Quality management

system

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A quality management system (QMS) is a

collection of business processes focused
on consistently meeting customer
requirements and enhancing their
satisfaction. It is aligned with an
organization's purpose and strategic
direction (ISO9001:2015). It is expressed
as the organizational goals and
aspirations, policies, processes,
documented information and resources
needed to implement and maintain it. Early
quality management systems emphasized
predictable outcomes of an industrial
product production line, using simple
statistics and random sampling. By the
20th century, labor inputs were typically
the most costly inputs in most
industrialized societies, so focus shifted to
team cooperation and dynamics,
especially the early signaling of problems
via a continual improvement cycle. In the
21st century, QMS has tended to converge
with sustainability and transparency
initiatives, as both investor and customer
satisfaction and perceived quality is
increasingly tied to these factors. Of QMS
regimes, the ISO 9000 family of standards
is probably the most widely implemented
worldwide – the ISO 19011 audit regime
applies to both, and deals with quality and
sustainability and their integration.

Other QMS, e.g. Natural Step, focus on

sustainability issues and assume that
other quality problems will be reduced as
result of the systematic thinking,
transparency, documentation and
diagnostic discipline.
The term "Quality Management System"
and the initialism "QMS" were invented in
1991 by Ken Croucher, a British
management consultant working on
designing and implementing a generic
model of a QMS within the IT industry.

Elements
1. Quality objectives
2. Quality manual
3. Organizational structure and
responsibilities
4. Data management
5. Processes – including purchasing
 6. Product quality leading to customer
satisfaction
7. Continuous improvement including
corrective and preventive action
8. Quality instrument
9. Document control

Concept of quality –
historical background
The concept of a quality as we think of it
now first emerged from the Industrial
Revolution. Previously goods had been
made from start to finish by the same
person or team of people, with
handcrafting and tweaking the product to
meet 'quality criteria'. Mass production
brought huge teams of people together to
work on specific stages of production
where one person would not necessarily
complete a product from start to finish. In
the late 19th century pioneers such as
Frederick Winslow Taylor and Henry Ford
recognized the limitations of the methods
being used in mass production at the time
and the subsequent varying quality of
output. Birland established Quality
Departments to oversee the quality of
production and rectifying of errors, and
Ford emphasized standardization of
design and component standards to
ensure a standard product was produced.
Management of quality was the
responsibility of the Quality department
and was implemented by Inspection of
product output to 'catch' defects.

Application of statistical control came

later as a result of World War production
methods, which were advanced by the
work done of W. Edwards Deming, a
statistician, after whom the Deming Prize
for quality is named. Joseph M. Juran
focused more on managing for quality.
The first edition of Juran's Quality Control
Handbook was published in 1951. He also
developed the "Juran's trilogy", an
approach to cross-functional management
that is composed of three managerial
processes: quality planning, quality
control, and quality improvement. These
functions all play a vital role when
evaluating quality.

Quality, as a profession and the

managerial process associated with the
quality function, was introduced during the
second half of the 20th century and has
evolved since then. Over this period, few
other disciplines have seen as many
changes as the quality profession.

The quality profession grew from simple

control to engineering, to systems
engineering. Quality control activities were
predominant in the 1940s, 1950s, and
1960s. The 1970s were an era of quality
engineering and the 1990s saw quality
systems as an emerging field. Like
medicine, accounting, and engineering,
quality has achieved status as a
recognized profession[1]

As Lee and Dale (1998) state, there are

many organizations that are striving to
assess the methods and ways in which
their overall productivity, the quality of their
products and services and the required
operations to achieve them are done.
 Medical devices
The two primary, state of the art,
guidelines for medical device
manufacturer QMS and related services
today are the ISO 13485 standards and the
US FDA 21 CFR 820 regulations. The two
have a great deal of similarity, and many
manufacturers adopt QMS that is
compliant with both guidelines.

ISO 13485 are harmonized with the

European Union medical devices directive
(93/42/EEC) as well as the IVD and AIMD
directives. The ISO standard is also
incorporated in regulations for other
jurisdictions such as Japan (JPAL) and
Canada (CMDCAS).

Quality System requirements for medical

devices have been internationally
recognized as a way to assure product
safety and efficacy and customer
satisfaction since at least 1983 and were
instituted as requirements in a final rule
published on October 7, 1996 . The U.S.
Food and Drug Administration (FDA) had
documented design defects in medical
devices that contributed to recalls from
1983 to 1989 that would have been
prevented if Quality Systems had been in
place. The rule is promulgated at 21 CFR
820 .

According to current Good Manufacturing

Practice (GMP), medical device
manufacturers have the responsibility to
use good judgment when developing their
quality system and apply those sections of
the FDA Quality System (QS) Regulation
that are applicable to their specific
products and operations, in Part 820 of
the QS regulation. As with GMP, operating
within this flexibility, it is the responsibility
of each manufacturer to establish
requirements for each type or family of
devices that will result in devices that are
safe and effective, and to establish
methods and procedures to design,
produce, and distribute devices that meet
the quality system requirements.

The FDA has identified in the QS regulation

the 7 essential subsystems of a quality
system. These subsystems include:

Quality system

Management controls;
 Design controls;
Production and process controls
Corrective and preventative actions
Material controls
Records, documents, and change
controls
Facilities and equipment controls

all overseen by management and quality

audits.

