Section 1 Scope
Section 2 Normative references
Section 3 Terms and definitions
Core Requirements
Section 4 Context of the organization
Section 5 Leadership
Section 6 Planning
Section 7 Support
Section 8 Operation
Section 9 Performance evaluation
Section 10- Improvement
ISO 9001:2015 Structure Comparison
with ISO 9001:2008
ISO 9001:2015 ISO 9001:2008
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Context of the organization 4. Quality management system
5. Leadership 5. Management responsibility
6. Planning 6. Resource management
7. Support 7. Product realization
8. Operation 8. Measurement, analysis and
improvement
9. Performance Evaluation
10. Improvement
SECTION
Ensure appropriate:
Identification and description (e.g. a title,
date, author, or reference number)
format (e.g. language, software version,
graphics) and media (e.g. paper, electronic)
review and approval for suitability and
adequacy
7.5.3 Control of Documented Information
Leadership
Planning
Support
Operation
Release of Control of
products and nonconforming
services outputs
Plan, implement and control the processes (see
4.4), needed to meet the requirements for the
provision of products and services, and to
implement the actions determined in Clause 6,
by:
Determining the requirements for the products
and services
Establishing criteria: for the processes and for
the acceptance of products and services
Determining the resources needed to achieve
conformity to the product and service
requirements
Implementing control of the processes in
accordance with the criteria
Determining and keeping documented
information to the extent necessary: to have
confidence that the processes have been
carried out as planned and to demonstrate
conformity of products and services to their
requirements
The output of this planning shall be suitable
for the organization's operations
Control planned changes and review the
consequences of unintended changes, taking
action to mitigate any adverse effects, as
necessary
Ensure that outsourced processes are
controlled (see 8.4)
8.2.1 Customer communication
Communication with customers shall include:
Providing information relating to products and services
Handling enquiries, contracts or orders, including changes
Obtaining customer feedback relating to products and
services, including customer complaints
Handling or controlling customer property
Establishing specific requirements for contingency
actions, when relevant
8.2.2 Determining the requirements for products
and services
Ensure that:
The requirements for the products and services
are defined, including:
oAny applicable statutory and regulatory
requirements
oThose considered necessary by the organization
The organization can meet the claims for the
products and services it offers
8.2.3 Review of the requirements for 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
Conduct a review before committing to supply
products and services to a customer, to include:
Requirements specified by the customer, including
the requirements for delivery and post-delivery
activities
Requirements not stated by the customer,
but necessary for the specified or intended
use, when known
Requirements specified by the organization
Statutory and regulatory requirements
applicable to the products and services
Contract or order requirements differing from
those previously expressed
Ensure that contract or order requirements
differing from those previously defined are
resolved
Confirm customers requirements before
acceptance, when the customer does not
provide a documented statement of their
requirements
8.2.3.2 The organization shall retain
documented information, as applicable:
On the results of the review
On any new requirements for the products
and services
8.2.4 Changes to requirements for products
and services
Ensure that relevant documented information
is amended and that relevant persons are
made aware of the changed requirements,
when the requirements for products and
services are changed
8.5.2 Identification and traceability
Use suitable means to identify outputs when it is
necessary to ensure the conformity of products and
services
Identify the status of outputs with respect to
monitoring and measurement requirements
throughout production and service provision
Control the unique identification of the outputs when
traceability is a requirement
Retain the documented information necessary to
enable traceability
The organization shall implement
planned arrangements, at appropriate
stages, to verify that the product and
service requirements have been met.
Release of products and services to the
customer shall not proceed until the planned
arrangements have been satisfactorily
completed, unless otherwise approved by a
relevant authority and, as applicable, by the
customer
Performance Evaluation
Improvement