Internal auditing is required by the ISO 9001 standard, and the internal audit program is a self-check mechanism which companies use to periodically verify that they meet ISO 9001 requirements. But audits are not only necessary to maintain ISO certification, they’re also a powerful tool for improving the effectiveness of the quality management system (QMS) and the efficiency of operational processes.
As important and useful as internal audits are, some business owners dread them. There are company owners who believe that ISO 9001 internal audits merely duplicate the work of registrars. For them, internal audits represent a waste of resources and an unnecessary disruption of regular work activities.
Other business owners have a more pessimistic outlook and view internal auditors as a kind of business police force, hiding essential data and sometimes outright lying to maintain the illusion of compliance. However, companies make their ISO 9001 internal audit program a police function to enforce compliance. This may satisfy ISO’s requirements – but it’s the loss of a great opportunity.
The truth is that these criticisms are only justified if the ISO 9001 internal audit program is incorrectly implemented. In fact, well-set-up ISO audit program could be leveraged to become one of the most powerful tools to improve your business.
Internal audits are mandatory, but why not do them in a way that maximizes the return for your business?
I believe you can really add value from a well-planned and maintained audit system. I’ll explain what ISO 9001 internal audits are, how to benefit from them, and what you need to do to ensure compliance.
My following tips will help you improve your internal audit processes and change the primary focus from identifying non-conformances to discovering opportunities for improvement.
💡 Tip 1: Involve More People
Knowledge is a key asset of your business. Systematically distributing it internally can strengthen your organisation and drive improvement.
Nominate an Executive Champion – By appointing a member of Top Management as the champion of the internal audit program as opposed to the Quality Manager or a Lead Auditor, the organisation can send a strong signal to employees that the internal audit program is of high importance. Nominating a single executive doesn’t excuse other managers from getting involved, but it does provide a focus and single point of accountability.
This champion should: Visibly support the audit program through regular communications about the program, holding updates on its performance and obtaining and assigning resources.
Appoint more Internal Auditors – Rather than have a limited number of internal auditors, train as many willing employees in audit techniques as you can. Not only does this approach spread the load, but the organization can also plan a higher number of smaller, more focussed audits that take less time, reducing the downtime for both auditors and the area getting audited.
Training more internal auditors also results in a higher number of employees with knowledge in the requirements of ISO 9001:2015 and the organization’s quality management system (QMS). In addition, the more auditors from different parts of the organization, the higher the opportunity for cross-departmentation ideas. And don’t restrict the pool of internal auditors to more experienced employees. Train newer recruits and use audits as a way to familiarise them with relevant departments.
Have Mentors (Buddy System) – Once an organisation has a team of trained and experienced auditors, they can introduce a mentoring process or buddy system to boost the number of internal auditors and support new trainees. A mentor (or buddy) provides support for the new auditor to prepare for their audits and transfer knowledge and facilitates beneficial networks that share a focus on improvement.
The buddy system can work outside the official hierarchy. For example, someone in production might mentor someone in sales, helping the auditor to interpret the requirements of the standard for an area they may not otherwise know.
Getting everyone involved with identifying areas for improvement and creating solutions is an excellent way to increase staff ownership of their role in the QMS and creates a positive environment that benefits employees and encourages them to remain with an organization long term.
💡 Tip 2: Add Problem Solving Techniques to Auditor Skills
Training internal auditors in problem-solving techniques and encouraging them to apply them during audits will result in a deeper insight into the real or root causes of non-conformances. Solutions that address root causes will be more effective and sustainable.
Without taking the time to identify the underlying problems, the organization may find itself addressing symptoms rather than the real issues. Here are several methods that an auditor can use to analyse problems better and ultimately arrive at more effective solutions. These include 5 Whys, Flowcharts, Cause and Effect Diagrams and Mind Mapping etc.
💡 Tip 3: Go Beyond Compliance
Rather than focus solely on compliance during internal audits, make the identification of potential improvements the primary aim. Just because an area is doing what the documents say it should, doesn’t mean it’s the right thing to do it or the best way to do it.
Moreover, if an employee isn’t doing what their work instructions say they should, they might have an excellent reason for not doing so. Rather than focus on the fact that they’re not complying, ask them questions like:
- What frustrates you about this process?
- Why are you doing this task the way you are?
- How would you do this better?
- If you can’t make the changes, who can?
Conducting process audits rather than procedural audits promotes a much stronger focus on organisational effectiveness. Instead of following an activity from input to output, a process audit tries to determine whether the tasks, resources and behaviours are managed efficiently to generate the end result, and whether the result matches the planned objectives.
You can gather so much data from a process audit and from that can do deep dives on say your sample size i.e., 5. You can select five pieces of equipment, check 5 maintenance records, 5 calibration records, last 5 production batches, 5 performance measures, 5 competence records of operators and loop back to 5 controlling schedules etc.
The key to enabling this approach is to use forms and checklists that cover the requirements of ISO 9001 but can easily be customized and expanded to incorporate a process approach.
💡 Tip 4: Use Audit Findings for Improvement Projects
When an audit reveals significant problems, use the outcome as an opportunity to involve auditors and auditees in a project to identify the root cause, devise solutions and then assess the effectiveness of changes. Rather than limit the auditor’s responsibilities to carrying out the audit and follow-up of corrective actions, get them involved in helping to resolve the problem. Their expertise in quality improvement methods and the requirements of the ISO 9001 standard, along with their independence of the process and their different perspective, may result in more robust solutions than if the work area is left to find a solution in isolation.
If the problem is apparent across more than one area, create a cross-functional team to develop effective, organization-wide changes – you already have process and improvement experts in your team – make sure you use them.
💡 Tip 5: Show the Effectiveness of the Audit Program
When problems are identified during an internal audit, the work area should gather baseline data before implementing a solution. Once the data has been collected, improvements can be devised, applied and their impact measured. By comparing the new measurements to the baseline, you can verify that the changes have made a positive impact. The data can then be communicated throughout the organization as proof that the audit program is providing value, consequently increasing motivation and enthusiasm for the audit program, and encouraging involvement.
Providing data to back up the need for changes is one factor in keeping staff engaged with the QMS and providing increased job satisfaction.
This type of evidence-based decision making is one of the seven underlying principles of the ISO 9001:2015 standard. And even though it’s not explicitly mentioned in the internal audit clause, this principle should be factored into the corrective action and follow-up stages of the audit process.
💡 Tip 6: Recognize and Reward Those Who Contribute
Encouraging involvement in, acceptance of, and support for internal audits are vital for the long-term sustainability and success of the audit program. Communicating the positive outcomes and benefits that result from the program is one way of ensuring this.
For example, if an auditor identifies a problem related to product quality and the department manager subsequently devises a solution that decreases customer complaints, the organization can communicate these results along with the methods the team used to diagnose the problem, identify the solution, and verify the success. In that way, the rest of the business learns from the process and is more likely to be enthusiastic about achieving similar outcomes in their areas.
This type of recognition and reward creates a positive feedback loop and offers encouragement and incentive for everyone to play a part in the audit program and help develop a culture of improvement. Recognition might be as simple as highlighting the employees in the company newsletter or sending a note of appreciation from the CEO, right through to monetary rewards and formal awards ceremonies. Speaking from experience, I have previously worked in a system like this, and it worked really well!
Conclusion
When applying the ISO 9001 requirements for internal audits, companies can either do the bare minimum to comply with the standard (!) or they can invest in their system and people to create a framework that adds significant, long-term value and becomes the cornerstone of their continuous improvement efforts, sustainability, and business success.
