O 9001:2015 Requirements for

a Quality Management System

ISO 9001 states the requirements for your Quality Management System (QMS). There
are 10 sections (clauses) in ISO 9001, with additional subclauses related to the Plan-
Do-Check-Act system. However, only sections 4-10 contain requirements that are
auditable. To successfully implement ISO 9001:2015 within your organization, you must
satisfy the requirements within clauses 4-10 along with meeting customer and
applicable statutory and regulatory requirements.
Summary of each section of ISO 9001:2015
Requirements

Section 1 Section 2 Section 3 Section 4 Section 5

Section 6 Section 7 Section 8 Section 9 Section 10

Section 0: Introduction
This section introduces the purpose, principles and key concepts of the standard,
including risk-based thinking and the process approach. Learn More:
Section 00: Introduction
 Seven Quality Principles

Section 1: Scope
This section defines the scope of the 9001:2015 standard. In summary, the scope
includes specifying requirements for a QMS of any organization. Learn More:
 Section 01: Scope of ISO 9001:2015

Section 2: Normative References

The supporting standard referenced in ISO 9001:2015 and is indispensable for its
application is ISO 9000:2015 which covers terminology and fundamentals. This and
other supporting standards make up the 9000 series.
Learn More: ISO 9001 Supporting Standards

Section 3: Terms and Definitions

Terminology used throughout this standard comes directly from ISO 9000:2015, Quality
management systems – Fundamentals and vocabulary.

Section 4: Context of the Organization

When you are implementing your Quality Manual System (QMS), the first step for ISO
9001 requirements is to thoughtfully align your business objectives and intent with the
QMS. Determine external and internal issues, the needs and expectations of interested
parties, quality management system scope and its processes. Learn more:
Section 04: Context of the Organization
 ISO 9001 Processes, Procedures and Work Instructions
 Quality Management System Scope
 ISO 9001:2015 Exclusions and Requirements
 Relevant Interested Parties
 What is a Process Approach?

Section 5: Leadership
Section 5 of the ISO 9001:2015 requirements covers leadership responsibility. Top
management must demonstrate leadership and commitment, establish and
communicate a quality policy, and ensure responsibilities and authorities are assigned,
communicated and understood. Learn More:
Section 05: Leadership’s Responsibilities
 Leadership’s Responsibilities and Commitment
 Quality Policy

Section 6: Planning
Clause 6 of the ISO 9001:2015 requirements covers Organizational Quality
Management System planning to address organizational risks, opportunities, changes
and quality objectives. Learn More:
Section 06: Planning for the Quality Management System
 ISO 9001:2015 Risk Management
 Planning to Achieve Quality Objectives

Section 7: Support
Clause 7 of the ISO 9001:2015 requirements covers the resources needed for the QMS
this covers: providing resources, ensures employees are competent and aware, and
includes documented information to support your quality management system. Learn
More:
Section 07: Supporting the Quality Management System
  ISO 9001 Resource Management
 ISO 9001:2015 Documented Information
 Facing the Challenge of Documenting your ISO System

Section 8: Operation
Clause 8 covers the plan and control processes needed to meet the requirements for
products and services (design and development, external providers, production and
service provision, release of products and services, nonconforming outputs). Learn
More:
Section 08: Quality Management System Operations
 Control of External Providers
 Customer Communication
 Identification and Traceability
 Incoming Inspection: Do we have to inspect everything?
 Objects, Outputs, Products and Services

Section 9: Performance Evaluation

ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and evaluate
your quality management system. Learn More:
Section 09: Evaluating the Quality Management System’s Performance
 Customer Satisfaction
 Effective Management Review
 ISO 9001 Internal Audit
 Auditing without a Procedure

Section 10: Improvement

ISO 9001:2015 requirements for clause 10 are based around continual improvement.
Select opportunities for improvement, take action against nonconformities, implement
corrective actions as necessary, and continually improve your quality management
system. Learn More:
Section 10: Improving the Quality Management System
 Continual Improvement
 Nonconformity and Corrective Action
  What is Root Cause Analysis (RCA)?

