Chapter 5
Objectives
• After going through this chapter, you will be able to
understand:
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The meaning of ISO 9000,
Accreditation benefits and operational details of 1S09000,
The meaning of QMS,
The international / national regulating bodies for Health
care QMS
Introduction
• The Outside-in Organisation is about bad news and
good news. The bad news is that few managers actually
run their companies from the outside in, starting with
customers and prospective customers and making sure
that all their strategies and actions are chosen and
implemented from a strong customer perspective.
• The good news is that the outside-in discipline, a
commonsense yet revolutionary approach can turn the
bad news into opportunity.
ISO 9000
• ISO 9000 is series of standards for maintain effective
quality assurance system for manufacturing and service
industries, developed and published by International
Organization for Standardization (ESO).
• ISO 9000 deals with the fundamentals of Quality
Management Systems (QMS), including management
principles on which the family of standards is based. ISO
9000 was first published in l987.
Evolution
• Base for ISO 9000 is BS 5750 series of standards
proposed by BIS in year 1979 to ISO
• However history of ISO 9000 can be traced back up to
MIL-Q-9858 standard published in year 1959 by US,
Department Of Defence. BSI has been certifying agency
for their quality management systems since l974.
• Today, BIS claims to certify organizations at nearly
70,000 sites globally.
Evolution
ISO 9000 Requirements include:
Approve documents before distribution;
Provide correct version of documents at points of use;
Use your records to prove that requirements have been met; and
Develop a procedure to control your records.
What is ISO 9000?
• ISO 9000 is important in the first instance because it
gives organizations some guidance on how to manage
quality. Secondly, mechanisms exist by which an
organization can be certified for conforming to ISO 9000
specifications.
• With this certification in hand, an organization can
better sell its product or service to its customer. It can
say that the product or service is the result of a process
that continually tested for quality.
What is ISO 9000?
• Rules exist for how such certification should be done,
and organizations exist which certify other organizations
as performing reliable ISO 9000 certifications.
• In the United Kingdom, Australia and India 3rd party
audits of ISO 9000 compliance involves a system audit
every three years and five- six mini-audits within each
three year span. To receive certification a company must
show that its documentation follows the quality
standard and that its people follow the documentation
Benefits of Accreditation to ISO 9000
• Benefits to organization:
– Provides senior management with an efficient management
process,
– Sets out areas of responsibility across the organization,
– Mandatory if you want to tender for some public sector
work,
– Communicates a positive message to staff and customers,
Benefits of Accreditation to ISO 9000
• Benefits to organization:
– Identifies and encourages more efficient and time saving
processes,
– highlights deficiencies,
– Reduces costs,
– Provides continuous assessment and improvement,
– Marketing opportunities.
Benefits of Accreditation to ISO 9000
• Benefits to customers:
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–
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Improved quality and service,
Delivery on time,
Right first time attitude,
Fewer returned products and complaints,
Independent audit demonstrates commitment to quality.
ISO Manual of Standard
• The term ‘ISO 9000’ is usually used to refer to a set of
intimately related standards. One standard is a roadmap
for the others. These standards cover quality design,
quality management, and quality assurance for different
kinds of companies depending on the extent to which
they design as well as manufacture products.
• Another one of the standards covers risks, costs and
benefits, management responsibility, quality system
principles, and other building blocks that help users
customize quality standards to conform to real—life
situations.
ISO Manual of Standard
PROCESS
Design
QUALITY
CONTROL
Production
Distribution
QUALITY
RECORDS
ISO 9001
• It’s an international Standard. This Standard sets out all
the elements that should exist in a sound quality
management system.
• The elements are written as ‘requirements’ - things you
are ‘required’ to do.
ISO 9001
• They can be applied to any quality management system
where you:
– Need to demonstrate that your organization can
consistently provide services (or products) that meet the
requirements of your customers, and any applicable
regulation
– Want to enhance the satisfaction of your customers
through the effective use of your system
ISO 9001
• The Standard has 8 sections. The requirements are in
sections 4 — 8:
– Section 4 is an ‘overall’ one for the system. It contains
requirements applicable to the system throughout,
including requirements to define processes, for
documentation, and for records
– Section 5 is about the responsibility of management,
particularly ‘top management’ - the decision-makers. It
includes requirements for customer focus through quality
policy, planning, defining responsibilities, setting objectives
and reviewing performance,
ISO 9001
• The Standard has 8 sections. The requirements are in
sections 4 — 8:
– Section 6 is about resources. its aim is to ensure that
people performing work affecting service/product quality
are competent, and that suitable infrastructure (from
facilities to tools & equipment) is provided.
– Section 7 is on service/product ‘realization’ or core business
activities — all the processes & activities involved in
delivering your services or products. It contains the most
requirements, from communicating with customers
ISO 9001
• The Standard has 8 sections. The requirements are in
sections 4 — 8:
– Section 8 covers measurement, analysis and improvement.
It sets requirements for checking how you are performing,
assessing performance, identifying and fixing various
problems, and improving your system.
ISO 9002 & 9003
• ISO 9002:
– Model for quality assurance in production, installation, and
servicing had basically the same material as ISO 9001 but
without covering the creation of new products.
• ISO 9003:
– Model for quality assurance in final inspection and test
covered only the final inspection of finished product, with
no concern for how the product was produced.
How does ISO 9000 Operates
• The ISO 9000 certificate is suitable for all sizes of
organization and is well established around the world as
an invaluable quality management system.
• It is suitable for organization in all industry sectors and
will help your organization to improve management
processes to compete locally and/or globally.
• The process encompasses the entire organization and
requires senior management buy-in, it is not just a
function of the Quality Department.
