ISO 9001 common non-conformance examples and How to Address Them
Introduction: In this article, we will explore the prevalent non-conformances frequently encountered during ISO 9001:2015 quality management system audits. These common issues have been compiled from experiences, and categorized by the relevant clauses or sections of the standard. By addressing these non-conformances, organizations can enhance their compliance with ISO 9001:2015.
Clause 4: Identification of Interested Parties and Process Monitoring One significant change introduced in the 2015 version of ISO 9001 is the requirement to identify and define interested parties. Unfortunately, many organizations are falling short in this regard. It is crucial for your organization to meet this new requirement. Additionally, in Clause 4, we find that many companies are struggling to fulfill the requirement of monitoring and measuring processes. Ensuring your processes are adequately monitored is essential for maintaining the quality management system's effectiveness.
Clause 6: Planning Actions for QMS Changes and Risk Evaluation Another noteworthy addition in ISO 9001:2015 is the requirement for planning actions when making changes to the Quality Management System (QMS). Many organizations are failing to comply with this requirement. Furthermore, auditors are frequently discovering issues with organizations properly evaluating risks. It is imperative to evaluate risks comprehensively across your entire organization, including areas often overlooked, such as warehouses and external factors.
Clause 7: Accuracy in Measurement Devices and Record-Keeping Accurate measurement devices are mandatory in Clause 7. Organizations must ensure they use appropriate measuring tools to avoid inaccuracies. Additionally, maintaining records of training, education, and ongoing findings is essential. This record-keeping helps track progress and compliance with ISO 9001:2015 requirements.
Clause 8: Control of Operations and Vendor Approval Clause 8 focuses on the control of operations, and auditors frequently identify issues with first-piece and receiving inspections. It is also essential for organizations to have a robust process for approving vendors and eliminating those that do not meet ISO 9001:2015 requirements. Many organizations neglect to define the materials involved in their processes, leading to non-conformances. Prior to audits, organizations should thoroughly examine their operations to ensure compliance with requirements.
Clause 9: Internal Audits and Risk Mitigation Despite language changes, internal audits in Clause 9 have remained largely consistent between the 2008 and 2015 versions. However, auditors often discover organizations failing to meet the requirements, with common shortcomings including the lack of addressing risk mitigation or actions related to QMS performance. It is crucial for an organization's internal auditor to identify and address these shortcomings.
Clause 10: Non-Conformances and Corrective Actions, Including Customer Complaints Clause 10 addresses non-conformances and corrective actions, with the added inclusion of addressing customer complaints in ISO 9001:2015. While customer complaints are often recorded, organizations frequently fall short of meeting the requirements due to a lack of defined corrective actions. It is vital for organizations to establish clear processes for addressing non-conformances, including those arising from customer complaints.
Conclusion: By recognizing and addressing these common non-conformances in ISO 9001:2015 quality management systems, organizations can enhance their compliance, improve their processes, and ultimately maintain a robust and effective QMS. Regular self-assessment and proactive measures will contribute to long-term success in meeting ISO 9001:2015 requirements.
Reading sources:
Here are some reading sources that can provide further information on common ISO 9001:2015 non-conformances and how to address them:
- ISO 9001:2015 Standard:
The primary source is the ISO 9001:2015 standard itself. Reading the standard will provide you with a comprehensive understanding of its requirements and how to comply with them. You can obtain a copy of the standard from the ISO website or through your national standards body.
- ISO.org:
The International Organization for Standardization (ISO) website (www.iso.org) offers a wealth of information and resources related to ISO standards. You can find articles, guides, and publications specific to ISO 9001:2015 and its implementation.
- ISO 9001:2015 Handbook:
Consider reading handbooks or guides specifically written to explain ISO 9001:2015 and its practical implementation. Such resources often provide insights into common non-conformances and tips on how to address them.
- Quality Management System Books:
There are numerous books available on quality management systems and ISO 9001. Look for reputable authors who discuss ISO 9001:2015 compliance, non-conformances, and corrective actions. Some recommended books include "ISO 9001:2015 Explained" by Charles Cianfrani and "ISO 9001:2015 Internal Audits Made Easy" by Ann W. Phillips.
- Industry Journals and Magazines:
Industry-specific journals and magazines often feature articles on ISO 9001:2015 implementation and common challenges faced by organizations. Examples include "Quality Progress" and "Quality Digest."
- Online Forums and Communities:
Participating in online forums and communities related to quality management and ISO 9001 can provide practical insights and real-world experiences from professionals and organizations. Websites like LinkedIn and specialized forums like Elsmar Cove can be valuable resources.
- Training and Certification Courses:
Consider enrolling in ISO 9001:2015 training and certification courses offered by accredited organizations. These courses often cover common non-conformances and best practices for compliance.
- Consulting Firms and Auditors:
Consulting firms and ISO auditors often publish articles and case studies related to ISO 9001 implementation. Their websites and publications can be excellent sources of information.
- Regulatory and Accreditation Bodies:
Check with your local regulatory and accreditation bodies, as they may provide guidance documents and resources related to ISO 9001 compliance and common non-conformances.
Remember to verify the credibility and relevance of the sources you consult, as ISO standards and quality management practices may evolve over time. Keeping up-to-date with the latest information and best practices is crucial for successful ISO 9001 implementation and compliance.
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