Service & Support

Philips Healthcare service engineered to your QMS

ISO 13485:2016 service procedures, IEC 60601-1 preventive maintenance intervals, and NIST-traceable calibration discipline for dental and oral health equipment programs.

Service tiers for clinical and procurement governance

Compare coverage without guessing what documentation arrives after installation. Each tier defines response windows, asset records, software notes, and audit-ready reporting.

Service Tier	Coverage	On-site Response	Documentation
Platinum 24/7	365d × 24h, all fault classes	≤ 4h	IQ/OQ/PQ + 21 CFR Part 11 audit trail
Gold	Mon-Sun 07:00-19:00	≤ 8h	OQ/PQ + signed service report
Silver	Mon-Fri 08:00-17:00	NBD parts shipping	PM compliance log
Per-Call	On-demand	24-72h	Service report only

Methodology that starts before the crate leaves the warehouse

Site conditions, infection-control requirements, and staff training belong in the planning stage so owners can defend lifecycle cost, MTBF/MTTR assumptions, and compliance records during committee review.

01
ISO 13485 Scope Definition
Service scope maps to your QMS interface: complaint routing, device history records, document retention, and preventive maintenance evidence.
02
21 CFR 820.50 Supplier Controls
Philips Healthcare qualifies OEM and third-party service partners with documented capabilities, escalation paths, and training records.
03
IEC 62304 Software Lifecycle
Scanner, imaging, and chairside software updates include release rationale, cybersecurity notes, rollback guidance, and user notification language.
04
Documentation Package
Service assessment plan, FRACAS notes, trend analysis, PM evidence, and IFU updates are bundled for biomedical engineering and facility leadership.

Service boundaries

What the tiers do—and do not—cover

Platinum ≤4h on-site paths apply to contracted urban ZIP/postal codes; rural sites default to Gold or Silver logistics unless a local FSE depot is written into the agreement.
IQ/OQ/PQ and 21 CFR Part 11 audit-trail packages are available for software-connected imaging and scanner SKUs; mechanical chairs without networked controllers receive PM logs and signed service reports instead.
MTBF / MTTR figures shared in proposals are planning assumptions from the prior four-quarter FRACAS set, not warranties of clinical uptime.
Adverse-event / MDR reporting remains the manufacturer’s regulatory duty; facility complaint intake still must follow the buyer’s QMS interface.

Request the Full Service Methodology Whitepaper

Covers installation readiness, spare parts policy, cybersecurity triage, recall handling, and reporting templates for dental equipment programs.

Philips Healthcare service engineered to your QMS

Service tiers for clinical and procurement governance

Methodology that starts before the crate leaves the warehouse

ISO 13485 Scope Definition

21 CFR 820.50 Supplier Controls

IEC 62304 Software Lifecycle

Documentation Package

What the tiers do—and do not—cover

Request the Full Service Methodology Whitepaper