ISO9001 System Document Package (10) | Procedure for Control of Monitoring and Measurement Resources (7.1.5)

Document Description: This document is the implementation procedure for clause 7.1.5 "Monitoring and Measurement Resources" of ISO 9001:2015, which is a second-level document (procedure document) of the Quality Management System (QMS). It is to be used in conjunction with the "Procedure for Infrastructure and Equipment Management" (the 9th document in the package). Its core function is to ensure that the monitoring and measurement resources (gauges, instruments, testing equipment, inspection software, etc.) used by the company to verify product conformity are always under control, with accurate, reliable, and traceable measurement results, preventing misjudgment of conforming products or release of nonconforming products due to inaccurate measurements. It is applicable to all manufacturing, processing, and inspection enterprises that require quality judgments based on test data, especially those in industries with high metrological requirements such as machining, electronics, automotive parts, and medical device manufacturing. Service-oriented enterprises can simplify and apply it to the control of satisfaction survey tools and service monitoring equipment. The procedure focuses on solving four main issues: equipment inventory and identification management, the formulation and implementation of calibration/verification plans, the maintenance of the measurement traceability chain, and the handling and evaluation of equipment abnormalities.

1. Purpose

To standardize the entire process management of the configuration, calibration, use, maintenance, and disposal of monitoring and measurement resources, ensuring that monitoring and measurement activities are suitable for the requirements of monitoring and measurement. This guarantees that the measurement equipment is accurate, traceable, and under control, providing a reliable basis for product conformity judgments and meeting the requirements of clause 7.1.5 of ISO 9001:2015 and applicable laws, regulations, and customer requirements.

2. Scope of Application

2.1 This procedure applies to the control of all monitoring and measurement resources used in the operation of the company's QMS, including:

(1) Measuring instruments and measurement equipment used for product inspection, testing, and process monitoring, such as calipers, micrometers, dial indicators, hardness testers, tensile testing machines, coordinate measuring machines, electronic scales, thermometers, and pressure gauges;

(2) Instruments and meters used for monitoring process parameters, such as temperature controllers, flow meters, level gauges, and tachometers;

(3) Software and automated inspection systems (including measuring equipment with built-in software) used for inspection and testing;

(4) Standard materials, comparison samples, gauges, inspection tools, and templates used as inspection references.

2.2 This procedure does not apply to ordinary tools and office equipment used only for reference and not for product conformity judgments (such as tape measures and ordinary clocks). Such equipment is managed by the respective departments and is not included in the controlled scope of this procedure.

3. Responsibilities

3.1 Quality Department (or the department responsible for metrological management):

(1) Manage all monitoring and measurement resources of the company, establish, and maintain the "Inventory of Monitoring and Measurement Equipment";

(2) Prepare the annual calibration/verification plan, implement calibration, verification, and periodic checks;

(3) Manage the status identification of measurement equipment, and review and confirm the sealing, suspension, and scrapping of equipment;

(4) Organize the handling and evaluation of abnormal measurement equipment (misalignment, out-of-tolerance).

3.2 Equipment Usage Departments (Production Department, Inspection Laboratory, etc.):

(1) Propose configuration requirements and additional applications for monitoring and measurement resources;

(2) Be responsible for the daily storage, correct use, and maintenance of the equipment under their jurisdiction;

(3) Report any equipment abnormalities, damages, or overdue calibrations to the Quality Department promptly;

(4) Cooperate with the implementation of calibration/verification and periodic checks.

3.3 Procurement Department: Implement the procurement of monitoring and measurement resources according to the "Procedure for Control of Purchasing and External Provision," ensuring that the purchased equipment comes with a factory conformity certificate and traceability documentation.

3.4 General Manager/Management Representative: Approve the configuration plan and major disposal decisions for monitoring and measurement resources, and provide the necessary resources.

4. Work Procedures

4.1 Configuration and Acceptance

4.1.1 The usage department fills out the "Application Form for Configuration of Monitoring and Measurement Resources" based on product inspection, process monitoring, and customer requirements, noting the equipment name, model, precision/resolution requirements, quantity, purpose, and expected delivery time, and submits it to the Quality Department for review.

