The ISO system audit is coming, what materials should be prepared? The data list is super useful!

Date：2020/9/8　　Clicks：1290

ISO9001: 2015 Quality Management System

1. Personnel Administration Department

1. Company organization chart, job responsibilities; department organization chart and job responsibilities

2. Training schedule of the company last year and this year

3. New personnel training records must be complete

4. Personnel file roster

5. Signing the labor contract and work injury insurance

6. Statistical analysis of turnover rate

7. Certificate of employment for special jobs, such as electrician certificate

2. Quality Department
1. Department organization chart and job responsibilities.

2. Customer complaint resume

3. Process monitoring (incoming material, first piece, inspection record form, finished product inspection form, shipment inspection form, quality exception handling sheet)

4. Treatment of unqualified products [unqualified incoming materials (unqualified material handling form, special procurement form), unqualified manufacturing process (abnormal quality handling form), unqualified finished product inspection (abnormal quality handling form)]

5. Internal audit schedule

6. Internal Audit Report

7. Management review report

8. Department personnel training and related records (sign-in form and records, assessment, post certificate)

9. Monitoring and measurement equipment management (measurement equipment account, instrument calibration schedule, instrument calibration certificate), external calibration report of company equipment and internal calibration records

10. 8D response to major customer complaints

11. Quality reports, statistical analysis of data (daily, weekly, monthly)

12. Quality target statistics and implementation status, tracking records (on a monthly basis), improvement reports

13. Inspection record report (incoming material, process, finished product shipment inspection report)

14. Document control center, document management (internal document/external document list, legal and regulatory document list, document receiving and dispatching record management, management of expired and obsolete documents)

3. Production Department

1. Department organization chart and job responsibilities

2. Production process flow chart

3. Production report

4. Workshop management system

5. Related process processing or test records

6. Maintenance record, scrap application form, scrap rate control

7. The fulfillment of order delivery

8. 6S management status (main on-site inspection: corresponding SOPs should be attached to the workshop process, material labels should be affixed to glue bottles, etc., zebra crossings and signs in the work area, chemical areas and signs, and qualified and unqualified products are divided and marked. , Color box management), employees at the production site must wear related labor insurance products such as masks

9. Equipment Check List

4. Purchasing Department
1. Department organization chart and job responsibilities

2. List of qualified suppliers

3. Supplier Survey Form

4. Supplier Evaluation Form

5. Monthly and annual supplier evaluation form

6. Procurement plan

7. Environmental protection materials of key materials need to prepare effective third-party inspection reports (valid for one year)

5. Warehouse Department
1. Department organizational structure and job responsibilities

2. How to implement first-in first-out management

3. Inventory management

4. Inventory records

5. Material receiving and dispatching management account

6. Accounts, things, and cards are consistent

7. Fire safety

8. Warehouse Management Regulations

9. The temperature and humidity point inspection record table of the electronic silo and solder paste in the warehouse

6. Technology, R&D, Engineering, and Equipment Department
1. Department organizational structure and job responsibilities

2. Design and development task book

3. New product review meeting and records

4. Trial production report

5. Design more management

6. Design and development project plan

7. Technical data drawing management

8. Related product work instructions SOP

9. Equipment management account

10. This year's annual equipment maintenance schedule

7. Sales Department
1. Contract order review record

2. Customer Satisfaction Survey Form

3. Customer complaint information feedback form

4. New Year Sales Plan

8. PMC Department
1. Production weekly/monthly schedule, plan and delivery achievement rate

9. Representatives of managers
1. Setting of quality goals for the new year

2. Management review

3. Company quality planning

4. Decisions on handling major quality accidents

10. General Manager's Office
1. Resource Management

2. Resolutions on appointment of major personnel

3. Company development plan and direction

ISO14001: 2015 Environmental Management System

1. Each department
1. In accordance with the "Waste Management Regulations", each department shall mark the waste collection containers of the department, and strictly follow the waste classification and storage, and implement education and training for employees to fully understand and understand.

2. Daily inspection and maintenance records of machinery and equipment (inspection records, spot inspection records, processing records, etc.)

2. Warehouse
1. Chemical management (MSDS, masks, gloves, chemical management by personnel, etc.)

2. List of dangerous chemicals

3. Maintenance Department
1. Equipment inspection and maintenance records (waste water treatment system, air compressor and other large machines)

2. Special equipment use safety inspection certificate (elevator, gas storage tank, etc.)

4. Document Control Department
1. Business License

2. Pollution Discharge Permit

3. Environmental monitoring report (waste water, exhaust gas, noise, oil fume)

4. Proof of wastewater, hazardous solid waste, and septic tank cleaning (five forms)

5. Environmental Information Exchange Form for Related Parties

6. Environmental impact assessment report --- The pre-evaluation of environmental impact and its conclusions will be carried out by a legally qualified environmental impact assessment agency;

