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.

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.

Continual revision of the system and auditing will ensure the quality management system is updated
with any new requirements and address any new opportunities.