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Consultant : Mr. Kirankumar S. GhanapuramEmail : [email protected]
Mobile : +91 9011017501
• Doing it right when no one is looking
• Quality is not an Act, it is a habit
• “ Quality is never an accident; it is always the result of intelligent effort ”
• The standard of something as measured against other things of a similar kind;
the degree of excellence of something
• Meeting the needs and exceeding the expectations of the patients
• Delivering all and only the care that the patient and family needs
• A doctor may say: “The kind of care that may relive the pain and suffering and
restore health to the best possible level”
• A patient may say, “The best possible treatment that is timely, safe and
affordable, and can restore his health to his earning capacity at the earliest”
• International Organization for standardization (ISO) is a nongovernmentalorganization founded 1947 based in Switzerland with world wide federation of175 member countries.
• The main objective of the ISO is to develop standards recognized internationally
• ISO 9001:2008 is the most widely recognized international standard forCertification
• It is a generic standard that affords any organization the ability to demonstratea commitment to quality and end user satisfaction.
• The standards can be used as guideline for orientation or can be adopted asrules to be followed. They are classified as generic or specific.
• There are 2 generic standards: ISO 9001:2008 & 14001:2004 with essentialcriteria for implementing quality & environmental management systems,respectively.
• These ISO standards are not Product Standards. They are more concernedabout Management & Processes and do not contain requirements for specificproduct.
"... providing the highest level of professional care with the most effectiveutilization of resources, the minimum risk to patient’s, the highest level ofpatient's satisfaction and with results improving health status."
But.....Quality needs more than standards, it needs...
...a fundamental change in the way people think and work
...a change in the way people relate to each other
...a quality culture...
Conformance to standards
Wanting to conform
Conformance to standards
• Generic Standards – Gives Flexibility
• International Recognition
• Customer (Patient Focus)
• Process Oriented
• Less Resource Intensive
• Gives Hospital the choice - Defining the Bar
• Can be Integrated with other Public Health Standards – IPHS, FFH, NABH, IMC RBNQA, National and International Quality Awards etc..
WHAT TO EXPECT
- When an ISO system is implemented as
a tool for continual improvement andprocess standardization
- if the ISO system reflects and is alignedwith the organization’s philosophy andmission
But…..DO NOT EXPECT- Specific requirements from certification standards- Good results without top management involvement (Remember they are management standards intended to improve the overall performance of an organization)- Without people involvement
Good Results
QUALITY MANAGEMENT SYSTEM 9001:2008Clause 1:
Scope (General & Application of standards)
Clause 2: Normative Reference (ISO 9000:2005 QMS Fundamentals & Vocabulary)
Clause 3: Terms & Definitions ISO 9001
Clause 4: 4.1 General requirements 4.2 Documentation Requirement
4.2.1 General4.2.2 Quality Manual4.2.3 Control of Document4.2.4 Control of Records
Clause 5: Management Responsibility 5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility, authority
& Communication5.6 Management Review
Clause 6: Resource Management 6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment
Clause 7: Product Realization 7.1 Planning for product realization7.2 Customer related process
7.2 1. Understanding the Requirements7.2.2. Review of the requirements
7.3 Design & development7.4 Purchasing7.5 Production & Service provisions7.6 Control of Monitoring & measuring equipments
Clause 8: Measurement, Analysis & Improvement8.1 General 8.2. Monitoring & Measurement
8.2.1 Customer satisfaction8.2.2 Internal Audit8.2.3 Monitoring measurement of process8.2.4 Monitoring & Measurement of products
8.3 Control of Non-conforming Product8.4 Analysis of Data8.5 Improvement
8.5.1Continual Improvement8.5.2 Corrective Actions8.5.3 Preventive Actions
Measurement, analysis and improvement
Product
Input Output
Management responsibility
Resource management
Clause 5
Clause 6 Clause 8
Clause 7
Product
realization
Satisfaction
Value adding activities
Patients Patients
General Requirements
Information flow
Clause 4
PATIENT’S
PERSPECTIVE
• Friendly & Competent Staffs
• Clean buildings
• Time utilization
• Availability of Medicines and tools
• Minimum cost
• Important information provided
• Rights of patients
STAFF’S
PERSPECTIVE
• Technical Competence
• Regular trainings
• Proper working environment
• Proper diagnostics for guidance
• Functional equipments
• Availability of Medicines and tools
• Rational work load
DIRECTOR’S/ HOD’S
PERSPECTIVE
• High coverage & Maximum cure rate
• Meeting programme goals
• Achieving performance indicators
• Effectiveness of services
• Efficiency
• Technical competence of staffs
• Satisfied Patients
LEVEL 1-
Policy 4.2.2
LEVEL 2- Procedures 4.2.3, 4.2.4, 8.2.2, 8.3,
8.5.2 & 8.5.3 (+ optional procedures)
LEVEL 3- Documents needed to plan, operate & control process
LEVEL 4- Evidence of results achieved & activities performed (see control records:
4.2.4)
Describe school policy relating to each ISO 9001 requirement
Quality Manual
Procedure(Who, What, When, Where)
Operational Documentation(How)
Quality Records
Customer focus
Leadership
Involvement of people
Process approach System
approach to Management
Continual Improvement
Factual Approach to
Decision making
Mutually beneficial supplier
relationship
• Random Structured interviewsTo determine their level of awareness and compliance with organization policies and procedures.To assess their awareness levels of their rights, privileges and patient rights.To determine their satisfaction levels
• Observation
• Visits to various areas
• Facility surveys and tours
• Review of documents
• Adherence to statutory obligations
• Regular Management Reviews
• Promptness in Corrective & Preventive Actions
• Promptness in Support Demand from Directors
• Top Management Commitment
• Involvement of People
Expected Response
Response of Medical Fraternity
• Please contact us for Healthcare Quality Assurance & Certifications consulting
services.
•Our consulting services are –
NABH (All Level)
NABH Safe I
ISO 9001:2015
Nursing Excellence