Implementing an ISO 9001:2000 Based Quality Management System

1. Make the decision, commit to implement and make a senior person responsible for the system.
This person will report directly to the CEO on the progress and needs of the QMS implementation. This person must be an advocate of the QMS.

2. Form an Implementation Team and review need for a QMS advisor/consultant.
Select up to eight personnel from a cross section of grades and functions. In virtually all organizations, implementing a QMS is too big a project for one person. Implementing an QMS will affect all departments and levels of employees. Having a good representation of employees on this team will help ensure the decisions made are appropriate and will help with achieving buy-in across the organization.

3. Conduct an assessment (gap analysis) and report to senior management.
The report will identify the adequacy of current procedures and the need for new procedures.

4. Identify the processes, the sequence and interaction of these processes, needed for the quality management system and their application throughout the organization.
Flow chart your processes, describe process inputs and outputs and the interaction of the processes in your organization.

5. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
Decide on what you define as "effective" for each process, then determine methods and criteria, i.e. will you use SPC to monitor some processes.

6. Create a Quality Policy, Set Objectives and Targets, and create an Action Plan.
Communicate the policy across the organization, develop agreed upon objectives and targets and the plan for achieving the objectives and targets.

7. Develop leaders to create and sustain employee awareness.
All leaders and the implementation team must learn so they understand and can explain.

8. Define organizational structure and responsibilities.
Define and document how the responsibilities of the QMS will be met. Keep this list or matrix up to date with job titles as a formal document.

9. Involve all employees as appropriate, in developing and improving their system.
By training and awareness sessions, flowcharting of processes, team reviews of procedures and flowcharts.

10. Decide on the procedure for documentation structure.
Use this from day one of developing QMS documentation.

11. Flowchart key processes showing all interfaces.
Start with core processes and then tie in the support processes.

12. Create all forms in line with agreed coding procedure.
Every form should belong to a process, remove redundant forms.

13. Correlate all forms to flowcharts.
Every form should have a place, if not check completeness of flowchart.

14. Review flowcharts for accuracy.
By "accuracy" we mean what actually happens!

15. Develop and use flowcharts as documented procedures.
Ensure process objective(s) also address environmental aspects.

16. Review, reconcile, approve and issue as-is procedures.
Involve everyone and do not ignore comments. Process owners may approve.

17. Prepare new procedures and train staff to implement them.
These may include QMS auditing.

18. Issue new procedures and the environmental management program.
This will be the first program implemented by the QMS.

19. Describe the whole system in an QMS manual.
Keep it slim and simple for customers, every employee and suppliers.

20. Launch the system and respond quickly to revision requests.
Throw a well-deserved party! Invite continuous improvement.

21. Start auditing to continually improve your integrated system.
Your trained audit team will come from action 15. Cover suppliers too.

22. Conduct pre-assessment at least four months before any Registrar.
Use a registered systems auditor and ensure all corrective actions are up to date.

 

If you would like help with any or all of these steps, call us at 909-484-7545 or email us at webmail@systemsquality.com.