Quality Manual
• The Quality Management System first requires a Quality
Manual to be written. This document is the backbone of
the Management System, and is where announce
organizational intentions.
• This is often the document where the company records
the Quality Policy and Objectives, and sometimes adds
the company’s Mission and/or Vision Statement.
• While preparing the Quality Manual Following points
should be keep in mind,
Quality Manual
• The scope of the Quality
Management System:
commonly pointed out,
there are only six
documented procedures
required by the ISO
standard
– This is in place to identify
the limit of the system and
is based on the scope
agreed with the registrar • A description of the
interaction of processes:
to be placed on the ISO
certificate.
– This is most simply done
with a flowchart that
• The documented
identifies all the processes
Procedures:
in the organization with
– Established for the Quality
arrows showing how they
Management System (or
connect
references): As is
Departmental Procedure
• ISO 9000 specifically requires the organization to have
documented procedures for the six Activities: Control of
documents (clause 4.2.3), Control of records (Clause
4.2.4), Internal audit (Clause 8.2.2), Control of
nonconforming product (8.3), Corrective action (8.5.2),
& Preventive action (8.5.3).
• From an ISO 9000 perspective, there are no mandatory
procedures required for HR or IT departments as
supporting functions for an organization.
• It is recommended, however, that you have your
processes documented to ensure accountability for
actions, consistency and standardization.
Specification
• The ISO 9000 standards are formulated on the Concept
that the assurance of the consistent product quality is
best achieved by application of two kinds of standards,
one of them is Product Standards (Technical
specifications)
• Product standards provide the technical specifications
that apply to the characteristics of the product and the
characteristics of the processes by which the product is
produced. Product standards are specific to the
particular product
Quality System Management
• The Management systems are that used to achieve,
monitor, control, and improve the functional, financial,
and human relations performance of organization.
• Management system includes mechanisms for
allocating, organizing, and improving resources. It
should incorporate quantitative metrics and other
criteria to monitor and evaluate the performance of the
organizational units and personnel.
British Standards Institution (BSI)
• The British Standards Institution (BSI) is the national
standards body (NSB) representing the interests of the
UK across all of the European and international
standards organizations and through their committees.
• BSI has published more than 21,000 standards that
dictate proper procedures from apiculture to the
transportation industry.
• Independent of government, BSI is globally recognized
as an independent body serving both the private and
public sectors.
Joint Commission accredits (JCA)
• The Joint commission accredits is an independent,
non—profit Organization and certified more than
twenty thousand health care organizations / programs
in United States.
• It and its certification is recognized US nationwide as a
symbol of quality which reflects commitment to
meeting certain performance standards.
Indian Counter parts in accreditation of
hospital and Laboratories
• To establish and operate national accreditation structure
and promote quality through National Quality
Campaign; an independent, not-for-profit Society, was
set up jointly by the Government of India and the Indian
Industry represented by the three premier industry
associations (i.e. Associated Chambers of Commerce
and Industry of India (ASSOCIIAM), Confederation of
Indian Industry (CII) and Federation of Indian Chambers
of Commerce and Industry (FICCI)).
Quality Council of India (QCI)
• Quality Council of India is governed by a Council of 38
members with equal representations of government,
industry and consumers. Chairman of QCI is appointed
by the Prime Minister on recommendation of the
industry to the government.
• The Department of Industrial Policy & Promotion,
Ministry of Commerce & Industry, is the nodal ministry
for QCI. It functions through the executive boards in the
specific areas i.e. Accreditation for Conformity
Assessment Bodies, Healthcare Establishments,
Education & Vocational Training Providers
Quality Council of India (QCI)
• Vision of QCI is to be among the world’s leading national
apex quality facilitation, accreditation and surveillance
organizations, to continuously improve the climate,
systems, Processes and skills for total quality.’ Some of
its Objectives are:
– Establish and maintain an accreditation structure in the
country,
– Provide right and unbiased information on quality related
standards,
– Spread quality movement ¡n the country through National
Quality Campaign,
– Facilitate up-gradation of equipment's and techniques
related to quality,
Quality Council of India (QCI)
National Accreditation Board for Hospitals &
Healthcare Providers (NABII)
• National Accreditation Board for Hospitals & Healthcare
Providers (NABH) is a constituent board of Quality
Council of India, set up to establish and operate
accreditation program for healthcare organizations.
• The board is prepared to cater to much desired needs of
the consumers and to set benchmarks for progress of
health industry. The board is supported by all
stakeholders including industry, consumers, government
and has full functional autonomy in its operation.
National Accreditation Board for Testing and
Calibration Laboratories (NABL)
• National Accreditation Board for Testing and Calibration
Laboratories (NABL) is an autonomous body under the
guidance of Department of Science & Technology,
Government of India.
• NABL has been established with the objective to provide
Government, Regulators and Industry with a scheme of
laboratory accreditation through third-party assessment
for formally recognizing the technical competence of
laboratories.
Accreditation of Small Healthcare
Organization
• Small Healthcare Organization are those healthcare
organizations having bed strength up to 50 beds and
Day Care centers (up to 50 beds) are in control of
supportive and utility facilities that are appropriate and
relevant to the services being provided by organization.
• Hospital Accreditation is a public recognition by a
National Healthcare Accreditation Body, of the
achievement of accreditation standards by a Healthcare
Organization.
Accreditation of Small Healthcare
Organization
• In India, Heath System currently operates within an
environment of rapid social, economical and technical
changes. Such changes raise the concern for the quality
of health care.
• Small Health care Organization (SHCO) ¡s an integral
part of health care system. Accreditation would be the
single most important approach for improving the
quality of SHCO.
Chapter 5