ISO9001 System Document Package (1) | Quality Manual (Part 1): Policy, Objectives, and Organizational Responsibilities

The Quality Manual is the highest-level document in the Quality Management System (QMS), serving as the "constitution" of the system: it translates the requirements of ISO 9001:2015 into the company's commitments, responsibilities, and process framework, demonstrating to customers, certification bodies, and other stakeholders that the company has the capability to consistently provide conforming products and services. This document is the first part of the Quality Manual, covering six key elements: cover page, issuance order, manual description, quality policy, quality objectives, organizational structure, and responsibility allocation. It provides template clauses that can be directly replaced with the company's name and data. The second part of the manual (the second document in the package) will provide a process list, turtle diagram, clause comparison table, and procedure document index. This template is suitable for small and medium-sized manufacturing, trading, and service companies preparing to establish or update their ISO 9001:2015 system, as well as for companies integrating scattered system documents into a systematic manual.

0. Manual Preliminary Pages: Cover Page and Issuance Order

(1) Cover Page Elements (Template)

(2) Issuance Order (Template Text)

Issuance Order

In accordance with GB/T 19001—2016 / ISO 9001:2015 "Quality Management System - Requirements," and in combination with the company's actual situation, the Quality Manual (Version A/0) has been compiled. This manual outlines the company's quality policy and objectives, describes the processes of the quality management system and their interactions, and clarifies the responsibilities and authorities of each position. It serves as the guiding document for the company's quality management system and the code of conduct for all employees in quality activities.

This manual will be officially implemented from August 18, 2026. All employees must study it diligently, strictly adhere to it, and implement it resolutely. Each department should, based on the requirements of this manual, compile, improve, and implement the corresponding procedure documents, work instructions, and record forms.

General Manager (Signature): ____________

Date: August 10, 2026

1. Purpose

1.1 To establish and maintain a documented quality management system, ensuring its compliance with the requirements of GB/T 19001—2016 / ISO 9001:2015 and applicable laws and regulations.

1.2 To demonstrate to customers, certification bodies, and other relevant parties that the company has the capability to consistently provide products and services that meet requirements and legal regulations.

1.3 To clarify the quality policy, quality objectives, and responsibilities and authorities of all levels of personnel, providing a basis for the operation, monitoring, maintenance, and improvement of the quality management system.

1.4 To serve as the foundational document for internal audits, customer audits, certification audits, and management reviews, unifying the understanding and actions of all employees regarding the quality management system.

2. Scope of Application

2.1 This manual applies to the entire process of establishing, implementing, maintaining, and continuously improving the company's quality management system.

2.2 This manual covers the product/service scope: _______ (Example: Design, manufacturing, and sales of electronic components; or: Warehouse logistics services). The product scope should align with the company's business license and certification application scope.

2.3 This manual applies to all employees of the company, including management, functional departments, and production/service front-line positions.

2.4 Explanation of non-applicable clauses. ISO 9001:2015 has eliminated the concept of "exclusions." If a requirement in the standard is indeed not applicable to the company's processes, the reason should be stated in the manual and documented. Example (for companies without design and development activities):

This manual does not include the detailed provisions of ISO 9001:2015 Clause 8.3 "Design and Development" because all products are manufactured according to customer-provided drawings, formulas, or process requirements. The company does not undertake design and development responsibilities and does not manage outsourced design and development. If the business expands to include self-designed and developed products, the manual will be revised and the corresponding procedure documents will be added.

2.5 The procedure documents referenced in this manual apply to the respective process management departments and related positions. In case of any inconsistency with other documents, this manual shall prevail.

3. Responsibilities

(1) Organizational Structure (Text Example)

General Manager └─ Management Representative (can be concurrently held by a Deputy General Manager or Quality Director) ├─ Quality Department　├─ Production Department　├─ Technical Department　├─ Purchasing Department ├─ Sales Department　├─ Administrative and Human Resources Department　├─ Warehouse and Logistics Department　└─ Finance Department

Note: The department settings, names, and reporting relationships should be drawn according to the company's actual situation, and a formal organizational structure chart should be attached. If the organizational structure changes, the relevant sections of the manual should be updated within 7 to 10 working days.

