What Are the Most Common Causes of ISO 9001 Non-Conformance?
In this article, we’ll look at some of the numerous causes of ISO 9001 non-conformance, including:
- Lack of employee training
- Inadequate management commitment
- Ineffective process controls
- Insufficient documentation
- Resistance to change
- Poor communication
What is ISO 9001?
ISO 9001 is an international quality management system (QMS) standard. The International Organization for Standardization (ISO) publishes the standard. This international agency comprises the national standards bodies of over 160 countries.
Organizations primarily use the standard to show that they can consistently provide services and products that:
- Meet customer requirements.
- Adhere to regulatory standards.
Organizations use this standard more often than others and can only certify to it and none of the others.
What is ISO 9001 Nonconformity?
Clause 10.2 of ISO 9001:2015 states that nonconformity happens when the organization fails to meet the requirements of mandatory clauses.
Nonconformity can refer to a regulatory body’s requirements, the organization’s internal requirements, or even the requirements of the business’s customers.
People can therefore cause nonconformity by things like:
- Not following the company’s internal procedures.
- Not upholding the quality standards.
- Not taking the actions required to satisfy customers.
If the company does not follow ISO 9001 requirements, it must take several actions that the standard defines.
What Are Common Causes of ISO 9001 Non-Conformance?
Failure to Document Processes and Insufficient Record-Keeping
Nonconformity is often the result if processes are not documented at all, or if the documents are inadequate. These processes could relate to the ISO 9001 standard or internal company processes and procedures. Even processes that seem simple at first can contain intricacies that people have learned over time and take for granted.
This often becomes apparent if someone has been executing the process for years and then hands it over. The organization may have documented the process when it was first implemented. However, it may have then made subtle changes later to optimize the process, but never documented these changes.
An organization also often only documents a process once it has been running for a while. The person responsible for it must then produce the document. A person familiar with the process may however find some steps obvious and doesn’t include them in the document.
ISO 9001 compliance requires proper record-keeping and documentation. Failing to do this will result in errors and inconsistencies in implementing a QMS. To prevent this, organizations should establish a document control system that defines the procedures to create, update, and archive documentation. Organizations also need to review and update their documentation regularly to ensure it stays accurate and relevant.
Inadequate Training and Awareness
Even if a process has been documented thoroughly and accurately, expecting someone to follow the process based purely on the document is unrealistic.
One of the many advantages of creating and implementing process documentation is to simplify the onboarding process for new employees to ensure they have a detailed understanding of their roles and responsibilities.
Another cornerstone of onboarding new employees is however training. This should cover:
- What does an employee need to know how to do?
- What resources and tools do they need to optimize their learning?
- How will you assess their performance?
Process documentation would be one of the resources made available to new employees so that they can meet quality objectives and minimize non-conformance. Although less training will be required if documentation is available, it can’t be eliminated.
Employees at all levels should be made fully aware of the company’s QMS, as well as their responsibilities within the framework, with the focus being on those that relate to meeting quality objectives. Insufficient training and lacking awareness can easily lead to non-conformance.
An organization should therefore provide comprehensive training programs and continuous learning opportunities to ensure that employees remain informed about the latest ISO 9001 requirements and best practices.
Inadequate Commitment from Management
Without a strong commitment from the C-suite, successful implementation of ISO 9001 is not very likely. Top management not being fully invested in the process often leads to poor implementation of the QMS, ineffective communication, and inadequate resource allocation.
To overcome these issues, top management must demonstrate their commitment by ensuring that necessary resources are provided, setting clear objectives, and participating in the QMS development actively.
Ineffective Process Monitoring and Control
One of the ISO 9001 requirements is that organizations should define and implement processes aimed at meeting quality objectives. Ineffective process monitoring and control can lead to non-conformance. An organization should implement effective process control systems, including using KPIs (key performance indicators) to monitor and measure performance. Regular management reviews and internal and external audits should also be undertaken to identify areas that can be improved and ensure that the QMS is operating as required.
Poor Coordination and Communication
For ISO 9001 implementation to be successful, effective coordination and communication among various organizational functions and departments are critical. Poor communication can result in non-conformance, duplication of efforts, and misunderstandings. To prevent this from happening, an organization should encourage cross-functional collaboration, promote a culture of open communication, and establish clear communication protocols and channels.
Resistance to Change
Implementing an ISO 9001 Quality Management System often leads to an organization changing its existing systems and processes significantly. Resistance to change can hamper the implementation of a QMS and result in non-conformance. To prevent this from happening, the organization should provide support and training to help employees adapt to the new reality, communicate the benefits of the changes, and involve employees in decision-making processes.
Causes of ISO 9001 non-conformance can vary from things like lack of employee training, inadequate management commitment, ineffective process controls, insufficient documentation, resistance to change, and poor communication.
When the organization recognizes and addresses these issues, it can achieve ISO 9001 compliance, improve its QMS, and enjoy the benefits of enhanced business growth, customer satisfaction, and performance.
Using nonconformance reporting software can go a long way towards making this process easy and effective.