1. Integrated Consulting Solutions
Module 8:
Maintenance and Calibration

2. What you need to know about maintenance in ISO 9001
The organisation shall determine and maintain the infrastructure necessary to achieve conformity of product.
This means maintaining equipment which is critical.
The organization determines the type and frequency.

3. What you need to know about calibration in ISO 9001
The business itself must decide:
what equipment, what monitoring and measuring
equipment requires calibration;
and when and where the equipment is to be used.

4. What you need to know about calibration in ISO 9001
ensure all calibration is traceable to a national standard.
Have evidence of being calibrated e.g. a sticker
Protect equipment from damage or adjustment
have a process for determining what you do if a piece of equipment is inaccurate;
keep records of your calibration;
ensure that the capability of any software you use matches your requirements.

5. Why do Maintenance? How important is maintenance?
If you want confidence that machines are behaving
and performing as designed, then you institute a
regular maintenance program.

6. Why do Calibration? To be able to know that the measure of that test
equipment is accurate, you need to have it calibrate
against a known standard.

7. What This Module Covers
In this module we will be:
Considering whether you need a maintenance process and if necessary creating a maintenance process.
Creating a maintenance schedule
Creating a calibration schedule
Creating a calibration process or procedure

8. In Your Pack In your pack you will find:
A sample Maintenance Schedule.
A sampleCalibration Schedule.

9. Do you need a maintenance process ?/ creating a maintenance process
Exercise One
Do you need a maintenance process ?/ creating a maintenance process
Workbook
Look back at the first page and ask yourself the questions in the first paragraph.
e.g. Is there any equipment whose reliable operation is critical to your product/ service conformity?
Document
Script

10. Do you need a maintenance process ?/ creating a maintenance process
Exercise One
Do you need a maintenance process ?/ creating a maintenance process
Choosing a maintenance system
There are many alternatives.
Also, consider the following
Software?
In-house or external?
Frequency of maintenance?
Do a regular review of your system.
Breakdown
Contracts with external providers.

11. Do you need a maintenance process ?/ creating a maintenance process
Exercise One
Do you need a maintenance process ?/ creating a maintenance process
Instruction
Take the time now to work out the simplest and most suitable method in your organization.
Consider what software or system you are CURRENTLY using and try to integrate whatever maintenance system into that- to minimize change.

12. Creating a Maintenance Schedule
Exercise Two
Creating a Maintenance Schedule
Workbook
Question 1:
Brainstorm/ create a list of all those pieces of infrastructure, transport and production equipment that need a regular preventive maintenance program.
Document
Calibration Schedule

13. Creating a Maintenance Schedule
Exercise Two
Creating a Maintenance Schedule
Instruction
Take time now to look at the template provided.
Fill in those columns that you need to.

14. Creating a Maintenance Schedule
Exercise Two
Creating a Maintenance Schedule
Very important to determine who is responsible for the implementation of the maintenance system.
Records are important in your system and need to be stored adequately.
Instruction
Add these points to your process/ procedure

15. Creating a Calibration Schedule
Exercise Three
Creating a Calibration Schedule
Workbook
Determine if you will be “seeking exclusion for calibration” based on calibrateable equipment NOT being critical to your product/ service conformity.

16. Creating a Calibration Schedule
Exercise Three
Creating a Calibration Schedule
Workbook
If you have a piece of measuring equipment that is only an indicative measurement, you don't need to have that calibrated.
If it is used to measure an absolute value, then you need to have it calibrated.

17. Creating a Calibration Schedule
Exercise Three
Creating a Calibration Schedule
Instruction
Take time to list all those pieces of monitoring and measuring equipment that require calibration at some frequency.
Then complete as many of the columns in the register as you can.

18. Creating a calibration process or procedure
Exercise Four
Creating a calibration process or procedure
A procedure or a simple paragraph?
You may not need a formal procedure.
If you do, use one of the procedure templates.
Fairly simple needs?:- create a short paragraph describing your process and covering the points given.

19. Creating a calibration process or procedure
Exercise Four
Creating a calibration process or procedure
What to include:
the person or persons responsible
how that calibration is to be carried out
how the equipment is to be identified
where the records are kept
who is responsible for keeping the records
possibly include the service provider
Process when equipment out of tolerance.

20. Creating a calibration process or procedure
Exercise Four
Creating a calibration process or procedure
What to include:
the person or persons responsible
how that calibration is to be carried out
how the equipment is to be identified
where the records are kept
who is responsible for keeping the records
possibly include the service provider
Process when equipment out of tolerance.

21. Creating a calibration process or procedure
Exercise Four
Creating a calibration process or procedure
Workbook.
Take the time now to formulate a process (or procedure) for how you will handle calibration referencing the previous points.

22. That is the end of module eight.
Congratulations!
That is the end of module eight.
You are ready to contact your consultant to check your work.