What are clauses 9-10 in the ISO 9001 standard?

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:

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 Citation Certification, 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.