1. ISO
PRESENTED BY DR.PRIYANKA R. PHONDE.
ITM HEALTHCARE MANAGEMENT
ROLL NO : KHR2011EMBAHC5P007
FACULTY :DR.DEV TANEJA
SUBJECT : TOTAL QUALITY MANAGEMENT IN HOSPITALS
29/01/2012 11:00AM

2. About ISO
• ISO (International Organization for Standardization) is
the world's largest developer and publisher
of International Standards.
• ISO is a network of the national standards institutes
of 163 countries, one member per country, with a
Central Secretariat in Geneva, Switzerland, that
coordinates the system.
• ISO is a non-governmental organization that forms a
bridge between the public and private sectors.
• ISO has developed over 18,500 International Standards
on a variety of subjects and some 1100 new ISO
standards are published every year.

3. • The three official languages of the ISO
are English, French, and Russian. The
organization's logos in two of its official languages
English and French.
• The organization which today is known as ISO began in
1926 as the International Federation of the National
Standardizing Associations (ISA)
• ISO is a voluntary organization whose members are
recognized authorities on standards, each one
representing one country. The bulk of the work of ISO
is done by the 2700 technical committees,
subcommittees, and working groups. Each committee
and subcommittee is headed by a Secretariat from one
of the member organizations.

5. STAGES OF ISO
• International Standards are developed by ISO
technical committees (TC) and subcommittees
(SC) by a process with six steps:
• Stage 1: Proposal stage
• Stage 2: Preparatory stage
• Stage 3: Committee stage
• Stage 4: Enquiry stage
• Stage 5: Approval stage
• Stage 6: Publication stage

7. • Stage 1: Proposal
– A proposal is submitted to ISO by industry members who feel that an International Standard is needed for
their product or service. ISO forms technical committees (TC) and subcommittees (SC) to discuss the
proposal. The committees vote on the proposal, and if the vote is accepted the standard moves to the
second stage.
• Stage 2: Preparatory
– A group of experts is gathered by the TCs and SCs formed in the proposal stage and is put under the charge
of a project chairman. The experts pen and revise a working draft of the standard that outlines the
technical specifications that must be met by the standard. Once the experts are satisfied with the technical
draft of the specification, the document is sent to the parent committee of the group for review.
• Stage 3: Committee
– The working draft created during the preparatory stage is registered by the Central Secretariat of ISO and
circulated among the TC and SC groups formed for the standard. The committees reviewing the draft can
vote to send the document to the next stage as a draft International Standard or revise the document .
• Stage 4: Enquiry
– The draft International Standard (DIS) is circulated among the member bodies of ISO for review, voting and
comment. Member bodies have five months to respond to the DIS. If two-thirds of the TC and SC members
approve of the DIS, and if three-quarters of the member bodies of ISO approve of the DIS, the draft is
revised and moves into the Approval Stage. If the voting requirements are not met, the draft is returned to
the Committee Stage for further revision.
• Stage 5: Approval
– The final version of the DIS is submitted for a second vote among the member bodies of ISO. Member
bodies have two months to place their votes. The draft is approved if two-thirds of the TC and SC members
and three-quarters of the member bodies of the ISO vote in favor of the DIS. Any technical comments
received at this stage are saved for later review.
• Stage 6: Publication
– Minor editorial changes are made to the final International Standard, which is then published by ISO.
Within three years, the new standard is reviewed by the TC/SC and member bodies of the organization and
revised if necessary.

9. Why did one hospital pursue
certification in 9001:2000
• If hospital is looking to enhance its healthcare
quality management system. What makes ISO
unique is that it relies on the individual
organization to establish, document, implement
and maintain a quality management system and
continually improve its effectiveness.
• ISO assists the organization in designing and
ensuring its documented processes are effective
and support its mission.

10. ISO 9001 Certification for Hospital
Quality Management Systems
• An ISO 9000 implementation gives a basic road
map for integration of all functions involved in
total health care services, for ensuring a better
quality of service to the patients.
• The latest version, the ISO 9001:2008, is
especially relevant to the Healthcare Services
Sector as it focuses on fulfilling customer
(patient) expectations, improving the quality of
an organization’s business and management
processes.

12. Hospital aspiring for an ISO 9001
Certification are:
• Acceptable quality care at affordable prices.
• Timely care.
• Clear communication to the patients.
• Best practices for fixing appointment and service
delivery.
• Reliable diagnostic and laboratory support.
• Reliable support services like canteen, ambulance,
pharmacy, etc.
• Safe and pleasant environment.
• Technical competence, courtesy and attitude of staff.

15. NABH & NABL Accreditation
Assistance
• The National Accreditation Board for Hospitals & Healthcare
Providers (NABH) Standards is today the highest benchmark
standard for hospital quality in India. Though developed by the
Quality Council of India on the lines of International Accreditation
Standards like the JCI, ACHS and the Canadian Hospital
Accreditation Standards, the NABH is however seen as a more
practical set of Standards, topical and very relevant to India’s
unique healthcare system requirements.
• National Accreditation Board for Testing & Calibration Laboratories
(NABL), similar to the NABH, is also an autonomous body, under the
Quality Council of India. The primary objective being to maintain an
accreditation system for laboratories suitable for India, developed
in accordance with relevant national and international standards
and guides. The NABL Accreditation is a formal recognition of the
technical competence of a laboratory based on third party
assessment and following international guidelines.

16. • Why ISO Certification
• ISO is generic standard, which means that it can be applied to any organization,
large or small, whatever its product or service, in any sector of activity, and
whether it is a business enterprise, a public administration or a government
department. no matter what the organization's scope of activity if it wants to
establish a proper management system, than ISO 9001 gives the essential features.
• Benefits of QMS
• International, expert consensus on state-of-the-art practices for quality
management.
• Common language for dealing with customers and suppliers worldwide.
• Increase efficiency and effectiveness.
• Model for continual improvement.
• Model for satisfying customers and other stakeholders.
• Build quality into products and services from design onwards.
• Comply with government regulations.
• Integrate with global economy.
• Sustainable business
• Unifying base for industry sectors
• Qualify suppliers for global supply chains
• Technical support for regulations
• Transfer of good practice to developing countries
• Tools for new economic players
• Regional integration
• Facilitate rise of services

18. Some examples ..
• Surgical Gloves • Castors and Wheels on
ISO 10282: 2002 details packaging and storage
requirements for surgical gloves. The goal of the
Hospital Beds
standard is to prevent cross-contamination ISO 22882: 2004 specifies technical requirements
between patients. and dimensions for wheels and locking
mechanisms on hospital beds.
• Heating Pads and
• Medical Face-Mask
Blankets
ISO 80601: 2009 covers safety concerns related to
Quality
heating pads, blankets and other electrical ISO 22609 does not cover a mask's resistance
bedding used on pediatric patients to airborne pathogens.
ISO 22609:2004 addresses a laboratory testing
method which measures how effectively
medical face masks resist penetration by a
splash of synthetic blood.

19. THANK YOU.