Quality Manual: Definition, Components, and Requirements

A quality manual is a core document that defines how a company’s Quality Management System (QMS) is structured, implemented, and maintained. The quality manual plays a crucial role in communicating quality policies, roles, responsibilities, and documented procedures while supporting regulatory compliance and operational consistency. Closely tied to the QMS, the manual provides a framework for achieving and demonstrating compliance with relevant QMS requirements.

Key components of a quality manual include the scope of the QMS, quality objectives, documentation hierarchy, defined responsibilities, core processes, and applicable regulatory references. QMS frameworks such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and ICH Q10 either mandate or recommend maintaining a quality manual to ensure traceability and audit readiness.

Creating a quality manual involves a structured process that ensures the document is accurate, compliant, and aligned with operational practices. The steps for creating a quality manual cover everything from defining the manual’s purpose and documenting procedures to gaining approval, training employees, and ensuring continuous updates. Following this approach ensures that the manual accurately reflects current practices and supports ongoing regulatory alignment.

QMS software enhances quality manual management by automating version control, approvals, access permissions, and linking the manual to quality processes. This strengthens audit readiness, reduces errors, and improves operational efficiency.

SimplerQMS, a validated QMS software for life science companies, enables compliant and dynamic management of quality manuals and related QMS processes.

What Is a Quality Manual?

A quality manual is a core document that outlines how an organization’s QMS operates. The quality manual defines the structure and components of the QMS, including quality policies, procedures, processes, roles, and responsibilities. The manual also includes references to supporting documentation such as Standard Operating Procedures (SOPs), forms, and quality records. The quality manual serves as a top-level reference within the quality documentation hierarchy.

The purpose of a quality manual is to communicate the organization’s quality management approach to both internal and external stakeholders. Quality manual supports compliance, reinforces leadership accountability, and provides structure during audits and inspections. The manual also serves as a training and onboarding tool to help new employees understand quality expectations and responsibilities.

Key functions of a quality manual include documenting quality policies and objectives and describing the interaction between QMS processes and SOPs. Quality manual standardizes processes like Corrective and Preventive Actions (CAPA) and ensures proper control over QMS documentation and records. Quality manual supports consistency, enhances traceability, and promotes audit readiness across the organization. As a central reference document, the quality manual enables consistent application of the QMS.

Several standards, regulations, and guidelines in life sciences require or recommend maintaining a quality manual, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, EU MDR, EU IVDR, EU GMP, ICH Q10 ISO 17025:2017, and others. These frameworks emphasize the importance of a documented and maintained QMS to ensure product quality, regulatory alignment, and continuous improvement.

How Does a Quality Manual Relate to a QMS?

A quality manual is an integral component of a QMS, serving as the foundational document that outlines how the QMS is structured, implemented, and maintained. The quality manual ensures that all quality-related processes are clearly defined, properly documented, consistently applied, and aligned with applicable regulatory requirements.

The quality manual supports quality management system implementation by providing a structured framework that communicates the organization’s approach to quality. The manual outlines key quality policies, objectives, roles, responsibilities, and procedures, and helps translate policies into actionable, operational procedures. Throughout QMS maintenance, the quality manual strengthens internal consistency, facilitates management oversight, and drives continuous improvement through transparent documentation.

By documenting process flows, responsibilities, SOPs, and document control practices, the quality manual serves as a practical reference for daily operations.

The quality manual also evidences top management’s responsibility for quality outcomes and their ongoing commitment to meeting customer requirements and regulatory expectations.

What Are the Benefits of a Quality Manual?

A quality manual offers significant benefits by organizing, standardizing, and communicating the structure of an organization’s QMS.

The main benefits of a quality manual are outlined below.

• Organizes the QMS: Establishes a clear and structured framework for quality policies, procedures, processes, and responsibilities within the organization.
• Improves Traceability and Document Control: Establishes clear links to SOPs, records, and quality documentation needed for compliance and audit readiness.
• Ensures Compliance: Supports alignment with regulatory and industry-specific requirements such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, EU MDR, and others.
• Improves Quality Performance: Helps minimize variability and reduce process errors to ensure consistent delivery of high-quality products or services.
• Enhances Audit Readiness: Serves as a reliable reference during internal audits and external inspections by outlining the QMS structure and procedures.
• Increases Operational Efficiency: Streamlines workflows through standardization, reducing redundancy, waste, and inefficiencies.
• Strengthens Internal Communication: Promotes a shared understanding of quality expectations across departments and personnel.
• Supports Employee Training and Onboarding: Functions as a core training tool that introduces new employees to company-specific quality procedures and responsibilities.
• Builds Customer and Stakeholder Confidence: Demonstrates a strong commitment to quality and compliance, enhancing trust, reputation, and credibility.
• Enhances Management Oversight: Provides leadership with a comprehensive view of the QMS, facilitating data-driven decisions and quality-focused governance.
• Enables Accountability: Clearly defines roles, responsibilities, and expectations to reinforce ownership and accountability at every level.
• Centralizes Documentation: Consolidates all QMS-related references into a single source of truth, improving access and version control.
• Drives Continuous Improvement: Supports corrective and preventive actions by identifying nonconformities and enabling systematic QMS enhancement.

