Element · 01
Value-Stream Mapping
Map your actual value streams and pain points before writing a single procedure.
Specialist PracticeISO 9001 · ISO 10005
Quality System Design and Process Improvement
Policy, process architecture, procedures and records — designed to fit how your organisation actually works, and improved on a measurable cycle.
Overview
What is quality system design?
The deliberate design of the quality architecture that governs how your organisation delivers work: the policy, the process map, the procedure hierarchy, the records model, the KPIs and the improvement rhythm. Built to satisfy ISO 9001 and sector standards, but shaped around how your teams actually operate.
Jags Assurance designs and develops Quality Management Systems for Healthcare and Medical Device organizations, building ISO 13485-aligned processes and documentation to support regulatory submissions and consistent day-to-day quality operations. Off-the-shelf QMS templates fail because they codify a generic organisation, not yours. We start from your value streams and constraints, design a lean process architecture that matches, then layer in the standard clauses so certification is a by-product, not the objective. Improvement is designed in from day one — with measurable KPIs and a management-review cadence that actually drives change.
This is delivered against ISO 9001, supplemented by ISO 10005 quality-plan guidance and your organisation's own process, sector and contractual requirements — the standard is the floor, not the full scope.
What’s included
Scope you can rely on.
Element · 02
Process Architecture
Level-1 process map, level-2 procedures and interaction map — lean and standards-aligned.
Element · 03
Procedure & Records Design
Fit-for-purpose procedures, work instructions and records model — no over-documentation.
Element · 04
KPI & Dashboard Design
Process KPIs, dashboards and management-review packs that actually drive decisions.
Element · 05
Process Improvement
Waste elimination, cycle-time reduction and first-pass yield improvement on priority processes.
Element · 06
Change Management
Training, roll-out and adoption support so the designed system becomes the operated system.
Design workflow
Design, deploy, improve.
A staged approach — first design a QMS that fits, then deploy it with adoption in mind, then improve it on a measurable cycle.
- STEP 01Discover
Value-stream mapping, stakeholder interviews and current-state baseline.
- STEP 02Design
Process architecture, procedure hierarchy, records and KPI model.
- STEP 03Deploy
Roll-out with training, document control and adoption tracking.
- STEP 04Improve
Measured improvement cycles on priority processes, tied to management review.
Business outcomes
Where the value lands.
- A QMS that fits how work actually flows — not a compliance shell.
- Fewer procedures, better followed, with real evidence.
- Process KPIs that drive management-review decisions.
- A continual-improvement loop tied to business outcomes.
What you receive
Deliverables
- 01Value-stream and current-state baseline
- 02Level-1 process architecture map
- 03Procedures, work instructions and records templates
- 04KPI catalogue and dashboards
- 05Management review pack template
- 06Improvement backlog with prioritisation
Aligned to
ISO 9001ISO 10005ISO 9004
FAQ
Frequently Asked Questions
Delivered across North America, with India and the UAE coming soon.
What is a QMS in the medical device industry?
A Quality Management System (QMS) in this context is the documented set of processes, procedures, and controls a company uses to ensure medical devices are consistently designed, manufactured, and distributed to meet regulatory and safety requirements, most commonly structured around ISO 13485.
Is ISO 13485 required for medical device companies?
ISO 13485 is widely required or expected by regulators and customers in the medical device sector, and is often a prerequisite for regulatory submissions and market access in multiple jurisdictions, though specific requirements vary by country and device classification.
How is QMS development different from ISO certification?
QMS development is the process of designing and building the actual quality system, documentation, and procedures your organization will operate under. Certification is a separate step where an accredited third-party body audits that system against the ISO 13485 standard and issues certification.
What does Jags Assurance do during a QMS development engagement in healthcare?
We assess your current processes against ISO 13485 (or the applicable standard for your device classification), design or refine the required documentation and procedures, and prepare your team through training so the system operates correctly day to day, not just at audit time.
Does QMS development cover both design and manufacturing processes?
Yes, a properly built QMS for medical devices typically covers the full lifecycle relevant to your organization's scope, including design controls, supplier management, production and process controls, and post-market surveillance requirements where applicable.
Get in touch
Talk to a QMS DesignerReady to redesign a QMS that actually gets used?
Send us your current pain points — we'll propose a design programme within one business day.