Toolkit Only
A licensed document foundation for a capable internal team to review and adapt.
- Core procedures, templates and guidance
- Toolkit structure and implementation sequence
- Internal-use licence
- Focused handover discussion
Implementation options
Choose the support that matches the change.
Some teams need a strong starting framework. Others need the framework translated into their QMS, introduced to the organisation and tested through real project evidence.
QMS-Aligned Customisation
Adapt the toolkit to your organisation, terminology, responsibilities, products and existing controls.
- Current-state review
- Gap and overlap mapping
- Tailored procedures and forms
- Defined interfaces with the existing QMS
- Review workshop and implementation plan
Supported Implementation
Embed the process through workshops, training, pilot use and review of the first evidence set.
- Everything in QMS-Aligned Customisation
- Role-based workshops and training
- Pilot application to a live project
- Record and evidence review
- Readiness assessment and improvement actions
Timeframes are indicative and depend on scope, existing maturity, device complexity and availability of the responsible team. Pricing and licence terms are agreed according to the toolkit, organisation and level of support required.
Additional support
Independent review and remediation
Assess an existing QMS, development file or evidence set against the relevant process and expected deliverables, then turn findings into an owned remediation programme.
Partner model
Customised and white-label use
For consultants, development partners and larger organisations that need a consistent internal framework across products or client engagements. Terms are agreed case by case.
Choose the level after we understand the problem.
A short discussion is usually enough to determine whether you need a toolkit, customisation or implementation support.