Maintenance Evidence Where the Auditor Looks for It

Clause 7.1.5 of ISO 9001 asks whether your measuring equipment is maintained and calibrated. Clause 8.5.1 asks whether production runs under controlled conditions, which includes suitable infrastructure. Clause 8.7 asks what you did about the parts that ran while the machine was drifting. The answers live in maintenance records — and in most plants those records sit in a separate CMMS, a spreadsheet or a clipboard that the quality system never sees.

Synesis QMS closes that gap by building the maintenance workflow into the quality system. The Asset Management group gives maintenance the tools of a full CMMS — equipment master, preventive maintenance schedules, work orders with task checklists, labor and parts, downtime tracking with failure codes, calibration, a tool crib, spare parts with a stock ledger, maintenance vendors and purchasing — while sharing one database, one user directory, one approvals inbox and one audit trail with document control, nonconformance, CAPA, audits and management review.

One source of truth per fact. A machine's meter reading is the latest reading on file. Work-order labor, downtime hours and part cost are derived from the labor rows, the downtime event and the stock ledger — never typed into a summary field. A preferred vendor on a part is mirrored into the part record, not maintained twice. That discipline is what makes the reliability numbers on the dashboard and in management review trustworthy.

Synesis QMS Asset Calendar showing work orders, PM due dates, calibration due, tool returns, deliveries, warranty and contract expiries for the month with a next-30-days panel
Asset Calendar — work orders, PM due dates, calibration, tool returns, expected deliveries, warranty and service-contract expiries on one calendar, with the next 30 days and overdue count at a glance.

Asset Management Capabilities

Equipment Master

Assets, Tags, Meters, Timeline

Asset tag, location hierarchy, supplier, commissioning date, service contract, acquisition cost, meter readings and status (in service, down, quarantined, retired). A timeline tab shows every work order, calibration and downtime event for the machine.

Preventive Maintenance

Calendar or Meter Triggers

PM schedules by calendar interval or meter reading, with task templates and parts kits copied into each generated work order. Completing the work order rolls the schedule forward and updates the equipment's last and next service.

Work Orders & Checklists

Preventive · Corrective · Safety

Task checklists with required checks; completion is blocked until required steps pass, and a failed required check raises a Quality Event. Labor rows and issued parts roll up to the work order's hours and cost automatically.

Downtime & Failure Codes

MTTR Measured Once

Log an unplanned downtime and the equipment goes down and a corrective work order opens. Closing the event returns the machine to service and mirrors hours and root cause to the work order; critical equipment or long stoppages raise a nonconformance.

Calibration & Impact Assessment

ISO 9001 · 7.1.5

Calibration assets with specifications, due dates and record history including as-found readings. An out-of-tolerance result opens an impact assessment covering product made since the last good calibration, which can raise an NC.

Spare Parts & Stock Ledger

Signed Movements, Reorder

Every receipt, issue and adjustment is a signed movement; balances cannot go below zero. Low-stock and fits-equipment views; reorder creates one draft purchase order per preferred vendor.

Tool Crib

Checkout · Return · Repair

Tools with home bins, checkout and check-in history, due-back dates on the calendar and an in-repair state for damaged returns. Tool returns show in each employee's task inbox.

Vendors & Purchasing

Approved Through My Approvals

Maintenance vendors are suppliers in the same supplier module quality uses. Purchase orders above your threshold route to the approvals inbox; receipts post stock movements and rejected quantity raises a nonconformance.

CAPA Action to Work Order

Closed-Loop Corrective Action

A CAPA action that requires maintenance work is dispatched as a work order. Completing the work order completes the action, and the CAPA record shows the evidence.

Reliability Numbers Management Review Can Trust

Asset Dashboard

PM compliance, open and overdue work orders, downtime and MTTR by equipment, calibration due, low stock and purchasing status on one page.

Management Review Section

"Equipment Reliability & Maintenance" is a standing section of the management review report, generated from the same records — clause 9.3 evidence with no re-typing.

Reports & Excel Exports

PM compliance, parts reorder, tool checkouts, equipment master, downtime and reliability, purchasing status — each with an Excel export for the people who still want the spreadsheet.

Role-Based Access

Maintenance, tools, parts, locations and purchasing are permission modules in the same security matrix as quality — technicians see their work, quality sees the evidence.

Put Maintenance Evidence in Your Quality System

See PM schedules, work orders, downtime, calibration and purchasing working alongside CAPA and audits in a live demo.

Request a QMS Demo