Case study · Medical Devices
QMS Implementation & Certification
From zero to certification-ready — with a system built for daily use
ZLG guides your organization from initial gap assessment through documentation, training, internal audits, and management review to the day your certification body arrives — and beyond it.
A certification audit you walk into prepared: documented processes that match reality, records that demonstrate operation, trained people, and no surprises.
Sound familiar?
Challenges this service solves
- A customer now requires certification — with a deadline
- You failed or barely survived a certification or customer audit
- Documentation was written years ago and matches nothing
- Nobody in-house has implemented a QMS before
- Previous consultants left binders, not a working system
- You hold certification but the system adds no business value
Scope
What the service includes
Gap assessment
Evidence-based review of your current state against the target standard, with prioritized findings.
Project plan
Realistic roadmap with owners, milestones, and dependencies aligned to your target date.
Process mapping
Processes mapped from how work actually happens — then improved.
QMS documentation
Right-sized procedures, work instructions, and forms your people will actually use.
Risk-based thinking
Practical risk registers and controls integrated into operations.
KPI development
Metrics that serve business decisions and satisfy the standard.
Training
Role-based training including internal auditor certification for your team.
Internal audits & management review
First audit cycles and reviews executed with coaching, generating required evidence.
Certification audit preparation
Readiness review, mock audit, and day-of support through Stage 1 and Stage 2.
Consulting and certification are — and must be — separate
ZLG prepares your organization; an independent, accredited certification body audits it and makes the certification decision. No consultant can guarantee certification, and you should be skeptical of any who claims to. Through our partnership with KCertification we can connect you with an accredited certification pathway for ISO 9001, ISO 13485, and ISO 14001, while our consulting role remains fully independent of the certification decision.
Deliverables
- Gap assessment report and project plan
- Complete QMS documentation set
- Process maps, risk registers, and KPI definitions
- Trained personnel with certificates and records
- Internal audit and management review evidence
- Certification audit readiness review and mock audit report
- Post-certification support plan
Standards supported
- ISO 9001
- ISO 13485
- AS9100
- IATF 16949
Typical timeline
Most implementations run several months from gap assessment to certification-audit readiness, driven by organization size, site count, existing maturity, and internal resource availability. We build the honest timeline in week one — not a sales timeline.
Working together
Who does what
Your team
- Commit leadership sponsorship and decision-making
- Assign a project owner and process owners
- Review and validate documentation against real practice
- Execute processes to generate operating records
- Select and contract your certification body
ZLG
- Assess, plan, and drive the implementation
- Draft documentation and design metrics with your team
- Train personnel and certify internal auditors
- Run initial internal audits and coach management review
- Prepare you for — and support you through — the certification audit
Related
Keep exploring
Questions
Frequently asked
Do you guarantee certification?
No consultant can guarantee certification — that decision belongs to your independent certification body. What we do is prepare your system, your records, and your people so you walk into the certification audit with objective evidence that the system works. We also clearly separate our consulting role from the accredited certification body that issues your certificate.
How long does QMS implementation take?
Typical implementations run several months from gap assessment to certification audit readiness, depending on organization size, site count, existing documentation, and resource availability. We build a realistic project plan during the Assess and Prioritize phases rather than quoting a one-size-fits-all number.
Ready to talk specifics?
A 30-minute conversation is usually enough to map your fastest path to a measurable result.