Quality professionals acknowledge the importance of passing a relevant ISO certification audit, but despite their best efforts, it can often be a challenge to ensure that the rest of an organisation follows suit. It is therefore paramount that a business is in sync to meet these discipline specific standards to demonstrate that the minimum requirements are being implemented at the very least.
As ISO standards are acknowledged for protecting consumers, companies and their respective sectors, it makes meeting these conditions a priority for organisations across the board. However, not meeting these standards, by failing an ISO 9001 audit for example, can lead to both financial and reputational damage that can take a substantial amount of time to rectify. Thankfully, failing an ISO audit can easily be amended with the correct approach.
In this blog, we outline the key information to help you ensure that your business is aligned when preparing for an ISO certification audit, including:
- The costs of a failed audit
- How to pass certification audits
- How to ensure conformance in the future
Firstly, it is crucial to understand the procedure should you fail an ISO audit.
What is the procedure to follow if you have failed an audit?
If you fail an audit, by demonstrating ISO 9001 non-conformance for example, you may be required to take additional steps to meet the standard. The adjustments required would depend on the level of non-compliance which include:
- Minor nonconformity – A failure to fully comply with a requirement which is not likely to result in management system failure. However, this can prevent certification or re-certification if there are many minors in the same area or if minors are endemic in all areas of the business.
- Major nonconformity – Prevents certification as it represents an absence or total breakdown of a system designed to address a specific requirement, or several minor non-conformances related to the same requirement.
After failing an ISO audit, you would be provided with key information on where the nonconformities were found. Once these have been outlined, you will be required to design a corrective plan and submit this to the Certification Body for their approval.
What are the costs of a failed ISO audit?
Senior management failing to commit to ISO requirements can lead to conformance not being embedded into the business. Simply put, the company has not followed the clauses set out in the standards.
But what is the real cost to your business when you fail an ISO certification audit?
Of course, there is the initial direct cost for the auditor’s time. However, it’s the lost opportunity cost which really hits your bottom line.
Here are the six associated costs of failing an ISO audit:
- The new business cost: What percentage of your new business requires certification for certain ISO standards? ISO 9001:2015, for example, is a common requirement for many high-value tenders. Without certification, your organisation loses credibility.
- The loss of existing business cost: If you have failed a re-certification audit, your customers may no longer be able to work with you if you are not certified to the standards their business requires as part of their supplier assessments.
- The reputation cost: ISO certification is crucial for competitive advantage. Losing certification or failing to achieve certification to an ISO standard can hold your business back as your stakeholders can form a negative opinion of you for not making the grade.
- The efficiency cost: The clauses in the standards set out minimum requirements that you must implement. In terms of efficiency, however, your quality management system should be low cost, demonstrate high performance and provide the right outcomes.
- The morale cost: How long have you worked on your policies and procedures? You want an ISO certificate to prove it! But ISO certification requires teamwork and cannot be just one person’s work. Failing an ISO audit has an impact on your team morale which has associated costs of loss of productivity.
- The compliance cost: There are standards such as ISO 13485, a medical device standard that meets the comprehensive requirements for a QMS. This aligns with many global regulations, making it easier to sell products to a global marketplace. Costs will increase if there is not certification to demonstrate the organisation is already compliant.
How can you pass your certification audits?
Avoid the unnecessary costs to your business and pass your ISO certification audits by implementing the following 5 steps:
- Streamline the operations of a management system with an integrated ISO software management tool. Ensure important documented information is managed and that system performance data is readily available. Take much of the hard work out of running the system and leave your staff with the time to focus on more value adding elements of the management system.
- Implement policies, procedures and processes which are robust, collaborative and well tested.
- Ensure leadership at all levels of the organisation are engaged and working to support the system, not acting to subvert it.
- Read the standard and follow it!
- Make continual improvement part of your culture.
How can you manage your ISO audits?
Ideagen’s ISO compliance software is used by organisations in some of the world’s most regulated industries and allows you to manage and maintain ISO standards.
When faced with an audit to prove your quality credentials, our software provides everything required to simplify, maintain and strengthen your ISO conformance.
Our software offers impressive features that allow you to:
- Manage your ISO responsibilities from a single source of truth
- Build a powerful baseline for multiple standards
- Meet your auditors’ expectations
- Grow your business and stay ahead of your competitors