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

Document Description: This document is the implementation procedure for clause 7.1.5 "Monitoring and Measurement Resources" of the ISO 9001:2015 standard. It is a second-level document (procedure document) within the quality management system (QMS) and is used in conjunction with the "Infrastructure and Equipment Management Procedure" (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 qualified products or release of non-conforming products due to inaccurate measurements. It is applicable to various manufacturing, processing, and inspection companies that need to make 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 companies can simplify it for use in managing 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, maintaining the measurement traceability chain, and handling and evaluating equipment anomalies.

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 consistent with the requirements for 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 the ISO 9001:2015 standard 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 quality management system, 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 meters, and tachometers;

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

(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). These devices are managed by the respective departments and are not included in the controlled scope of this procedure.

3. Responsibilities

3.1 Quality Department (or Metrology Management Department):

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

(2) Prepare the annual calibration/verification plan, implement calibration, verification, and interim 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 (inaccurate, out-of-tolerance) measurement equipment.

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 custody, correct use, and maintenance of the equipment under their jurisdiction;

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

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

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

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 "Monitoring and Measurement Resource Configuration Application Form" 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 reports to the management representative for approval before transferring the application to the procurement department for implementation.

4.1.3 After the new equipment arrives, the Quality Department, together with the usage department, follows these steps for acceptance:

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

(2) Check the factory-issued certificate of conformity, calibration/verification certificate, or other traceability proof;

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

(4) Register the equipment in the "Monitoring and Measurement Equipment Inventory," assign a number, and affix a status label before putting it into use. If the acceptance is nonconforming, 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, 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 "Qualified" label: Calibrated/verified and within the validity period;

(2) Yellow "Conditional Use" label: Partial functions are normal and meet specific measurement purposes, or used at a lower level after calibration (must specify the allowable measurement range);

(3) Red "Suspended" label: Inaccurate, overdue for calibration, damaged and awaiting repair, or awaiting scrapping. 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 blurry, or is damaged, the usage department should report to the Quality Department for a replacement. Equipment whose status cannot be confirmed should be suspended from use and recalibrated before further use.

4.3 Calibration and Verification Management

4.3.1 The Quality Department compiles the "Annual Calibration/Verification Plan" by December each year, 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 and health 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 critical measurement equipment having a shorter cycle;

(3) Calibration/verification can be conducted by sending the equipment 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 prepare 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, updates the inventory, and replaces the green label if the results are qualified. If the results arenonconforming, the equipment is handled according to the 4.5 Abnormal Handling and Traceability process.

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

4.4 Interim Checks

4.4.1 The Quality Department should arrange interim 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 Interim checks can be conducted using the standard comparison method (regularly measuring and recording results using a stable standard), the equipment comparison method, or the re-measurement method. The check results are recorded in the "Interim Check Record Form." If an abnormality is found, handle it 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: calibration/verificationnonconformingor out-of-tolerance, damage or functional abnormalities, overdue for calibration, missing labels that prevent status confirmation, misuse, or impact from collisions.

4.5.2 The Quality Department organizes the handling of suspended equipment:

(1) If repairable, send it for repair and recalibrate/reverify, and resume use if qualified;

(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 reactivation, the equipment must be recalibrated/reverified and found to be qualified.

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

(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 disposal measures in the "Measurement Equipment Abnormal Handling and Traceability Record Form."

4.6 Use and Maintenance

4.6.1 Operators must be trained and qualified before operating 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 "Calibration and Interim Check Work Instruction" 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 appropriate 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, they must be re-confirmed, and the confirmation records should be archived. Confirmation methods include: testing with samples of known results, comparing with independently calibrated equipment, or 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 Qualified Equipment / Handling Suspended Equipment fornonconformingResults → Interim Checks (for Critical Equipment) → Use and Daily Maintenance → Suspending Use for Abnormalities → Traceability Evaluation and Disposal → Scrapping/Sealing and Inventory Cancellation

4.8 Related Forms and References

This procedure involves the following forms: "Monitoring and Measurement Equipment Inventory," "Monitoring and Measurement Resource Configuration Application Form," "Annual Calibration/Verification Plan," "Calibration/Verification Record," "Interim Check Record Form," "Measurement Equipment Abnormal Handling and Traceability Record Form," "Equipment Suspension/Sealing/Scrapping Application Form," and "Equipment Loan and Return Handover Record."

5. Related Records

5.1 "Monitoring and Measurement Equipment Inventory" — 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 "Interim Check Record Form" — Retain for at least 3 years.

5.4 "Measurement Equipment Abnormal Handling and Traceability Record Form" — Retain for at least 3 years, and retain in sync with related inspection records if they involve product traceability.

5.5 "Monitoring and Measurement Resource Configuration Application Form," "Equipment Suspension/Sealing/Scrapping Application Form," and "Equipment Loan and Return Handover Record" — Retain for at least 2 years.

5.6 Record management is conducted according to the "Record Control Procedure" (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 "Document Control Procedure," "Record Control Procedure," "Procurement and External Provision Control Procedure," "Infrastructure and Equipment Management Procedure," "Human Resources Management Procedure," "Nonconforming Product Control Procedure."

6.3 Third-level documents: "Calibration and Interim Check Work Instruction," "Incoming Inspection Work Instruction," "Process Inspection Work Instruction," "Finished Product Inspection Work Instruction," and various measurement equipment operating procedures.

6.4 Referenced standards and regulations: "People's Republic of China Metrology Law," 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 the Company's Actual Situation

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

2. Equipment Range Adjustment: The inventory range should be "as much as possible but not overly expanded" — only include equipment used for product conformity judgments and critical process monitoring. Tape measures and steel rulers used as ordinary tools 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 companies, a uniform 12-month cycle can be initially used. After 1 to 2 years of operation, the cycle can be appropriately extended to 18 to 24 months based on historical calibration data (continuous qualification, stable deviation), or shortened to 6 months for frequently out-of-tolerance equipment, forming a "data-based cycle optimization."

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

5. Outsourcing Testing Coordination: 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. Pay special attention to whether there are devices with "labels within the validity period but actually overdue" or "in-use devices without labels."

2. Check whether 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 that they indicate traceability to national standards or the International System of Units (SI). Check if devices with only a "certificate of conformity" and no traceability information are incorrectly treated as calibrated.

4. Inquire whether interim checks are conducted for critical equipment, whether the check standards are reliable, and whether the check records are complete.

5. Traceability Verification: Retrieve a historical case of an inaccurate device to check whether the affected products have been traced and evaluated, 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 — a complete inventory but widespread overdue calibrations is a high-risk area for internal audit nonconformities. It is recommended that the Quality Department export a "near-expiry equipment list" monthly to provide a 1-month early warning.

2. Formalistic label management — failing to replace labels promptly after calibration or labels lacking validity period information, leading to the inability to determine the status of the equipment on-site.

3. Ignoring software confirmation — only calibrating the hardware of detection systems (such as coordinate measuring software, image measurement instruments) without confirming the software, which can easily result in nonconformities during audits.

4. Superficial traceability evaluation — only replacing the equipment after inaccuracy without evaluating the measurement results of affected products during the period, leading to potential nonconforming products being overlooked.

5. Incorrect use of symbols: In this procedure and related forms, the expression of time cycles should uniformly use the full-width "～" (such as 6～12 months), avoiding the use of the half-width "~".

Accurate and traceable measurements ensure reliable judgments.

Knowledge Number: 2.3.1

Knowledge code: 2.3.1

Version: v20260809

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