The document provides an overview of quality assurance standards and ISO 9001 accreditation. It discusses what ISO 9001 is, its requirements and certification process. The benefits of accreditation for organizations and customers are improved quality, safety, and compliance. Key parts of a quality management system are also summarized like its objectives, goals and core elements. Guidance is provided on interacting professionally with auditors during an audit to clarify questions and admit issues, while working towards continuous improvement.

1. QUALITY
ASSURANCE
STANDARD
BY:
JOANNA R. ANTONIO, RN

2. LEARNING OBJECTIVES
What is
ISO 9001
Accreditation
Benefits and
Operational
Details
What is QMS The International
/ National
regulating bodies
for Healthcare
QMS
Describe the Audit
approach and Learn
useful tip on
handling on Audit
session

3. “ It is not enough to do your best;
You must know what to do.
Then do your best”
-W. EDWARDS DIMING

4. ABOUT ISO
• Non-governmental organization (NGO) stablished in 1947, based in Geneva,
Switzerland.
• Has a membership of over 165 national standards institutes from countries in all
regions of the world.
• The world largest developer of voluntary International Standards, based in global
and market relevance.

5. WHAT IS ISO 9001?
• Is an International standard that many companies use
to insure that their quality assurance system is in place
and effective.
• ISO 9001 Is a quality management system (QMS)
standard that requires an organization to meet its own
requirements in those of its customers and regulators.
• It is based on the plan-do-check-act methodology.
• Improving quality and enhancing patient safety
through the implementation of a quality management
system is the best way to provide patient centered
care.
• Focuses on the effectiveness of clinical, business and
support processes to ensure high quality care is
provided.

6. ISO 9000 FAMILY
• ISO 9000:2005 Fundamentals and vocabulary
• ISO 9001:2008 Quality Management Systems
requirements
• ISO 9004:2009 Guidelines for performance
improvements
• ISO 19011:2002 Audit of management system
Some Facts about ISO 9001:2008
• Originated in 1987
• Certificates issued worldwide
• ‘03 - 497,919 companies in 149 countries
• ’06 - 897,866 companies in 170 countries
• ’09 - over 1.2 Million companies in 178 countries

7. ACCREDITATION BENEFITS AND IMPORTANCE
• 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,
• Identifies and encourages more efficient and time saving
processes,
• Highlights deficiencies, Reduces costs,
• Provides continuous assessment and improvement,
• Marketing opportunities.
•
Benefits to customers:
• Improved quality and service
• Delivery on time
• Right first time attitude
• Fewer returned products and complaints
• Independent audit demonstrates commitment to quality.

8. ACCREDITATION BENEFITS AND IMPORTANCE
In health care:
• Ensure quality and safety in the treatment of the
patients.
• Identify and manage risk to patients, staff in the
organization
• Determine, manage, monitor and improve complex and
interrelated processes
• Comply with relevant International and national legal
requirements
• Implement best practice routines and procedures
• Prevent incidents from occurring
• Identify areas of improvement and ensure continual
enhancement of your quality management system
• Provide assurance to patience, authorities, and other
stakeholders the you have implemented a well-
functioning management system and are committed to
continual improvement

9. REQUIREMENTS OF ISO 9001:2008
Quality
Management
System
(Clause 4)
Management
Responsibility
(Clause 5)
Measurement
Analysis &
Improvement
(Clause 8)
Resource
Management
(Clause 6)
Product
Realization
(Clause (Clause
7)
Regulation
and
Customer
Feedback
Regulation
and
Customer
Requirement
s
Maintain Effectiveness of the
Quality Management System
Product

10. REQUIREMENTS OF ISO 9001:2008
Quality
Management
System
Management
Responsibility
Resource
Management
Product
Realization
Measurement
Analysis &
Improvement
4.1 General requirements
4.2 Documentation
requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of
Documents
4.2.4 Control of
Records
5.1 Management
commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility,
Authority and
Communication
5.6 Management
Review
6.1 Provision of
resources
6.2 Human resources
infrastructure
6.4 Work Environment
and contamination
control
7.1 Planning of Product
realization
7.2 Costumer –related
processes
7.3 Design and
Development
7.4 Purchasing
7.5 Production and
service provision
7.6 Control of
monitoring and
measuring equipment
8.1 General
8.2 Monitoring and
measurement
8.3 Control of non
conforming products
8.4 Analysis of data
8.5 Improvement

