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Generally the setting up of Quality Management System (QMS) and the registration process consists of following steps:

Generally the setting up of Quality Management System (QMS) and the registration process consists of following steps:

1. Nomination of Quality Coordinator/Manager. Make a Top Management person responsible for your integrated system.
This person will report directly to the CEO and receive the needed training. 

2. Working Team Formulation. Form a Working Team and consider need/role of an advisor.
A typical team consists of 5 - 7 personnel selected from diverse disciplines of the organisation. It is recommended that no more than eight personnel are on the working team.  These need to be a cross section of grades and functions.

3. Gap Analysis (optional). Conduct a Gap analysis or audit using ISO 9001-2008 and generate a report.
The report will identify adequacy of as-is practices/procedures and the need for new procedures and/or revisions.

4. Identify Key Processes. Flowchart key processes showing all interfaces.  Include system processes, such as Internal Audit, Corrective Action, Preventive Action, Management Review.
Start with core processes, determine  linked processes and then tie in the support processes.  Can be continued to a "How to" or work instruction level.

5.  Determine Value of Mapped Processes.  Identify the value of each activity/process. Eliminate the non-value added activities/processes.  Combine appropriate activities/processes to achieve streamlined value-added processes.

6. Determine Process Measurements. Evaluate the streamlined processes and determine appropriate processes to ensure the achievement of customer satisfaction and business objectives.

7. Implement Streamlined Processes. Provide employees with instructions on the new processes and request feedback on improvements to the value-added activities. Involve employees in developing and improving the system. Continue implementation until all processes are under control.

8. Develop Quality Manual.  Describe your overall system in your quality policy manual. Include the Quality policy statement.
Keep it slim and simple for customers, every employee and suppliers.

9. Determine Organizational Structure. Define organizational structure and responsibilities.
Keep this up to date with names and job titles as a formal document. An organisational chart is just one part of meeting this requirement.

10. Develop Forms. Link all forms/reports to processes/procedures/work instructions.
Every form should belong to a process, remove redundant forms and every form should have a place, if not check completeness of flowchart.

11. Review Processes. Review processes and flowcharts for accuracy.
By "accuracy" we mean what actually happens!

12. Launch System. Launch the system and respond quickly to revision requests.
Invite continuous improvement.

13. Conduct Internal Audits and Improve. Audit and improve your system to raise value and reduce avoidable costs.
Your trained audit team will come from action 15. Cover suppliers too.

14. Pre-Assessment. Conduct pre-assessment at least two months before the Registration Audit.
Use a registered lead auditor and ensure all corrective action records are up to date.  Consider having JJMS to conduct your pre-assessment.

15. Registration Audit

 

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Last modified: 03/08/12