1) The General Hospital in Pasighat, Arunachal Pradesh began an initiative to obtain ISO certification in June 2009 with support from various organizations. 2) An assessment was conducted of the hospital's operations and documentation to identify gaps against ISO standards. Training manuals and programs were developed to educate staff. 3) Key positions like Management Representative and Document Controller were appointed to lead the certification process. Documentation was developed at four levels - a quality manual, procedures, work instructions, and forms/registers. 4) Implementation involved standardizing processes, improving signage and communication, enhancing medical storage, implementing biomedical waste management, and reorganizing medical records. Photos show improvements made across various areas.

1. ISO CERTIFICATION
IN GENERAL HOSPITAL
PASIGHAT
By Arnab Sarkar,
ISO Consultant, Hospital Quality
General Hospital Pasighat

2. INTRODUCTION:
Hospital services in our country, whether high end
Multi or Single Specialty, Tertiary or Secondary
Care or first level Primary Health Centres, most
suffer because of an unstructured co-ordination
between support functions, right from
registration to the final discharge of the patient.
Whether it is maintaining or recording the
history of customer health, or providing timely
services like nursing, diet supply, housekeeping
or equipment management (very little in these
day of advanced technology), it is increasingly
being felt that the patients just don't feel
medication alone as all important but are equally
sensitive to other components of the health care
support services too.

3. What is Good for Hospitals ?
in Small & Medium Hospitals
Good Reputation of Hospital
Continuous Improvement
Providing
Good Courteous & Trained Staff
the greatest
Growth in Facilities good to the
greatest
Hasslefree Operation
number
High Success Rates but
Each Case
Large & Increasing Clientele
Important

4. Drivers for Growth
Reputation of the Hospital
Feedback & Customer Satisfaction
Infection Good Team Working
Control Accounting
Waste Documented
Transparent
Management Systems &
Working
Review Operating
Training
Procedures Discipline
Professional Management Material
Expertise Commitment Resources

5. ADVANTAGES OF ISO
CERTIFICATION:
Organisational Benefits:
Standardization - Helps the Hospital set up achievable set of
Quality of Service Levels.
Helps build up a quality conscious Organization, through all
round awareness of on the importance of quality.
Service Related Benefits:
Service Quality - Consistency in the quality of service achieved in
time.
Enhanced Patient Satisfaction.
Better Quality of Care - Standardization of support services
assists medical professionals in providing better quality of care

6. ADVANTAGES OF ISO CERTIFICATION
CONTINUED:
Operational Benefits:
Increased Productivity - Quality Conscious, Trained and
motivated employees working towards the common goal of
quality, leads to exponential increase in productivity.
Cost Savings - The savings achieved through a well documented
and standardized process is tremendous.
Efficient Operation of Support Services - The functioning of
various support services can be streamlined to achieve maximum
efficiency and resource utilization.

7. ADVANTAGES OF ISO CERTIFICATION
CONTINUED:
Other Benefits:
International Acceptance and Visibility - Accreditation and
Certification could be an effective marketing and branding tool for
the Hospital. (social status and recognition in case of Public
Sector hospitals)
Corporate & Institutional Clients - Will lead to increased business
from the corporate and institutional clients through empanelment
for employee reimbursements and packages like pre-employment
and annual check-ups.

8. INITIAL STAGE OF THE ISO
CERTIFICATION IN GENERAL HOSPITAL
PASIGHAT
The ISO Certification in the General Hospital
Pasighat was started in the month of June 2009
with great initiation of NHSRC, New Delhi and
RRC, North East, Guwahati and active
participation of the NRHM, Arunachal Pradesh
and Top Management of the Hospital.
The commencement of the Project was done by the
Consultants engaged by the NHSRC (National
Health System Resource Centre) ACME
Consulting, Chennai.

