Expert ISO 9001 & 27001 Implementation Consultant Needed
Budget: $25 – $50 USD
Project Title: ISO 9001 and ISO 27001 Consultant
Project Overview:
We are a small U.S.-based Clinical Research Organization (CRO) preparing for ISO 9001 and ISO/IEC 27001 certification. We already have a partially developed Quality Management System (QMS) and Information Security Management System (ISMS), including SOPs, internal audits, and management review processes.
We are NOT looking for a full-service expensive consulting firm. We need a practical, experienced consultant to support and guide our internal team.
Scope of Work:
* Conduct gap analysis against ISO 9001:2015 and ISO/IEC 27001:2022
* Review existing SOPs and documentation (QMS + ISMS)
* Provide clear recommendations for compliance gaps
* Support risk assessment and risk register validation
* Assist with internal audit preparation and/or execution
* Prepare us for Stage 1 audit (readiness review)
* Optional: support during Stage 2 audit if needed
What We Already Have:
* SOP structure in place (Document Control, Risk Management, etc.)
* Internal Audit program (ongoing)
* Management Review process
* CRO-specific operations (biospecimen, clinical research workflows)
Ideal Candidate:
* Certified ISO 9001 and/or ISO 27001 Lead Implementer or Lead Auditor
* Experience working with small or mid-size companies (preferably CRO, healthcare, or biotech)
* Practical, no “template-only” approach
* Able to work with partially implemented systems (not starting from zero)
Engagement Model:
* Part-time / hourly (flexible)
* Focused support (not full implementation)
* Budget-conscious approach preferred
Deliverables:
* Gap analysis report
* Action plan with priorities
* Feedback on key documents
* Audit readiness support
Additional Notes:
We prefer a consultant who can work efficiently with our internal team and avoid unnecessary complexity. Our goal is to pass certification with a lean, practical system — not overengineered documentation.
Please include:
* Your ISO certifications
* Relevant experience (especially healthcare / CRO if applicable)
* Estimated hours or approach
Project Overview:
We are a small U.S.-based Clinical Research Organization (CRO) preparing for ISO 9001 and ISO/IEC 27001 certification. We already have a partially developed Quality Management System (QMS) and Information Security Management System (ISMS), including SOPs, internal audits, and management review processes.
We are NOT looking for a full-service expensive consulting firm. We need a practical, experienced consultant to support and guide our internal team.
Scope of Work:
* Conduct gap analysis against ISO 9001:2015 and ISO/IEC 27001:2022
* Review existing SOPs and documentation (QMS + ISMS)
* Provide clear recommendations for compliance gaps
* Support risk assessment and risk register validation
* Assist with internal audit preparation and/or execution
* Prepare us for Stage 1 audit (readiness review)
* Optional: support during Stage 2 audit if needed
What We Already Have:
* SOP structure in place (Document Control, Risk Management, etc.)
* Internal Audit program (ongoing)
* Management Review process
* CRO-specific operations (biospecimen, clinical research workflows)
Ideal Candidate:
* Certified ISO 9001 and/or ISO 27001 Lead Implementer or Lead Auditor
* Experience working with small or mid-size companies (preferably CRO, healthcare, or biotech)
* Practical, no “template-only” approach
* Able to work with partially implemented systems (not starting from zero)
Engagement Model:
* Part-time / hourly (flexible)
* Focused support (not full implementation)
* Budget-conscious approach preferred
Deliverables:
* Gap analysis report
* Action plan with priorities
* Feedback on key documents
* Audit readiness support
Additional Notes:
We prefer a consultant who can work efficiently with our internal team and avoid unnecessary complexity. Our goal is to pass certification with a lean, practical system — not overengineered documentation.
Please include:
* Your ISO certifications
* Relevant experience (especially healthcare / CRO if applicable)
* Estimated hours or approach
Related categories:
Project Management
Training
Compliance
Risk Assessment
Consulting
Change Management