ISO
9001:2015 sets out the criteria for a quality management system and is the only
standard in the family that can be certified to (although this is not a
requirement). It can be used by any organization, large or small, regardless of
its field of activity. In fact, there are over one million companies and
organizations in over 170 countries certified to ISO 9001.
This
standard is based on a number of quality management principles including a
strong customer focus, the motivation and implication of top management, the
process approach and continual improvement. These principles are explained in
more detail in the Quality Management Principles. Using ISO 9001:2015 helps
ensure that customers get consistent, good quality products and services, which
in turn brings many business benefits.
ISO 9001 is defined as the
international standard that specifies requirements for a quality management
system (QMS). Organizations use the standard to demonstrate the ability to
consistently provide products and services that meet customer and regulatory
requirements. It is the most popular standard in the ISO 9000 series and the
only standard in the series to which organizations can certify.
ISO 9001
was first published in 1987 by the International Organization for
Standardization (ISO), The current
version of ISO 9001 was released in September 2015.
It presents fundamental management and quality
assurance practices that can be applied by any organization. The requirements
represent an excellent foundation of planning, control, and improvement for
just about any enterprise. Without a QMS, organizations have little chance of
sustaining any improvements or innovations they might realize.
ISO
9001:2015 is an international standard related to quality management,
applicable to any organization from all types of business sectors and
activities. ISO 9001:2015 provides a framework to respond to changing quality
requirements in balance with society, economics and environment.
ISO 9001:2015 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 ISO 9001:2015 are generic and are intended to be applicable
to any organization, regardless of its type or size, or the products and
services it provides.
Key
Points
Ensures
your products and services effectively meet customer and applicable
statutory
and regulatory requirements.
Allows
you to measure your progress towards continual improvement of business
performance
creating a benchmark.
Creation
of knowledge database for effective exchange of company knowledge.
Stakeholder
and Risk management.
High
Level Structure (HLS) to easily integrate with more than one standard.
QMS
closely aligned with core business processes.
ISO
9001:2015 is the latest revision of the ISO 9001 standard. In it, there are 10
sections (clauses) with supporting subsections (subclauses). The requirements
to be applied to your quality management system (QMS) are covered in sections
4-10. 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.
Section
0: Introduction
Section
1: Scope
Section
2: Normative References
Section
3: Terms and Definitions
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
User questions & answers