What Are the Key Components of a Quality Manual?

The key components of a quality manual include the following elements.

• Scope and Applicability: Defines the boundaries of the QMS, specifying which products, services, departments, or locations are covered and outlining any justified exclusions or non-applications.
• Quality Policy and Objectives: Documents top management’s formal commitment to quality and establishes measurable objectives that support the organization’s strategic direction and continual improvement efforts.
• QMS Documentation Structure Overview: Describes the hierarchy and organization of quality documents, including the quality manual, policies, procedures, standard operating procedures, work instructions, and quality records.
• Roles and Responsibilities: Clarifies the roles, authorities, and responsibilities of personnel involved in implementing, monitoring, and maintaining the QMS, promoting accountability and effective process ownership.
• Documented Processes and Procedures: Summarizes the key QMS processes (e.g., CAPA, document control, internal audits) and references the documented procedures that govern their execution to ensure consistency and compliance.
• Regulatory and Standards Compliance References: Lists applicable standards, guidelines, and regulatory requirements that the organization complies with, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, EU MDR, and other relevant frameworks.

Scope and Applicability

The scope and applicability section of a quality manual defines the boundaries of the quality management system.

The scope and applicability section identifies the organizational units, sites, products, services, and processes included within the QMS and justifies any exclusions or non-applications.

A clearly defined scope ensures that all stakeholders understand what the QMS governs, promoting alignment, accountability, and regulatory compliance.

Quality Policy and Objectives

The quality policy and objectives section outlines top management’s formal commitment to quality and establishes measurable goals aligned with the organization’s strategic direction.

The quality policy expresses the principles and intent guiding the QMS. The objectives serve as actionable targets that support continual improvement. Including these elements ensures that all departments operate with shared quality goals and regulatory alignment.

The quality manual and the quality policy serve distinct purposes. The quality manual describes how the QMS functions, whereas the quality policy explains why quality is essential to the organization, reinforcing leadership commitment.

QMS Documentation Structure Overview

The QMS documentation structure overview outlines how documentation is organized and controlled within the quality management system.

QMS documentation structure overview illustrates the relationship between different levels of documentation, including the quality manual, procedures, standard operating procedures, work instructions, and records. This structure ensures proper document control, version traceability, and consistency in QMS implementation.

Below is a visual representation of the QMS document pyramid, illustrating the hierarchical structure of QMS documentation.

Roles and Responsibilities

The roles and responsibilities section defines the individuals or departments responsible for implementing and maintaining the QMS.

Responsibilities, authority levels, and interdepartmental interactions are clearly outlined to ensure clarity and efficiency.

A clear definition of roles reduces ambiguity, minimizes overlaps, and promotes effective execution of quality-related tasks across all organizational levels.

Documented Processes and Procedures

The documented processes and procedures section summarizes key QMS activities such as CAPA, training, internal audits, risk management, document control, change control, and others. This section also includes or references specific SOPs and work instructions that detail how each process is performed.

Standardizing procedures across the organization helps reduce variability, support regulatory compliance, and improve operational consistency.

Regulatory and Standards Compliance References

The regulatory and standards compliance references section lists the applicable standards, regulations, and guidelines that the QMS adheres to. These may include ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, EU MDR, EU IVDR, and ICH Q10, among others.

Referencing these requirements reinforces the organization’s commitment to meeting applicable regulatory requirements and supports audit readiness.

What Are Quality Manual Requirements?

The following standards and regulations either require or strongly recommend maintaining a quality manual as part of an effective QMS in life science industries.