4.1.2 The Quality Department reviews the measurement capability requirements and traceability requirements, confirms the appropriate selection, and then submits it to the Management Representative for approval before transferring it to the Procurement Department for implementation.

4.1.3 After the new equipment arrives, the Quality Department, together with the usage department, conducts the acceptance according to the following steps:

(1) Verify that the equipment nameplate, model, accessories, and manual match the contract/application form;

(2) Check the factory conformity certificate, calibration/verification certificate, or other traceability documents;

(3) Perform functional checks and precision verification according to the manual or acceptance specifications;

(4) Register the accepted equipment in the "Inventory of Monitoring and Measurement Equipment," assign a number, and affix a status label before putting it into use. If the acceptance is不合格, handle it according to the procurement return process.

4.2 Inventory and Identification Management

4.2.1 The Quality Department assigns a unique number to each controlled device (numbering rule: department code - equipment category code - sequence number, e.g., ZJ - YL - 001) and registers the following information: equipment name, model specification, factory number, precision/resolution, installation/usage location, responsible person, calibration cycle, last calibration date, next calibration date, and status (in use, suspended, sealed, scrapped).

4.2.2 Controlled equipment must have a status label, which is divided into three types:

(1) Green "合格" label: Calibrated/verified and within the valid period;

(2) Yellow "准用" label: Partial functions are normal but meet specific measurement purposes, or used at a lower grade after calibration (must specify the allowed measurement range);

(3) Red "停用" label: Misaligned, overdue for calibration, damaged and awaiting repair, or scrapped and awaiting disposal. No one is allowed to use the equipment without authorization.

4.2.3 The label content must include at least: equipment number, calibration validity period, calibration unit, and responsible person. If the label falls off, becomes blurred, or is damaged, the usage department should report to the Quality Department for a replacement. Any in-use equipment with an unclear status should be suspended and re-calibrated before further use.

4.3 Calibration and Verification Management

4.3.1 The Quality Department compiles the next year's "Calibration/Verification Plan" in December, determining the calibration/verification method and cycle for each device:

(1) For measuring instruments that are subject to mandatory verification by the state (such as those used for trade settlement, safety protection, medical care, and environmental monitoring), send them to a legally authorized metrological technical institution for verification, following the verification regulations for the cycle;

(2) For non-mandatory verification equipment, determine the cycle based on usage frequency, precision requirements, past calibration results, and stability, generally 6 to 12 months, with a shorter cycle for critical measurement equipment;

(3) Calibration/verification can be conducted through sending for inspection, on-site calibration, or by commissioning a qualified third-party institution. The calibration institution must have the appropriate qualifications (CNAS accreditation or legal metrological authorization).

4.3.2 Implementation of Calibration/Verification:

(1) The Quality Department notifies the usage department one week in advance to arrange for equipment scheduling and alternative arrangements;

(2) The Quality Department uniformly sends and retrieves the equipment for inspection, ensuring proper protection and recording of the handover;

(3) After calibration/verification, the Quality Department verifies that the certificate information matches the equipment inventory, confirms the results, updates the inventory, and replaces the green label. If the results are不合格, the equipment is handled according to the 4.5 abnormal handling process.

4.3.3 When external traceability conditions are unavailable (such as special inspection tools, custom gauges, and comparison templates), the "Work Instruction for Self-Calibration/Comparison" should be compiled, using certified standard materials or traceable benchmark equipment for comparison, and retaining the comparison records.

4.4 Periodic Checks

4.4.1 The Quality Department should arrange periodic checks for the following equipment between two calibrations:

(1) Measurement equipment that is frequently used, prone to drift, or easily damaged;

(2) Measurement equipment that plays a key role in product quality judgments;

(3) Equipment with specific requirements from customers or laws and regulations.

4.4.2 Periodic checks can be conducted using the comparison method with a stable standard (regularly measuring and recording results with the same stable standard), the inter-equipment comparison method, or the re-measurement method. The check results are recorded in the "Periodic Check Record Form." If abnormalities are found, handle them according to 4.5.

