Hire the Best ISO 9001 Specialists
in Pakistan

✅ 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.

🏆🎖️ Top Rated Plus Upwork Freelancer 👋 Hi, I’m Saif Ur Rehman, Certified ISO & HSE Consultant and Qualified Engineer with a strong reputation for delivering high-impact compliance solutions, Audit-ready documentation, and tailored ISO Management systems across diverse companies. With a passion for excellence and a deep understanding of International Standards, I help businesses achieve operational efficiency, regulatory compliance, and sustainable growth through expertly crafted ISO, HSE, WHS, and risk management framework all documentation. 📌 My Services 📄 ISO Documentation, Gap Analysis, Implementation & Certification ✅ Manuals | Policies | QAQC docs | ITPs & ITCs | SOPs with templates | Flowcharts | Audit Checklists ✅ Internal/External Audits | Risk Registers | Gap Assessments ✅ Full IMS & ISMS compliance: QHSE + Information Security Management System 🛡️ HSE, ESG & Risk Management ✅ JSA | SWMS | RAMS | SDS | Incident Statistics ✅ Method Statements | HSE Plans | Technical Training | NDIS Compliance documentation ✅ WHS / OSHA / NEBOSH / GradIOSH-Compliant Support 📝 Technical & Research Writing ✅ Bidding Documents | Reports | Research Papers | Thesis 🎓 Certifications & Expertise ✅ ISO 9001:2015 (Quality Management System - QMS) ✅ ISO 27001:2022 (Information Security & Cyber Security - ISMS) ✅ ISO 14001:2015 (Environmental Management System - EMS) ✅ ISO 45001:2018 (Occupational Health & Safety - OHS) ✅ ISO 13485:2016 Medical Devices QMS ✅ ISO 22301:2019 (Business Continuity Management System - BCMS) ✅ ISO 17025:2017 (Laboratory Management System - LMS) ✅ ISO 22000:2018 (Food Safety Management System - FSMS & HACCP Plans) ✅ ISO 31000:2018 (Risk Management) ✅ ISO 50001:2018 (Energy Management System – EnMS) ✅ ISO 41001:2018 (Facility Management System - FMS) ✅ ISO 20000:2018 (IT Service Management System – ITSMS) ✅ ISO 42001: 2023 (Artificial Intelligence Management System – AIMS) ✅ ISO 20121:2024 (Event Sustainability Management System - ESMS ✅ ISO 26000, 26030:2019 & 14064 GHG ✅ NVQ Level 6 GradIOSH Occupational Health & Safety ✅ NEBOSH International General Certificate (IGC) ✅ Occupational Safety & Health (OSHA) ✅ cGMP & FDA 21 CFR Part 820 & 111 ✅ SOC 2 & HIPAA 🔷 Partnering with top certification bodies like ASIB, UKAF, UKAS, UAF, IAS, JAS-ANZ, and IAF. I help organisations achieve compliance, streamline operations, and meet global standards for long-term success. 🚀 Why Choose Me? ✨ Top Rated Plus – Trusted by global International clients ⏱️ Fast delivery – On-time & detail-focused 📈 Quality-driven – Customized & audit-ready documents 🌍 Industry-experienced – Engineering, Manufacturing, IT, Pharma 📩 Let’s Collaborate! I can perform quality projects. Feel free to contact me for more details. SAIF UR REHMAN

I offer professional ISO Certification & HSE Management System Consultancy to help businesses achieve compliance, optimize processes, and enhance operational efficiency. My expertise includes ISO Standards Certification & Documentation includes Manuals, Policies, Procedures, SOPs, Work Instructions, Process Flowcharts, Formats, and Internal Compliance Audits & Risk Management. Additionally, I provide comprehensive consultancy in Health, Safety & Environment (HSE), covering detailed documentation, Risk Assessments, JSA, SWMS, RAMS, Method Statements, Work Instructions (WI), SDS, HSE Statistics, and Technical HSE Training Modules. 