• ISO 9001:2015: ISO 9001:2015 sets QMS requirements for establishing and maintaining a QMS across all industries to ensure consistent quality and customer satisfaction. Although the 2015 revision no longer explicitly mandates a quality manual, organizations are still required to maintain documented information that supports QMS operations. Many businesses continue to use a quality manual to document the scope, key processes, and interactions within the QMS, ensuring clarity, consistency, and regulatory alignment.
• ISO 13485:2016: ISO 13485:2016 specifies QMS requirements for organizations involved in the lifecycle of medical devices. A quality manual is explicitly required under ISO 13485, serving as a central document that outlines the structure of the QMS, references relevant procedures, and describes the interaction between quality system processes.
• FDA 21 CFR Part 820: FDA 21 CFR Part 820, known as the Quality System Regulation (QSR), outlines documentation and procedural requirements for medical devices marketed in the United States. Although FDA 21 CFR Part 820 does not explicitly mandate a quality manual, manufacturers are expected to maintain comprehensive documentation. This documentation should demonstrate how the quality system is structured, implemented, and controlled.
• EU MDR (Regulation (EU) 2017/745): The EU Medical Device Regulation (EU MDR) establishes requirements for the safety, performance, and quality of medical devices within the European Union. EU MDR does not explicitly require a quality manual, but it mandates a documented QMS and technical documentation. A quality manual helps fulfill this requirement by outlining the QMS structure, responsibilities, and post-market activities to support compliance and audit readiness.
• EU IVDR (Regulation (EU) 2017/746): The EU In Vitro Diagnostic Regulation (EU IVDR) sets requirements for the safety, performance, and quality of in vitro diagnostic medical devices in the European Union. EU IVDR does not explicitly require a quality manual, but it mandates a documented QMS and technical documentation. A quality manual supports this requirement by outlining the structure of the QMS, key responsibilities, and post-market performance activities, thereby promoting regulatory compliance and audit readiness.
• EU GMP (Good Manufacturing Practice): The EU Good Manufacturing Practice (GMP) guidelines establish requirements for the consistent production and control of medicinal and related health products manufactured within and exported to the European Union. EU GMP states that the pharmaceutical quality system should be defined and documented, and that a quality manual or equivalent documents should be established. A quality manual helps fulfill this requirement by outlining the QMS structure, referencing critical procedures such as CAPA and document control, and supporting GMP compliance across operations.
• ICH Q10: ICH Q10 provides a comprehensive model for a pharmaceutical quality system applicable across the entire product lifecycle, from development to discontinuation. While ICH Q10 does not explicitly mandate a quality manual, it recommends establishing a quality manual or equivalent documentation. This manual should describe the pharmaceutical quality system, including the quality policy, scope, process linkages, and management responsibilities.
• ISO 17025:2017: ISO/IEC 17025:2017 establishes general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. The 2017 revision no longer explicitly requires a quality manual, unlike previous editions. However, laboratories are still required to document their management system, including policies, objectives, and operational procedures. Many laboratories continue to maintain a quality manual to compile this information.
• EU GDP Guidelines (2013/C 343/01): The EU Guidelines on Good Distribution Practice (GDP) set quality system requirements for the wholesale distribution of medicinal products within the European Union. While the guidelines do not explicitly mandate a quality manual, they require a defined and documented QMS covering responsibilities, procedures, and resource management. A quality manual is strongly recommended as a centralized document to demonstrate operational control, ensure consistency, and support compliance during regulatory inspections.
• Good Clinical Practice (ICH GCP E6/R2): ICH GCP E6(R2) is an internationally recognized standard for the ethical and scientific conduct of clinical trials involving human subjects. ICH GCP E6(R2) applies to sponsors, investigators, contract research organizations (CROs), and trial sites. While ICH GCP does not explicitly mandate a quality manual, it requires comprehensive documentation of responsibilities, procedures, and quality assurance measures to ensure subject protection and data integrity. Maintaining a quality manual is strongly recommended to consolidate SOPs, investigator responsibilities, CAPA systems, and data handling processes. It supports consistent trial execution, enhances oversight, and promotes compliance during audits and inspections.

ISO 9001:2015

ISO 9001:2015 is an international standard for QMS, developed by the International Organization for Standardization. ISO 9001:2015 outlines criteria for establishing, implementing, and maintaining a QMS to ensure the consistent delivery of products and services that meet customer and regulatory requirements. The standard applies to organizations of all types and sizes, aiming to enhance quality performance and increase customer satisfaction.

Although the ISO 9001:2015 revision no longer explicitly requires a quality manual, it emphasizes the need for documented information to support QMS operations. As a result, most organizations still maintain a quality manual to consolidate and communicate the structure, scope, and interaction of their QMS processes.

The following clauses from ISO 9001:2015 support the structure typically found in a quality manual.

