3. Why Quality Management System
• Quality management is focused not only on product quality, but also
the means to achieve it.
• Means for achieving quality products are business processes
• Processes is a series of activities which utilizes resources to produce
output
• For processes to produce desired output its elements (Man, Material,
Method, Machine and Milieu) must be properly controlled
• For business to succeed, processes together with their interactions
must be managed
• QMS can be expressed as the organizational structure, procedures,
processes and resources needed to implement quality management.

5. Implementing ISO 9001: 2008
1. Identify the goals you want to achieve
Typical Goals Included
• Be more efficient and profitable;
• Meet customer requirements;
• Achieve customer satisfaction;
• Increase market share;
• Maintain market share;
• Improve communications and morale;
• Reduce costs and liabilities; and
• Increase confidence in the production system.
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6. Implementing ISO 9001: 2008
2. Identify what others expect of you
These are the expectations of interested parties
(stakeholders) such as:
• Customers and end users
• Employees
• Suppliers
• Shareholders
• Society
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7. Implementing ISO 9001: 2008
3. Obtain information about the ISO 9000 family
4. Apply the ISO 9000 family of standards in your
management system
5. Obtain guidance on specific topics within the
quality management system
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8. Implementing ISO 9001: 2008
6. Establish your current status; determine the gaps
between your quality management system and the
requirements of ISO 9001:2008
You may use one or more of the following:
• Self assessment
• Assessment by an external party
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9. Implementing ISO 9001: 2008
7. Determine the processes that are needed to supply
products to your customers
Review the requirements of the ISO 9001:2008 section
on Product Realization to determine how they apply or
do not apply to your quality management system
including;
• Customer related processes
• Design and/or development
• Purchasing
• Production and service operations
• Control of measuring and monitoring devices
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10. Implementing ISO 9001: 2008
8. Develop a plan to close the gaps in step 6 and to
develop the processes in Step 7
9. Carry out your plan
10. Undergo periodic internal assessment
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11. Implementing ISO 9001: 2000 QMS
11. Do you need to demonstrate conformance?
If yes, go to step 12 If no, go to step 13
You may need or wish to show conformance
(certification/registration) for various purposes, for
example:
• Contractual requirements
• Market reasons or customer preference
• Regulatory requirements
• Risk management
• To set a clear goal for your internal quality development
(motivation)
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12. Implementing ISO 9001: 2008 QMS
12. Undergo independent audit
13. Continue to improve your business
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14. «Internal» Barriers
Resources
Lack of management time/employee’s time
Multitasked employees
Rapid turnover of employees
Lack of skills / training

15. «Internal» Barriers
Attitude
Resistance to change
Inconsistent management support (inertia)
Discrepancy between perceived benefits and
costs involved (no “marketing value” for top
management)
Not enough “empowerment” of the people in
charge of the QMS (too low in the hierarchy)

16. « Internal » Barriers
«Interpretation»
bad experience with earlier versions of ISO
9000 (“bureaucratic”)
interrupted implementation process
“fear” of what continual improvement implies

17. «External» Barriers
high certification costs
changing economic context (QMS not a
priority of the company)
almost no advantage on the market place
lack of sector specific examples
discrepancies in interpretation by the
consultants
lack of experience of the consultants

18. If you are in Tanzania contact us at
info@tansheq.com