The document outlines the key changes in ISO 9001:2015, including updated principles, clauses, and terminology, such as replacing 'product' with 'products and services.' It emphasizes modifications in documentation requirements and introduces new concepts like 'documented information' and 'context of the organization.' Additionally, it highlights the importance of understanding interested parties and traceability within the framework.

1. ISO 9001:2015
What’s new about it?
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2. Contents:
 Change in principles
 Change in clauses
 Change in terminology
 Key changes in Documentation Requirements
 Key changes in clauses and what they mean?
 What’s good about - Annexure A:
- no requirements for Organization's QMS
documentation to mirror that of this documented
-no requirements for using some terms
 What about exclusions?
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3. Changes in Principles
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4. Change in clauses
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5. Change in Terminology/New Terminology
 Product replaced by “Product and Services”
 Documented Information
 Design and Development
 Interested Party
 Context of the organization
 Traceability
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6. Product and Services
 ISO 9001:2008 used the term “product to include all
output categories whereas ISO 9001:2015 uses
“products and services”
 The term “product and services” includes all output
categories such as hardware, services, software and
processed materials.
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7. Documented Information
 The terms “documented procedure” and “record” have
been replaced by “Documented Information”
 Where ISO 9001:2008 uses the term documented
procedures ( to define, control or support a process)
whereas ISO 9001:2015 uses the term Documented
Information.
 ISO 9001:2008 uses the term “records” but ISO
9001:2015 uses Documented information.
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8. Design and Development
 Set of processes that transforms requirements for an
object into more detailed requirements
Note- to entry: The requirements (3.03)forming input to
design and development can be expressed in a
broader, more general sense
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9. Interested party
 Person or organisation that can affect, be affected by,
or perceive themselves to be affected by a decision or
activity.
 Example: Customers , owners, people in an
organisation, suppliers, bankers, unions, partners or
society that may include competitors or opposing
pressure groups.
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10. Context of the organisation
There are two new clauses relating to the context of the
organisation;
 4.1 Understanding the organisation and its
context
 4.2 Understanding the needs and expectationsof
interested parties.
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11. Traceability
 Ability to trace the history, application or location of
an object.
 When considering a product or a service,
traceability can relate to:
 The origin of materials and parts
 The processing history
 The distribution and location of the product or
service after delivery.
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