π§ Preventive Maintenance Program (Clause 7.1.3)
Verify that a preventive maintenance program exists for all critical equipment. Check that maintenance intervals are defined based on equipment criticality and manufacturer recommendations.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.1.3
Is there a preventive maintenance program for all critical equipment?
How often is each machine/equipment serviced or inspected? (weekly, monthly, quarterly)
Maintenance intervals documented per equipment type, based on manufacturer recommendations, frequency appropriate for criticality, intervals justified
Maintenance Philosophy: Preventive maintenance costs less than breakdown maintenance. Regular service prevents expensive failures.
π Maintenance Planning and Scheduling (Clause 8.1)
Verify that maintenance work is planned and scheduled to minimize production impact. Check that maintenance schedules are communicated to production in advance.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
8.1
Is maintenance work planned and scheduled to meet production requirements?
Maintenance calendar created, scheduled during downtime when possible, production schedule coordinated, resource allocation planned
7.4
Are maintenance schedules communicated to production in advance?
Production notified of planned maintenance, advance notice given, impact on production assessed, contingency arrangements made
⚠️ Scheduling Risk: Unplanned maintenance disrupts production. Good scheduling minimizes business impact and improves planning.
π Maintenance Procedures and Documentation (Clause 7.5)
Verify that maintenance procedures and equipment manuals are documented and accessible. Check that maintenance personnel have clear guidance for their work.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.5
Is there a maintenance procedure or manual for each equipment/machine?
Are maintenance schedules documented and accessible to maintenance staff?
Maintenance schedule posted, electronically available, accessible to maintenance team, frequently used equipment highlighted
Documentation Value: Clear procedures ensure consistent maintenance and reduce risk of missing important steps or safety requirements.
π¨ Breakdown Repair and Emergency Response (Clause 8.1)
Verify that emergency/breakdown repairs are handled promptly to restore equipment and resume production. Check that emergency procedures are defined and response times are tracked.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
8.1
Are emergency/breakdown repairs handled promptly to restore equipment?
Emergency contact list available, on-call technicians designated, response time target set, spare parts on hand for common failures
8.1
Are breakdown repairs documented with time to repair?
Breakdown events recorded, repair time tracked, root cause investigated, mean time to repair (MTTR) calculated
⚠️ Production Impact: Long equipment downtime costs money and can impact delivery schedules. Fast breakdown response is critical.
π Maintenance Records and Logbooks (Clause 7.5)
Verify that maintenance work is documented in logbooks or systems. Check that records include what was done, when it was done, and who performed the work.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.5
Is maintenance work documented in a logbook or system?
Maintenance records kept per equipment, digital or paper logbook maintained, date/time recorded, technician name recorded, work performed documented
7.5
Are maintenance logbooks easily accessible for review?
Records stored near equipment or in accessible location, historical records archived, easy to retrieve maintenance history, equipment performance tracked
Maintenance History: Good records help identify recurring problems and patterns that indicate equipment wear or design issues.
π¦ Spare Parts Inventory Management (Clause 7.5)
Verify that spare parts inventory is managed to support maintenance activities. Check that critical spares are stocked and availability is tracked.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.5
Are spare parts inventory and availability documented?
Spare parts list maintained, critical parts identified, reorder points set, parts tracked in inventory system, expiration dates monitored where applicable
7.5
Are common failure parts stocked or readily available?
High-failure parts in stock, suppliers identified for quick delivery, backup supplier relationships, emergency ordering procedures defined
⚠️ Availability Risk: Waiting for spare parts can extend downtime from hours to days. Strategic spare parts stocking is essential.
π Predictive Maintenance and Condition Monitoring (Clause 6.1)
Verify that predictive maintenance techniques are used to anticipate equipment failures. Check for condition monitoring and performance trending.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
6.1
Is predictive maintenance used? (condition monitoring, vibration analysis, temperature trending)
Condition monitoring technology implemented for critical equipment, vibration or temperature sensors, trending data collected, alerts for out-of-spec conditions
6.1
Are equipment performance trends analyzed to prevent failures?