4.5 Abnormal Handling and Traceability

4.5.1 If any of the following situations occur, the usage department should immediately stop using the equipment and notify the Quality Department:不合格 calibration/verification, out-of-tolerance, damage or functional abnormalities, overdue for calibration, missing labels, or misuse or impact.

4.5.2 The Quality Department organizes the handling of the stopped equipment:

(1) If repairable, send it for repair, then re-calibrate/verify, and resume use if合格;

(2) If irreparable or the repair cost exceeds the replacement cost, process the scrapping, remove it from the inventory, and recover the red label;

(3) If not used for a short term, process the sealing, and do not arrange for calibration during the sealing period. Before reusing, ensure it is calibrated/verified and合格.

4.5.3 For equipment found to be misaligned, the Quality Department must trace and evaluate the impact of the measurement results issued during the misalignment period:

(1) Review the calibration/verification records, usage records, and inspection reports of the equipment to determine the affected time period and measurement batches;

(2) Re-test or assess the affected products and processes. If necessary, trace the released products, notify the customer, and take appropriate actions;

(3) Record the evaluation results and corrective actions in the "Record Form for Abnormal Handling and Traceability of Measurement Equipment."

4.6 Use and Maintenance

4.6.1 Operators must be trained and qualified before operating the measurement equipment. Before use, they should check the status label, calibration validity period, and appearance of the equipment, and use it according to the operating procedures (see third-level document "Work Instruction for Calibration and Periodic Check of Measuring Instruments" and the equipment manual). Do not use the equipment beyond its specified range or precision.

4.6.2 The usage department is responsible for the daily maintenance and storage protection of the equipment. Precision equipment should be stored in dedicated containers, and the environment should maintain the required temperature and humidity. Equipment should not be borrowed or lent out without the approval of the Quality Department, and a handover record must be kept.

4.6.3 Inspection software and automated detection systems must be confirmed (verified to meet the intended use) before their initial use. After software changes or upgrades, re-confirmation is required, and the confirmation records should be archived. Confirmation methods include: testing with samples of known results, comparing with independently calibrated equipment, and comparing with reference standards.

4.7 Process Overview (Textual Flowchart)

Configuration Application → Review and Approval → Procurement and Acceptance → Inventory and Numbering → Affixing Labels → Compiling Annual Calibration Plan → Implementing Calibration/Verification → Replacing Labels for合格 Equipment / Handling不合格 Equipment → Periodic Checks (for Key Equipment) → Use and Daily Maintenance → Stopping Use for Abnormal Equipment → Traceability Evaluation and Disposal → Scrapping/Sealing and Inventory Cancellation

4.8 Related Forms

This procedure involves the following forms: "Inventory of Monitoring and Measurement Equipment," "Application Form for Configuration of Monitoring and Measurement Resources," "Annual Calibration/Verification Plan," "Calibration/Verification Record," "Periodic Check Record Form," "Record Form for Abnormal Handling and Traceability of Measurement Equipment," "Application Form for Suspension/Sealing/Scrapping of Equipment," and "Handover Record for Equipment Borrowing and Returning."

5. Related Records

5.1 "Inventory of Monitoring and Measurement Equipment" — Long-term retention.

5.2 "Annual Calibration/Verification Plan" and "Calibration/Verification Record" (including original or copies of calibration certificates) — Retain for 2 years after the equipment is scrapped.

5.3 "Periodic Check Record Form" — Retain for at least 3 years.

5.4 "Record Form for Abnormal Handling and Traceability of Measurement Equipment" — Retain for at least 3 years, and retain with related inspection records if product traceability is involved.

5.5 "Application Form for Configuration of Monitoring and Measurement Resources," "Application Form for Suspension/Sealing/Scrapping of Equipment," and "Handover Record for Equipment Borrowing and Returning" — Retain for at least 2 years.

5.6 Record management is executed according to the "Procedure for Control of Records" (the 4th document in the package), and records should be clear, complete, and traceable.

6. Related Documents

6.1 "Quality Manual" — Chapter 7.1.5 "Monitoring and Measurement Resources."

6.2 "Procedure for Control of Documents," "Procedure for Control of Records," "Procedure for Control of Purchasing and External Provision," "Procedure for Management of Infrastructure and Equipment," "Procedure for Human Resource Management," "Procedure for Control of Nonconforming Products."