(2) Position Responsibilities Template Clauses

3.1 General Manager

3.1.1 Lead the formulation and approval of the quality policy and objectives, ensuring they are aligned with the organization's purpose and strategic direction.

3.1.2 Ensure the acquisition of necessary resources (human, facilities, environment, funds, etc.) for the quality management system.

3.1.3 Appoint the management representative and define their responsibilities and authorities.

3.1.4 Lead management reviews to ensure the ongoing suitability, adequacy, and effectiveness of the quality management system.

3.1.5 Bear ultimate responsibility for product quality and the effectiveness of the quality management system.

3.2 Management Representative

3.2.1 Responsible for establishing, implementing, and maintaining the processes required by the quality management system.

3.2.2 Report to the General Manager on the performance and improvement opportunities of the quality management system.

3.2.3 Implement effective measures to enhance the awareness of all employees in meeting customer and legal requirements.

3.2.4 Responsible for external communication regarding quality management system matters (certification bodies, customers, etc.).

3.3 Quality Department

3.3.1 Responsible for incoming, process, and final product inspections, as well as the management of measuring instruments.

3.3.2 Responsible for organizing internal audits, controlling nonconforming products, and tracking the implementation of corrective actions.

3.3.3 Responsible for the statistical analysis of quality data and the management of quality records.

3.4 Production Department

3.4.1 Organize production according to process documents and work instructions, being responsible for process quality and delivery schedules.

3.4.2 Responsible for the daily maintenance of production equipment and 5S management on the production floor.

3.4.3 Responsible for the implementation of process identification, product protection, and first article inspection.

3.5 Technical Department

3.5.1 Responsible for the preparation and revision of process documents and work instructions.

3.5.2 Responsible for design and development (if applicable) and the management of technical standards and samples.

3.5.3 Participate in the review of nonconforming products and provide technical handling recommendations.

3.6 Purchasing Department

3.6.1 Responsible for the selection, evaluation, re-evaluation, and management of the list of qualified suppliers.

3.6.2 Responsible for the implementation of procurement plans and tracking the arrival of purchased materials.

3.6.3 Participate in the handling of quality issues with purchased materials.

3.7 Sales Department

3.7.1 Responsible for identifying customer needs, reviewing contracts/orders, and communicating with customers.

3.7.2 Responsible for customer satisfaction surveys and the handling, communication, and tracking of customer complaints.

3.7.3 Responsible for the receipt and registration of customer property (if applicable).

3.8 Administrative and Human Resources Department

3.8.1 Responsible for personnel recruitment, training organization, and capability evaluation.

3.8.2 Responsible for ensuring the availability of office infrastructure and work environments.

3.8.3 Responsible for the archiving management of controlled documents and records, and the management of the archive room.

3.9 Warehouse and Logistics Department

3.9.1 Responsible for the receipt, identification, storage, protection, and distribution of materials and finished products.

3.9.2 Responsible for regular inventory checks and the inspection of expired materials.

3.9.3 Responsible for coordinating product delivery and transportation protection.

(3) Responsibility Allocation Table (RACI Matrix Example)

(A = Responsible for execution, R = Approval/Ultimate responsibility, C = Participation and support, I = Informed. The rows and roles can be added or deleted according to the company's actual processes.)

4. Work Procedures

(1) Preparation, Approval, and Maintenance of the Manual

4.1.1 Preparation: The management representative organizes the Quality Department to draft the manual, ensuring that it covers all applicable clauses of ISO 9001:2015 and is consistent with the procedure documents and work instructions.

4.1.2 Approval: The manual is reviewed by the Quality Manager, re-reviewed by the management representative, and approved by the General Manager before release. The approval date must not be later than the implementation date.

