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.

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Implementing ISO 9001: 2008Implementing ISO 9001: 2008

1.1. Identify the goals you want to achieveIdentify the goals you want to achieve

Typical Goals IncludedTypical Goals Included

• Be more efficient and profitable;Be more efficient and profitable;• Meet customer requirements;Meet customer requirements;• Achieve customer satisfaction;Achieve customer satisfaction;• Increase market share;Increase market share;• Maintain market share;Maintain market share;• Improve communications and morale; Improve communications and morale; • Reduce costs and liabilities; andReduce costs and liabilities; and• Increase confidence in the production system. Increase confidence in the production system.

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Implementing ISO 9001: 2008Implementing ISO 9001: 2008

2.2. Identify what others expect of youIdentify what others expect of you

These are the expectations of interested parties These are the expectations of interested parties (stakeholders) such as: (stakeholders) such as:

• Customers and end users Customers and end users • Employees Employees • Suppliers Suppliers • Shareholders Shareholders • Society Society

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Implementing ISO 9001: 2008Implementing ISO 9001: 2008

3.3. Obtain information about the ISO 9000 familyObtain information about the ISO 9000 family

4.4. Apply the ISO 9000 family of standards in your Apply the ISO 9000 family of standards in your management systemmanagement system

5.5. Obtain guidance on specific topics within the Obtain guidance on specific topics within the quality management systemquality management system

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Implementing ISO 9001: 2008Implementing ISO 9001: 2008

6. 6. Establish your current status; determine the gaps Establish your current status; determine the gaps between your quality management system and the between your quality management system and the requirements of ISO 9001:2008 requirements of ISO 9001:2008

You may use one or more of the following: You may use one or more of the following:

• Self assessment Self assessment

• Assessment by an external party Assessment by an external party

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7. Determine the processes that are needed to supply 7. Determine the processes that are needed to supply products to your customers products to your customers

Review the requirements of the ISO 9001:2008 section Review the requirements of the ISO 9001:2008 section on Product Realization to determine how they apply or on Product Realization to determine how they apply or do not apply to your quality management system do not apply to your quality management system including; including;

• Customer related processes Customer related processes • Design and/or development Design and/or development • Purchasing Purchasing • Production and service operations Production and service operations • Control of measuring and monitoring devicesControl of measuring and monitoring devices

Implementing ISO 9001: 2008Implementing ISO 9001: 2008

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Implementing ISO 9001: 2008Implementing ISO 9001: 2008

8.8. Develop a plan to close the gaps in step 6 and to Develop a plan to close the gaps in step 6 and to develop the processes in Step 7develop the processes in Step 7

9.9. Carry out your planCarry out your plan

10.10. Undergo periodic internal assessmentUndergo periodic internal assessment

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Implementing ISO 9001: 2000 QMS11. Do you need to demonstrate conformance? 11. Do you need to demonstrate conformance?

If yes, go to step 12 If no, go to step 13 If yes, go to step 12 If no, go to step 13 You may need or wish to show conformance You may need or wish to show conformance (certification/registration) for various purposes, for (certification/registration) for various purposes, for example: example:

• Contractual requirements Contractual requirements

• Market reasons or customer preference Market reasons or customer preference

• Regulatory requirements Regulatory requirements

• Risk management Risk management

• To set a clear goal for your internal quality development To set a clear goal for your internal quality development (motivation) (motivation)

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Implementing ISO 9001: 2008 QMSImplementing ISO 9001: 2008 QMS

12.12. Undergo independent auditUndergo independent audit

13.13. Continue to improve your businessContinue to improve your business

«Internal» Barriers«Internal» Barriers

Lack of management time/employee’s time

Multitasked employees

Rapid turnover of employees

Lack of skills / training

Resources

Discrepancy between perceived benefits and costs involved (no “marketing value” for top management)

«Internal» Barriers«Internal» Barriers

Resistance to change

Not enough “empowerment” of the people in charge of the QMS (too low in the hierarchy)

Inconsistent management support (inertia)

Attitude

« Internal » Barriers« Internal » Barriers

bad experience with earlier versions of ISO 9000 (“bureaucratic”)

“fear” of what continual improvement implies

interrupted implementation process

«Interpretation»

almost no advantage on the market place

«External» Barriers«External» Barriers

high certification costs

lack of sector specific examples

changing economic context (QMS not a priority of the company)

discrepancies in interpretation by the consultantslack of experience of the consultants

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