📌 I also specialize in preparing high-quality bidding documents tailored to project requirements. ➤ My Areas of Expertise: ✅ ISO 9001:2015 – Quality Management System (QMS) ✅ ISO 27001:2022 – Information Security Management System (ISMS) & Cyber Security ✅ ISO 14001:2015 – Environmental Management System (EMS) ✅ ISO 45001:2018 – Occupational Health & Safety Management System (OHSMS) ✅ ISO 13485:2016 – Medical Devices QMS ✅ ISO 22301:2019 – Business Continuity Management System (BCMS) ✅ ISO 22000:2018 (Food Safety Management System – FSMS), ✅ ISO 31000:2018 (Risk Management), ✅ ISO 50001:2018 (Energy Management System – EnMS), ✅ ISO 41001:2018 (Facility Management System - FMS), ✅ ISO 20000-1:2018 (IT Service Management System – ITSMS), ✅ ISO 21001:2018 (Educational Organizations Management System – EOMS), ✅ ISO 37001:2016 (Anti-Bribery Management System – ABMS), ✅ ISO 15189:2022 (Medical Laboratories Quality Management System – MLQMS). ✅ ISO 42001: 2023 (Artificial Intelligence Management System – AIMS) ✅ NEBOSH International General Certificate (IGC) ✅ Occupational Safety & Health (OSHA) ✅ SOC 2 & HIPAA Compliance ✅ Lean Six Sigma Implementation, GMP, CE, FDA, Halal 🔷 Partnering with top certification bodies like ASIB, UKAF, UKAS, UAF, IAS, JAS-ANZ, and IAF. I help organisations achieve compliance, streamline operations, and meet global standards for long-term success. Are We a Good Match? We are a perfect fit if you: 😟 Need world-class, battle-tested security and privacy policies—FAST! 📌My solutions have successfully passed audits. 💡 Want to stop struggling with compliance? ✔ I simplify compliance requirements, security questionnaires, and complex document templates. 🚀 Looking to break into enterprise sales? ✔ I provide a turnkey, enterprise-grade security framework to support long-term business growth. 🤝 Want expert support? ✔ I work with an experienced senior team (architects, pen testers, engineers, developers, auditors, and consultants) that regularly helps clients land enterprise accounts. Security Questionnaire & Vendor Assessment Tools: 🔷 SIG, SIG Lite, CAIQ, VAS, HECVAT, OneTrust, Graphite Connect, Centrl, Whistic, Process Unity Security & Compliance Frameworks: 🔷 ISO 27001, SOC 2, HIPAA, ISO 27017, ISO 27018, PCI-DSS, ISO 42001 ⭐Feel free to contact me if you need to chat about your project or if you are not sure if it's the appropriate solution for your business. ⭐ Regards, Umair Ansar

Medical Devices Expert / ISO 13485 / ISO 14971 / FDA / MDR / SaMD | EU MDR, FDA, SFDA, CE & Technical Files | PRRC I am a Senior Regulatory Affairs Consultant with 8+ years of hands-on experience in global medical device compliance. I specialize in guiding high-risk devices, Class III implantables, IVDs, SaMD, and combination products through EU, FDA, SFDA, UKCA, TGA, and DRAP regulatory pathways, ensuring audit-ready documentation, compliance, and timely market approvals. I provide end-to-end regulatory solutions, including device classification, technical documentation, regulatory submissions, post-market surveillance, risk management, and PRRC services. My goal is to help companies navigate complex regulations efficiently while maintaining the highest standards of safety and performance. 🌐 Global Regulatory Expertise: 🔹 EU MDR 2017/745 – CE marking, Technical Documentation, EUDAMED registration, UDI compliance, PRRC services (Article 15) 🔹 US FDA – 510(k) submissions, Quality System Regulations (21 CFR Part 820), post-market compliance 🔹 SFDA (Saudi Arabia) – Class C device submissions, PMS reporting, local regulatory compliance 🔹 UKCA / MHRA – Device registration, compliance audits 🔹 TGA (Australia) – Regulatory approvals, documentation compliance 🔹 DRAP (Pakistan) – Device registration, submissions 📌 Core Regulatory Deliverables: - Clinical Evaluation Reports (CERs) – MDR Annex XIV & MEDDEV 2.7/1 Rev.4 - Biological Evaluation Reports (BERs) – ISO 10993 series - Risk Management Files – ISO 14971:2019 - Technical Documentation – DHF, DMR, DHR, CE marking dossiers, FDA submissions - Verification & Validation Reports - Post-Market Surveillance (PMS) & PMCF Reports - Declaration of Conformity & GSPR Checklist - Labelling & Instructions for Use (IFU) 💼 Regulatory Project Experience: - Balloon stents & catheters – CER, BER, Technical File - Hypodermic needles – FDA & CE submissions - Wound management devices – PMS and technical documentation - Breast cancer detection