Hire the Best ISO 9001 Specialists

✅ 14+ years of Experience ✅ ISO Consultant (9001:2015/27001:2022/FSSC/FDA/UL-94-181/Food/HACCP/CCP/PRP's) ✅ Proven Results in ISO 9001, 27001, 14001, 45001, 22000, FSSC, SQF, 14064, 14065, 21001, 42001, ISO 51001:2024 ✅ISO 13485 and MDSAP-aligned Medical Device QMS readiness ✅ ISO AS9100D, EN9120 Specialist ✅ SOC 2 and CMMC Specialist ✅ CCPA/CPRA Compliance Specialist (Opt-Out Mechanisms, Data Sharing/Selling Controls) ✅ Legal and Regulatory Copywriter for Packaging Compliance ✅ Certified Quality Professional ✅ Secure SDLC & Privacy-by-Design Implementation ✅ ISO 14064-14065 Greenhouse Gas Emission (Certification & Accreditation) ✅ ISO 14064-1,14064-2,14064-3 (Verification and Validation) ✅ SAP S4/HANA QM Certified ✅ SQFI Implementation Expert ✅ Sustainability Data Management ✅ Internal Audit Expert ✅ Policy Writing ✅ SOP Specialist ✅ Company Policies and Procedures Manual ✅ Work Instruction & Checklist Draft Specialist ✅ FDA Regulations (Food, BRC, REACH, RoH) ✅ Data Visualization Expert ✅ Process Optimization Pro ✅ Process Mapping ✅ Document Control ✅ Manufacturing Data Specialist ✅ Virtual Assistance ✅ Operations & Process Structuring Consultant ⚡ Comprehensive Auditing: In-depth audits for ISO 9001 (Quality Management Systems) and ISO 27001 (Information Security Management Systems), ensuring compliance and identifying areas for improvement. ⚡ Customized Solutions: Tailored advice and strategies to meet your specific organizational needs, while aligning with international standards. ⚡ Continuous Improvement: Guidance on implementing best practices for ongoing quality and security enhancements. ⚡ Risk Management: Expert analysis and recommendations to mitigate risks, ensuring robust and resilient systems. ⚡ Training and Support: Providing staff training and support to understand and effectively implement ISO standards. 🚀Specialized Expertise🚀 in Quality Control, Assurance, and Audit Management across diverse sectors including manufacturing, healthcare, food, petrochemical, and automotive industries, I have consistently demonstrated leadership in achieving ISO 9001, BRC, ISO 27001, and ISO 14001 certifications. My proficiency extends to Data Visualization, where I leverage advanced techniques to drive insights and informed decision-making. In addition to my certification leadership, I have successfully spearheaded process safety initiatives and optimized business processes. My adeptness in SAP implementation and Quality Management (QM) ensures seamless operations and adherence to best practices. Furthermore, I possess a strong track record in complaint handling and process optimization. As an ISO Consultant and Writer, I am dedicated to crafting meticulous Policy & Procedure Documentation aligned with ISO standards, while ensuring full compliance with GDPR requirements. My commitment to excellence is evident in my punctual delivery and relentless pursuit of customer satisfaction, reinforced by consistently positive client feedback. In all my endeavors, I priorities not only quality and efficiency but also the safeguarding of data protection and privacy, thereby fostering trust and confidence in every project undertaken.

I help international businesses work more effectively in China and Asia through supplier searching, technical sourcing, quality & compliance support, SOP/process improvement, and localisation. With 25+ years of experience across manufacturing, international trade, quality management, inspection/certification, and bilingual business support, I help clients reduce risk, improve execution, and make better decisions. 🔎China Sourcing & Supplier Support • Supplier / manufacturer searching • OEM / ODM • Supplier screening & due diligence • Factory capability review • Supplier communication • Supply chain coordination ✅Quality, Compliance & Risk Support • Factory audits • Product inspection • Lab testing coordination • Quality / compliance review • Supplier risk assessment • Corrective action & improvement support 📋SOPs, Processes & Operational Improvement • Management Systems certification consulting • Process mapping • Workflow documentation • BPM / BPMN support • SOP writing • Procedures, checklists & templates • Process improvement & standardisation 🌏China Localisation & Bilingual Business Support • English–Chinese / Chinese–English translation • Business & technical translation • Bilingual business writing • Interpretation support • China-facing communication support • Localisation for practical business use ⭐Why Clients Work With Me • 25+ years in international trade, tech sourcing, quality, compliance, and operations • Led 200+ onsite audits/inspections and translated over 1 million tech & business words • Extensive industrial exposure in E&E, consumers, bulk, machinery, chemical and biology • Strong understanding of both China-side execution and international business expectations • Practical support that connects supplier selection, quality, process, and communication 🤝Available For • Long-term business partnership • Short-term projects • Ongoing support • China-side support when appropriate 📩Let's Connect If you are looking for practical support across China and Asia sourcing, supplier assessment, quality & compliance, SOPs, China-side communication, and localisation, feel free to message me.

