Introduction To ISO 9001 2015
Introduction To ISO 9001 2015
Introduction To ISO 9001 2015
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. Figure 2 illustrates
how Clauses 4 to 10 can be grouped in relation to the PDCA
cycle.
Figure 2 — Representation of the structure of this
International Standard in the PDCA
NOTE Numbers in brackets refer to the clauses in this International Standard.
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) is essential for achieving an effective
quality management system. The concept of risk-based thinking has been
implicit in previous editions of this International Standard including, for
example, carrying out preventive action to eliminate potential nonconformities,
analysing any nonconformities that do occur, and taking action to prevent
recurrence that is appropriate for the effects of the nonconformity.
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 with the 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.
Annex B provides details of other International Standards on quality
management and quality management systems that have been developed
by ISO/TC 176.
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
management system requirements, while others are limited to providing
guidance to the application of this International Standard within the
particular sector.
A matrix showing the correlation between the clauses of this edition of this
International Standard and the previous edition (ISO 9001:2008) can be
found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.
1 Scope
This International Standard specifies requirements for a quality management
system when an organization:
•a) needs to demonstrate its ability to consistently provide products and
services that meet customer and applicable statutory and regulatory
requirements, and
•b) aims to enhance customer satisfaction through the effective application
of the system, including processes for improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
All the requirements of this International Standard are generic and are
intended to be applicable to any organization, regardless of its type or size,
or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only
apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal
requirements.
2 Normative references
The following documents, in whole or in part, are normatively referenced in
this document and are indispensable for its application. For dated
references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments) applies.
•ISO 9000:2015, Quality management systems — Fundamentals and
vocabulary
Bibliography
[1] ISO 9004, Managing for the sustained success of an organization — A quality management approach
ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for
[2]
organizations
ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
[3]
organizations
ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution external to
[4]
organizations
[5] ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring
[6] ISO 10005, Quality management systems — Guidelines for quality plans
[7] ISO 10006, Quality management systems — Guidelines for quality management in projects
[8] ISO 10007, Quality management systems — Guidelines for configuration management
ISO 10008, Quality management — Customer satisfaction — Guidelines for business-to-consumer
[9]
electronic commerce transactions
ISO 10012, Measurement management systems — Requirements for measurement processes and
[10]
measuring equipment
[11] ISO/TR 10013, Guidelines for quality management system documentation
[12] ISO 10014, Quality management — Guidelines for realizing financial and economic benefits
[28] www.iso.org/tc176/sc02/public
[29] www.iso.org/tc176/ISO9001AuditingPracticesGroup