9. STEPS OF INITIATION OF ISO IN PASIGHAT
As-is Analysis Report:
The As-is analysis report is the basic gap analysis report
based on the ISO standards (available in standard books)
and the IPHS guidelines with applicable number of bed
strength of the hospital.
The As-is analysis report is made broadly in 3 parts viz. Part
A, Part B and Part C.
Part A:
The Part A of the As-is analysis report mainly consists of the
process flows of the various applicable processes of the
hospital’s OPD, IPD, Diagnostics and other supportive and
administrative processes of the hospital.

10. As-is Analysis Report continued:
Part B:
After the Part A, the Part B is the most important part of the
As-is Analysis report. All the identified gaps of the hospital
in different places according to the ISO standards and the
IPHS norms are collected as raw data and compiled in a
preset format of the report. The gaps are also made
relevant to the particular clause it is applicable to as well
as the clauses are also rated according to their severity.
Part C:
The Part C is the descriptive summary of the Gap report of
the General Hospital Pasighat according to the IPHS
standards.

11. Preparation of Training Manual
The second stage of the programme was to prepare
the training module based on the ISO clauses
and its standards and its implementation in the
General Hospital Pasighat. The Training manual
was also distributed to the senior and junior level
staffs during different training sessions.
The training manual has to be used as the ready
reference for all the staffs among whom the
training was given for the use in Internal audit,
final audits and increasing awareness.

12. Training Programmes
The training programmes were also conducted for
all categories of staffs where there was active
participation from all level of staffs and the
impact of the training was also found in the daily
hospital activities.
The training comprises of the ISO awareness,
Audits, Documentation, Waste management and
many other things.

13. APPOINTMENTS OF DIFFERENT
MANAGEMENT PERSONS UNDER ISO
CERTIFICATION PROCESS
For the implementation of the ISO standards in the hospital the
different management officials were selected and appointed in the
hospital. They are mainly:
1. Management Representative – Dr. K. Lego, DDHS (T&R).
2. Dy. Management Representative – Dr. T. Tali, Sr. Medicine
Specialist.
3. Document Controller – Dr. O. Moyong, Medical Superintendent.
4. Training In-charge – Dr. S. Bhattacharjee, SMO (SG) cum
Training Officer.
5. Internal Audit In-charge – Dr. T. Basar, Sr. Ortho. Surgeon.
6. Core Team Members.

14. Documentation
The documentation of the General Hospital
Pasighat was done in 4 levels. They are:
Level 1 – Quality Manual.
Level 2 – Quality Systems Procedure for Clinical
Procedures, Administrative Procedures and
Mandatory Procedures.
Level 3 – Work Instructions for the different
important activities of the hospital. the same WI
were distributed in relevant departments.
Level 4 – Forms and Formats and different
registers in the hospital. all the forms, formats,
registers and files of the hospital have a unique
code.

15. Implementation
Then came the turn for the implementation of the standards as
prepared in the 4 levels of the documentation. The things
which were documented are supposed followed as the same and
whatever is being practiced has to be documented only. It is a
vice versa process.
The forms and formats were also prepared as per the
requirement of the department. Registers were given codes and
printed. The facility for the Bio-medical waste management
was provided along with the proper guidelines and training.
The signage system was improved and the citizen charter and
other things were displayed.

16. Implementation contd.
The public addressing system and the Intercom facility was
installed to overcome the communication gap between inter-
departments.
The legal requirements were kept ready as per the guidelines.
Calibration of the important measuring equipments were done
from the external agency called ETDC, Guwahati. Followed by
that the internal calibration of the other measuring equipments
were also done in the hospital.
*Photos of the said changes are shown in the following slides.

17. The wash basins before the
implementation of ISO
standards were very
unhygienic. There were no
standard of hand washing
instructions displayed.
After the implementation of
ISO standards the wash
basins were far modified and
the cleanliness is also clearly
visible. There is now well
displayed hand washing
instructions at every hand
washing area.

