What happens if you fail ISO 9001?

Failing any task can be discouraging as you may begin to fear what happens next. Failing an ISO audit means that you may face the risk of removal of your certified status.

This only happens when an external audit has revealed major non-conformances that organisations have failed rectify. However, failing the ISO 9001 certification audit is a rarity if you follow the proper steps. This article will outline the reasons for failing an ISO audit and the critical grades to ensure that such an event does not materialise.

Reasons for ISO 9001 failure

If the internal and external audits are conducted properly, they will highlight areas that require improvement to achieve compliance.

Therefore, one of the biggest reasons organisations fails the ISO 9001 audit is that they do not carefully read the audit report to understand what is recommended. Some of the common reasons for a failed ISO 9001 audit include the following:

• Loss of key personnel: Some organisations fail ISO 9001 audits when their employees responsible for implementing ISO standards retire or withdraw, leaving a compliance gap. Hence, it becomes essential for your company to fill the position with the new employee when a handover isn’t conducted or create appropriate training to ensure that someone within the ranks rises to the new role. If you want to learn more about the internal audit process, be sure to read the iso 9001 Internal audit article
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• Incomplete quality records: ISO 9001 requirements state that organisations must have a clearly defined quality policy, quality objectives and work instructions that describe how their processes work. Creating these documents may be difficult, so you should not hesitate to hire external resources to help you with this process. We suggest you read the ISO 9001 Documentation page to familiarise yourself with the documents and how to prepare them.
• Inappropriate objectives and targets: An essential part of your Quality Management System (QMS) is to set a series of objectives and targets that help define your business aim. To achieve compliance, these goals are typically aligned with the ISO standard. These targets also help show how financially successful the business is and how it meets its legal, operational and business requirements. Without appropriate objectives, you will not have a management system that systematic. Therefore, you will fail to meet one of the basic requirements of the ISO 9001 standard. If you are not ready with how to define goals, we suggest two ISO 9001 Preparation articles
  And read How to write quality objectives of ISO 9001.

Hence, hiring an individual who can identify training gaps within your organisation and sort your quality records and objectives becomes essential. 

ISO 9001 consultant

ISO 9001 consultants are similar to tutors who provide tuition to students struggling in their Academia. With the help of their customised guidance, even weak students can clear exams. Similarly, with the help of the advice of an ISO 9001 consultant, even those organisations struggling to meet the standard’s requirements can earn the certification process.

Essentially, an ISO 9001 consultant will explain the benefits of the quality management system to the top management and interview process owners within your organisation. By interviewing and observing key personnel within your organisation, the ISO 9001 consultant will be able to identify any compliance gaps. If any compliance gaps have been identified, the consultant will recommend training programmes to enhance the skill set of your existing personnel.

Your ISO 9001 consultant will also review your records to identify ancient documents. After discarding these documents, the consultant will help you create versions of the papers that adhere to the standard’s recommendations. In the same manner, the consultant with sit with members of the top management and process owners who regularly interact with your QMS to create quality objectives and targets that adhere to ISO 9001 recommendations.

A bonus of hiring an ISO 9001 consultant is that they conduct an in-depth gap analysis to identify any lags in your current management system. This reduces any chances of not clearing the certification audit. Hence, in other words, hiring an experienced, well-reputed and specialised ISO 9001 consultant maximises your chances of acquiring the ISO 9001 certificate.

ISO 9001 certification process

When discussing your records, your auditor will look for evidence that you have evaluated your staff competency through a documented training procedure, specified job descriptions, robust recruitment procedures and induction checklists. When you hire an ISO consultant, these role specifications, training procedures, induction checklists and staff handbooks are provided that describe the expected behaviours of staff members. 

Similarly, when discussing objectives and targets, your auditor will look for proof that your business objectives and targets are well documented. When you hire an ISO 9001 consultant, not only will your marks be well registered, but they will also be measurable and realistic.

Having said that, when an organisation clears its internal audits and meets all compliance requirements per the ISO 9001 consultant, it can only apply for an external audit. In the rare chance that areas do not meet the recommendations of the ISO 9001 standard, the organisation is given some time to modify its processes.

In the rare chance that an organisation fails an ISO audit, it will be given detailed information about the reasons for failure and actions required to address them. Addressing these identified nonconformities prepares you for a follow-up or a new audit.

Conclusion

Hiring an ISO 9001 consultant maximises your chances of acquiring your certification. Many organisations fail this certification audit only when they do not interpret their audit report appropriately. Therefore, if you take the appropriate amount of time in your pre-certification steps, you will not fail your certification audit.