software (SaMD) – Clinical evaluation & global regulatory strategy - IVD blood collection & DNA/RNA extraction kits – CE marking & regulatory submissions 🏆 Regulatory Experience Highlights: - Acting as PRRC, ensuring EU MDR & EUDAMED compliance for clients - Preparing, reviewing, and maintaining technical files, CERs, BERs, Risk Management Files, DHF/DMR/DHR, PMS reports - Managing global regulatory submissions across EU, FDA, SFDA, UKCA, TGA, and DRAP - Advising on device classification, intended use, borderline cases, and combination devices - Implementing and auditing Quality Management Systems in compliance with ISO 13485:2016 - Ensuring risk management and product lifecycle compliance per ISO 14971:2019 My expertise includes: • ISO 13485 Quality Management System implementation • Quality Manual preparation and documentation control • SOP (Standard Operating Procedure) development • Work Instruction creation • Form and template development • CAPA (Corrective and Preventive Action) systems • Nonconformity and deviation management • Risk Management documentation (ISO 14971) • Gap Analysis for ISO 13485 and EU MDR compliance • Internal audit preparation and audit support • Technical Documentation / Technical File preparation • Device Master Record (DMR) and Device History Record (DHR) • Change Control and Document Control systems • Supplier qualification and vendor management • Complaint handling and Post Market Surveillance (PMS) • Clinical Evaluation documentation support • Validation protocols and reports Validation Expertise: • IQ (Installation Qualification) • OQ (Operational Qualification) • PQ (Performance Qualification) • Process Validation • Equipment Validation • Cleaning Validation • Packaging Validation 🧩 Regulatory Standards & Compliance Knowledge: - ISO 13485:2016 – QMS implementation & audit readiness - ISO 14971:2019 – Risk management for medical devices - ISO 10993-1 – Biocompatibility evaluation - ISO 62366 – Usability engineering - ISO 15223-1 / ISO 20417 – Labelling & device information - IEC 60601-1 / IEC 62304 / IEC 82304-1 – Electrical & software safety - FDA 21 CFR Parts 11 & 820 – Quality system and electronic records Why Hire Me for Regulatory Affairs: ✅ Global Expertise: End-to-end RA support across EU, FDA, SFDA, UKCA, TGA, and DRAP ✅ High-Risk Device Specialist: Class III implantables, combination devices, IVDs, SaMD, borderline cases ✅ Comprehensive Documentation: CERs, BERs, Technical Files, DHF/DMR/DHR, PMS, labelling, IFU ✅ PRRC Services: Acting as your dedicated MDR compliance officer ✅ Audit-Ready & Compliant: Standards-driven, meticulous, reliable, and timely ✅ Strategic Guidance: Regulatory strategy, classification, submissions, lifecycle compliance Let’s Connect: Message me to discuss your device regulatory needs. I provide expert guidance to achieve fully compliant, market-ready, and audit-proof documentation worldwide.

I am a master’s graduate with a strong passion for Information Security and regulatory compliance. I specialize in developing and implementing documentation aligned with ISO 27001, HIPAA, and HITRUST standards, helping organizations strengthen their security posture and meet compliance requirements with confidence. With a solid background in secure software systems and a deep understanding of information security best practices, I bring a practical, risk-based approach to protecting sensitive data while supporting business objectives. In addition to Information Security compliance, I have a proven track record of creating clear, comprehensive, and user-friendly software documentation tailored to organizational needs, including: Architecture diagrams, Use case documentation, Installation guides, Release notes, User Manuals, Online Help guides, Admin guides, FAQs. My goal is to simplify complex technical and compliance requirements into structured, actionable documentation that supports security, efficiency, and long-term organizational success.

