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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 ID: 40388628
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13 freelancers are bidding on average $32 USD/hour for this job

Hi, thanks for your time to read my proposal. I am a seasoned management consultant with diverse experiences in ISO 9001 and ISO 27001 end to end development, implementation and certifications and completed similar projects. I am IRCA UK certified Lead Auditor in, ISO 9001, ISO 27001, ISO 22000, ISO14001, ISO 17025 I will deliver as per your mentioned requirements and proficient in all areas. I will do complete review and update of your existing documents. Help in implementing and record's. Conduct gap assessment, internal audit, guide your team. Support in stage 1 and stage 2 audits, Prepare and resolve all post audit observations and N C if any. Note: TOTAL hours cannot be predicted without seeing your existing preparations. But I assure best cost effective solution. Please respond so that we can discuss and move forward. Regards
$30 USD in 40 days
5.2
5.2

With over a decade of experience in compliance and project management, I am confident I am the right fit for your ISO 9001 and ISO/IEC 27001 certification needs. While being a Certified Project Manager, I have also garnered extensive certifications in both ISO 9001 and ISO/IEC 27001. My understanding of the unique challenges faced by small and mid-size companies, particularly in the healthcare and biotech industries, aligns well with your requirements as a Clinical Research Organization (CRO). Working closely with your internal team, I will conduct a thorough gap analysis to ascertain key compliance areas that need focus. I will deliver more than just a templated approach; my aim is to provide efficient and lean solutions that enable you navigate these complex certifications smoothly. My prior experience has equipped me to deal with systems that are partially implemented, so rest assured your existing QMS & ISMS structure won't be disregarded. In terms of an engagement model, I appreciate your budget-conscious approach and assure you of delivering within those parameters. Plus, working part-time and hourly brings flexibility for both of our teams. To underline the value I bring to your project, my deliverables would include a comprehensive gap analysis report, clear-cut action plan with priorities highlighted, detailed feedback on key documents and strong audit readiness support.
$30 USD in 40 days
2.9
2.9

Greetings! You need an ISO 9001 and ISO 27001 consultant for your small CRO. Gap analysis, SOP review, risk assessment support, internal audit preparation, Stage 1 readiness. Part-time, budget-conscious. I can help you in doing that for you. Here is what I will deliver: Gap analysis report against ISO 9001:2015 and ISO 27001:2022 Action plan with priorities Feedback on existing QMS and ISMS documents Risk assessment and risk register validation support Internal audit preparation assistance Stage 1 audit readiness I can work efficiently with your internal team. Send me your existing SOPs and documentation. Thanks, Revival
$25 USD in 40 days
1.5
1.5

Hello, My name is Dmytro, an ideal ISO 9001 and ISO 27001 Implementation Consultant for your project. Being a certified lead implementer with over a decade of experience in shipping robust systems, I understand the practical importance of lean, efficient processes to meet certification standards. I have a track record of creating production SaaS platforms and AI-powered features with a focus on scalability and streamlined delivery. One significant advantage I bring to the table is my proficiency in conducting comprehensive gap analyses to ascertain noncompliance points better. This skill will enable me not only to recognize gaps in your existing QMS and ISMS but also prioritize addressing them effectively while working with your team's workflows. My specialized experience in various sectors, especially in healthcare where compliance is highly regulated, gives me unique insights into addressing CRO-specific requirements. My work style aligns perfectly with your engagement model. I believe in phased milestones, keeping clear documentation to ensure seamless handoff and employing ambitious yet achievable plans to save on cost and time. Choose me for an artisanal approach that eschews templates for pragmatic solutions - that's what you get when you combine my proven skills with my budget-conscious mindset! Thanks!
$25 USD in 32 days
0.0
0.0

As an experienced Project Management professional with over 10 years of expertise, I have carefully reviewed the requirements for the ISO 9001 and ISO 27001 implementation project. I am confident in my ability to deliver exceptional results and guide your team effectively through the process. I am well-versed in conducting gap analyses, reviewing existing documentation, and providing practical recommendations for compliance. I am open to discussing further details and tailoring my approach to meet your specific needs. Let's connect in chat to discuss how I can support your organization in achieving ISO certification. Looking forward to collaborating with you on this project.
$25 USD in 40 days
0.0
0.0