• Clause 4.3 – Determining the Scope of the QMS: Requires a defined scope and justification for any exclusions.
• Clause 4.4 – Quality Management System and Its Processes: Requires identification of QMS processes, their sequence, interactions, and responsibilities.
• Clause 5.2 – Quality Policy: Requires a documented and communicated quality policy aligned with the organization’s strategic direction.
• Clause 5.3 – Organizational Roles, Responsibilities, and Authorities: Requires a clear definition and communication of roles and responsibilities.
• Clause 7.5 – Documented Information: Requires documented procedures and records necessary to ensure effective QMS operation and conformity to requirements.

ISO 13485:2016

ISO 13485:2016 specifies requirements for a QMS specific to the medical device industry. ISO 13485:2016 provides a framework for organizations involved in the design, production, installation, and servicing of medical devices to ensure compliance with regulatory and customer requirements.

Compliance with ISO 13485:2016 is mandatory for medical device manufacturers and related suppliers operating in regulated markets.

ISO 13485:2016 explicitly requires the creation and maintenance of a quality manual.

The manual is a key document for demonstrating the structure and integrity of the QMS. The quality manual should define the organization’s quality system, reference relevant documented procedures, and describe how QMS processes interact and function together.

The quality manual shall include the following, as defined in Clause 4.2.2 of ISO 13485:2016.

• Clause 4.2.2(a): Define the scope of the QMS, including any justifications for exclusions or non-applications.
• Clause 4.2.2(b): Document or reference all procedures established for the QMS.
• Clause 4.2.2(c): Describe the interaction between QMS processes and how they function together to ensure product quality and regulatory compliance.

FDA 21 CFR Part 820

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), establishes current good manufacturing practice (cGMP) requirements for medical devices marketed in the United States. The regulation is a mandatory regulatory framework for medical device manufacturers and operators that specifies how to ensure that devices are designed and produced to be safe, effective, and compliant with U.S. regulations.

While the FDA 21 CFR Part 820 does not explicitly reference a “quality manual,” it requires extensive documentation that aligns closely with the structure and purpose of a quality manual.

Key sections of 21 CFR Part 820 that reflect quality manual content are listed below.

• §820.20 – Management Responsibility: Requires documented procedures for implementing and maintaining the quality system.
• §820.20(a) – Quality Policy and Objectives: Mandates that executive management establish a quality policy and measurable quality objectives.
• §820.20(b) – Organizational Structure: Requires definition and communication of roles, responsibilities, and reporting relationships.
• §820.20(c) – Management Review: Requires management review procedures and records to ensure ongoing system effectiveness.
• §820.22 – Internal Quality Audits: Requires procedures and documentation for conducting internal audits.
• §820.40 – Document Controls: Requires formal procedures for document approval, distribution, revision control, and recordkeeping to maintain current and compliant documentation.

EU MDR

The EU Medical Device Regulation (MDR) governs the safety, performance, and quality of medical devices marketed in the EU and applies to all parties included in the supply chain. MDR requires a documented QMS that supports CE marking, risk management, clinical evaluation, and post-market surveillance.

Although the EU Medical Device Regulation (MDR) does not mandate a “quality manual” by name, the regulation requires extensive documentation of QMS components that are typically compiled in a quality manual. This includes quality objectives, process responsibilities, risk controls, and post-market activities.

A quality manual helps demonstrate regulatory compliance and prepares organizations for notified body assessments and unannounced audits.

Key provisions of the EU MDR relevant to quality manual content include the following.

• Article 10(9) – Quality Management System: Requires manufacturers to establish, document, implement, maintain, and continually improve a QMS covering all stages of the product lifecycle.
• Annex IX, Chapter I – QMS Documentation: Requires documentation of organizational structure, responsibilities, procedures, risk management, performance evaluation, and post-market surveillance processes.
• Annex II – Technical Documentation: Mandates technical documentation to be linked with the QMS, typically referenced in the quality manual.
• Annex III – Post-Market Surveillance Plan: Requires a documented Post-Market Surveillance (PMS) plan to be integrated into the QMS and often included or referenced in the quality manual.

EU IVDR

The EU In Vitro Diagnostic Regulation (IVDR) sets out regulatory requirements for in vitro diagnostic (IVD) medical devices, including reagents, kits, and software used to examine specimens derived from the human body.

The EU In Vitro Diagnostic Regulation (IVDR) applies to manufacturers and supply chain actors marketing IVDs in the EU. IVDR classifies products based on risk (A–D) and introduces stricter oversight than its predecessor.

