Presentation of International Organization for Standardization (ISO)

1. HEALTH MANAGEMENT SEMINAR
International Organization
for Standardization (ISO)

2. Contents
• Background / introduction
- ISO 9001:2008
- Quality Management System
• Principles of Healthcare (requirement & implementation)
- Customer focus
- Measurement analysis and improvement
- Process approach
- Document control
- Audit and reporting
• Advantages and disadvantages
• Issues and challenges

3. Background & Introduction ISO Family of
Standards
• International Organization for Standardization (ISO) founded in Geneva in 1947.
• Greek word isos : equal
• Original purpose – to provide standardization of technical specifications for
products traded in the international marketplace.
• More than 150 countries are members of ISO, and more than 18,000 ISO standards
are used worldwide.
• The ISO 9001 family of QMS standards was first developed in 1987 and revised in
1994, 2000, and 2008.

4. Background / Introduction
• ISO 9001 – “Consistent, conforming products”
• ISO 14001 – “Prevention of pollution”
• OHSAS 18001 – “Safe working conditions”
• ISO 50001 – “Efficient energy usage”
• ISO 22000 – “Safe food”

5. Background ISO 9001
• First introduce in the United Kingdom by its Ministry of Defense
• As a requirement for a quality standard measurement for their supplier to
follow a standard operating procedure.
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6. History –The Development of ISO
1970’s
• BS9000
• BS5179
1979 BS5750
1987 ISO 9001:1987
1994 ISO 9001:1994
2000 ISO 9001:2000
2008 ISO 9001:2008
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7. Quality Management System (QMS)
• Its goal is to address all functions that are necessary to meet customer
requirements.
• Its system is based on defining, managing and improving the key processes of an
organization
• Thus, it defined as the framework or infrastructure used by an organization to
support and manage its policies, procedures, practices and planning activities.
• Enables an organization to better meet customer expectations and decrease
problems and errors.

8. PRINCIPLES OF ISO REQUIREMENTS
MEASUREMENTANALYSISAND IMPROVEMENT
DOCUMENTCONTROL
CUSTOMER FOCUS
PROCESSAPPROACH
AUDITSAND REPORTING

9. Measurement analysis and improvement
to demonstrate
conformity to
product
requirements
to ensure
conformity of
the quality
management
system
to continually
improve the
effectiveness
of the quality
management
system

10. 8.5 Improvement
Continuous improvement Corrective actions PreventiveActions
Analysis of Data (Comply)
Control of non conforming product (Comply)
Monitoring and Measurement
Customer satisfaction Internal audit
Monitoring measurement
& processes
Monitoring &
measurement of products
Principles

11. Customer
satisfaction
• Measurement of
performance
• Management review
Internal audit
• Requirement of
international standard
• QMS requirement
• Effectively implement and
maintained
Monitoring
measurement
of process
• Measurement of QMS
• Ability to achieve planned
result
• Correction and corrective
action should be taken
• e.g Quality Objective
Monitoring
measurement
product
• Validation and verification of
product
• Delivering to customer
MONITORING
AND
MEASUREMENT

12. • The organisation shall ensure that product which does not conform to
product requirements is identified and controlled to prevent its unintended
use or delivery.
• A documented procedure (Work Procedure) shall be established to define
the controls and related responsibilities and authorities for dealing with
nonconforming product.
• E.g. infants weighing scale in MCH clinic
Control of non conforming product (Comply)

13. • The organisation shall determine, collect and analyse appropriate data to demonstrate the
suitability and effectiveness of the QMS and to evaluate for continuous improvement.
Analysis of Data – Management Review
The analysis of data shall provide information relating to:
a) customer satisfaction
b) conformity to product requirements
c) characteristics and trends of processes and products including
opportunities for preventive action (risk assessment)
d) suppliers

14. Improvement
Continuous improvement
through the use of the -
-Quality policy,
-Quality objectives,
-Internal and external audit results,
-Analysis of data,
-Management Reviews
-Raising/documenting an
Opportunity for Improvement
(OFI)corrective and/or preventive
action.
Corrective action
take action to eliminate the causes
of non conformities in order to
prevent recurrence.
Corrective actions shall be
appropriate to the effects of the non
conformities encountered.
Preventive action
to eliminate the causes of potential
nonconformities in order to prevent
their occurrence.
-shall be appropriate to the effects
of the potential problems

15. Document control
01
02
03
This clause requires that the quality system provide timely access to
approved instructions for the accurate and timely provision of patient
care and support functions.
The right documents must be available and indexed so they
are readily accessible.
The clause requires that providers establish and maintain
documented procedures and that pertinent documents and data are
available at all locations where operations essential to the effective
functioning of the quality system are performed. All charges must be
approved, and all obsolete documents must be promptly removed.

