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I will draft iso 9001 iso 13485 quality management framework documentation qms
Theresa lake
About this gig
Is your company preparing for an ISO audit, or do corporate clients demand an established Quality Management System (QMS) before signing contracts? Establishing a structured framework shouldn't derail your daily operations.
I specialize in building professional, audit-ready ISO documentation tailored to your specific organizational workflows.
Frameworks & Documentation Covered:
- ISO 9001:2015 (Standard Quality Management Systems)
- ISO 13485:2016 (Medical Devices Quality Requirements)
- Standard Operating Procedures (SOPs) & Work Instructions
- Quality Manuals, Policy Statements, & Control Forms
- Internal Audit Checklists & Gap Analysis Mapping
The Delivery Strategy:
- We analyze your current operational workflows and structure.
- I design custom, professional documentation matching your industry.
- You receive complete operational files ready for implementation.
Message me to structure your corporate compliance framework.
Get to know Theresa lake
Theresa lake
CE and UKCA Compliance Consultant
- FromUnited States
- Member sinceAug 2026
- Avg. response time1 hour
Languages
English
Certified Regulatory Affairs Specialist with 8+ years of experience helping global manufacturers, Amazon sellers, and hardware startups launch safely. I bridge the gap between complex EU/UK directives and your engineering reality. Specializing in Technical File compilation, Risk Assessments, Declaration of Conformity drafting, and ISO Quality Management frameworks. Let’s get your products audit-ready, compliant, and legally protected.
FAQ
Do you issue formal ISO certificates directly to companies?
No. A freelancer cannot issue official ISO certificates. Only an accredited, independent third-party registrar or certification body can perform the physical registration audit. I build the exact operational frameworks, technical paperwork, manuals, and records required to pass that audit flawlessly
Can you customize documents for specialized fields like medical devices?
Yes. I routinely design specialized Quality Management Systems tailored to medical hardware and diagnostic tools under the strict guidelines of ISO 13485. This includes implementing specialized risk management, validation records, and batch traceability documentation.
What is the difference between an SOP and a Quality Manual?
A Quality Manual is an overarching corporate document outlining your company’s core commitment to quality standards. Standard Operating Procedures (SOPs) are granular, step-by-step technical blueprints detailing how specific employees execute precise tasks inside your business to maintain that stand
Can you adapt your templates to fit an already existing corporate system?
Absolutely. I do not use rigid, generic templates. I evaluate your current business processes, management style, and industry requirements to write tailored, custom policies that seamlessly blend with your existing operational software or physical tracking methods.
How long does a full corporate ISO documentation setup take to compile?
Basic procedures are finalized within a few business days. However, a complete, multi-departmental, audit-ready Quality Management System dossier for the Premium tier requires a rigorous deep dive into your operations, typically taking 10 to 14 days to fully finalize.
Do you assist with root cause analysis and corrective actions (CAPA)?
Yes. Managing non-conformities is a core pillar of keeping an ISO framework active. I can build clear Corrective and Preventive Action (CAPA) logs, document handling templates, and continuous improvement tracking matrices so your team can easily document operational mistakes.
Is a Non-Disclosure Agreement (NDA) possible before we begin?
Yes. Corporate operational structures, internal data networks, and factory layouts are highly confidential trade secrets. I treat all client workflows with enterprise-grade privacy and am fully prepared to review and sign your formal NDA prior to document mapping.
Can you design documentation for remote or software-as-a-service (SaaS) teams?
Yes. ISO 9001 is highly versatile. I regularly adapt quality management frameworks to fit fully remote organizations, software firms, digital platforms, and logistics companies by mapping out code-deployment procedures, customer success standards, and cloud data controls.
