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Summary

Your Quality Manual serves as the foundation document of your Quality Management System (QMS), establishing your company’s quality policy, objectives, and organizational structure while demonstrating compliance with ISO 13485:2016, FDA QSR, and EU MDR requirements.

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Why is Quality Manual, Policy & Objectives important?

The Quality Manual exists because regulators need assurance that your organization has a systematic approach to quality management rather than relying on ad-hoc practices. It demonstrates to regulatory bodies, notified bodies, and auditors that your company has clearly defined quality responsibilities, measurable objectives, and a commitment to continuous improvement. Your quality policy communicates your organization’s core values regarding quality to all stakeholders, while quality objectives provide concrete, measurable targets that guide daily operations and strategic decisions. This document also establishes the management representative role, which is legally required and makes this person accountable for quality system effectiveness.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation):
  • Quality policy and objectives are mandatory under Section 820.20(a)
  • Management representative must be formally designated with authority (820.20(b))
  • Quality manual must document the QMS and reference all procedures (820.40)
  • Must demonstrate management responsibility for the quality system
Special attention required for:
  • Management representative designation - this person receives FDA warning letters
  • Responsible Corporate Officer Doctrine (Park Doctrine) - executives remain liable
  • Document control requirements (820.40) for manual maintenance
  • Management review integration (820.20(c))

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Guide

Your Quality Manual establishes the framework for your entire QMS. Start by defining your company’s role as manufacturer, authorized representative, or distributor, as this determines your regulatory obligations and scope.

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Defining Your Quality Policy

Your quality policy should be a concise statement that reflects your company’s mission while committing to regulatory compliance and continuous improvement. Write it in language that resonates with your team and customers. Include commitments to meet legal requirements, maintain an effective QMS, and establish measurable quality objectives.

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Establishing Quality Objectives

Quality objectives must be measurable and achievable while aligning with your quality policy. Focus on QMS effectiveness rather than just product quality metrics. Consider objectives like “achieve 95% employee training completion rates,” “maintain zero major audit findings,” or “respond to customer complaints within 48 hours.” Avoid overly specific technical metrics in your quality manual, as these should be captured in your key performance indicators (KPIs) that can be updated more frequently without revising your foundational quality documents.

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Management Representative Selection

Choose your management representative carefully. This person will be legally accountable for QMS effectiveness and will receive regulatory correspondence including warning letters. In startups, this should typically be a C-suite executive due to the Responsible Corporate Officer Doctrine. The representative needs sufficient authority to ensure QMS compliance across all organizational levels.

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Organizational Structure Documentation

Document your management team with clear roles and responsibilities. Include the quality representative and other key personnel who manage, perform, or verify quality-affecting work. This provides auditors with a clear understanding of your quality organization and accountability structure.

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Process Overview and Exclusions

List all QMS processes your organization implements and clearly document any ISO 13485:2016 exclusions based on your product characteristics. Software-only devices can exclude sterilization and contamination controls, while hardware devices may only exclude specific requirements based on whether they’re sterile or implantable.

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Example

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Scenario

MedTech Solutions develops a mobile application for diabetes management. As a software-only medical device manufacturer, they need to establish their Quality Manual to define their quality policy, set measurable objectives, and designate management responsibilities before pursuing FDA 510(k) clearance.

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Example Quality Manual Structure

Quality Policy: “MedTech Solutions is committed to developing innovative digital health solutions that improve patient outcomes while maintaining the highest standards of safety, security, and regulatory compliance. We will continuously improve our Quality Management System, meet all applicable regulatory requirements, and empower our team to deliver exceptional quality in everything we do.” Quality Objectives:
  • Achieve 100% completion of mandatory employee training within 30 days of hire
  • Maintain zero major nonconformities during internal and external audits
  • Respond to customer feedback and complaints within 48 hours
  • Complete management review annually with documented improvement actions
  • Ensure 95% of quality objectives are met during each management review cycle
Management Structure:
  • CEO: Sarah Johnson (Top Management)
  • VP of Quality: Michael Chen (Management Representative)
  • CTO: David Kim (Software Development)
  • VP of Operations: Lisa Rodriguez (Business Operations)
Scope and Exclusions: The QMS applies to all software development, post-market surveillance, and quality management activities. The following ISO 13485:2016 sections are excluded due to software-only product characteristics:
  • 6.4.2 Contamination control
  • 7.5.2 Cleanliness of product
  • 7.5.5 Particular requirements for sterile medical devices
  • 7.5.7 Sterilization process validation
  • 7.5.9.2 Implantable medical device requirements
  • 7.5.11 Preservation of product

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Q&A