consultants, ensuring you’ve got the right person for the job is crucial.
Your internal auditor or team of auditors need to have strong analytical skills, an advanced understanding of the ISO 9001 guidelines and the ability to give impartial advice. Beyond this, you’ll benefit from choosing someone who’s trustworthy and good with people, as they’ll be regularly working with various members of your organisation to improve systems.
While it may be tempting to rush into things, make sure you’ve done your research first. That way, you can get the most out of the internal auditing process, as you’ll have a thorough, competent individual leading your team towards certification success.
2. Be Prepared to Accept Constructive Criticism
If you’re not willing to take on the professional advice of your auditing expert or, at the very least, consider the points they raise, you’ll likely get very little out of the process.
It’s important to go into your ISO 9001 internal audit with an open mind, otherwise the time and money you invest in the cause will be all but redundant.
This is why appointing an auditor that you trust is essential. You may not always enthusiastically agree with everything they suggest but, if this is the case, don’t be afraid to ask why they’ve made certain proposals.
Remember that your auditor is there to help you achieve ISO 9001 compliance and, thus, they’re going to give objective advice to assist you in reaching this objective.
Interested in Conducting an ISO 9001 Internal Audit?
For more information about the topics discussed in this article, please get in touch with our team of ISO 9001 internal auditing specialists today. With extensive experience in a diverse range of industries, we have the knowledge and expertise to help you achieve your compliance objectives.