11. ISO 9001 CERTIFICATION PROCESS
Implementation
of QMS
Conduct internal
Audit and review
result by top
management
Selection of
certification
buddy
Confirmation of
Registration
Stage 2 Audit Stage 1 Audit
Continual
Improvement
and
Surveillance
Audit

12. PDCA CYCLE
PDCA stands for Plan-Do-Check-Act,
and is a cyclical method for
continuous improvement of
processes.

14. WHAT IS QUALITY?
• The totality of features and
characteristics of a product or service
that bear on its ability to satisfy stated or
implied needs.
“Quality is the result of a carefully
constructed cultural environment. It
has to be the fabric of the
organization, not part of the fabric”.
Philip B. Crosby

15. QUALITY MANAGEMENT SYSTEM
- Used to achieved, monitor, control,
and improved the functional,
financial, and human relation
performance of organization.
- Includes mechanism for allocating,
organizing, and improving resources.
It should incorporate quantitative
metrics and other criteria to monitor
and evaluate the performance of the
organizational unit and personnel.

16. OBJECTIVES OF QMS
- To satisfy customers through a quality
products/services
- To gain self confidence – we get what
we planned
- To achieve competitiveness in both the
local and overseas markets
- To use as a blueprint for efforts to
improve the quality system of the
organization

17. GOALS OF QMS
- To ensure compliance with
company and industry standards
- Defining the processes to result in
the production of quality products
and services, rather than in
detecting defective products or
services after they have been
produced

18. BENEFITS OF QMS
Provides a framework for...
- Existing quality functions and processes
- Consistency across the organization
- Improved customer relations
- Consistent approach to complying with customer & internal quality
requirements
- Accountability
- Continual improvement
- Provides a structured framework to all existing processes
- Identifies the sequence of all processes
- Documents all processes to avoid personal dependencies
- Documented procedures help to perform consistent operational
activities
- Consistency in processes leads to quality product or services
- Increased satisfaction level of internal & external customers

19. CORE ELEMENTS OF QMS
1. Quality policy and objectives
2. Quality manual
3. Organizational structure and responsibilities
4. Data management
5. Processes
6. Customer satisfaction with Product/Service
quality
7. Continuous improvement
8. Quality instruments
9. Document control and management

20. EIGHT QUALITY MANAGEMENT PRINCIPLES

21. The International / National
Regulating bodies for Healthcare QMS
Joint Commission International (JCI)
- Is an independent, non-profit organization and
certified more than 22,000 healthcare
organizations/programs in USA.
- It and its certification is recognized US nationwide as
a symbol of quality which reflect commitment to
meeting certain performance standards.
Quality Council of India (QCI)
- Is a non-profit organization, was stablished as a national
body for accreditation on recommendations of expert
mission of EU after consultations in Inter-Ministerial
Task Force , Committee of Secretaries and Group of
Ministers through a Cabinet decision in 1996.

22. THE INTERNATIONAL / NATIONAL
REGULATING BODIES FOR HEALTHCARE QMS
British Standards Institution (BSI)
- Is the national standard body representing the
interests of the UK across all the European and
International standards organizations and through
their committees.
- BSI has published more than 21,000 standards that
dictates proper procedures.

23. HOW TO HANDLE THE AUDIT SESSION
• Do not panic
• Ask and clarify
• Admit obvious non-conformities
• Offer evidence and explain patiently
• Take note of improvement of highlighted
areas by the Auditor
• Show Internal Audit report when necessary
• Polite
• Professional
• Positive/Receptive
• Sincere
• Commitment
• Formal but not overly serious
AUDITEE’S CONDUCT

24. INTERACRTING WITH AUDITORS
• Assume auditors are familiar with your
organization’s QMS
• Challenge auditors
• Show more competence in ISO
• Argue internally
• Express unfairness
• Ask for solution
• Fix conformities on the spot
• Be honest and open
• Recognize they may be experts
• Realize they may not be subject matter experts
• Understand the purpose of the meeting and
review related records prior to interviews
• Turn mobile phone to silent mode