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Implementing a Quality Management System

World Quality Day Symposium – Nov. 10, 2011

A Financial PerspectiveBy

Cecil D. White

Defining the QMS?

The benefits?

The Costs?

Is it worth it?

Presentation Topics

1

2

4

3

What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?

�Policies,

�Processes

�Procedures

What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?

�Required for planning and executing

business processes

�To meet customer requirements

�Accredited to International

Standards by a Registrar

ISO 9001:2008 is an example

A Cultural Transition

A PHILOSOPHY

Change

It Requires …..

1. Leadership

2. Determination

3. Resilience

4. Commitment

5. Engagement

Requires Leadership

RESILIENCE

How to Engage your Employees?

It Requires …..

1. Trust

2. Inspiration

3. Openness

4. Training

5. Incentives

Create a Trusting Environment

Be Inspirational

Be an Excellent Communicator

Create a Learning Evironment

Offer Rewards & Recognition

What are the benefits?

�State of Preparedness

�Size of Organization

�Complexity of processes

Success Determined by

ISO ISO ISO ISO STANDARD 10014:200610014:200610014:200610014:2006

Quality Management Guidelines

for

realizing financial and

economic benefits

A Strategic Choice

� Effective Application of ISO 9000 QM

Principles = Financial & Economic benefits

� Financial benefit results from cost-effective

management practices within the

organization.

� Economic benefit results from improvements

in the overall worth and health of the

organization.

ISO 9001 Management Principles1. Customer Focus

2. Leadership

3. People Involvement

4. Process Approach

5. Systems Approach

6. Continual improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

Derived Benefits� improved profitability, improved revenues, improved

budgetary performance,

� reduced costs, improved cash flow, improved return on

investment,

� increased competitiveness, improved customer retention and loyalty, improved effectiveness of decision making, optimized

use of available resources,

� heightened employee accountability, improved intellectual

capital, optimized, effective and efficient processes,

� improved supply chain performance, reduced time to market,

� enhanced organizational performance, credibility and

sustainability.

Realization of Benefits

INPUTSINPUTSINPUTSINPUTS OUTPUTSOUTPUTSOUTPUTSOUTPUTSPROCESSPROCESSPROCESSPROCESS

The Inputs1. Customer Focus

2. Leadership

3. People Involvement

4. Process Approach

5. Systems Approach

6. Continual improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

The Process

� Assess requirements,

� Plan activities,

� Allocate appropriate resources,

� Implement continual improvement

actions,

� Measure results to determine

effectiveness,

Financial Benefits

� improved profitability,

� improved revenues,

� improved budgetary performance,

� reduced costs,

� improved cash flow,

� improved return on investment,

Output / Result

Increased Productivity

Everyone Wins

Everyone Wins

What are the costs?

�State of Preparedness

�Size of Organization

�Complexity of processes

Costs Determined by

Costs

1. Registrar

2. Internal

Registrar1. Auditor’s Fees & Expenses

2. Application Fee

3. Registration Fee

4. Initial Assessment

5. Registration audit

6. Surveillance Audits

7. Re-registration

Internal Cost1. Sensitization

2. Gap Analysis

3. Training

4. Documentation

5. Implementation

6. Internal Audits

7. Consultant

Beware

of

The

Iceberg

Effect

Only

10%

Visible

Is it worth it?

Implementing ISO 9000:2001

A Case Study

NHF 2003�Government Agency

�Startup company

�Provision of benefits

�Customer base – 150,000

�Single location

�Employees - 34

Steps to ISO 9000 Certification1. Hire Quality Management Consultant

2. Conduct Gap Analysis

3. Establish Quality Policy

4. Redefine Business Processes

=> 3 Core Processes

� Individual Benefits

� Institutional Benefits

� Health Promotions

5. Company Wide Quality Seminar

6. Prepare Quality Manual (electronic records)

5. Quality Policies

6. Quality Objectives

5. 21 Procedures

7. Establish Quality Metrics

8. Prepare Work Instructions

Steps to ISO 9000 Certification

9. Quality Training for ALL

9. Audit Training (34 employees)

10.Appoint Lead Auditors

11.Conduct Pre-Assessment Audits (2)

12.Contract Registrar

� ISOQUAR Ltd (2005 – 2009)

� NCBJ (2009 – present)

Steps to ISO 9000 Certification

13.Registration Audit

13.Audit Training (34 employees)

14.Conduct Internal Audits

13.2 per year

15.Surveillance Audits

13.2 per year

16.Re-Registration Audits

� 2008, 2011

Steps to ISO 9000 Certification

How much does it cost?

•First Year – US$ 18,000

•Annual – US$ 5,000

How much does it cost?

•First Year – US$ 18,000

•Annual – US$ 5,000

Our Experience

�A QMS involves more that HARD

measures of quality

�SOFT Measures

�Teamwork

�Empowerment

�Management style

�Working environment

Lessons Learnt

1.Shift in Management Philosophy

2.Culture of Continuous Improvement

3.Training is Key

4.Effective Communications

5.Recognition of Achievements

6.Results in Improved Productivity

NHF UPDATE

�Expansion through Merger

�Mature organization

�Provision of benefits, Supply

Chain, Retail Pharmacy

�Customer base – 450,000

�Multiple Locations

�Employees - 250

THE END

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