ISO9001 System Document Package (2) | Quality Manual (Part 2): Process Identification and Clause Correspondence

The "Quality Manual (Part 2)" is a component of the Quality Manual, to be used in conjunction with Part 1: Part 1 addresses "Commitment and Organization" (quality policy, quality objectives, organizational structure, and responsibility allocation), while Part 2 focuses on "Processes and Document Structure." This part identifies the processes required by the company's Quality Management System (QMS) through process lists, turtle diagrams, and process interaction diagrams, and specifies their sequence and interactions. It also demonstrates the coverage of all applicable clauses of ISO 9001:2015 through a clause correspondence table, and links the secondary procedure documents to the manual, forming the top-level framework of the four-tier document structure: "manual—procedures—work instructions—records." This document is suitable for various organizations establishing or transitioning to the ISO 9001:2015 system, especially small and medium-sized manufacturing and service enterprises seeking initial certification, and organizations that need to provide evidence of the implementation of the process approach to certification bodies. This article provides directly usable process list templates, turtle diagram templates, clause correspondence tables, and procedure document index examples.

1. Purpose

1.1 To specify the methods for identifying the processes required by the company's QMS, the process list, and the sequence and interactions of these processes, ensuring that the system covers all requirements of clause 4.4 of the standard.

1.2 To establish the correspondence between the clauses of ISO 9001:2015 and the sections of the manual and procedure documents, providing a basis for internal audits, management reviews, and certification audits.

1.3 To clarify the responsible departments (process owners) and performance monitoring requirements for each process, ensuring that the process approach moves from a "paper concept" to "daily management."

2. Scope of Application

2.1 Applicable to all processes within the scope of the company's QMS, including customer-oriented processes, support processes, and management processes.

2.2 Applicable to all departments and positions related to the QMS, as well as all procedure documents, work instructions, and record forms referenced in the manual.

2.3 This part, together with "Quality Manual (Part 1)," constitutes a complete manual document. Part 1 focuses on policies, objectives, and organizational responsibilities, while this part focuses on process identification and document structure. They are to be used in conjunction and are inseparable.

3. Responsibilities

3.1 General Manager: Approves the process list, process interaction diagram, and all sections of this manual; appoints process owners; chairs management reviews to evaluate process performance.

3.2 Management Representative (Quality Responsible Person): Organizes process identification and the preparation and review of turtle diagrams; maintains the current validity of the clause correspondence table and procedure document index; reports system performance to the General Manager.

3.3 Process Owners (Department Heads): Clearly defines the inputs, outputs, resources, job capabilities, work instructions, and performance indicators for their respective processes according to the turtle diagram requirements; responsible for collecting and improving performance data for their processes.

3.4 Document Control Center: Responsible for the distribution, control, revision, and recovery of this manual and its accompanying procedure documents; registers the version status of the procedure document index.

4. Work Procedures (Manual Main Text Example)

4.1 Process List (Example of Section 4.1 of Chapter 4 of the Manual)

4.1.1 The company categorizes the processes required by the QMS into three types using the process approach:

(1) Customer-Oriented Processes (COP, Customer Oriented Process): Processes directly related to customer requirements and satisfaction, forming the main flow of product realization;

(2) Support Processes (SP, Support Process): Processes that provide resources, equipment, and capability support for customer-oriented processes;

(3) Management Processes (MP, Management Process): Management processes that provide planning, monitoring, evaluation, and improvement for the system.

4.1.2 The company's process list is as follows (Table 1). Each process owner is responsible for preparing the turtle diagram for their process according to section 4.2:

Table 1 QMS Process List

4.1.3 The process list is reviewed annually before the management review. When there are significant changes in the organizational structure, product type, or outsourcing scope, the Management Representative organizes an immediate review and revision of the list.

4.2 Turtle Diagram (Example of Section 4.2 of Chapter 4 of the Manual)

4.2.1 The turtle diagram is a standardized tool used by the company to describe individual processes, consisting of six elements: inputs, outputs, what is used (resources), who does it (position/capability), how it is done (documents/methods), and performance indicators (how to monitor).

4.2.2 Turtle diagram template (Table 2). Each process owner fills out the template as shown below:

Table 2 Turtle Diagram Template

4.2.3 Requirements for preparing turtle diagrams: One diagram per process, prepared by the process owner with the help of departmental key personnel, and reviewed by the Management Representative. Performance indicators must correspond item-by-item to the quality objectives breakdown table in "Quality Manual (Part 1)." Approved turtle diagrams are managed as controlled documents, and revisions must follow the "Document Control Procedure."

4.3 Process Interaction Diagram (Example of Section 4.3 of Chapter 4 of the Manual)

4.3.1 The sequence and interactions of the company's processes are as follows (text version of the interaction diagram):

                    ┌────────────────────────────────────────┐
                    │  Management Processes MP1～MP5 (Plan—Do—Check—Act)  │
                    └───────┬────────────────────▲───────────┘
                            │ Planning/Resources/Objectives  │ Performance Report/Improvement Requirements
Customer Requirements ──► COP1 ──► COP2 ──► COP3 ──► COP4 ──► COP5 ──► Product Delivery
Contract Review     Design and Development    Procurement      Production      Protection and Delivery               │
                            ▲                    │                ▼
                            └── Support Processes SP1～SP5 Full Support ──► COP6 Customer Satisfaction
                                                               Monitoring and Feedback (Loop)

4.3.2 Explanation of interaction relationships:

(1) Main Flow: Customer requirements (including legal and regulatory requirements) are confirmed through COP1 contract review and then sequentially pass through COP2 design and development, COP3 procurement, COP4 production, and COP5 protection and delivery, ultimately delivering products and services to the customer.