https://the9000store.com/iso-9001-2015-requirements/iso-9001-2015-context-of-the-
organization/

Type of
Clause Topic documented Requirement
information
The scope of the
Determining
organization’s QMS shall be
4.3 the scope of Document
available and be maintained
the QMS
as documented information.
To the extent necessary, the
organization shall maintain
QMS and its
4.4.2 a Document documented information to
processes
support the operation of its
processes.
To the extent necessary, the
organization shall retain
QMS and its documented information to
4.4.2 b Record
processes have confidence that the
processes are being carried
out as planned.
Communicatin The quality policy shall be
5.2.2 a g the quality Document available and maintained as
policy documented information.
Quality The organization shall
objectives and maintained documented
6.2.1 Document
planning to information on the quality
achieve them objectives.
The organization shall retain
appropriate documented
Monitoring and
information as evidence of
7.1.5.1 measuring Record
fitness for purpose of the
resources
monitoring and measurement
resources.
7.1.5.2 Measurement Record Measuring equipment shall
a traceability be calibrated or verified, or
 both, at specified intervals, or
prior to use, against
measurement standards
traceable to international or
national measurement
standards; when no such
standard exists, the basis for
calibration or verification shall
be retained as documented
information.
The organization shall retain
appropriate documented
7.2 d Competence Record
information as evidence of
competence.
The organization’s QMS shall
include documented
Documented information determined by
7.5.1 b Document
information the organization as being
necessary for the
effectiveness of the QMS.
The organization shall retain
Review of the documented information, as
requirements applicable, on the results of
8.2.3.2 Record
for products review and on any new
and services requirements for products
and services.
The organization shall
consider the documented
Design and
information needed to
8.3.2 j development Record
demonstrate that design and
planning
development requirements
have been met.
The organization shall retain
Design and
documented information on
8.3.3 development Record
design and development
inputs
inputs.
The organization shall apply
controls to the design and
Design and
development process to
8.3.4 f development Record
ensure that documented
controls
information of these activities
is retained.
 The organization shall retain
Design and
documented information on
8.3.5 development Record
the design and development
outputs
outputs.
The organization shall retain
Design and documented information on
8.3.6 development Record design and development
changes changes and the results of
reviews.
Control of
The organization shall retain
externally
documented information of
provided
8.4.1 Record these activities and any
process,
necessary actions arising
products and
from the evaluations.
services
The organization shall control
the unique identification of
the outputs when traceability
Identification
8.5.2 Record is a requirement, and shall
and traceability
retain documented
information necessary to
enable traceability.
When the property of a
customer or external provider
Property is lost, damaged or otherwise
belonging to found to be unsuitable for
8.5.3 customers or Record use, the organization shall
external report this to the customer or
providers external provider and retain
documented information on
what has occurred.
The organization shall retain
documented information
describing the results of the
Control of review of changes, the
8.5.6 Record
changes person(s) authorizing the
change, and any necessary
actions arising from the
review.
8.6 Release of Record The organization shall retain
products and documented information on
 the release of products and
services. The documentation
shall include evidence of
services conformity with the
acceptance criteria and
traceability to the person(s)
authorizing the release.
The organization shall retain
documented information that
describes the nonconformity,
Control of
actions taken, any
8.7.2 nonconforming Record
concessions obtained and
outputs
identifies the authority
deciding the action in respect
of the nonconformity.
The organization shall retain
Monitoring,
documented information as
measurement,
9.1.1 Record evidence of the results [of
analysis and
QMS performance
evaluation
evaluation].
The organization shall retain
documented information as
evidence of the
9.2.2 f Internal audit Record
implementation of the audit
program and the audit
results.
The organization shall retain
Management documented information as
9.3.3 Record
review outputs evidence of the results of
management reviews.
The organization shall retain
documented information as
Nonconformity evidence of the nature of the
10.2.2 and corrective Record nonconformities and any
action subsequent actions taken
and the results of any
corrective action.