Performance data tracked over time, trends analyzed, early warning signals identified, maintenance triggered before failure occurs
Advanced Maintenance: Predictive maintenance prevents sudden failures by identifying equipment degradation before it becomes critical.
Verify that equipment performance KPIs are tracked and analyzed. Check that maintenance effectiveness is measured through uptime, reliability, and failure metrics.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
9.1.1
Are maintenance KPIs tracked? (equipment uptime, mean time between failures, maintenance cost)
Uptime % calculated, MTBF (mean time between failures) tracked, maintenance cost monitored, OEE (overall equipment effectiveness) measured
9.1.1
Are equipment breakdowns recorded and analyzed?
Breakdown data collected with cause codes, failure mode analysis performed, trending by equipment/location, improvement actions prioritized
⚠️ Measurement: "If you can't measure it, you can't manage it." Regular KPI tracking shows maintenance program effectiveness.
Verify that critical equipment is identified and backed up with contingency plans. Check that equipment failure would significantly impact product quality or production capacity.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
6.1
Are critical equipment identified that could impact product quality if they fail?
Verify that maintenance technicians are trained and qualified for the equipment they maintain. Check that specialized skills are documented and certificates are current.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.2
Are maintenance technicians trained on equipment operation and maintenance procedures?
Training records maintained, equipment-specific training documented, on-the-job training conducted, competency verified
7.2
Are maintenance staff certified for specialized equipment? (welding, hydraulics, electrical)
Certifications current and on file, licenses maintained where required, specialized training up-to-date, refresher training scheduled
7.2
Are training records maintained for maintenance personnel?
Training matrix showing technician skills, training dates documented, competency assessments performed, development plans in place
⚠️ Safety Risk: Untrained technicians on complex equipment can cause injuries or damage. Proper training is essential for safety and quality.
π Equipment Modification and Change Control (Clause 8.2.4)
Verify that when equipment is modified or upgraded, changes are documented and communicated. Check that maintenance procedures are updated for modified equipment.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
8.2.4
When equipment is modified or upgraded, are changes documented and communicated?
Equipment change form used, modification documented with drawings, maintenance procedures updated, technicians trained on changes
Documentation Update: Modified equipment requires updated procedures and technician retraining. Maintenance can't rely on old procedures.
π’ Maintenance Communication and Coordination (Clause 7.4)
Verify that maintenance work and schedules are communicated to production and quality teams. Check that equipment issues are escalated appropriately.
CLAUSE
AUDIT QUESTION
WHAT TO LOOK FOR
7.4
Are maintenance schedules and updates communicated to production and quality teams?
Production schedule coordinated, equipment issues reported promptly, meetings held between maintenance and operations, communication procedures documented
Coordination: Good communication between maintenance and production prevents surprises and allows better planning.
Preventive maintenance not scheduled; maintenance reactive only
Maintenance Records Missing
No logbooks or records of maintenance work performed
Untrained Technicians
Maintenance personnel without formal training or certifications
No Spare Parts Inventory
Common failure parts not stocked; long downtime waiting for parts
Poor Equipment Condition
Equipment noticeably neglected; signs of wear not addressed
Frequent Breakdowns
Excessive equipment failures; high downtime impacting production
No Critical Equipment List
Critical equipment not identified; no backup plans
Outdated Procedures
Maintenance procedures don't match current equipment or processes
No Performance Tracking
Equipment uptime, MTBF, and maintenance costs not measured
Poor Communication
Production surprised by maintenance; no advance scheduling
✨ Conclusion
This comprehensive ISO 9001 equipment maintenance audit checklist in tabular format covers all critical aspects of maintenance management from preventive maintenance programs through predictive maintenance and technician competence. Effective maintenance audits verify that equipment is systematically maintained to prevent failures, technicians are properly trained and qualified, maintenance is documented, and equipment performance is monitored. Strong equipment maintenance directly impacts product quality, production reliability, and operational efficiency.
Remember: Equipment is only reliable if it's properly maintained. Preventive maintenance prevents costly breakdowns, extends equipment life, and ensures consistent production quality. Systematic maintenance management is essential for manufacturing excellence.
π Explore Related Audit Guides
This blog is part of a comprehensive ISO 9001 internal audit series:
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