ISO9001 System Document Package (29) | Change Management Procedure (6.3/8.5.6)

Document Description: This procedure corresponds to ISO 9001:2015 standard clauses 6.3 "Planning of changes" and 8.5.6 "Control of changes." It is a pivotal procedure in the quality management system (QMS) that spans the "planning—support—operation" three major sectors. This procedure incorporates two types of changes into a unified management system: one is systemic changes (organizational structure adjustments, process redesign, significant resource changes, etc., corresponding to 6.3), which require changes to be implemented in a controlled and planned manner without compromising the integrity and effectiveness of the system; the other is product realization changes (changes in personnel, equipment, materials, methods, environment, etc., affecting product conformity, corresponding to 8.5.6), which require changes to be reviewed, authorized, and documented to ensure that the product continues to meet requirements after the change. Many companies make changes without proper planning and communication, leading to issues such as updated drawings not being known on-site, changed materials not being accompanied by updated inspection standards, and unverified equipment parameters, resulting in batch accidents—rooted in uncontrolled changes. This procedure is applicable to all types of manufacturing and service companies, especially those with frequent changes, multiple small batches, or many customer engineering changes, and can be directly applied and tailored according to the organization's scale.

Note: This procedure is a template. Terms like "our company" and "responsible department" should be replaced with the corresponding department names of the actual company.

1. Purpose

To standardize the proposal, review, approval, implementation, verification, and solidification of various changes within our company, ensuring:

1. Changes to the quality management system (QMS) are implemented in a controlled and planned manner, maintaining or enhancing the system's integrity and effectiveness (corresponding to 6.3);
2. Changes affecting product conformity in production and service provision are reviewed, authorized, and verified, ensuring that the product continues to meet customer and regulatory requirements after the change (corresponding to 8.5.6);
3. Change information is synchronized across relevant departments to prevent discrepancies between documents, on-site conditions, and the supply chain;
4. Changes and their reviews, authorizations, and necessary measures are documented to ensure traceability.

This procedure references the definitions of terms from ISO 9000:2015 as follows:

1. Change: Any alteration to the QMS, processes, product realization conditions, or requirements;
2. Design and Development: A set of processes that convert customer requirements (for products, processes, services) into more detailed requirements (changes in design and development are managed according to the "Design and Development Control Procedure");
3. Documented Information: Information and its carriers that the organization needs to control and maintain (change records are managed according to the "Record Control Procedure").

Changes are categorized into three types based on the object and risk level:

• A Class (Systemic Changes): Organizational structure adjustments, QMS document revisions, major process redesigns, significant resource changes, etc., corresponding to 6.3;
• B Class (Permanent Product Realization Changes): Permanent changes in personnel, machinery, materials, methods, environment, measurement, etc., affecting product conformity, corresponding to 8.5.6;
• C Class (Temporary Changes): Short-term, risk-controlled, and time-limited changes (such as temporary equipment substitution, personnel replacement, emergency material substitution, temporary parameter adjustments, or inspection arrangements).

2. Scope of Application

This procedure applies to the management of all systemic and product realization changes within the scope of our company's QMS, covering the entire process from proposal, classification, review, approval, implementation preparation, verification, solidification, revocation, to statistical analysis.

The boundaries between this procedure and related documents are as follows:

1. Changes in design and development outputs (drawings, specifications, BOM modifications) are reviewed and verified according to the "Design and Development Control Procedure" clause 8.3.6. After approval, the implementation (breakpoints, document, and on-site transitions) is managed according to this procedure's B Class changes;
2. When customers propose engineering changes (ECN), changes involving contract/order conditions are first reviewed according to the "Control of Processes Related to the Customer" procedure, then implemented internally according to this procedure;
3. Changes from external suppliers (materials, processes, factory relocation, sub-supplier changes) are reported by suppliers according to the "Purchasing and External Provision Control Procedure" requirements. Our company reviews and verifies these changes according to this procedure's B Class changes;
4. Textual revisions to system documents (without changing processes or responsibilities) are managed according to the "Document Control Procedure." Substantive changes involving processes, responsibilities, or resources must first be approved according to this procedure's A Class changes;
5. Permanent changes in processes, materials, etc., triggered by nonconformities are approved according to the "Nonconforming and Corrective Action Procedure." If the implementation involves changes, it is managed according to this procedure.

3. Responsibilities

The responsible department has the authority to supervise the implementation of changes. No department or individual may implement changes without approval. Changes that fail verification must not be transferred to batch or formal operation.