If your product needs to pass regulatory scrutiny or your workplace needs to survive a real audit, I'm the consultant, you call. I'm an ISO & Safety Consultant with 15+ years of hands-on experience helping manufacturers, eCommerce brands, SaaS companies, and construction firms build compliance systems that hold up under real-world inspections not just on paper. Whether you're facing a product labeling violation, an OSHA inspection, an ISO certification audit, or need GHS-compliant SDS documentation fast — I build inspection-defensible systems aligned with the exact standards that matter to your business and your regulators. 🛠️ 𝐖𝐇𝐀𝐓 𝐈 𝐃𝐄𝐋𝐈𝐕𝐄𝐑 ► 𝐏𝐑𝐎𝐃𝐔𝐂𝐓 𝐒𝐀𝐅𝐄𝐓𝐘 & 𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐂𝐎𝐌𝐏𝐋𝐈𝐀𝐍𝐂𝐄 ✔ Product Package Label Compliance (EU & USA) FDA, EU 1169/2011, REACH, GHS labeling, multilingual label review ✔ FDA / FCC / CPSC regulatory support labeling, declarations of conformity, pre-market filings ✔ Product safety risk assessments and compliance gap analysis ✔ CE Marking, RoHS, REACH EU market access documentation ► 𝐎𝐒𝐇𝐀 & 𝐖𝐇𝐒 𝐖𝐎𝐑𝐊𝐏𝐋𝐀𝐂𝐄 𝐂𝐎𝐌𝐏𝐋𝐈𝐀𝐍𝐂𝐄 ✔ OSHA compliance programs inspection-ready policies and documentation ✔ Safe Work Australia (WHS) systems site-specific implementation ✔ Incident Investigation & Root Cause Analysis (RCA) actionable findings, not surface fixes ✔ Safety Manuals, SOPs & Policies clear, usable, site-relevant ✔ Job Safety Analysis (JSA / JHA) and HAZID-based risk assessments ► 𝐂𝐇𝐄𝐌𝐈𝐂𝐀𝐋 𝐒𝐀𝐅𝐄𝐓𝐘 𝐒𝐃𝐒 / 𝐆𝐇𝐒 / 𝐇𝐀𝐙𝐂𝐎𝐌 ✔ SDS authoring & review GHS-compliant, jurisdiction-specific (US, AU, EU) ✔ HazCom program development OSHA 1910.1200 aligned ✔ Amazon SDS & labeling compliance hazmat listings, dangerous goods classification ✔ Chemical inventory management and regulatory reporting ► 𝐈𝐒𝐎 𝐂𝐄𝐑𝐓𝐈𝐅𝐈𝐂𝐀𝐓𝐈𝐎𝐍 & 𝐀𝐔𝐃𝐈𝐓 𝐑𝐄𝐀𝐃𝐈𝐍𝐄𝐒𝐒 ✔ ISO 9001 (Quality) · ISO 14001 (Environmental) · ISO 45001 (OHS) · ISO 27001 (Information Security) ✔ Full system implementation from gap analysis to certification audit ✔ Internal audits & corrective action management ✔ Documented QMS, EMS & OHSMS built around your real operations ⚠️ 𝐖𝐇𝐄𝐑𝐄 𝐂𝐋𝐈𝐄𝐍𝐓𝐒 𝐔𝐒𝐔𝐀𝐋𝐋𝐘 𝐒𝐓𝐑𝐔𝐆𝐆𝐋𝐄 𝐀𝐍𝐃 𝐇𝐎𝐖 𝐈 𝐅𝐈𝐗 𝐈𝐓 ❌ Generic templates that fail audits ✅ Custom systems built around your actual operations and regulatory context ❌ Product label rejected — EU or USA market entry blocked ✅ End-to-end label review against FDA, EU 1169/2011, REACH, and GHS — market-ready documentation ❌ Compliance done, but risks still exist ✅ I close the gap between documentation and what actually happens on-site ❌ Policies employees don't follow ✅ Clear, plain-language SOPs and training-ready materials your team will actually use ❌ No clear link between docs and real operations ✅ End-to-end traceability from risk register to corrective action\ 📊 𝐖𝐇𝐀𝐓 𝐘𝐎𝐔 𝐂𝐀𝐍 𝐄𝐗𝐏𝐄𝐂𝐓 ✔ Audit-ready documentation that survives real inspector scrutiny ✔ Faster ISO certification and smoother regulatory approval cycles ✔ Reduced risk of penalties, listing suspensions, and compliance failures ✔ Systems your team actually understands and uses day to day ✔ No copy-paste templates everything built for your specific operations 🌍 𝐈𝐍𝐃𝐔𝐒𝐓𝐑𝐈𝐄𝐒 𝐒𝐄𝐑𝐕𝐄𝐃 Manufacturing | Construction | Chemicals | Logistics | SaaS | eCommerce 📩 𝐂𝐀𝐋𝐋 𝐓𝐎 𝐀𝐂𝐓𝐈𝐎𝐍 Need compliance that holds up under real scrutiny? Send me a message. I'll review your situation and tell you exactly what you need. No unnecessary paperwork. No copy-paste templates. Just clear, defensible compliance systems built around your operations. Regards, Muhammad Arif