10.2 Nonconformity and corrective action (10.2.1)

10. IMPROVEMENT

10.2 Nonconformity and corrective action

10.2.1

When a nonconformity occurs, including any arising from complaints, the organization shall:

• a) react to the nonconformity and, as applicable: (via 8.7.1)
• 1) take action to control and correct it;
• 2) deal with the consequences;
• b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
• 1) reviewing and analysing the nonconformity;
• 2) determining the causes of the nonconformity;
• 3) determining if similar nonconformities exist, or could potentially occur;
• c) implement any action needed;
• d) review the effectiveness of any corrective action taken;
• e) update risks and opportunities determined during planning, if necessary; (via 6.1.2)
• f) make changes to the quality management system, if necessary. (via 6.3, 7.5.2 & 7.5.3)

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

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9.3 Management Review (9.3.2)

9. PERFORMANCE EVALUATION

9.3 Management Review

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 via  6.1.1 & 6.1.2);
• f) opportunities for improvement

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9.1 Monitoring, measurement, analysis and evaluation (9.1.3)

9. PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

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; (via 8.5.1, 8.6, 8.7.1)
• b) the degree of customer satisfaction; (via 9.1.2)
• c) the performance and effectiveness of the quality management system; (via 9.1.1)
• d) if planning has been implemented effectively; (via 6.1.2, 6.2.2, 8.1, 8.3.2)
• e) the effectiveness of actions taken to address risks and opportunities; (via 6.1.2 (b)(2))
• f) the performance of external providers; (via 8.4.1 & 8.4.3)
• g) the need for improvements to the quality management system. (via 10.3)

NOTE Methods to analyse data can include statistical techniques.


Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 10.3 (Continual Improvement)

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6.1 Action to address risks and opportunities (6.1.2)

6. PLANNING

6.1 Action to address risks and opportunities

6.1.2

The organization shall plan

• a) actions to address these risks and opportunities;
• b) how to:
• 1) integrate and implement the actions into its quality management system processes (see 4.4 via  4.4.1 & 4.4.2);
• 2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

Go to
Clause 8.1 (Operation planning & control)
Clause 9.3.2 (Management Review)


Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 5.1.2 (Customer focus)
Clause 8.5.5 (Post delivery activities)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)
Clause 10.2.1 (Nonconformity and corrective action)

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6.1 Action to address risks and opportunities (6.1.1)

6. PLANNING

6.1 Action to address risks and opportunities

6.1.1

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

• a) give assurance that the quality management system can achieve its intended result(s);
• b) enhance desirable effects;
• c) prevent, or reduce, undesired effects;
• d) achieve improvement.

Go to clause 8.1 (Operation planning & control)
Go to clause 9.3.2 (Management Review)



Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 10.1 (Improvement)

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5.1 Leadership and Commitment (5.1.2)

5. LEADERSHIP

5.1 Leadership and Commitment

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

• a) customer (via 8.1) and applicable statutory and regulatory requirements (via 8.2.2) are determined, understood and consistently met;
• b) the risks and opportunities (via 6.1.2) that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
• c) the focus on enhancing customer satisfaction (via 9.1.2) is maintained.

Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 10.1 (Improvement)
Clause 8.5.5 (Post delivery activities)

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4.4 Quality management system and its processes (4.4.1)

4. CONTEXT OF THE ORGANIZATION

4.4 Quality management system and its processes

4.4.1

The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

• a) determine the inputs (via 8.2.1) required and the outputs expected (via 5.1.2) from these processes;
• b) determine the sequence and interaction of these processes;
• c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; (via 8.1, 8.5.1, 9.1.1)
• d) determine the resources needed for these processes and ensure their availability (via 7.1.2, 7.1.3, 7.1.4, 7.1.5 & 7.1.6);
• e) assign the responsibilities and authorities for these processes (via 5.3)
• f) address the risks and opportunities as determined in accordance with the requirements of 6.1 (via 6.1.1 & 6.1.2);
• g) evaluate these processes (via 9.1.3, 9.2.1 & 9.3.1) and implement any changes needed (via 8.5.6) to ensure that these processes achieve their intended results;
• h) improve the processes and the quality management system. (via 10.3)

Go to clause 6.1.2 (Risk and opportunities)
Go to clause 6.3 (Planning changes)
Go to clause 8.1 (Operation planning & control)

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