ISO 9001 · AS9100 · ISO 13485
Quality Systems & Audit Readiness
Start with a quality-system gap review. Understand where you stand, which gaps matter, and what to do next.
Colabmo helps small and mid-sized organizations connect quality requirements with the processes, documentation and evidence used in everyday work.
A clear starting point
Agreed requirements and review scope.
Evidence-based findings and gaps.
Prioritized actions for your next step.
What the gap review covers
Whether you are establishing a quality system, preparing for an audit or addressing recurring findings, the review gives you a practical basis for deciding what needs attention.
We agree the applicable standard and edition, organizational scope, customer requirements and review criteria with you. We then examine the selected processes, documents and records, and discuss how the work is performed.
The review identifies both documented gaps and areas where more evidence is needed. Its conclusions reflect the scope and evidence reviewed.
What you receive
- A summary of the review scope, requirements and evidence examined.
- Findings that distinguish identified gaps from items needing further evidence.
- A prioritized action plan with proposed responsibilities and next steps.
- A review discussion to help your team understand the findings and agree an improvement scope.
Deliverables, timing and fees are agreed before work begins.
Support for your quality-system requirements
Three standards, with the same practical focus on processes, responsibilities and evidence. The review is tailored to the requirements that apply to your organization.
ISO 9001
Quality management across your business
Connect customer requirements, day-to-day processes and improvement activities. Review areas can include process management, document control, internal audits, corrective action and management review.
AS9100
Aerospace quality-system support
Bring quality, engineering, purchasing and production together around applicable requirements. Review areas can include customer and supplier requirements, risk and configuration documentation, audit preparation and corrective action.
ISO 13485
Medical-device quality-system support
Strengthen the connection between procedures, product-development activities and retained records. Review areas can include document and record control, risk-management interfaces, corrective action and internal audit preparation.
How the review works
- Discuss the need. Tell us about your organization, quality-system objectives, current challenges and any known audit dates.
- Agree the scope. Define the requirements, processes, evidence, people and deliverables included in the review.
- Review the evidence. Examine the agreed documents and records and discuss actual practice with the relevant process owners.
- Prioritize the next steps. Review the findings together and identify a practical improvement scope.
What helps us get started
- Your applicable standards and quality-system scope.
- A process overview and key procedures.
- Relevant records and any previous audit findings.
- Customer requirements and known deadlines.
- The people responsible for the processes in scope.
From gap review to ongoing improvement
Your team can use the findings to plan its own improvements or agree a separate implementation scope with Colabmo.
Our improvement cycle follows Plan–Do–Check–Act (PDCA):
- Review · Plan: Use the gap review to agree priorities, owners and acceptance criteria.
- Implement · Do: Implement scoped process, documentation and corrective-action changes.
- Verify · Check: Review evidence and check whether actions address the agreed gaps.
- Improve · Act: Update the system, hand over records and ownership, and set the next review priorities.
Colabmo provides consulting, implementation and audit-preparation support. Independent certification decisions remain with the certification body.
Relevant expertise
Diggy Breiling's work spans quality systems, risk management, technical documentation, operations and business systems. That cross-functional perspective helps connect requirements with the people responsible for carrying them out.
View Diggy's profile·Meet our expertsSupporting planning resources
For projects involving displays or related systems in aerospace, medical devices, simulation or transportation, our shared industry guides provide requirements-planning and supplier-coordination context. Check each guide's scope and revision status before use.
Explore the industry guidesStart with a clear picture of your quality system
Tell us which standard applies, what you want to improve and whether you have an upcoming audit. We can discuss the scope of a gap review.