Service
ISO readiness for laboratories, healthcare, and quality-driven industries
MQS supports readiness for ISO 15189, ISO 17025, ISO 9001, and ISO 13485 as applicable to your organization. We help translate requirements into practical systems and prepare for assessment; accreditation or certification is issued by the appropriate independent body.
Who this is for
- Medical and testing laboratories
- Healthcare and service organizations
- Manufacturers and medical device organizations
Common challenges
- Unclear differences between standards
- Quality documentation disconnected from operations
- Limited preparation for external assessment
How MQS can support you
The exact scope is agreed with you after an initial consultation.
- ISO 15189: medical laboratory QMS and technical competency readiness
- ISO 17025: testing and calibration readiness, method validation and measurement uncertainty support
- ISO 9001: QMS, risk-based processes, supplier evaluation, and customer feedback
- ISO 13485: medical device quality systems, design controls, CAPA, and post-market processes
- Internal audit preparation and assessment support
- Surveillance and renewal readiness
How the engagement works
- 1
Discovery
We learn about your organization, services, goals, and quality, regulatory, or expansion priorities.
- 2
Gap assessment
We review procedures, records, and practices against the standards that apply to you, and report findings plainly.
- 3
Action plan
We agree on priorities, responsibilities, and a realistic sequence of work.
- 4
Implementation support
We work with your team to implement quality systems, develop procedures, prepare applications where needed, and train staff.
- 5
Inspection support
We help you prepare for external inspections and can attend alongside your team.
- 6
Follow-up
We help you respond to citations and sustain improvements over time.
Frequently asked questions
Which ISO standard applies to us?
It depends on your activities and objectives. We review your scope and agree the relevant standard before planning the engagement.
Talk to us about iso quality & accreditation readiness
Tell us about your quality, compliance, licensing, or growth priorities. We will recommend practical next steps.