Welcome! I am Yamira Munkel, a seasoned Regulatory and Quality Expert with over a decade of experience in the pharmaceutical industry. With GxP-Background. Certified PRRC (EU MDR 2017/745 / EU IVDR 2017/746, Responsible Person (GDP Directive 2001/83/EC), Responsible Person (Cosmetics EU Cosmetics Regulation 1223/2009). I am passionate about guiding businesses through complex pharmaceutical regulatory requirements. My expertise includes technical writing, such as Standard Operating Procedures (SOPs), and in-depth knowledge of Quality Management Systems (QMS) that comply with ISO standards and global regulatory frameworks. Furthermore, my experience encompasses EudraLex Volume 4, ensuring that pharmaceutical products adhere to jurisdictional compliance standards. I also possess extensive expertise in GDPR, Computer System Validation (CSV), lead auditing, CE certification, and ISO 9001 and ISO 13485 compliance. Research, technical documentation, and regulatory submissions are among my core competencies. If you require regulatory affairs expertise, quality management system guidance, or support with regulatory submissions in the pharmaceutical industry, I am here to assist. My vast experience in regulatory and quality affairs ensures that your products meet international standards and compliance requirements. Let’s collaborate to bring your pharmaceutical products to market with confidence and compliance! I look forward to connecting with you!

# ISO 27001, GDPR, SOC 2, GRC, AI GOVERNANCE AND AUDIT READINESS I help SaaS, technology, fintech, marketplace and service companies become audit-ready for ISO 27001, GDPR, SOC 2 readiness, EU AI Act readiness, ISO 42001 readiness, security questionnaires, vendor risk, AI governance and GRC documentation. Many companies have policies, procedures and security documents, but struggle to prove they are followed. The same problem now exists with AI: teams use AI tools, but often lack ownership, risk assessment, approval workflows, monitoring and evidence. That is where my work creates value. My focus is simple: * Requirement * Risk * Policy * Control * Process * Evidence * Monitoring * Audit Readiness This makes your compliance and AI governance program easier to manage, explain and defend during audits, customer reviews, vendor checks and AI risk reviews. # WHAT CLIENTS HIRE ME FOR * ISO 27001 AND ISMS SUPPORT - ISMS documentation - ISO 27001 readiness - Gap assessments - Control mapping - Risk treatment tracking - Evidence review - Management review input * AI GOVERNANCE, ISO 42001 AND EU AI ACT READINESS - AI governance documentation - ISO 42001 readiness support - EU AI Act readiness support - AI system inventory - AI use case register - AI risk assessment structure - AI impact assessment support - AI control mapping - AI vendor risk review - AI approval workflow - AI monitoring and evidence structure - Responsible AI documentation * GDPR, PRIVACY AND DATA PROTECTION - GDPR documentation - Privacy process reviews - Vendor privacy checks - Data protection evidence - Regulatory requirement mapping - Privacy risk documentation - Legal and privacy requirements translated into controls * GRC PROGRAM DEVELOPMENT - Compliance obligation registers - Regulatory change tracking - Control libraries - Risk registers - Remediation trackers - Audit plans - Evidence repositories - Policy lifecycle management - KPI and KRI tracking - Management reporting * RISK ASSESSMENT AND VENDOR RISK - Information security risk assessments - Compliance risk workshops - Vendor risk reviews - AI vendor reviews - Control self-assessments - Outsourcing risk reviews - Third-party risk documentation - Remediation planning * AUDIT AND EVIDENCE PREPARATION - Audit planning - Evidence collection - Evidence review - Interview preparation - Control testing documentation - Audit finding analysis - Corrective action tracking * POLICIES, PROCEDURES AND QUESTIONNAIRES - Information security policies - AI governance policies - Access control procedures - Incident response documentation - Business continuity documentation - Vendor risk procedures - Data protection documentation - Control narratives - Audit reports - Decision records - Security questionnaire responses # WHY WORK WITH ME Auditors, customers and management do not only want policies. They want ownership, working controls, traceable evidence, measurable follow-up and proof that the process is followed. With AI, companies need to know which AI tools are used, who owns them, what data they process, what risks exist, what approvals are required, what controls are in place and what evidence proves responsible use. I translate regulatory, security, privacy, AI and framework requirements into clear actions for engineering, IT, product, management and business teams. This reduces confusion and speeds up evidence collection. # TYPICAL PROJECTS - ISO 27001 gap assessments - GDPR documentation review - AI governance setup - ISO 42001 readiness support - EU AI Act readiness support - AI system inventory creation - AI risk assessment structure - Security policy creation - Risk register setup - Compliance obligation registers - Internal audit checklists - Audit evidence preparation - Vendor risk assessments - Security questionnaire responses - AI vendor risk reviews - Control mapping - KPI and KRI setup - Management review preparation - Corrective action tracking - GRC documentation cleanup # MY WORKING APPROACH I start by understanding your audit goal, documentation, risks, ownership, evidence, AI usage, stakeholders and deadlines. Then I structure the work into clear priorities, deliverables and next steps. My approach is detailed, calm and evidence-driven. I avoid unnecessary complexity and focus on what auditors, customers, management and internal teams need to see. The goal is to build a working compliance and AI governance structure that your team can understand, maintain and improve. # WHAT YOU GET Clear documentation, control mapping, audit-ready evidence structure, AI governance structure, risk and remediation tracking, and business-friendly explanations for all stakeholders. You get someone who connects compliance, privacy, security and AI requirements with real processes, owners, evidence and improvement actions. If your company is preparing for an audit, certification, customer security review, AI governance project, vendor assessment or internal compliance