IVDR mandates a documented QMS tailored to the risk class of the IVD device, emphasizing analytical and clinical performance, traceability, and post-market follow-up.

While the regulation doesn’t explicitly refer to a quality manual, maintaining one is considered best practice. A quality manual helps organize critical documents such as conformity assessments, Post-Market Performance Follow-up (PMPF) plans, and performance evaluation procedures.

Key requirements addressed in a quality manual under IVDR are listed below.

• Article 10(8) – Quality Management System: Requires manufacturers to establish, document, implement, and maintain a QMS proportional to device risk class.
• Annex IX – Conformity Assessment Based on a QMS and Technical Documentation: Requires documentation of procedures, responsibilities, performance evaluation, and post-market activities.
• Annex II – Technical Documentation: Requires technical documentation to be linked to QMS processes, typically summarized or referenced in the quality manual.
• Annex III – Post-Market Surveillance: Requires a PMPF plan, which is often integrated and referenced within the quality manual to support lifecycle monitoring and improvement.

EU GMP

EU GMP guidelines set quality and safety requirements for the manufacture and control of medicinal and related health products within the European Union and those exported to the EU.

While the term quality manual is not explicitly used, EU GMP requires pharmaceutical manufacturers to establish a documented pharmaceutical quality system that includes defined responsibilities, procedures, CAPA, document control, and change management. A quality manual or equivalent documentation is expected to consolidate this information, ensuring consistency and demonstrating ongoing GMP compliance.

Key document expectations include those found in Chapter 1 of the EU GMP guidelines, which outline the Pharmaceutical Quality System (PQS). This chapter requires the documentation of responsibilities, procedures, training activities, CAPA, and change control processes. These elements are typically outlined or referenced in a quality manual or an equivalent document.

ICH Q10

ICH Q10 is a globally recognized guideline that outlines a model for a comprehensive pharmaceutical quality system spanning the entire product lifecycle.

ICH Q10 applies to manufacturers of pharmaceutical drug products and active pharmaceutical ingredients (APIs) and is endorsed by major regulatory authorities, including the FDA and EMA.

ICH Q10 encourages organizations to document essential quality system elements, such as the quality policy, management responsibilities, continual improvement systems, and quality risk management strategies.

While the guideline does not mandate a quality manual by name, clause 1.8 recommends establishing a quality manual or equivalent documentation to describe the pharmaceutical quality system in a structured and accessible format.

Key documentation expectations under Clause 1.8 are listed below.

• Clause 1.8(a): The quality manual (or equivalent documentation) should include the organization’s quality policy.
• Clause 1.8(b): The quality manual (or equivalent documentation) should define the scope of the pharmaceutical quality system.
• Clause 1.8(c): The quality manual (or equivalent documentation) should identify pharmaceutical quality system processes, their sequences, linkages, and interdependencies. Tools such as process maps and flowcharts may be used.
• Clause 1.8(d): The quality manual (or equivalent documentation) should describe management responsibilities within the QMS.

ISO 17025:2017

ISO/IEC 17025:2017 outlines general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. ISO/IEC 17025:2017 applies to all laboratories regardless of their size or the scope of activities.

The standard enables laboratories to demonstrate that they operate competently and generate valid results, thereby supporting international recognition of their services.

The 2017 revision removed the mandatory requirement for a formal quality manual, offering flexibility in how laboratories document their management system. However, under Clause 8.2, laboratories are required to document and maintain policies and objectives and ensure they are implemented throughout the organization.

In practice, many laboratories still choose to maintain a quality manual to consolidate this documentation in a structured and accessible format.

Below are listed key documentation expectations relevant to the quality manual as outlined in ISO/IEC 17025:2017.

• Clause 8.2.1: Requires the laboratory to establish, document, and maintain policies and objectives for fulfilling the standard’s purpose.
• Clause 8.2.2: These policies shall address competence, impartiality, and consistent operation.
• Clause 8.2.4: Requires that all QMS documentation be linked or referenced – an approach commonly facilitated through a structured quality manual.
• Clause 8.2.5: All personnel shall have access to relevant parts of the management system.

EU GDP Guidelines (2013/C 343/01)

The EU GDP Guidelines (2013/C 343/01) establish requirements to ensure that the quality and integrity of medicinal products are maintained throughout the supply chain. These guidelines apply to wholesalers, distributors, and logistics providers operating within the European Union.

While the term quality manual is not explicitly mentioned, GDP requires a documented QMS that includes organizational structure, responsibilities, procedures, and resource management.

A quality manual is often used to consolidate this information and demonstrate compliance during inspections.