4. Work Procedures

4.1 Identification and Proposal of Changes

When any of the following situations occur, the relevant department should propose a change application:

1. Systemic Changes (A Class): Organizational structure adjustments, reassignment of responsibilities; process redesign or changes in outsourcing scope; QMS document revisions; major updates to production sites or critical equipment; significant changes in regulations, standards, or customer requirements;
2. Product Realization Changes (B Class): Implementation of product design changes (including customer ECNs); changes in process methods or parameters; replacement or major repairs of equipment, tooling, or molds; changes in raw materials, components, or suppliers; changes in key personnel positions; significant changes in production environment; changes in inspection methods or standards; changes in packaging or transportation methods; software version upgrades affecting product realization;
3. Temporary Changes (C Class): Temporary substitutions for equipment failures, personnel replacements, emergency material substitutions, temporary parameter adjustments, or inspection arrangements.

The change proposing department fills out the "Change Request Form," specifying: the object and content of the change, the reason for the change (with supporting evidence, such as customer notifications, nonconformity reports, improvement proposals), the expected effective date, the scope involved (product/process/department/supplier), and a preliminary impact assessment.

4.2 Classification and Acceptance of Changes

Upon receiving the "Change Request Form," the responsible department organizes a preliminary classification within 2 working days:

In case of classification disputes, the higher level is chosen. All accepted changes are uniformly numbered and registered in the "Change Log," with the numbering rule: A/B/C-Year-Sequence Number (e.g., B-2026-037).

4.3 Review of Changes

The review content must include at least the following:

1. Purpose and Necessity of the Change: Whether it is indeed necessary, and whether there are alternative solutions;
2. Potential Impact Analysis: Impact on product quality, process capability, delivery, cost, safety, and environment; impact on downstream processes, inventory items, in-process items, and delivered products (traceability and handling if necessary); impact on stakeholders (customers, suppliers); special characteristics (SC/CC) must be assessed (changes in special characteristics must be reported to and approved by the customer);
3. System Integrity (A Class): Whether the change affects the interaction between system processes, and whether it triggers a chain of adjustments in responsibilities, documents, and resources;
4. Resources and Capabilities: Whether the required equipment, personnel skills, and funds are available, and whether training is needed;
5. Verification Plan: What verification or confirmation is needed (pilot production, trial production, first article inspection, type testing, small batch tracking, etc.), and the criteria for successful verification;
6. Breakpoint and Transition Arrangements: When the old state will stop, when the new state will start, how inventory items and in-process items will be handled, and the identification and traceability methods for the transition.

The review conclusion is filled into the "Review Opinion" section of the "Change Request Form": Agree/Disagree/Agree after modification, and the responsible department for implementation, verification requirements, and breakpoint date are clearly specified. If the change is not approved or requires modification, the reasons are communicated in writing to the proposing department.

4.4 Approval of Changes

1. Approval is conducted according to the authority specified in section 4.2. Changes involving product safety, regulatory compliance, or customer-specified requirements must be approved by the General Manager and reported to the customer for their approval before implementation;
2. After approval, the responsible department distributes the "Change Request Form" and implementation plan to relevant departments, specifying accompanying tasks and completion deadlines for document revisions, training, and material handling.

4.5 Implementation Preparation of Changes

1. Document First: For changes involving process documents, work instructions, inspection standards, and control plans, the documents must be revised and approved before distribution, ensuring "document changes first, then on-site changes." On-site changes without document updates are strictly prohibited;
2. Training Confirmation: Training on the change content must be provided to operators, inspectors, and relevant personnel, and they must confirm their understanding before being allowed to operate;
3. Material and Inventory Handling: Handle old version materials, in-process items, and finished goods according to the breakpoint plan—label and use items that can be used, isolate and scrap or accept with concessions items that cannot be used, and ensure that handling records are traceable;
4. Supplier Synchronization: For changes involving external suppliers, formally notify the supplier and confirm their completion time and verification results.

4.6 Implementation and Verification of Changes

1. For B Class changes, conduct pilot production, first article inspection, and type testing according to the verification plan. The number of verification samples and verification items are determined by the risk. Record the verification results in the "Change Verification Record Form";
2. After successful verification, approved changes can be transferred to batch production. If verification fails, stop implementation, identify the cause, and if necessary, revise the plan and re-verify or revert to the original state;
3. After implementing A Class changes, set an observation period of 1 to 3 months (6 months for major changes such as system revisions). The responsible department tracks the system's operational performance (goal achievement, internal and external audit results, process performance indicators) to confirm that the system's effectiveness has not decreased;
4. During the implementation of C Class temporary changes, the responsible department must strengthen product monitoring (such as increasing inspection frequency) and record the implementation details.

