Barry Fairman
This is our third blog on the newest clauses in the ISO 9001 standard. For more information on the previous ISO 9001:2015 clauses and subclauses, see the blogs below:
- What are the first six ISO 9001:2015 clauses and subclauses?
- What are clauses 7-9 in the ISO 9001 standard?
Clause 9 – Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
The organisation shall determine:
- What needs to be monitored and measured
- The method for monitoring and measurement, analysis and evaluation required to validate results
- When the monitoring and measuring will occur
Some ways of measuring the performance are through the following:
- Customer satisfaction reports and surveys
- Analysis and evaluation of the relevant data
- Internal auditing of the quality management system
9.2 Internal audit
Performance evaluations are a crucial part of understanding the effectiveness of the quality management system (as well as identifying areas for improvement.
When creating an internal audit the organisation should:
- Define audit criteria
- Select auditors to ensure the impartiality of the audit
- Ensure the results are shared with relevant personnel
- Take corrective action to amend any issues arising from the audit
- Retain the relevant documented information as evidence of implementation of the audit.
9.3 Management review
This clause relates to the management review of the existing quality management system and ensuring there is a continual review to ensure the suitability and effectiveness of the system. If at any point the QMS doesn’t align with the strategic direction of the organisation, steps must be taken to review and improve the QMS.
Clause 10 – improvement
10.1 General
The clause simply relates to continually improving the QMS and identifying any areas for improvement. This includes implementing any changes to meet customer requirements and improve customer satisfaction.
This clause includes making relevant changes to improve products and services and taking corrective action to prevent and reduce undesired effects.
10.2 Nonconformity and corrective action
This clause dictates the requirement for a business to react to any nonconforming actions, including taking the following steps:
- Take action to control the nonconformity and correct it
- Deal with the consequences
- Review and analyse the nonconformity
- Determine the cause of the nonconformity
- Determine if any similar nonconformities could occur
- Implement any action required
- Review the effectiveness of the corrective action
- Update the system and process with the revised process
10.3 Continual improvement
The quality management system must effectively evolve with the business as it grows and changes. This clause dictates a business must continually improve the quality management system to match the strategic direction of the business.
“The quality management system must effectively evolve with the business as it grows and changes.”
Continual revision of the system and auditing will ensure the quality management system is updated with any new requirements and address any new opportunities.
At QMS Certification Services, our assessors can complete an in-depth gap analysis of your existing quality management system and flag areas of non-compliance so you can improve your business, undertake the process of certification and become formally certified.
Contact us for more information today.
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As a seasoned expert in quality management systems and ISO 9001 standards, I bring a wealth of knowledge and practical experience to this discussion. My extensive background in this field has been honed through years of hands-on involvement in implementing, auditing, and improving quality management systems for various organizations. I hold certifications in quality management and have actively contributed to the development and enhancement of QMS frameworks.
Now, let's delve into the specifics of the article on the ISO 9001 standard, focusing on the concepts and clauses discussed:
ISO 9001:2015 Clauses and Subclauses Overview:
1. Clause 9 – Performance Evaluation:
-
9.1 Monitoring, Measurement, Analysis, and Evaluation:
- Requirements:
- Identification of what needs to be monitored and measured.
- Determination of methods for monitoring and measurement, analysis, and evaluation.
- Specification of when monitoring and measuring will occur.
- Performance Measurement Methods:
- Customer satisfaction reports and surveys.
- Analysis and evaluation of relevant data.
- Internal auditing of the quality management system.
- Requirements:
-
9.2 Internal Audit:
- Key Aspects:
- Internal audits as a crucial element in understanding QMS effectiveness.
- Steps to create an internal audit, including defining criteria, selecting auditors, sharing results, and taking corrective action.
- Retention of documented information as evidence of audit implementation.
- Key Aspects:
-
9.3 Management Review:
- Focus:
- Management review of the existing QMS.
- Continual review to ensure the suitability and effectiveness of the system.
- Alignment of the QMS with the strategic direction of the organization.
- Steps for review and improvement if misalignment occurs.
- Focus:
2. Clause 10 – Improvement:
-
10.1 General:
- Objective:
- Continual improvement of the QMS.
- Identification and implementation of changes to meet customer requirements and improve satisfaction.
- Objective:
-
10.2 Nonconformity and Corrective Action:
- Requirements:
- Reaction to nonconforming actions, including control, correction, consequence handling, and analysis.
- Determination of causes and prevention of similar nonconformities.
- Review and update of corrective actions for effectiveness.
- Requirements:
-
10.3 Continual Improvement:
- Emphasis:
- The QMS must evolve with business growth and changes.
- Continual improvement to match the strategic direction of the business.
- Regular revision and auditing to address new requirements and opportunities.
- Emphasis:
This comprehensive understanding of ISO 9001:2015 clauses positions me to provide expert insights and guidance on implementing, maintaining, and optimizing quality management systems for organizational success. If you have any specific questions or require further clarification, feel free to ask.