Key documentation expectations under the EU GDP guidelines are outlined in Chapter 1.2 – Quality System, which requires a documented description of the quality system, including its structure, procedures, responsibilities, and resource allocation. This information is typically outlined or referenced in a quality manual or equivalent documentation.

Good Clinical Practice (ICH GCP E6/R2)

The International Council for Harmonisation (ICH) Good Clinical Practice Guideline E6 (R2) is a globally accepted standard for the ethical and scientific quality of clinical trials involving human participants. ICH GCP E6/R2 applies to sponsors, investigators, clinical research organizations (CROs), and trial sites involved in the conduct and oversight of human clinical studies.

While ICH GCP does not explicitly mandate the use of a quality manual, it emphasizes the need for comprehensive documentation of roles, responsibilities, SOPs, and quality assurance processes. A quality manual or equivalent document is widely used to consolidate this information in practice.

Below are listed key documentation expectations referenced in ICH GCP E6 (R2).

• Section 2.13 – Quality Assurance: Requires the implementation of systems to ensure quality in every aspect of the trial.
• Section 5.1 – Quality Assurance and Quality Control (Sponsor Responsibilities): Mandates procedures to ensure trial quality and data credibility.
• Section 5.5 – Trial Management, Data Handling, and Record Keeping: Requires sponsors to maintain SOPs for data handling, electronic systems, and documentation.
• Section 5.18 – Monitoring: Requires a documented monitoring plan and consistent oversight throughout the trial.
• Section 5.20 – Noncompliance and CAPA: Requires documentation of deviations and implementation of corrective and preventive actions.
• Section 8 – Essential Documents for the Conduct of a Clinical Trial: Requires maintenance of various trial-related documents, typically organized through a structured QMS.

Beyond the life science requirements, other industries also recognize the value of maintaining a quality manual as part of their quality management systems.

In the aerospace and automotive sectors, standards such as AS9100 and IATF 16949 explicitly require a quality manual that outlines the QMS scope, references procedures, and details process interactions. In contrast, standards like ISO 22000 for food safety and ISO/IEC 27001 for information security do not mandate a quality manual but require documented information to describe and control QMS processes.

How to Create a Quality Manual?

To create a quality manual and maintain it effectively within your QMS, consider following the steps outlined below.

1. Define the Purpose and Scope
2. Establish the Quality Policy and Objectives
3. Outline the QMS Documentation Structure
4. List Roles and Responsibilities
5. Describe Key Processes and Procedures
6. Reference Applicable Standards and Regulations
7. Use a Quality Manual Template
8. Review and Approve the Manual
9. Distribute and Train Employees
10. Schedule Regular Reviews and Updates

1. Define the Purpose and Scope

Defining the purpose and scope is the first essential step in creating a quality manual. This section explains why the manual exists and establishes the boundaries of the quality management system. This part should clearly describe the organization’s intent to document, implement, and maintain a systematic approach to quality and regulatory compliance.

The purpose typically includes communicating quality principles, aligning organizational objectives, and supporting internal and external audits. The scope identifies which departments, processes, sites, and product or service categories are covered under the QMS. The scope also includes justifications for any exclusions or limitations. Clearly defining the scope ensures that all stakeholders understand what is governed by the QMS and where responsibilities lie.

Best practices for writing the purpose and scope section include using clear, non-technical language and aligning the scope with applicable regulations such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820. This foundational section sets the stage for consistent quality practices and minimizes ambiguity in compliance coverage.

2. Establish the Quality Policy and Objectives

Establishing the quality policy and quality objectives involves documenting the organization’s overall commitment to quality and defining measurable goals that support continuous improvement and regulatory alignment.

The quality policy is a formal statement from top management that reflects the organization’s mission, regulatory alignment, and dedication to meeting customer expectations. Quality policy should be aligned with the strategic direction of the company and serve as a guiding principle for all quality-related activities.

Quality objectives are clearly defined, measurable goals that an organization sets to enhance the quality of its products, processes, and services. The purpose of establishing quality objectives is to define a strategic direction and provide a clear quality vision across all levels of the organization. Quality objectives may relate to product conformity, customer satisfaction, process efficiency, or regulatory compliance, depending on the industry context.

To ensure effectiveness, the quality policy should be concise, regularly reviewed for relevance, and effectively communicated throughout the organization. The quality policy and objectives should be easily accessible, frequently referenced in audits and training, and linked to applicable standards. Organizations may also reference their quality policy directly within the manual or include it as an appendix with a clear cross-reference.