4.7 Revocation or Formalization of Temporary Changes (C Class)

1. C Class changes must specify an effective period on the "Change Request Form" (generally not exceeding 30 days, and in special cases, not exceeding 90 days);
2. Before the expiration, the responsible department confirms: if the temporary reason has been eliminated, revert to the original state and record the revocation date; if further continuation is needed, assess and convert to a B Class permanent change, following the complete review process. Avoid "temporary changes becoming permanent, dragging on for months or even years";
3. Record the revocation or formalization status in the "Change Log" and "Change Request Form."

4.8 Solidification and Statistical Analysis of Changes

1. After successful verification, the responsible department verifies that all accompanying documents have been revised, training has been completed, and identification has been updated, and then closes the change item;
2. Records related to changes (request forms, review opinions, verification records, breakpoint handling records) are archived according to the "Record Control Procedure" to ensure traceability from the finished product to the changes it has undergone;
3. The responsible department conducts quarterly statistical analysis of the number, type, first-time verification pass rate, and quality issues caused by changes, forming analysis opinions to be used as inputs for data analysis (9.1.3) and management review (9.3);
4. For quality issues caused by poor change management, take corrective actions according to the "Nonconforming and Corrective Action Procedure," and if necessary, revise this procedure.

4.9 Work Flow (Text Version)

Change demand arises (customer ECN/internal improvement/supplier change/resource change/temporary emergency)
        ↓
(1) Proposal: Fill out the "Change Request Form" → Submit to the responsible department
        ↓
(2) Classification and Acceptance: Determine level within 2 working days (A Systemic/B Product Realization/C Temporary)
        ↓
(3) Review: Impact analysis + Verification plan + Breakpoint plan (A Class special meeting, B Class co-signing)
        ↓
(4) Approval: A Class by General Manager / B Class by Management Representative or Deputy General Manager / C Class by Department Head
        (Changes involving product safety, regulations, or customer-specified requirements → Customer approval)
        ↓
(5) Implementation Preparation: Document revision and distribution → Training confirmation → Material and inventory handling → Supplier synchronization
        ↓
(6) Implementation and Verification: Pilot production/first article/type testing → Successful verification → Batch production
        ↓
(7) C Class Expiration: Revert or convert to B Class permanent change and follow the complete process
        ↓
(8) Solidification and Closure: Verify document, training, and identification updates → Close log → Archive
        ↓
(9) Statistical Improvement: Quarterly statistical analysis → Data analysis/management review → Process improvement

4.10 Form References

This procedure involves the following forms, with formats as per the fourth-level document record form templates:

5. Related Records

1. "Change Request Form" (including review opinions and approval signatures);
2. "Change Log";
3. "Change Verification Record Form" (including pilot production, first article, and test data);
4. "Change Breakpoint and Material Handling Record";
5. Records of document revisions and training (as per the "Document Control Procedure" and "Human Resource Management Procedure").

All records are archived according to the "Record Control Procedure." For changes involving product safety, regulatory traceability, or customer contractual requirements, the retention period must comply with regulations and customer requirements and should not be less than the product lifecycle.

6. Related Documents

• ISO 9001:2015 "Quality Management System—Requirements" clauses 6.3, 8.5.6;
• "Quality Manual";
• "Document Control Procedure," "Record Control Procedure";
• "Design and Development Control Procedure";
• "Control of Processes Related to the Customer";
• "Purchasing and External Provision Control Procedure";
• "Production Process Control Procedure," "Identification and Traceability Control Procedure";
• "Nonconforming and Corrective Action Procedure";
• "Risk Management Procedure," "Human Resource Management Procedure," "Infrastructure and Equipment Management Procedure."