18. Medicine storage was in a
haphazard manner in the
medicine store and the
pharmacy of the hospital.
There was no formal
procedure for storage of
medicines.
The new medicine stores is
been used in the hospital. All
the medicines racks,
consumable racks etc are kept
separate

19. The Bio-medical waste
management practices in the
hospital were not there.
There was no color coded bins
available in the hospital in
any areas
There is a well practiced Bio-
medical waste management
system in the hospital. The
staffs are well trained in the
same and the color coded bins
are also facilitated. The waste
disposal chart of different
category is also displayed in
the hospital.

20. The Medical Records of the
hospital did not have a
separate section in the
hospital. The records were
bundled and kept in the
matron office itself.
A separate section exclusively
for the storage of medical
records is earmarked and
facilities are provided
accordingly. The records can
be easily retrievable now.

21. The signage system in the
hospital was not very
informative for the patients.
There was always confusion
for the department and
availability of the doctor.
The signage system is
redesigned for the hospital
and the new signage is
already installed in the
hospital. All the OPD of the
hospital is displayed with the
department name and doctors
availability.

22. Impact of implementation of ISO Standards
The implementation of the ISO Standards in the General
Hospital Pasighat has brought the success in achieving the
prestigious ISO certificate. The hospital has thus become the
first ever hospital in the whole state of its kind.
The stage 1 audit was conducted after the internal audit was
finished in the hospital in the month of Sep. 2010. and the
hospital was qualified for undergoing the final audit for the
Certification. In the month of Nov. 2010 the final audit was
conducted in the hospital and the recommendation was given
by the Auditors came from IRQS, Kolkata.
The hospitals positive efforts towards the achievement of the
ISO Certification and their team work in facing and
successfully completing the audit was very much appreciated
by the auditors. The top management played a vital role with
the support of each and every member.

23. RETENTION OF ISO
CERTIFICATION
After the ISO Certificate is achieved after such
great efforts and commitment from the
management and other members of the staffs,
the retention of the certificate is the most
important point.
The hospital faced stage 1 and stage 2 audit to get
the certificate.
and now it is not all over.
The hospital will again have to face periodical
audits called surveillance audits those will be
conducted by the same auditors every year. The
following activities in the coming slides will have
to be undertaken for successful retention.

24. The major activities for the retention of
Certificate are:
1. Out-patient and In-patient satisfaction survey analysis on
an monthly basis and analysis of the same.
2. Monthly Indicators of the hospital performance and its
analysis monthly to measure the variation in gradual
improvement in the services.
3. Quarterly conduction of the internal audits in the
hospital and its report generation. the internal audit will
be conducted by the internal audit in-charge.
4. Employee satisfaction should be conducted by the
management bi-annually.
5. Conduction of the Medical Audit in the hospital.
6. Internal Calibration of the different measuring
equipments in the hospital.
7. Regular updating of the forms and formats and
implementation of new registers in the hospitals.

25. The major activities for the retention of
Certificate contd:
1. Maintenance of all the applicable checklist in the
different areas of the hospital.
2. Supplier rating should be done time to time. (twice
in a year).
3. Medicines and Materials storage / inventory
analysis in the hospital.
4. Conduction of Management Review Meeting at-least
once in a month.
5. Validation of Hospital laboratory test.
6. Swab culture test in critical areas of the hospital.
7. Effective Bio-medical Waste Management and
continuous training programmes on BMW and other
issues.

26. Suggestions for future:
Participating of all the members of the hospital
in the ISO certification process is necessary for
the continuity of the quality management.
The Core Team should comprise all the Doctors of
the hospital, where everyone will have their own
duty.
Proper distribution of the work among the
Department heads.
Monthly targets to be set and these targets to be
achieved by the responsible person which will be
reviewed in the MRM.

27. The ISO Certification was only possible in
the General Hospital due to the combined
effort and kind co-operation of the whole
team.
If all the members of the hospital come
together and take up the responsibility of
their own the ISO will remain forever in
the hospital and the hospital will as well
as grow towards more higher level of
Quality Accreditation Processes.

28. THANK YOU FOR YOUR
PATIENCE