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