16. Type of document
ISO standard 9001
Quality manual
SOP
Work instruction
Act & regulations
Guideline
Circular
Desk file

17. Why must have document control??
.
All document in quality system
must be control.
To approved all document
before distributed.
To review and update the
document and to approved
again the document
To ensure all changes and new
amendments can be identified.
To ensure that relevant versions of
relevant documents are in place it is
used
To ensure document can be read
and assess at every time needed.
To ensure all the outsource
document must be identified and
control the distribution.
To prevent unintended use of
obsolete documents, and to provide
appropriate identification document
should be kept for any purpose

18. CUSTOMER FOCUS
Organizations depend on their
customers and therefore they
should understand current and
future customer needs, should
meet customer requirements
and strive to exceed customer
expectations.
KEY
BENEFITS
Increase
customer
value
Increase
customer
satisfication
Increase
customer
loyalty
Enchanced
repeat
business
Enchanced
reputation of
the
organization
Expanded
customer
base
Increased
revenue &
market
share

19. Implementation of customer focus in
MOH
• Establishing procedures to determine customer needs and translating into work instructions
• Establishing controls to consistently meet customer needs and for providing “state of art” service
• Identifying process owners, establishing roles and responsibilities and correct performance measures
• Communicating customer requirements throughout the organization and on time
• Validating the system, processes and controls – revalidating if necessary
• Establishing procedures to engage people, monitor team functions, performance and success
• Establishing procedures to meet customer expectations for products and service delivery including
those for returns, replacement and compensation
• Establishing procedures to collect, analyse, and determine the level of customer satisfaction
• Establishing procedures to handle complaints, taking timely corrective, preventive actions and
communicating back to customers if necessary

20. Benefit of Implementation
Consistency of service received and improved adherence to schedules
Greater confidence in ministry’s capability
The ability by customers to rely on the Ministry to provide what it promises
increased customer satisfaction and loyalty

21. PROCESS APPROACH
Consistent and predictable results are achieved more
effectively and efficiently when activities are understood
and managed as interrelated processes that function as a
coherent system.
The Quality Management System (QMS) consists of
interrelated processes.

22. Benefits:
Enhanced ability
Consistent and
predicable
outcomes
Optimized
performance
Enabling the
organization to
provide confidence
Implementations:
define establish understand determine manage

23. Audits and reporting
• a systematic, independent, and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which
audit criteria are fulfilled.
type objectives criteria

24. Process
Planning &
schedule
competence
Audit teamconducting
Follow up
Items
Records Documents
internal audit
Preventive
action
Correction
action
Non
conforming
product

28. Advantages & Disadvantages
challenges and barriers

29. ADVANTAGES OF ISO 9001
• Enhanced customer satisfaction and improved customer loyalty leading to repeat business
• Increased revenue and market share obtained through flexible and fast responses to market
opportunities
• Integration and alignment of internal processes which will lead to increased productivity and results
• Enhanced business performance and better cost management
• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the
organisation
• Increased credibility and competitiveness in the market
• Consistency in the delivery of your product or service
• Lower costs and shorter cycle times through effective use of resources
• Improved communication, planning and administration processes

30. Disadvantages of ISO 9001
• Owners/ Managers don't have sufficient understanding of ISO 9001
• Costly to implement at the start
• heavy emphasis on documentation
• long time scale possibly months to set the system up.
• Competitive disadvantage

31. Challenges and barriers
TOP MANAGEMENT INVOLVEMENTAND UNDERSTANDING
• Crucial in determining the successful implementation of the program
• Employee perceived the program as not important if found out their top
management did not put this program as the organisation top priority.
HUMANAND FINANCIAL RESOURCES
• Cost involved such as engaging consultant for the program, staff training,
documentation, human capital, audit and related certification.

32. QUALITY PERCEPTION AND STAFF RESISTANCE
• Targeting to the personnel directly
• Resistance to change of a person was seen as rejecting any effort by any parties to changed their existing comfort zone.
COOPERATION AMONG INTER DEPARTMENT
• Organization structural is complex and subdivide to few other department with different roles and objective to achieve
in a systemic and efficient ways.
• Leaders of the organization will affect the implementation directly.
• Implementation suffer setback as refining their objective and priority depending on the preference of the newly
appointed officers
ORGANISATION LEADERS

33. Why was ISO 9001 revised?
• Revised regularly to make sure they remain relevant to the marketplace.
• Take intoaccountthedifferentchallengesthatbusinessesnowface
• Due to globalization has changed the way we do business and organizations often
operate more complex supply chains
• Increased expectations from customers
• To remain relevant

34. What benefits does the new version bring?
• The new version of the standard brings the user a number of benefits.
• ISO 9001:2015:
• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a structured
manner
• Uses simplified language and a common structure and terms
• Is more user-friendly for service and knowledge-based organizations

35. Future challenges
• As the adoption of the new version requires changes to the existing
activities and documentation, the extra task may cause extra burden to the
staffs in order to achieve the new objective set by the organization.
• Most of the time, staffs do not perceive well with the new version.The
commitment from the staffs may significant affected the successful
implementation and maintenance of the program.

36. THANKYOU