A business doesn’t pass or fail an ISO 9001 audit as such.
An audit detects major non-conformances that need to be addressed before a business can achieve certification.
Sometimes an audit uncovers an issue with QMS non-compliance that management wasn’t aware of.
So, if your business has “failed” an ISO 9001 audit, consider it an opportunity to improve compliance.
Common reasons for failing an ISO 9001 audit
There are many reasons why a company might not meet all the requirements for compliance with ISO 9001.
Here are some of the most common reasons you should be aware of.
Loss of key personnel
If the staff member who is responsible for meeting ISO requirements for quality management leaves the business it can lead to gaps in compliance.
This is especially true if there isn’t a handover to a new employee.
If no new employee joins the company, those responsibilities must be reassigned to another person.
Changes to the ISO 9001 standard
Although rare, updates to ISO standards do happen.
After an update, companies have three years to meet the new requirements.
It’s possible for companies to fall short if they run out of time or don’t have the necessary expertise.
Lack of objectives and targets
Your QMS needs to set clear objectives and targets for constant adherence and improvement.
These must be well documented and monitored to identify issues with compliance.
An audit will look for these records as well as evidence that any issues were addressed.
Incomplete training or qualification records
An audit will look for documented proof that staff members have been trained and possess the skills to do their jobs.
These records should include defining job descriptions for each position, induction checklists and a staff handbook.
Failed internal audits
All companies should self-audit in order to identify issues with their QMS procedures or systems.
An ISO 9001 auditor will want proof of these audits and the results.
If audits are missed or the results are negative, this can impact the outcome of an external audit.
Management reviews
Companies must document their management reviews and keep minutes of these meetings.
Failure to do so could negatively affect your audit.
The auditor will assess the process of these reviews as well as the schedule for performing them.
What happens if you fail an external ISO audit?
Fortunately, it’s easy to recover if you fail an external ISO audit.
If your audit uncovers non-conformances, the auditing body will give you time to rectify these errors and present evidence of these corrections.
Once the auditor has seen that evidence, the audit will be reviewed.
Assuming the new evidence meets the criteria, the status of your audit will be changed to compliant.
What to do next
Failing an ISO 9001 audit provides an opportunity to improve and learn but it shouldn’t happen regularly.
This is a symptom of incomplete or inadequate QMS procedures and policies.
Following a failed audit, you should do an internal review of your QMS.
This should include the departments and personnel involved with quality management.
Reviewing your current QMS will help identify areas that can be improved and weak areas that might become a problem.
Any changes to your QMS must be communicated to the rest of the team or you risk non-compliance in the future.
How isoTracker’s auditing software can help after an ISO audit failure
An internal audit is one of the best ways to prepare for an external ISO 9001 audit.
Our auditing software helps your company ensure internal audits are sufficient and frequent enough.
It can also help you become compliant if you fail an external audit and show you what to do next.
Our auditing software forms part of a larger modular and fully integrated QMS software suite of products.
All these modules are designed to help companies simplify and improve their ISO 9001 compliance and overall quality management.
Contact us to find out more or sign up for a free 60-day trial.