EXECUTIVE SUMMARY Senior compliance, quality and risk governance leader with a 20+ year track record designing, implementing and maturing regulatory, risk and quality frameworks across legal services, professional bodies, healthcare, education and SaaS environments. Expert in developing governance systems that strengthen organisational resilience, achieve ISO certification, enhance regulatory alignment and drive continuous improvement. Experienced advising Boards and Executive Teams, leading enterprise risk initiatives, directing audit and assurance activity, and embedding frameworks aligned to ISO, SRA, CQC, OFSTED/OFQUAL, GDPR and the UK Digital Identity & Attributes Trust Framework (UKDIATF) & ISO 27566-1 . Recognised for building high-performing audit/compliance functions, stabilising complex environments, and delivering multi-stakeholder transformation programmes. A strategic operator with a hands-on approach to implementation, culture change and operational excellence. ________________________________________ LEADERSHIP CAPABILITIES • Governance Design & Maturity Frameworks • Enterprise Risk Management & Risk Governance • Compliance Strategy & Operating Model Development • ISO Certification Leadership (9001, 14001, 22301, 27001, 17025, 13485, 17065, 19011) • Regulatory Alignment (SRA, CQC, OFSTED, OFQUAL, UKDIATF, GDPR/DPA) • Audit & Assurance Leadership (Internal, Supplier, External, 3rd-party) • Board Reporting & Executive Stakeholder Management • Policy, Framework & Controls Development • Agile Project Delivery & Organisational Change • Quality, Operations & Continuous Improvement Leadership • Digital Compliance, Identity & Information Governance ** MDSAP/FDA 21 CFR 820.30, Medical Devices, ISO 13485 & 14971. ** clickup project management platform ________________________________________ RELEVANT LEADERSHIP EXPERIENCE Senior Compliance Officer (Contract) Directed compliance governance, operational assurance and ISO frameworks for a national professional body undergoing significant organisational expansion. Key Leadership Achievements: • Led ISO 9001, 14001 and 27001 certification programmes, ensuring third-party audit readiness and sustainable governance controls. • Designed organisational compliance workflows, quality systems and enterprise audit strategies. • Supported OFSTED and OFQUAL regulatory compliance for apprenticeships, adult learning and professional training frameworks. • Produced board-level governance reports, risk analysis and assurance outputs. • Designed an industry-specific Quality Standard—including scope definition, KPI structures, risk governance, due diligence, stakeholder strategy and budget oversight. • Established supplier governance and internal audit criteria for a multi-vendor environment. ________________________________________ Provides senior advisory leadership to regulated and high-risk organisations on compliance frameworks, governance maturity, enterprise risk and operational quality systems. Key Leadership Achievements: • Designed and embedded risk-based audit and assurance frameworks across legal and regulated services. • Advised on SRA Code of Conduct governance across multiple legal disciplines, improving oversight, client care, complaint management and risk controls. • Implemented multi-standard ISO Management Systems (9001, 14001, 22301, 27001) including readiness, documentation, gap analysis and audit leadership. • Developed organisation-wide governance documentation, risk registers, control frameworks and compliance monitoring programmes. • Managed audit teams delivering independent assurance to senior leadership. • Strengthened AML, sanctions, CDD/PEP, ABC, conflicts and client onboarding governance controls. • Supported Digital ID compliance for UKDIATF (SaaS) and contributed to PAS 1296 (Age Verification) aligned processes. • Delivered AgilePM-led transformation projects involving workflow redesign, operational optimisation and compliance digitalisation. ________________________________________ QUALIFICATIONS • Agile Project Management (AgilePM) – Foundation (Practitioner in progress) • Lead Auditor – ISO 9001 • Specialist knowledge: ISO 17025, ISO 13485, ISO 19011, ISO 17065 • Professional Presentations Training (SGS UK) ________________________________________ EDUCATION BSc (Hons) Quality Management, University of Salford HND Business & Finance, University of Salford

Professional Profile Spanning over eighteen years of meaningful experience in Quality Management and Food Safety, including Corporate Quality Management, Product Development, and Laboratory Operations in various export-oriented manufacturing companies supplying global brands. Demonstrated track record of leadership towards successful site certification from fundamental GMP/HACCP to GFSI Schemes (including 2nd party customer schemes) of diverse sectors. Holds IRCA/CQI/FSSC, PCQI and BRCGS Food and Packaging Lead Auditor Certifications.