Standard ISO 9001 : 2015
Quality management systems — Requirements
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for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally
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on all matters of electrotechnical standardization.
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develop this document and those intended for its further maintenance ar
described in the ISO/IEC Directives, Part 1. In particular the different
approval criteria needed for
different types of ISO documents should be noted.
Any trade name used in
this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the meaning of ISO specific
terms and expressions related to conformity asssment, as well as information
about ISO’s adherence to the World Trade Oanization
(WTO).
The committee responsible for this
document is Technical Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 2, Quality systems. This fifth edition cancels and
replaces the fourth edition (ISO 9001:2008), which has been technicall revised,
through the adoption of a revised clause sequence and the adaptation of the revised
quality management principles and of new concepts. It also cancels and replaces
the Technical Corrigendum ISO
9001:2008/Cor.1:2009
Introduction
0.1 General
The adoption of a
quality management system is a strategic decision for an organization that can
help to improve its overall performance and provide a sound basis for
sustainable development initiatives.
The potential benefits to an
organization of implementing a quality management system based on this
International Standard are:
a) the
ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements;
b) facilitating
opportunities to enhance customer satisfaction;
c) addressing
risks and opportunities associated with its context and objectives;
d) the
ability to demonstrate conformity to specified quality management system
requirements.
This International Standard can be
used by internal and external
parties.
It is not the intent of
this International Standard to imply the need for:
─
uniformity in the structure of different
quality management systems;
─
alignment of documentation to the clause
structure of this International Standard;
─
the use of the specific terminology of
this International Standard within the organization.
The quality management system
requirements specified in this International Standard are complementary to
requirements for products and services.
This International Standard employs
the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and
risk-based thinking.
The process approach
enables an organization to plan its processes and their interactions.
The PDCA cycle enables an
organization to ensure that its processes are adequately resourced and managed,
and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an
organization to determine the factors that could cause its processes and its
quality management system to deviate from the planned results, to put in place
preventive controls to minimize negative effects and to make maximum use of
opportunities as they arise (see Clause A.4).
Consistently meeting requirements
and addressing future needs and expectations poses a challenge for
organizations in an increasingly dynamic and complex environment. To achieve
this objective, the organization might find it necessary to adopt various forms of improvement in
addition to correction and continual improvement, such as breakthrough change,
innovation and re-organization.
In
this International Standard, the following verbal forms are used:
─ “shall”
indicates a requirement;
─ “should”
indicates a recommendation;
─ “may”
indicates a permission;
─ “can” indicates a possibility or a capability.
Information marked as
“NOTE” is for guidance in understanding or clarifying the associated requirement.
02. Quality management
principles
This International Standard is
based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the
principle is important for the organization, some exampleof benefits associated
with the principle and examples of typical actions to improve the
organization’s performance when applying the principle.
The quality management principles
are:
─
customer
focus;
─
leadership;
─
engagement of people;
─
process
approach;
─
improvement;
─
evidence-based decision making;
─
relationship management.
0.3 Process approach
0.3.1 General
This International
Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to
enhance customer satisfaction by meeting customer requirements. Specific
requirements considered essential to the adoption of a process approach are
included in 4.4.
Understanding and
managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach
enables the organization to control the interrelationships and
interdependencies among the processes of the system, so that the overall
performance of the organization can be enhanced.
The process approach involves the
systematic definition and management of processes, and their interactions, so
as to achieve the intended results in accordance with the quality policy and
strategic direction of the organization. Management of the processes and the
system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an
overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of
opportunities and preventing undesirable results.
The application of the
process approach in a quality management system enables:
a) understanding
and consistency in meeting requirements;
b) the
consideration of processes in terms of added
value;
c)
the achievement of effective process performance;
d) improvement of processes based on
evaluation of data and information.
0.3.2 Plan-Do-Check-Act
cycle
The PDCA cycle can
be applied to all processes and to the quality management system as a whole.
The PDCA cycle can be briefly
described as follows:
─
Plan : establish the
objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s
policies, and identify and address risks and opportunities;
─
Do : implement what
was planned;
─
Check : monitor and
(where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report
the results;
─
Act : take actions to
improve performance, as necessary
0.3.3 Risk-based thinking
Risk-based thinking (see Clause
A.4) essential for achieving an effective quality magement system. The concept
of risk-based thinking has been implicit in previous editions of this
International Standard including, for example, carrying out preventive to
eliminate potential nonconformities, analysing any nonconformities that do
occur, and taking action to prevent recurrence that is appropriate for the
effects of the onconformity.
To conform to the requirements of
this International Standard, an organization needs to plan and implement
actions to address risks and opportunities. Addressing both risks and
opportunities establishes a basis for increasing the effectiveness of the
quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation
favourable to achieving an intended result, for example, a set of circumstances
that
allow the organization to attract
customers, develop new products and services, reduce waste or improve productivity.
Actions to address opportunities can also include consideration of associated
risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can
provide an opportunity, but not all positive effects of risk result in opportunities.
0.4 Relationship with other management system standards
This International Standard applies
the framework developed by ISO to improve alignment among its International
Standards for management systems (see Clause A.1).
This International Standard enables
an organization to use the process approach, coupled PDCA cycle and risk-based
thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates
to ISO 9000 and ISO 9004 as follows :
─
ISO 9000 Quality management systems --
Fundamentals and vocabulary provides essential background for the proper
understanding and implementation of this International Standard;
─
ISO 9004 Managing for the sustained
success of an organization -- A quality management approach provides guidance
for organizations that choose to progress beyond the requirements of this
International Standard.
This International
Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety
management, or financial management. Sector-specific
quality management system standards based on the requirements of this
International Standard have been developed for a number of sectors. Some of
these standards specify additional quality managemet system requirements, while
others are limited to providing guidance to the application of this
International Standard within the particular
sector.
Quality management systems — Requirements
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1. Understanding the organization and its context
4.2. Understanding the needs and expectations of interested parties
4.3. Determining the scope of the quality management system
4.4. Quality management system and its processes
5.
Leadership
5.1. Leadership and commitment
5.2. Policy
5.3. Organizational
roles, responsibilities and authoritie
6. Planning
6.1 Actions to address risks and opportunities
6.2 6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.
Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8.
Operation
8.1
Operational planning and control
8.2
Requirements for products and services
8.3
Design and development of products and services
8.4
Control of externally provided processes,
products and services
8.5
Production and service provision
8.6
Release of products and
services
8.7
Control of nonconforming outputs
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.1 General
10.2 Nonconformity
and corrective action
10.3 Continual improvement
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