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ISO 9001 Clause 9 Performance Evaluation Overview

wilkshireconsulting
2 days ago
5 min read

Do you need a better understanding of Clause 9 Performance Evaluation of the ISO 9001 standard? In the next series of blog posts, we will be diving deeper to get a better understanding of Clause 9 Performance Evaluation sections 9.1 – 9.3.

Clause 9 Performance Evaluation focuses on how an organization monitors, measures, analyzes, and evaluates its quality management system (QMS) to ensure its working effectively.

Clause 9 requires organizations to gather performance data, analyze it, and use it to improve decision-making, enhance customer satisfaction, and ensure compliance with planned objectives.

9 Performance Evaluation consists of 3 different sections:

9.1 – Monitoring, Measurement, Analysis and Evaluation

9.2 – Internal Audit

9.3 – Management Review

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall evaluate the performance and the effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.

9.1.2 Customer satisfaction

The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.

NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.

9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) the need for improvements to the quality management system.

NOTE Methods to analyse data can include statistical techniques.

9.2 Internal audit

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:

a) conforms to:

1) the organization’s own requirements for its quality management system;

2) the requirements of this International Standard;

b) is effectively implemented and maintained.

9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management;

e) take appropriate correction and corrective actions without undue delay;

f) retain documented information as evidence of the implementation of the audit programme and the audit results.

NOTE See ISO 19011 for guidance.

9.3 Management review

9.3.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the quality management system;

c) information on the performance and effectiveness of the quality management system, including

trends in:

1) customer satisfaction and feedback from relevant interested parties;

2) the extent to which quality objectives have been met;

3) process performance and conformity of products and services;

4) nonconformities and corrective actions;

5) monitoring and measurement results;

6) audit results;

7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f) opportunities for improvement.

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews.

9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General

Organizations must determine:

· What needs to be monitored and measured

· The methods to be used

· When monitoring and measurement will take place

· When and how results will be analyzed and evaluated

This ensures that processes and outcomes are tracked in a planned and systematic way.

9.1.2 Customer Satisfaction

· Monitor customer perceptions using tools like:

o Surveys

o Complaints analysis

o Reviews and feedback

· This helps the organization understand how well it is meeting customer expectations.

An example of this is if a software company sends customer satisfaction surveys after product delivery and tracks Net Promoter Scores (NPS).

9.1.3 Analysis and Evaluation

Organizations must analyze collected data to determine:

· Process performance and product conformity

· Effectiveness of the QMS

· Opportunities for improvement

· Supplier performance

· Risk and trend analysis

An example of this is if a manufacturer uses defect rates and delivery data to identify underperforming suppliers and initiate corrective action.

9.2 Internal Audit

Organizations must conduct internal audits at planned intervals to:

· Verify conformity to ISO 9001 and internal QMS requirements

· Ensure the QMS is effectively implemented and maintained

Internal audit process must include the following:

1. Planning

2. Defining audit criteria and scope

3. Selecting unbiased auditors

4. Reporting audit findings

5. Taking corrective action

An example of this is if a logistics company schedules quarterly internal audits for all departments and uses a checklist to verify compliance with standard procedures.

9.3 Management Review

Top Management must review the QMS at planned intervals to ensure:

· Its suitability, adequacy, and effectiveness

· Alignment with strategic direction

Inputs to Management Review:

· Audit results

· Customer feedback

· Process performance

· Nonconformities and corrective actions

· Opportunities for improvement

· Changes in external and internal issues

· Performance of external providers

Outputs of Management Review:

· Decisions and actions related to:

o Improvement of the QMS and its processes

o Resource needs

o Revisions to quality objectives or policies

An example of this is if during an annual management review, a hospital identifies the need for upgraded equipment and staff training based on performance metrics and patient feedback.

In conclusion, Clause 9 Performance Evaluation Overview ensures that the QMS is not just implemented, but also monitored, evaluated, and continually improved. By systematically collecting and analyzing data, conducting internal audits, and engaging leadership in reviews, organizations can stay aligned with their goals and deliver consistent value to customers. In the next blog post we will be diving deeper into 9.1 Monitoring, Measurement, Analysis and Evaluation.

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