Permanently Audit Ready in 3 months

We have a proven 5 step process that ensures quality culture is embedded just that way you need it.

Includes:

• Assessment of the current situation against your desired needs
• Gap assessment for what needs to change to develop the culture you want
• implementation through leadership development, and putting learning into practice
• measuring success and communication
• Next steps analysis

We build ISO compliant Quality Management Systems tailored to your operations.  Practical, scalable, and aligned with regulatory standards.

Includes:

• ISO 9001 & ISO 13485 system design
• Standard Operating Procedures 
• CAPA and document control
• Certification readiness support
• Deviation & complaints systems
• Change management

We help to remove the pain of findings after a heavy audit leaving you to focus on the day to day.

Includes:

• Project management.
• Communication with auditee
• identification of best practise
• solutions that stick to stop repeating findings

We develop processes that stick, that means ensuring your people are competent and understand quality best practice.

Includes:

• Quality leadership coaching workshops
• Development workshops for all levels of the business
• Implementation of training & competence frameworks
• Vanilla GMP, ISO, regulatory training.

We believe that problem solving is a core pillar of a successful quality management system.  We develop and grow competence in this area sharing our 10000 hours of experience and handing it to you.

Includes:

• Root cause analysis benchmarking
• Problem solving training
• Problem solving workshops
• Root cause gap assessment and remediation

We build ISO-compliant Quality Management Systems (QMS) tailored to your operations - practical, scalable, and aligned with regulatory standards.

Includes:

• ISO 9001 & ISO 13485 system design
• Standard Operating Procedures (SOPs)
• CAPA and document control
• Certification readiness support