Usage Instructions

1. How to Adapt to the Company's Actual Situation

1. Organizational Adaptation: Small companies may not have a dedicated responsible department. The Quality Department or Enterprise Management Department can manage the log, classification, and supervision. "A Class changes approved by the General Manager, B Class changes approved by the Management Representative" can be combined into a single approval by the General Manager. Review co-signing can be simplified to the circulation of the "Change Request Form" for co-signing, but the five key steps of "proposal—review—approval—verification—solidification" cannot be omitted.
2. Process Adaptation: Manufacturing companies can supplement the 4M change matrix (personnel/machinery/materials/methods) in this procedure, creating a reference table in the appendix to specify "which changes must be reported, who verifies them, and whether to notify the customer." For service industries (logistics, property management, software), the change objects should be expanded to include process and system configuration changes (such as warehouse system parameter adjustments, service process changes, software version releases), and verification methods should include trial runs, small-scale gray tests, and customer feedback.
3. Industry Adaptation: For the automotive industry (IATF 16949), this procedure must align with 8.5.6.1 "Control of changes—Supplement," implementing verification activities for changes affecting product realization or conformity (including supplier-induced changes). When necessary, report to and obtain customer approval. Changes involving special characteristics (SC/CC) should include specialized verification plans. For medical devices and food industries, regulatory requirements for change verification and registration should be integrated into the review elements.
4. Threshold Adaptation: The default values for classification within 2 working days, C Class validity of 30 to 90 days, and A Class observation period of 1 to 6 months can be adjusted based on product complexity and industry pace. However, any adjustments should be documented and explained in training to ensure traceability during audits.

2. Audit Focus Points

1. External auditors verify 6.3/8.5.6 through "on-site backtracking": First, find the "latest on-site status" (new processes, new equipment, new supplier materials) in the workshop, then check the "Change Log" for corresponding records, whether they have been reviewed and approved, whether verification evidence is complete, and whether documents have been updated. Discrepancies between on-site status and documents without change records are typical serious nonconformities.
2. Common follow-up questions: "When was this new equipment installed? What verification was done? Do you have first article records?" "Did the inspection standards change when the new supplier's materials arrived?" "Was the temporary parameter adjustment last month revoked on time? Why is there no revocation record in the log?" "How many days did it take to complete the review after receiving the customer ECN? Do you have evidence of customer approval?"—The most frequent nonconformities are temporary changes not being revoked, supplier changes not being reported, and missing verification records.
3. Pay attention to the evidence chain for 6.3 and 8.5.6: For A Class changes, review management review or special meeting resolutions, change records for system document revisions, and internal audit conclusions for the changed system. For B Class changes, review the complete closed loop from the request form to review, approval, verification, document revision, training, and breakpoint handling. Auditors will randomly check 2 to 3 change items to verify the chain, and any missing link will result in the change being deemed uncontrolled.
4. The interface with the "Document Control Procedure" is a common audit point: Are document revisions made before on-site implementation ("document changes first, then on-site changes")? Are old versions of documents fully recovered? Are there any obsolete versions remaining on-site?

3. Common Errors

1. Change Management Only Covers "Drawing Changes": Writing the procedure as a replica of design changes, ignoring changes in equipment, material substitution, personnel replacement, and environmental changes—auditors often focus on these "non-design changes."
2. Uncontrolled Temporary Changes: C Class changes without specified durations, not logged, and not revoked on time, leading to temporary measures becoming long-term practices, posing ongoing risks; or changes implemented based on verbal agreements without any documented information.
3. Perfunctory Reviews: Impact analysis only states "minimal impact, agreed," without identifying impacts on inventory items, delivered products, downstream processes, or special characteristics; verification plans are left blank; signatures are merely for formality, with no one accountable for the conclusions.
4. Implementation Before Documentation: On-site changes in materials or parameters are made, and the "Change Request Form" is filled out a month later with backdated dates—auditors can easily detect this by comparing on-site status and document dates, and any quality issues arising from changes will lack traceability.
5. Document and On-Site Discrepancies: Changes are implemented, but work instructions and inspection standards are not revised, or revisions are not trained, leading to operators working according to old habits; "document changes first, then on-site changes" is a strict rule.
6. Unclear Breakpoints and Material Control: Old materials are not labeled or isolated, and new and old states are mixed in production lines and warehouses. Old materials are still used after the transition, breaking the traceability chain—breakpoint and material handling records must correspond to production batches.
7. Unmanaged Supplier Changes: Suppliers change materials or relocate factories without reporting, and our company does not require suppliers to establish a change reporting mechanism, leading to issues only being exposed when incoming materials are nonconforming or problems arise at the customer end—change reporting obligations should be specified in procurement contracts or quality agreements.

Controlled changes, quality remains in control

Knowledge code: 2.3.1

Version: v20260809

Author: QTank QTank is dedicated to providing systematic knowledge, methodologies, and practical tools for quality management professionals to help companies continuously improve their quality capabilities.