ISO Gap Assessment Services (Readiness & Risk Evaluation)
ISO Gap Assessment
Understand where you stand before you pursue certification.
An ISO gap assessment is the first and most critical step toward successful certification.
Before investing in full implementation, organizations need clarity:
What already meets the standard?
Where are the compliance gaps?
What risks exist in current processes?
How much effort is required to achieve certification?
Our ISO gap assessment services provide a structured, clause-by-clause evaluation so you can move forward with confidence.
What Is an ISO Gap Assessment?
An ISO gap assessment is a systematic review of your current processes and documentation against the requirements of a specific ISO standard.
The objective is to:
Identify missing requirements
Evaluate effectiveness of existing controls
Assess risk exposure
Determine certification readiness
Develop a structured implementation roadmap
It is not a certification audit — it is a diagnostic tool.
ISO Standards We Assess
We conduct ISO gap assessments for:
ISO 9001 – Quality Management Systems
ISO 14001 – Environmental Management Systems
ISO 13485 – Medical Device QMS
ISO/IEC 27001 – Information Security
AS9100 – Aerospace Quality Systems
Integrated Management Systems (IMS)
We also support revision transition gap assessments and multi-standard evaluations.
Our ISO Gap Assessment Methodology
Our approach is structured, practical, and risk-focused.
1. Scope & Context Review
We evaluate:
Organizational context
Interested parties
Scope definition
Leadership structure
Regulatory environment
Strong scope definition prevents implementation errors later.
2. Clause-by-Clause Evaluation
We assess conformity across:
Leadership & policy
Risk-based thinking
Operational controls
Performance evaluation
Internal audit processes
Corrective action systems
Documented information
We evaluate both documentation and operational evidence.
3. Process-Based Review
We examine:
Process inputs and outputs
Ownership and accountability
Performance metrics
Risk mitigation controls
Cross-functional interactions
ISO compliance must align with real workflows.
4. Gap Identification & Risk Ranking
We classify findings as:
Conforming
Minor gap
Major gap
High-risk exposure
This prioritizes remediation efforts and resource allocation.
5. Implementation Roadmap
You receive a structured roadmap including:
Required documentation
Process modifications
Training needs
Timeline estimates
Internal audit preparation steps
This becomes your certification action plan.
Why Organizations Start With an ISO Gap Assessment
Common scenarios include:
First-time certification planning
Uncertainty about readiness
Acquisition or organizational changes
Transitioning to a new ISO revision
Integrating multiple standards
Preparing for customer audits
A gap assessment reduces uncertainty and prevents costly missteps.
Benefits of a Professional ISO Gap Assessment
✔ Clear visibility of compliance status
✔ Reduced certification delays
✔ Prioritized remediation plan
✔ Accurate project scope definition
✔ Risk-based implementation focus
✔ Improved leadership clarity
✔ Stronger internal alignment
Without a gap assessment, implementation efforts often lack direction.
ISO Gap Assessment vs. Certification Audit
Gap Assessment:
Diagnostic and advisory
Identifies weaknesses before audit
Allows remediation without penalty
Certification Audit:
Conducted by an accredited certification body
Determines certification status
Can issue nonconformities impacting certification
A gap assessment ensures you are prepared before facing a certification audit.
Who We Work With
We conduct ISO gap assessments for:
Manufacturers
Aerospace & defense suppliers
Medical device companies
Technology firms
Engineering organizations
Growing companies preparing for first-time certification
Multi-site enterprises
Our assessments scale to your organizational size and risk profile.
Frequently Asked Questions
How long does an ISO gap assessment take?
Typically 1–3 days depending on scope and standard complexity.
Will we receive a written report?
Yes. You receive a structured gap report with prioritized recommendations.
Does a gap assessment guarantee certification?
No assessment can guarantee certification, but it significantly increases readiness.
Can the gap assessment transition directly into implementation support?
Yes. Many clients move directly into structured implementation following the assessment.
Ready to Evaluate Your ISO Readiness?
If you’re considering ISO certification or want to understand your current compliance posture, an ISO gap assessment provides the clarity you need to move forward strategically.
Certification success starts with accurate diagnosis.
Contact us.
info@wintersmithadvisory.com
(801) 558-3928