4.1.3 Release and Distribution: The Administrative and Human Resources Department uniformly numbers the manual, registers its controlled status and distribution number according to the "Document Control Procedure," and distributes it to the General Manager, management representative, department heads, and certification bodies, filling out the "Document Distribution/Recall Record."

4.1.4 Revision and Version Update: When there are significant changes in the organizational structure, product scope, standard requirements, or system processes, the department proposing the change fills out the "Document Change Request Form," which is reviewed by the management representative and approved by the General Manager. If the changes are substantial (e.g., more than one-third of the sections), a new version should be issued (e.g., A/0 to B/0), and the old version should be recalled, destroyed, or marked as "obsolete" and retained.

4.1.5 Review: During each management review, the suitability, adequacy, and effectiveness of the manual should be reviewed, and the conclusions should be recorded in the "Management Review Report."

(2) Manual Chapter Framework and ISO 9001:2015 Clause Comparison Table

(3) Key Clauses Original Points

4.3.1 Quality Policy (Template Clause for Chapter 5 of the Manual)

5.1 The company's quality policy: Customer-focused, quality-driven; continuous improvement, excellence pursued; full participation, right the first time.

5.2 Policy Interpretation: (1) Customer-focused — Identify and meet current and future customer needs, using customer satisfaction as the ultimate standard for all work. (2) Quality-driven — Adhere to "quality first," do not use nonconforming raw materials, do not transfer nonconforming semi-finished products, and do not release nonconforming products. (3) Continuous improvement, excellence pursued — Use the PDCA method to continuously optimize processes and improve product and service quality. (4) Full participation, right the first time — Each employee is responsible for the quality of their position and ensures that tasks are done correctly the first time.

5.3 Policy Communication: Communicate the policy to all employees through onboarding training, team morning meetings, quality boards, internal networks, etc., ensuring everyone understands and implements it. Also, communicate the policy to customers and other stakeholders through promotional materials, tender documents, etc.

5.4 Policy Review: Review the policy's ongoing suitability during management reviews. If there are significant changes in the organization's purpose, market environment, or strategy, the policy should be revised promptly.

(Replacement Tip: The quality policy should be tailored to the company's industry characteristics and strategic direction, avoiding the use of generic slogans. Elements such as "green and environmentally friendly," "safety compliance," and "innovation-driven" can be added to reflect the company's unique features.)

4.3.2 Quality Objectives (Template Clause for Chapter 6 of the Manual)

6.1 Company-level quality objectives (2026, example): (1) Customer satisfaction score ≥ 88 points, and not lower than the previous year's level. (2) First-time inspection pass rate ≥ 98%. (3) Customer complaint handling timeliness 100%, and zero major quality incidents. (4) Timely delivery rate of key suppliers ≥ 95%. (5) Closure rate of nonconformities from internal audits 100%.

6.2 Objective Requirements: Quality objectives should be consistent with the quality policy, measurable, and assessable, and should be broken down to relevant functional departments and positions.

6.3 Example of Departmental Objective Breakdown:

Department	Breakdown Objectives (Example)	Statistical Cycle	Assessment Method
Quality Department	Outgoing inspection pass rate ≥ 99%; inspection error rate ≤ 0.5%	Monthly	Inspection record statistics
Production Department	First-time pass rate ≥ 97%; equipment integrity rate ≥ 95%	Monthly	Production daily report statistics
Purchasing Department	Supplier on-time delivery rate ≥ 95%; incoming material pass rate ≥ 98%	Monthly	Arrival inspection records
Sales Department	Customer satisfaction ≥ 88 points; complaint response within 24 hours	Quarterly	Satisfaction survey
Administrative and Human Resources Department	Training plan completion rate ≥ 95%; key position certification rate 100%	Quarterly	Training records

6.4 Objective Management Process: In January each year, the General Manager leads the formulation of company-level objectives → The management representative organizes the breakdown to departments → Departments break down to teams/positions → Monthly/quarterly statistics on achievement → If not met, take improvement measures according to the "Quality Policy and Objectives Management Procedure" and "Corrective Action Procedure" → During management reviews, evaluate the achievement of objectives and update them in a rolling manner.