3. Outline the QMS Documentation Structure

Outlining the QMS documentation structure involves describing how quality-related documentation is organized, managed, and accessed within the organization. This step is essential for ensuring clarity, traceability, and consistency across all levels of documentation within the quality management system.

The documentation hierarchy typically begins with the quality manual, which serves as the top-level document. Below this are documented procedures that define how core QMS processes are performed, followed by standard operating procedures that provide detailed step-by-step instructions. Additional layers may include work instructions, forms, and records that provide objective evidence of conformity and operational effectiveness.

By organizing documentation in a structured hierarchy, organizations enable personnel to easily access the right level of detail for their responsibilities. This clarity enhances operational consistency, supports regulatory compliance, and ensures that quality processes are executed uniformly across all functions.

To improve usability and control, it is recommended to illustrate the documentation hierarchy within the quality manual, often using a diagram or table, and provide references or hyperlinks to relevant documents where possible. Organizations should also implement version control, approval workflows, and archiving rules to ensure only authorized, current versions are in use. This structure should reflect applicable standards such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820, depending on the regulatory environment.

4. List Roles and Responsibilities

Listing roles and responsibilities means identifying who is accountable for implementing, maintaining, and improving the QMS, along with clearly defined authority assignments across all relevant functions.

This section documents the responsibilities and authorities of individuals involved in QMS operations. Listing roles and responsibilities ensures that personnel understand their duties, from updating the quality manual to performing quality-critical activities within their departments.

Documenting the roles and responsibilities promotes accountability, improves operational clarity, and reduces the risk of gaps or overlaps in essential activities.

An important requirement is appointing a person responsible for maintaining the quality manual, commonly the Quality Assurance (QA) Manager or Quality Management Representative. These individuals ensure the manual remains accurate, aligned with current regulations, and regularly updated. Department heads, operational teams, and senior management also play defined roles in executing, monitoring, and improving QMS performance.

Including a responsibility matrix or organizational chart within the quality manual is an effective way to illustrate how responsibilities are distributed across the organization. These tools enhance audit readiness, streamline communication, and help demonstrate structured accountability during internal and external audits or regulatory inspections.

5. Describe Key Processes and Procedures

Describing key processes and procedures means identifying the core activities that form the foundation of the QMS and detailing how they are documented, standardized, and implemented.

These core processes typically include, but are not limited to, CAPA, internal audits, document control, training, change management, complaint handling, and risk management. The quality manual should summarize each process or reference the corresponding SOPs and work instructions that define how the activity is carried out.

Describing QMS processes ensures that essential quality tasks are consistently performed, accessible to relevant personnel, and traceable across the organization. This structured documentation enhances audit readiness, facilitates regulatory compliance, and aligns quality operations with applicable requirements.

Organizing processes by functional category (e.g., production, quality assurance, supplier management) helps ensure clarity and systematic coverage of the quality management system. Using an indexed or tabular format to link to SOPs, forms, and quality records maintained within the document control system helps ensure easy access and traceability. Designating process owners and illustrating interdependencies between activities promotes cross-functional alignment and accountability.

This level of clarity and structure is critical for demonstrating compliance with quality standards and regulations such as ISO 13485, ISO 9001, and FDA 21 CFR Part 820.

6. Reference Applicable Standards and Regulations

Referencing applicable standards and regulations means identifying the specific quality and regulatory frameworks that govern your organization’s QMS.

These may include globally recognized frameworks such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, EU MDR, EU IVDR, ICH Q10, ISO 17025, and EU GDP Guidelines. Each of these frameworks establishes essential requirements for quality assurance, risk management, documentation, and regulatory compliance.

Referencing standards and regulations in the quality manual demonstrates that the QMS is built on validated principles and fulfills applicable legal, regulatory, and industry-specific expectations. It also provides a clear context for auditors, regulatory authorities, and internal stakeholders reviewing the manual.

An effective practice is to cite the full name and version of each referenced standard, explain its relevance to the organization’s operations, and, where applicable, map key QMS processes to the appropriate clauses. This practice strengthens traceability, improves audit readiness, and reinforces alignment with current compliance requirements.

7. Use a Quality Manual Template

Using a quality manual template means applying a consistent structure, format, and terminology that simplifies manual creation, updates, and compliance alignment.

A clear and standardized layout ensures that all required components, such as the purpose and scope, quality policy, responsibilities, procedures, and referenced standards, are included systematically. This structure improves usability, facilitates internal reviews, and helps meet regulatory expectations more efficiently.

