Internal auditing of quality systems is a mandatory requirement for organizations hoping to certify their management based on the ISO 9001 standard. When auditing the Quality Management System, the organization verifies compliance with the requirements of the standard.
This is especially important before you get to the certification audit. The internal audit of quality systems evidences problems that can be solved before facing the external auditor and that, in fact, would be uncomfortable if they appeared at that critical moment.
But internal auditing of quality systems based on ISO 9001 also offers benefits after the system obtains certification. The reports of an internal auditor generate confidence in Senior Management and promote the continuous improvement of the System, which is a requirement of the standard.
How To Perform The Internal Audit Of Quality Systems Based On ISO 9001?
These types of evaluations can be carried out by internal auditors, trained within the organization. These professionals may be dedicated to that single function or this may be an accessory task to others, as is often the case in small organizations.
Internal quality auditors, experienced or novice, will find interesting a decalogue of recommendations to get the best out of an internal audit of quality systems based on ISO 9001:
1. Prepare and plan
Conducting an audit of an ISO 9001-based QMS requires time, availability of some employees, technological resources and a plan. This involves designing a schedule, ensuring the presence of the employees who will be interviewed, alerting those who must provide documentation or reports, guaranteeing the allocation of devices or other types of technological resources…
All this is part of the work plan. Planning is done according to the scope and objective of the audit. This can be just for one area, limited to certain requirements of the standard, or general, addressing all the chapters of the standard.
2. Prepare the questionnaires
Evidence collection is carried out using various methodologies. Document inspection is one of them, as well as interviews with employees who own key processes.
Many auditors, especially those with insufficient experience, have problems with interviews. A recurring reason for this is the lack of preparation of questionnaires.
Interviewees perceive the auditor’s lack of preparation. Questions should be precise, consistent and process-related. It is important to work in the writing, avoiding inquisitive and intimidating questions. In some cases, it is enough to request a description of how the process is carried out on a daily basis.
3. Collect evidence of conformity, not evidence of guilt
Auditors may be tempted to try to find culprits and treat them as violators. The goal of internal audit of quality systems is to gather evidence of compliance with system requirements.
Within that process you will find problems, nonconformities and other findings that, of course, must be reported and documented, but not judged or censored by the auditor. It is not the time, and it is not the competent person to do it.
4. Follow the program
The work plan, schedule, and checklist guide the internal auditor during the evaluation. Auditors often encounter problems that open other paths.
This is not a bad thing. But it’s important that those findings are mentioned and another audit is scheduled to explore those possibilities. In the current audit, the evaluator must adhere to the program, the plan prepared, the schedule and the specific scope and objectives of the moment.
5. Be empathetic with auditees
It is common for auditors to assume a dominant position over their auditees and establish barriers that hinder communication. Auditees are often intimidated by the practice of an audit simply because it is an evaluation of their work and a search for poorly executed problems or procedures.
It’s natural for employees to feel inhibited and self-conscious. An unempathetic auditor doesn’t help much at that time. The result is a blockage that prevents useful statements from being obtained to identify problems or to obtain evidence of compliance. Employees need to feel comfortable with the auditor and have the freedom to express what they think and what happens on a daily basis while carrying out their tasks.
6. Do not argue with the auditees
Empathy problems don’t always come from the auditor. It is fair to recognize that there are employees who do not take the audit very well. But the responsibility for professionalism and mastery of the situation falls on the auditor. He is the professional who is obliged to maintain control. Before falling into an argument or an exchange of heated voices, it is prudent to take note to include a gloss in the audit report.
7. Take appropriate notes
In the previous three councils, the auditor is invited to take notes and record them in the audit report. The ability to take good notes, which will then be the target of another audit, or trigger useful investigations to improve the system, is a skill that adds high value to the work of a quality internal auditor.
Notes should be appropriate, clear, reasoned and concise. Good grades generate future audits relevant and important to the overall purpose of this task: to obtain the continuous improvement of the system.
8. Hold an audit closing meeting
Some auditors do not consider the audit closing meeting essential. For the auditees, for the organization, for those in charge of the Quality Management System, and for the auditor himself, it is an opportunity to reinforce concepts, strengthen ties with the auditees, explain some points that could remain unfinished or clarify findings.
Many auditors take the opportunity to explain the reasons why certain events will be part of the final report, and that this does not take the auditees by surprise, generating disagreement or rejection towards the auditor’s work.
9. Produce the internal audit report of quality systems early
The distance in time, between the time the audit is carried out and the moment the final report is presented to Senior Management, is inversely proportional to the effectiveness of the activity.
The longer the time, the less efficient. Ideally, final reports of the internal audit of quality systems should be delivered the day after the closing meeting is held. 48 hours are acceptable.
10. Follow up on the implementation of corrective actions
The internal audit of quality systems does not end with the submission of the report. The auditor must monitor and follow up on the implementation of the corrective actions indicated in the reports to Senior Management.
Corrective actions are not always about solving problems. Some of them seek to improve management, which, it is reaffirmed, is one of the objectives of the internal audit of quality systems.
Digital Transformation, which leads to the automation of Management Systems, facilitates the performance of internal audits and the production of effective reports. Improved quality management is thus only a natural consequence. Training is another essential element.