(2) Support Relationships: SP1～SP5 provide personnel, equipment, measurement, document, and knowledge support for all customer-oriented processes. Any failure in a support process will affect the quality of the main flow output.

(3) Management Loop: MP1～MP5 form the PDCA cycle—MP1/MP2 complete planning, MP3 internal audit and COP6 customer satisfaction monitoring complete checking, MP4 management review outputs improvement decisions, and MP5 implements corrective actions and continuous improvement, with the results fed back to the planning layer to form a closed loop.

4.3.3 Process interaction relationship table (Table 3) for quick reference during audits:

Table 3 Customer-Oriented Process Interaction Relationships

4.4 Clause Correspondence Table (Example of Chapter 5 of the Manual)

4.4.1 The correspondence between the sections of this manual and the clauses of ISO 9001:2015 is shown in Table 4. This table serves as a reference for certification audit planning and internal audit checklist preparation.

Table 4 ISO 9001:2015 Clause Correspondence Table

4.4.2 Declaration of non-applicable clauses (example): The company does not engage in product design and development activities (products are provided by customers with drawings or produced according to national standards), so clause 8.3 is not applicable. This is hereby declared, and the reason for non-applicability is: product realization does not involve the company's own design and development, and design responsibility is borne by the customer. After confirmation by the certification body, clause 8.3 can be marked as "not applicable" in the correspondence table.

4.4.3 Key points of core clauses and corresponding sections of the manual (example for clause 4.4):

Key points of the standard: "The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes required and their interactions."

Corresponding section of the manual: The company establishes the QMS according to the methods described in sections 4.1～4.3, determines the required processes and their sequence, interactions, criteria, and methods through the process list (Table 1), turtle diagrams (Table 2), and process interaction diagrams (4.3), and provides the necessary resources and information. The system is monitored, evaluated, and continually improved through internal audits (9.2), management reviews (9.3), and corrective actions (10.2).

4.5 Procedure Document Index (Example of Chapter 6 of the Manual)

4.5.1 The procedure document index referenced in this manual is shown in Table 5, maintained by the Document Control Center, and updated in real-time with the release and revision of procedure documents.

Table 5 Procedure Document Index (Excerpt of Full Table Structure)

4.5.2 Document numbering rules: Quality Manual QM-2015; Procedure Documents QP-XX; Work Instructions WI-XX; Record Forms QR-XX. Departments establish their own document lists according to the "Document Control Procedure" for third and fourth-level documents.

5. Related Records

5.1 Process list review record (QR-01, one of the inputs for management review).

5.2 Review records for each process's turtle diagram (QR-01).

5.3 Manual co-signature and approval record (QR-02).

5.4 Manual distribution and recovery record (QR-03).

5.5 Manual change application form (QR-04).

The above records are archived and retained by the Document Control Center according to the "Record Control Procedure," with a retention period of no less than 3 years.

6. Related Documents

6.1 ISO 9001:2015 "Quality Management System—Requirements" (adopted as GB/T 19001-2016).

6.2 "Quality Manual (Part 1)": Policies, objectives, and organizational responsibilities.

6.3 Procedure documents QP-01～QP-27 in this package (as listed in Table 5).

6.4 "Document Control Procedure" and "Record Control Procedure."

Usage Instructions

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

1. Process List: Manufacturing companies can directly use the COP main flow in Table 1. Pure service or trading companies should remove COP2 design and development and add processes such as "service provision" and "outsourcing process management." Small enterprises can merge SP2 and SP3 into "equipment and measurement management" and merge MP2 and MP5, with a minimum of 8 processes, without the need to deliberately reach 16.

2. Turtle Diagram: One diagram per process, prepared by the process owner with the help of departmental key personnel and reviewed by the Management Representative. Performance indicators must correspond item-by-item to the quality objectives breakdown table in "Quality Manual (Part 1)," and the values should be supported by historical data, avoiding arbitrary numbers.

3. Clause Correspondence Table: Before deleting clauses, confirm whether they are truly not applicable. For companies without design and development, declare clause 8.3 as not applicable with a clear reason and certification body confirmation; failing to provide a reason will result in a nonconformity during the audit for "incomplete system coverage."

4. Procedure Document Index: Maintain consistency with the procedure document numbers in this package. Register each new document in the index as it is released; update the version number column after document revision to prevent discrepancies between the manual index and the controlled document list.

2. Audit Focus Points

1. Auditors will randomly select 3～5 processes and verify the site against the turtle diagrams—the most common source of nonconformities is inconsistency between "what is written" and "what is done." After approval, organize training for all employees to ensure understanding and implementation.

2. The clause correspondence table is a direct basis for audit planning. Each clause in the table should have corresponding evidence on-site; it is recommended to prepare an evidence list for each clause according to the correspondence table.

3. The process interaction diagram must reflect the PDCA loop and feedback loop. Process diagrams with only linear flows and no monitoring or feedback will be questioned for "lack of process approach implementation."

4. Process performance indicators must be supported by monitoring records, and the performance data for each process should be summarized and available in the management review inputs.

3. Common Errors

1. Copying turtle diagram templates from the internet or peers without adapting them to the company's actual processes, leading to mismatched inputs and outputs.

2. Listing only major clauses (4, 5, 6...) in the clause correspondence table without sub-clauses, making it difficult for auditors to verify each clause, leading to time-consuming and labor-intensive revisions.

3. Inconsistent numbering rules for the manual, procedure documents, and record forms, causing discrepancies in the document control ledger and making document control a major issue.

4. Not declaring non-applicable clauses or providing insufficient reasons, leading to certification bodies requesting additional explanations and delaying certification progress.

5. Process list and organizational structure being out of sync: Process owner positions have changed, but the list and turtle diagrams have not been updated accordingly.

Process list with turtle diagrams, clause correspondence table covers all

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.