The document provides an overview of Section 8 of the ISO 9001:2015 draft standard, which covers operational planning and control. Section 8 aims to ensure products and services meet customer requirements through a systematic process approach that covers determining requirements, design, externally provided products/services, production, delivery, and handling nonconforming outputs. It outlines the topics that will be covered in Section 8, including operational planning and control, design and development, production and service provision, and control of nonconforming outputs. Minor changes may still occur before the final standard is released.

1. ISO 9001:2015 DIS
Section 8, Operation
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2. Overall Purpose of this presentation
• This is an overview of Section 8 – Operations, as it
currently stands in the Draft International Standard (DIS)
and is subject to change when the Final Draft
International Standard (FDIS) version is released.
• Other clauses within the DIS are less likely to change
due to the structure that has been created in Annex SL
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3. Overall purpose of ISO 9001 Section 8
The purpose of ISO 9001:2015 DIS Section 8, Operation, is
to ensure that products and/or services that are provided to
customers are planned, realized and delivered meeting the
applicable requirements using a systemic process
approach.
This is applicable for determining the relevant
requirements, design and development, control of
externally provided products and services, product and
service provisions, and post delivery activities.
This section also ensures that organization has the
necessary processes planned if the product and/or service
does not meet specifications.
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4. ISO 9001:2015 - Outline
Sections
8.1 Operational Planning and Control
8.2 Determination of requirements for products and
services
8.3 Design and development of products and services
8.4 Control of externally provided products and services
8.5 Production and Service provision
8.6 Release of products and services
8.7 Control of nonconforming process outputs, products
and services
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5. ISO 9001:2015 – New Terms
• Outsource – make arrangement where an external
organization performs part of an organization’s
function or process
(Note: An external organization is outside of the management system,
although the outsourced function, or process, is within the scope.)
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6. Summary
• Section 8 is where the technical aspects of the
management standard housed. These focus on
Quality and Quality Management System
requirements.
• Fundamentally the requirements do not change in
principle. Some language, similar things said
differently but the spirit has not changed in this
section.
• You will still want to change your system – you don’t
want it to “look” old.
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7. We are here to help!
For more information please contact us!
• Colin Gray
– colin@cavendishscott.com 303 668 2500
• Emily Myers
– emily@cavendishscott.com 720 226 5968
• Dave Moskal
– dave@cavendishscott.com 303 386 6788
• Diana Lough
– diana@cavendishscott.com 720 212 7300
Or visit our Website for current status:
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