Using a quality manual template promotes consistency across departments, supports effective training and onboarding, and reduces the risk of omitting critical content. It also ensures that the quality manual remains easy to navigate and interpret for both internal users and external auditors.

Aligning the template with applicable regulatory requirements and including placeholders for document versioning, approval signatures, and revision history helps ensure consistency and compliance. Regular reviews of the template are recommended to maintain alignment with evolving regulatory expectations and internal process changes.

8. Review and Approve the Manual

Reviewing and approving the quality manual means verifying that its content is complete, accurate, and compliant with applicable regulatory and organizational requirements before formal release.

This step ensures the manual has undergone an internal review for consistency, clarity, and alignment with the QMS objectives. It confirms that all described processes, responsibilities, and referenced standards are correctly documented and support regulatory readiness.

The approval process validates that the manual accurately reflects the organization’s quality framework and demonstrates top management’s commitment to quality. The approval process also establishes clear accountability and ensures traceability of documented decisions.

Involving representatives from key departments such as Quality Assurance, Regulatory Affairs, and Operations during the review process helps ensure the manual is accurate, relevant, and comprehensive. After revisions, the document should be submitted for formal approval by top management or designated quality leadership. Approval records must include version numbers, signatures, and dates to support effective document control and audit traceability.

9. Distribute and Train Employees

Distributing and training employees on the quality manual means making the document accessible to relevant personnel and ensuring they understand its contents and requirements.

Once approved, the manual shall be disseminated using controlled methods, either electronically via a Document Management System (DMS), an electronic Quality Management System (eQMS), or through hard copies, as defined by the organization’s procedures.

Distributing and training employees on the quality manual helps ensure consistent application of the QMS across departments and functions. Regulatory bodies expect documented evidence that employees are aware of and adequately trained on the quality policies and procedures relevant to their roles.

Assigning training during onboarding, requiring acknowledgment of manual updates, maintaining training records, and issuing change notifications to highlight revisions help reinforce awareness and adherence to QMS requirements. Leveraging a DMS or an eQMS enables version control, access logs, and automated training workflows to improve compliance and efficiency.

10. Schedule Regular Reviews and Updates

Scheduling regular reviews and updates means establishing a formal process to keep the quality manual current and aligned with evolving regulatory, organizational, or operational changes.

Periodic review ensures that the manual reflects the latest company practices, personnel responsibilities, process changes, and compliance standards. It supports continuous improvement by identifying outdated content and implementing necessary revisions.

Maintaining the manual’s accuracy and relevance helps ensure it remains a reliable and authoritative source for internal use and external audits.

Assigning responsibility to a designated individual (e.g., QA Manager) and setting a defined review frequency (e.g., annually or biannually) are key practices for maintaining the quality manual. Organizations should also incorporate triggers for unscheduled reviews, such as changes in regulations, audit findings, or significant process changes. This approach ensures the manual remains a reliable and authoritative reference across the organization.

How Does QMS Software Support Quality Manual Management?

QMS software is a digital solution that automates, streamlines, and controls quality processes across an organization. For quality manual management, QMS software plays a critical role by centralizing the creation, review, approval, revision, distribution, and control of the manual and related documents. QMS software ensures that the most current version of the manual is always accessible, audit-ready, and aligned with regulatory requirements.

QMS software enhances document control by automating workflows for version management, approvals, and access permissions, ensuring full traceability and reducing the risk of outdated or inconsistent documentation. QMS software supports the use of standardized templates to maintain a consistent structure across the quality manual and supporting procedures.

By linking the quality manual to key QMS processes, the software ensures that the manual reflects real-world practices and supports continuous improvement. QMS software provides instant access to required documentation during inspections and audits, and maintains detailed audit trails, improving audit readiness.

SimplerQMS is a validated, cloud-based QMS software specifically designed for life science companies, including pharmaceutical, medical device, and biotechnology organizations. Beyond managing quality manuals, SimplerQMS supports a full range of QMS activities, including document control, employee training, supplier management, nonconformance handling, CAPA, audit management, and more.

The SimplerQMS software helps organizations achieve and maintain compliance with key industry standards and regulations, such as ISO 13485:2016, FDA 21 CFR Part 820, FDA 21 CFR Part 211, EU MDR 2017/745, EU IVDR 2017/746, ICH Q10, and EU GMP and GDP guidelines.

By automating quality processes and ensuring integration across the quality system, SimplerQMS enables organizations to manage their quality manual as a dynamic, compliant, and consistently maintained component of the QMS. This improves overall quality performance, reduces compliance risks, and enhances operational efficiency.