What are clauses 9-10 in the ISO 9001 standard?
Quality management systems must effectively evolve with the business as it grows and changes.
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 is 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
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.