By: Neal Stiemert
One of the requirements of the ISO 9001:2000 standard is that you have a preventive maintenance
process in place. As an auditor, I will share with you some typical audit findings related to the
maintenance process. I will also provide you with a sample section from a quality manual and a
Typical audit findings are:
- Maintenance schedule was not followed.
- Maintenance was not performed when scheduled.
- All equipment was not in the maintenance schedule.
- Equipment is only serviced during breakdown.
(Key requirements are in red)
The organization shall determine, provide and maintain
the infrastructure needed to achieve conformity to product requirements. Infrastructure includes,
a) buildings workspace and associated utilities,
b) process equipment (both hardware and software)
Section from a typical quality manual
Acme determines, provides and maintains the infrastructure needed to achieve product conformity.
- adequate buildings and workspace
- appropriate process equipment, both hardware and software
- necessary supporting services
Title: Equipment Maintenance and Repair
No. 6.7 Rev. A
Approved By: Frank Maintenance
This procedure applies to Acme manufacturing equipment periodic maintenance and repair.
1.0 CHECK PRODUCTION EQUIPMENT SCHEDULE
Daily maintenance is performed by Maintenance on each piece of equipment as indicated on the
The maintenance schedule is checked daily by Maintenance personnel for equipment due for
2.0 PERFORM MAINTENANCE
Maintenance is performed on the equipment by maintenance personnel or other designated
individuals as indicated on the instructions for each piece of equipment.
3.0 RECORD MAINTENANCE
The maintenance is recorded by the person performing the maintenance on the appropriate log or
checklist after the work is performed.
End of Document
- If any repair is necessary, the operator records the problem on the maintenance repair
log. Any repairs performed on equipment shall be recorded on the appropriate equipment log.
- Some repairs may be performed by an outside source. These repairs will be documented as
the same as above.
As always, the existence of your company is dependent on your ability to deliver quality
products and services that get to your customer on time. How well you plan and control your
processes are vital if you are to provide quality. A well-planned and well-executed
maintenance process will allow you to meet production and delivery schedules by preventing
unscheduled machine down time.
Here is a copy of the Preventive Maintenance sample procedure in PDF format:
Sample Preventive Maintenance Operating Procedure
I hope this information helps you with your transition. Feel free to contact me with any
questions at 800-959-0632.
Independent Quality Consultants, Inc.
About the Author
Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a
Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified
Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting
and training experience in the quality profession.
Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue
University and an officer and committee member in the Chicago and Minnesota sections of ASQ.
Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance
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