I specialize in a practical, "no-template" approach that respects your existing SOPs while ensuring they meet the rigorous 2022 standards. How I Will Add Value: Integrated Gap Analysis: I won’t reinvent the wheel. I will map your existing Document Control and Clinical Research workflows against the new ISO 27001:2022 Annex A controls and ISO 9001:2015 clauses to identify specific deltas. Risk-Based Validation: I will refine your Risk Register to ensure it captures both operational quality and data integrity, specifically tailored to biospecimen and clinical data security. Audit Readiness: I provide hands-on support for Internal Audits and Stage 1 reviews, ensuring your Statement of Applicability (SoA) and Management Review records are bulletproof before the external auditors arrive. Why My Approach Fits: Not Starting from Zero: I focus on "pruning and aligning" rather than creating administrative bloat. Technical Expertise: My background in complex process management allows me to understand your technical workflows—not just the compliance checklists. Deliverable-Focused: Whether it's validating your risk treatment plan or executing a rigorous internal audit, my goal is a successful Stage 2 recommendation. I am available to start with a high-level document scan to assess your current compliance "delta." Let's discuss how we can streamline your path to certification.
$38 USD in 40 days
0.0
0.0

Subject: ISO 9001 & 27001 Consultant – Practical QMS/ISMS Integration for your CRO I am writing to support your CRO’s ISO 9001 and ISO/IEC 27001 journey. As a Certified ISO 15189 Auditor with Good Clinical Practice (GCP) training, I offer three key advantages: Clinical Expertise: Nine years in high-complexity environments ensure I fluently manage research workflows, informed consent, and data confidentiality. Integrated Approach: I treat quality and security as a unified system, reducing administrative burdens by 30% through shared risk and document controls. Audit-Proven: I translate complex clauses into lean, actionable steps, ensuring your partially developed system is audit-ready without being over-engineered. I offer flexible support, starting with a risk register validation.
$25 USD in 24 days
0.0
0.0

Hi sir, I have 15 year of experience in iso 27001 and iso 9001 standard consultation. I have done more then 500 projects worldwide. I have understood your query. Please check my profile review for same. When we can start
$38 USD in 40 days
0.0
0.0

As a seasoned project manager with years of experience in quality and compliance, I am confident that my approach aligns perfectly with your needs as a lean organization seeking ISO certification. My extensive background in ISO 9001, AS9100D, and NADCAP environments has strengthened my understanding of the importance of practicality and simplicity in quality management systems – which are values you have emphasized. At Conley Quality Services, translating standards into pragmatic, scalable business processes is at the core of what we do. I don't believe in offering a "template-only" approach. Instead, I commit to thoroughly reviewing your existing SOPs and documentation, conducting a robust gap analysis, and providing clear recommendations to bridge those gaps. Incorporating a risk-based approach is another key competency that I bring to the table—something particularly relevant for the ISMS aspect of your project. My promise is an engagement model that's focused on giving you the necessary support without creating unnecessary complexity. Let's work together to build a solid foundation for your future success.
$40 USD in 40 days
0.0
0.0

As an experienced Compliance professional, I understand the significance of ISO certifications for businesses, especially in sectors like healthcare and biotech. My certifications as a Certified Fraud Examiner (CFE) and Digital Fraud & Risk Specialist aren't directly related to ISO 9001 and 27001, but they provide me with deep insights into risk analysis, corporate governance, and regulatory compliance that would be highly valuable for your project. I have successfully designed many robust frameworks to safeguard global platforms, including my experience at Amazon Web Services (AWS). With AWS being one among the largest cloud providers globally and having its own stringent security standards, I am confident that I can bring a similar level of quality and security to your project. Additionally, my experience working with Dun & Bradstreet would add a data-driven edge. My approach towards consultancy is rooted in practicality. I understand the need for lean systems rather than over-complicated templates. Hence, I appreciate the fact that you already have a partially developed Quality Management System (QMS) and Information Security Management System (ISMS)- this means we are not starting from scratch but building upon existing foundations. This results-oriented approach along with my international certifications makes me a strong contender for this project.
$38 USD in 40 days
0.0
0.0

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