6.3 Third-level documents: "Work Instruction for Calibration and Periodic Check of Measuring Instruments," "Work Instruction for Incoming Inspection," "Work Instruction for Process Inspection," "Work Instruction for Final Product Inspection," and various operating procedures for measurement equipment.

6.4 Referenced standards and regulations: "The Metrology Law of the People's Republic of China," ISO 9001:2015 "Quality Management System — Requirements," JJF 1001 "General Metrological Terms and Definitions," national metrological verification regulations, and calibration specifications.

Usage Instructions

1. How to Modify According to Actual Corporate Conditions

1. Organizational Structure Adaptation: The metrological function can be set up in the Quality Department, Equipment Department, or Technical Department. Just modify the corresponding department names in section 3 of the responsibilities and ensure that the responsible department has a dedicated person for inventory and plan management. In small enterprises, the Quality Department can designate a part-time metrologist.

2. Equipment Range Trimming: The inventory range should be "as much as needed" but not overly expanded—only include equipment used for product conformity judgments and critical process monitoring. Tools like tape measures and steel rulers used on the production floor can be excluded from control, but this exclusion should be clearly stated in the procedure to avoid being questioned during audits.

3. Determination of Calibration Cycle: For new enterprises, a uniform 12-month cycle can be initially applied. After 1 to 2 years of operation, the cycle can be appropriately extended to 18 to 24 months based on historical calibration data (consistent qualification, stable deviation), or shortened to 6 months for frequently out-of-tolerance equipment, forming a "data-driven cycle optimization."

4. Product Type Adaptation: Electronics enterprises should add controls for static protection, salt spray test chambers, and aging test equipment; chemical enterprises should include balances, pH meters, and viscometers; service enterprises can incorporate satisfaction survey systems and monitoring systems into monitoring resources, clearly defining their confirmation methods.

5. Integration of Outsourced Testing: If some projects are outsourced to external laboratories for testing (such as RoHS, mechanical properties), the procedure should specify that the laboratories must have CNAS/CMA qualifications, and the outsourced test reports should be included in the management of measurement results.

2. Audit Focus Points (Common Check Items for External and Internal Audits)

1. On-site random checks of 3 to 5 in-use devices to verify that the inventory information, status labels, and calibration validity periods are consistent; focus on whether there are "labels within the valid period but actually overdue" or "in-use devices without labels."

2. Check if the annual calibration plan covers all controlled devices, whether the plan execution rate is 100%, and whether there are approval procedures and risk assessments for delayed calibrations.

3. Review calibration certificates: Verify that the device numbers and names on the certificates match the inventory, and whether they indicate traceability to national standards or the International System of Units (SI); devices with only a "conformity certificate" and no traceability information should not be incorrectly considered as calibrated.

4. Inquire whether periodic checks are conducted for key devices, whether the check standards are reliable, and whether the check records are complete.

5. Traceability Verification: Retrieve a historical case of a misaligned device to check whether a traceability evaluation was conducted for the affected products, whether the evaluation conclusions are reasonable, and whether the records are closed-loop.

3. Common Error Reminders

1. Only building an inventory without implementing the plan—complete inventory but widespread overdue calibrations, a high-risk area for nonconformities during internal audits; it is recommended that the Quality Department export a "near-expiry device list" monthly to warn 1 month in advance.

2. Formalistic label management—failing to replace labels promptly after calibration, labels without validity period information, leading to inability to determine the status of devices on-site.

3. Ignoring software confirmation—only calibrating the hardware of software-equipped inspection systems (such as coordinate measuring machine software, image measurement instruments) without confirming the software, which can lead to nonconformities during audits.

4. Superficial traceability evaluation—only replacing the device after misalignment without evaluating the measurement results of affected products during the misalignment period, causing potential nonconforming products to be overlooked.

5. Incorrect use of symbols: In this procedure and related forms, time cycles should be uniformly expressed using full-width "～" (e.g., 6～12 months), avoiding the use of half-width "~".

Accurate and traceable measurements ensure reliable judgments.

Knowledge code: 2.3.1

Version: v20260809

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