5. Related Records

5.1 "Document Distribution/Recall Record" (QM-01)

5.2 "Document Change Request Form" (QM-02)

5.3 "Quality Objective Breakdown and Assessment Form" (QM-03)

5.4 "Management Review Report" (QM-04, including policy and objectives review conclusions)

5.5 "Meeting Sign-in Sheet" (QM-05)

5.6 "Organizational Structure Change Approval Form" (QM-06, if applicable)

(Note: The form number rules can be adjusted according to the company's habits. The filling and preservation of records should be executed according to the "Record Control Procedure," with a retention period of no less than 3 years or as required by regulations.)

6. Related Documents

6.1 GB/T 19001—2016 / ISO 9001:2015 "Quality Management System - Requirements"

6.2 "Document Control Procedure" (COP-01)

6.3 "Record Control Procedure" (COP-02)

6.4 "Quality Policy and Objectives Management Procedure" (COP-05)

6.5 "Human Resources Management Procedure" (COP-08)

6.6 "Management Review Procedure" (COP-26)

(Note: The procedure document numbers should be referenced according to the numbering rules in subsequent sections of the package. The company can unify the numbering system as needed.)

Usage Instructions

1. How to Modify According to the Company's Actual Situation

1. Organizational Structure Adaptation: Remove or merge departments that do not exist in the company (e.g., if there is no independent warehouse department, merge its responsibilities into the production department), and add actual positions (e.g., Quality Supervisor, Planner). The responsibility clauses, organizational structure chart, and responsibility allocation table must be consistent, which are the most frequently checked by auditors.

2. Product Type Adaptation: Manufacturing companies should follow the sequence "Design - Procurement - Production - Inspection - Delivery"; trading companies should highlight "Supplier Management and Incoming Inspection"; service companies (property management, logistics, consulting) should rewrite "Production Process Control" as "Service Provision Process Control" and add three types of documents: service specifications, service provision guidelines, and quality control guidelines.

3. Policy and Objectives Adaptation: The quality policy should not be copied from the template but should highlight 1-2 differentiating elements of the company. The numerical values of quality objectives should be set based on historical data from the past 2-3 years, aiming for achievable goals to avoid unrealistic targets that cannot be evaluated at year-end.

4. Non-Applicable Clauses: Only activities that truly do not exist can be declared non-applicable, and the reasons must be clearly stated. If a declared non-applicable activity is actually performed, it will be issued as a nonconformity during audits.

2. Audit Focus Points

1. Whether the policy is aligned with the organization's purpose and strategic direction, and whether it has been effectively communicated (ask front-line employees on-site if they can explain the policy's meaning).
2. Whether the objectives are measurable, consistent with the policy, broken down to relevant functions and levels, and regularly assessed.
3. Whether responsibilities and authorities are clearly defined, documented, and communicated within the organization.
4. Whether the appointment of the management representative is formal (it is recommended to issue a separate appointment letter) and whether their responsibilities are implemented.
5. Whether the manual is consistent with the procedure documents and actual practices, avoiding a "two-faced" situation.

3. Common Errors

1. Policy slogans are vague and cannot be evaluated for their achievement.
2. Only company-level objectives are set, without departmental breakdowns and statistical assessment records.
3. Responsibility allocation table does not match the actual signing and approval process (e.g., the manual states that the Quality Department approves, but in practice, the Production Department Manager signs).
4. The issuance order date is later than the implementation date, or the approval signature is missing.
5. The manual is not updated after revision, and the old version is still in use on-site.
6. Non-applicable clauses are omitted or the reasons stated do not match the facts.

The first part of the manual sets the tone: the policy guides direction, objectives are quantifiable, and responsibilities are assigned to individuals.

Knowledge code: 2.3.1

Version: v20260809

Author: Quality Think Tank Quality Think Tank is dedicated to providing systematic professional knowledge, methodologies, and practical tools for quality management practitioners, helping companies continuously improve their quality capabilities.