Because the QS regulation covers a broad

spectrum of devices and production
processes, it allows some leeway in the
details of quality system elements. It is left
to manufacturers to determine the
necessity for, or extent of, some quality
elements and to develop and implement
procedures tailored to their particular
processes and devices. For example, if it is
impossible to mix up labels at a
manufacturer because there is only one
label to each product, then there is no
necessity for the manufacturer to comply
with all of the GMP requirements under
device labeling.

Drug manufactures are regulated under a

different section of the Code of Federal
Regulations:

Organizations and awards

The International Organization for
Standardization's ISO 9001:2015 series
describes standards for a QMS addressing
the principles and processes surrounding
the design, development, and delivery of a
general product or service. Organizations
can participate in a continuing certification
process to ISO 9001:2008 to demonstrate
their compliance with the standard, which
includes a requirement for continual (i.e.
planned) improvement of the QMS, as well
as more foundational QMS components
such as failure mode and effects analysis
(FMEA).[2]
(ISO 9000:2005 provides information on
the fundamentals and vocabulary used in
quality management systems. ISO
9004:2009 provides guidance on quality
management approach for the sustained
success of an organization . Neither of
these standards can be used for
certification purposes as they provide
guidance, not requirements).

The Baldrige Performance Excellence

Program educates organizations in
improving their performance and
administers the Malcolm Baldrige National
Quality Award. The Baldrige Award
recognizes U.S. organizations for
performance excellence based on the
Baldrige Criteria for Performance
Excellence . The Criteria address critical
aspects of management that contribute to
performance excellence: leadership;
strategy; customers; measurement,
analysis, and knowledge management;
workforce; operations; and results.

The European Foundation for Quality

Management's EFQM Excellence Model
supports an award scheme similar to the
Baldrige Award for European companies.

In Canada, the National Quality Institute

presents the 'Canada Awards for
Excellence ' on an annual basis to
organizations that have displayed
outstanding performance in the areas of
Quality and Workplace Wellness, and have
met the Institute's criteria with
documented overall achievements and
results.

The European Quality in Social Service

(EQUASS) is a sector-specific quality
system designed for the social services
sector and addresses quality principles
that are specific to service delivery to
vulnerable groups, such as empowerment,
rights, and person-centredness. [1]
The Alliance for Performance Excellence
is a network of state and local
organizations that use the Baldrige Criteria
for Performance Excellence at the
grassroots level to improve the
performance of local organizations and
economies. browsers can find Alliance
members in their state and get the latest
news and events from the Baldrige
community.

Process
A QMS process is an element of an
organizational QMS. The ISO 9001:2000
standard requires organizations seeking
compliance or certification to define the
processes which form the QMS and the
sequence and interaction of these
processes. Butterworth-Heinemann and
other publishers have offered several
books which provide step-by-step guides
to those seeking the quality certifications
of their products[3], [4][5][6][7][8]

Examples of such processes include:

order processes,
production plans,
product/ service/ process
measurements to comply with specific
requirements e.g. statistical process
 control and measurement systems
analysis,
calibrations,
internal audits,
corrective actions,
preventive actions,
identification, labeling and control of
non-conforming products to prevent its
inadvertent use, delivery or processing,
purchasing and related processes such
as supplier selection and monitoring

ISO9001 requires that the performance of

these processes be measured, analyzed
and continually improved, and the results
of this form an input into the management
review process.

See also
Capability Maturity Model Integration
Cleaner production
Corrective and preventive action
Good manufacturing practice
ISO 9000
ISO 14001
List of management topics
List of national quality awards
Manufacturing process management
Process architecture
Quality
Quality assurance
Quality control
Quality management
Standard operating procedure
Technical documentation
Total quality management
Verification and validation

References
ICH1 Guidance E6: Good Clinical
Practice: Consolidated guideline (and
see Clinical Quality Management
System)
Pyzdek, T, "Quality Engineering
Handbook", 2003, ISBN 0-8247-4614-7
Juran, Joseph M. and De Feo, Joseph A.,
"Juran's Quality Handbook", 6th Edition,
1999, ISBN 978-0-07-162973-7
1. American Society for Quality (ASQ)
Certified Quality Engineer (CQE)
[Link]
ntrol/quality-engineer/index
2. Poksinska, Bozena; Dahlgaard, Jens
Jörn; Antoni, Marc (2002). "The state
of ISO 9000 certification: A study of
Swedish organizations". The TQM
Magazine. 14 (5): 297.
doi:10.1108/09544780210439734 .
3. Anton, Doug; Carole Anton (2006). ISO
9001 Survival Guide, Third Edition.
AEM Consulting Group, Inc. p. 100.
ISBN 978-0-9672170-8-6.
4. Tricker, Ray; Bruce Sherring-Lucas
(2005). ISO 9001:2008 In Brief, Second
Edition. Butterworth-Heinemann.
p. 192. ISBN 978-0-7506-6616-9.
5. Tricker, Ray (2005). ISO 9001:2000
Audit Procedures, Second Edition.
Butterworth-Heinemann. p. 320.
ISBN 978-0-7506-6615-2.
6. Tricker, Ray (2005). ISO 9001: 2000 For
Small Businesses. Butterworth-
 Heinemann. p. 480. ISBN 978-0-7506-
6617-6.
7. Hoyle, David (2005). ISO 9000 Quality
Systems Handbook, Fifth Edition.
Butterworth-Heinemann. p. 686.
ISBN 978-0-7506-6785-2.
8. Dobb, Fred (2004). ISO 9001:2000
Quality Registration Step-by-Step,
Third Edition. Butterworth-Heinemann.
p. 292. ISBN 978-0-7506-4949-0.

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