8.5 Production and service Provision (8.5.5)

8. OPERATION

8.5 Production and service Provision

8.5.5 Post-delivery activities

The organization shall meet requirements for post-delivery activities associated with the products and services.

In determining the extent of post-delivery activities that are required, the organization shall consider:

• a) statutory and regulatory requirements; (via 8.2.2)
• b) the potential undesired consequences associated with its products and services; (via 4.2,  6.1.2, 6.3, 8.1)
• c) the nature, use and intended lifetime of its products and services; (via 4.2, 8.1, & 8.2.2)
• d) customer requirements; (via 4.2, 5.1.2, 8.1, & 8.2.2)
• e) customer feedback. (8.2.1, 9.1.2)

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.


Cross reference
Clause 8.5.1 (Process control)

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8.4 Control of externally provided processes, products and services (8.4.2)

8. OPERATION

8.4 Control of externally provided processes, products and services

8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.

The organization shall:

• a) ensure that externally provided processes remain within the control of its quality management system;
• b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
• c) take into consideration:
• 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;
• 2) the effectiveness of the controls applied by the external provider;
• d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.

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8.3 Design and development of products and services (8.3.3)

8. OPERATION

8.3 Design and development of products and services

8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.

The organization shall consider:

• a) functional and performance requirements;
• b) information derived from previous similar design and development activities;
• c) statutory and regulatory requirements;
• d) standards or codes of practice that the organization has committed to implement;
• e) potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.

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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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8.2 Requirement for products and services (8.2.2)

8. OPERATION

8.2 Requirement for products and services

8.2.2 Determining the requirements related to products and services

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

• a) the requirements for the products and services are defined, including:
• 1) any applicable statutory and regulatory requirements;
• 2) those considered necessary by the organization;
• b) the organization can meet the claims for the products and services it offers.

Reference for requirement
Clause 5.1.2 (Customer focus)
Clause 8.5.1 (Production Control)
Clause 8.5.5 (Post delivery activities)

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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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4.2 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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