10.3 Continual improvement

10. Improvement

10.3 Continual Improvement

The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.

The organization shall consider the results of analysis and evaluation (via 9.1.3), and the outputs from management review (via 9.3.3), to determine if there are needs or opportunities that shall be addressed as part of continual improvement.


Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 9.1.3 (Performance analysis and evaluation)

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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 (9.3.3)

9. PERFORMANCE EVALUATION

9.3 Management Review

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


Cross Reference
Clause 10.3 (Continual Improvement)

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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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9.3 Management Review (9.3.1)

9. PERFORMANCE EVALUATION

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.


Cross reference
Clause 4.4.1 (QMS and its processes)

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9.1 Monitoring, measurement, analysis and evaluation (9.1.2)

9. PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

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.

Cross reference
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)

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8.5 Production and service Provision (8.5.6)

8. OPERATION

8.5 Production and service Provision

8.5.6 Control of changes

The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.


Cross reference
Clause 4.4.1 (QMS and its processes)

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8.3 Design and development of products and services (8.3.6)

8. OPERATION

8.3 Design and development of products and services

8.3.6 Design and development changes

The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

The organization shall retain documented information on:

• a) design and development changes;
• b) the results of reviews;
• c) the authorization of the changes;
• d) the actions taken to prevent adverse impacts.

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8.3 Design and development of products and services (8.3.4)

8. OPERATION

8.3 Design and development of products and services

8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

• a) the results to be achieved are defined;
• b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
• c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
• d) validation  activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
• e) any necessary actions are taken on problems determined during the reviews, or verification and validation  activities;
• f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation  have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

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8.3 Design and development of products and services (8.3.2)

8. OPERATION

8.3 Design and development of products and services

8.3.2 Design and development planning

In determining the stages and controls for design and development , the organization shall consider:

• a) the nature, duration and complexity of the design and development activities;
• b) the required process stages, including applicable design and development reviews;
• c) the required design and development verification and validation activities;
• d) the responsibilities and authorities involved in the design and development process;
• e) the internal and external resource needs for the design and development of products and services
• f) the need to control interfaces between persons involved in the design and development process;
• g) the need for involvement of customers and users in the design and development process;
• h) the requirements for subsequent provision of products and services;
• i) the level of control expected for the design and development process by customers and other relevant interested parties;
• j) the documented information needed to demonstrate that design and development requirements have been met.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation)

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8.2 Requirement for products and services (8.2.3)

8. OPERATION

8.2 Requirement for products and services

8.2.3 Review of requirements related to products and services

8.2.3.1

The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

• a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;
• b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
• c) requirements specified by the organization;
• d) statutory and regulatory requirements applicable to the products and services;
• e) contract or order requirements differing from those previously expressed.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues or advertising material.

8.2.3.2 Retain documented information

The organization shall retain documented information, as applicable:

• a) on the results of the review;
• b) on any new requirements for the products and services

Reference for requirement
Clause 8.5.1 (Production Control)

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8.1 Operational planning and control

8. OPERATION

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4 via 4.4.1 & 4.4.2) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6 (via 6.1.1, 6.1.2, 6.2.1, 6.2.2 & 6.3), by:

• a) determining the requirements for the products and services;
• b) establishing criteria for:
• 1. the processes;
• 2. the acceptance of products and services;
• c) determining the resources needed to achieve conformity to the product and service requirements;
• d) implementing control of the processes in accordance with the criteria;
• e) determining and keeping documented information to the extent necessary:
• 1. to have confidence that the processes have been carried out as planned;
• 2. to demonstrate the conformity of products and services to their requirements.

NOTE “Keeping” implies both the maintaining and the retaining of documented information.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).



Reference for requirement
Clause 4.4.1 (QMS and its processes)
Clause 5.1.2 (Customer focus)
Clause 8.5.1 (Production Control)
Clause 8.5.5 (Post delivery activities)
Clause 9.1.3 (Performance analysis and evaluation)

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7.5 Documented information (7.5.2)

7. SUPPORT

7.5 Documented information

7.5.2 Creating and updating

When creating and updating documented information, the organization shall ensure appropriate:

• a) identification and description (e.g. a title, date, author, or reference number);
• b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
• c) review and approval for suitability and adequacy.

Cross reference
Clause 10.2.1 (Nonconformity and corrective action)

 

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4.2 Understanding the needs and expectations of interested parties

4. CONTEXT OF ORGANIZATION

4.2    Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

1. the interested parties that are relevant to the quality management system;
2.  the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant

Go to
Clause: 4.3
Clause: 6.1.1


Cross reference
Clause 8.5.5 (Post delivery activities)

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4.1 Understanding the organization and its context

4. CONTEXT OF ORGANIZATION

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for consideration NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

Go to
Clause: 4.3
Clause: 6.1.1

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