7. EIA Approval---Approval opinions on EIA reports or declaration forms issued by the Environmental Protection Agency

8. Three simultaneous acceptance report

9. Waste treatment and industrial service contracts

10. List of important environmental factors

11. Environmental target index management plan

12. Environmental Factors Survey Form

13. List of applicable regulations and other compliance evaluations

14. Environmental factor evaluation form

15. Environmental Management Plan

16. Target completion statistics

17. Internal audit (plan, report, checklist)

18. Management review (plan, report, meeting minutes)

5. Administration Department
1. Fire acceptance certificate

2. Fire drill training and drills (including two annual plans and reports for the previous year and this year)

3. Chemical leakage training and exercises (including two annual plans and reports for the previous year and this year)

4. Training plans and training records related to ISO14001 management system (relevant plans and records for the previous year and two years this year)

5. Classification of trash bins [recyclable (green), non-recyclable (yellow), hazardous solid waste (red)]

6. Fire engineering maintenance contract

7. File/list of emergency facilities (such as forklifts, generators, fire extinguishers, etc.)

8. Chemical dangerous goods management personnel (trained, preferably hold an external training certificate)

9. Plant layout plan, sewage discharge plan

IATF16949: 2016

1. General Department
1. Qualification certificate (such as internal auditor certificate)

2. Organization Chart

3. Document control (document list, document manuscript, document identification, controlled state, document distribution record, document modification record, document destruction record)

4. Preparation and completion rate of production plan

5. Annual training plan and completion status (including training record sheet)

6. Job description and qualifications

7. Investigation and statistical analysis of internal employee satisfaction

8. Staff turnover analysis and improvement report

2. Purchasing Department
1. Supplier Survey Form

2. Supplier information (business license, system certificate, etc.)

3. Supplier Quality Management System Development Plan

4. Last year’s supplier audit plan and audit report

5. Monthly Supplier Performance Evaluation

6. List of qualified suppliers

7. List of qualified materials

3. Marketing Department
1. List of major customers

2. List of customer requirements (customer special requirements, quality technical agreements, product drawings, product development agreements, etc.)

3. Customer Satisfaction Survey Form

4. Customer satisfaction statistical summary analysis report

5. Customer complaint list

4. Technical Department
1. APQP full set of materials, PPAP, FMEA, product list, customer special requirements for newly developed products

2. List of countries/industry/company/other standards and quality standards to which the product applies

5. Quality Department
1. Various inspection records (receipt, process, finished product, full size)

2. Test records (performance test report, third-party test report)

3. Material report (provided by the supplier)

4. Process diagram

5. Quality goal achievement table and its trend (KPI)

6. System audit plan and audit report

7. Process audit plan and audit report

8. Product audit plan and audit report

9. Management review and review report

10. Summary of customer two-party audit

11. Customer Scorecard

12. List of measuring and testing equipment and verification certificate

13. List of system documents and records

14. Control of non-conforming products

15. Acceptance data of tooling and molds (one-time inspection pass rate, rework rate, scrap rate)

6. Production Department
1. Equipment ledger (identify key equipment)

2. Tooling Ledger

3. Special equipment verification certificate

4. Equipment maintenance plan/record/check sheet

5. Equipment maintenance records and equipment failure downtime rate statistics

6. Delivery time rate statistics

7. Finance Department
1. Statistics of the company's quality cost, including internal loss cost and external department loss cost accounting

8. Representatives of managers
1. Performance report of quality objectives

2. Company annual business plan

3. Formulation of plans for annual quality management system audit, product audit, and process audit

4. Organization and implementation of quality management system audit, process audit and product audit

5. Implementation of annual management review and determination of improvement projects

ISO22000: 2018 Food Safety Management System

1. Office
1. List of system documents

2. System Record List

3. Document issuance registration form

4. Change Record

5. Annual training plan and training records

6. List of personnel

7. Personnel Ability Confirmation Form

8. Internal audit records

9. Management review records

2. Supply and Marketing Department
1. List of raw material suppliers

2. Supplier’s business license

3. Production License

4. Type inspection report of sanitary indicators

5. Supplier evaluation record

6. Procurement plan/receipt records, etc. (including raw materials, auxiliary materials, additives and internal packaging materials) acceptance records

7. Customer Feedback Record

8. Product recall records or withdrawal of simulation exercise records

3. HACCP team
1. Emergency records or emergency plan drill records

2. HACCP plan

3. OPRP confirmation record

4. Verification Record

5. Control measure combination confirmation record

6. Analysis of the results of verification activities

7. Organize the company's improvement plan or improvement needs

4. Production Department (including workshop)
1. Equipment maintenance plan combined with maintenance records

2. Environmental sanitation control records (plant and workshop sanitation control, food contact surface disinfection control, hand washing disinfection control, chemical control, disinfectant preparation and concentration monitoring records, facilities and environmental disinfection records, pest control, personnel sanitation control, Control of outsiders or pollutants)

5. Quality Inspection Department
1. List of monitoring equipment

2. Compulsory inspection equipment account, periodic inspection schedule and inspection certificate

3. Incoming inspection records

4. Process inspection records

5. Finished product delivery inspection (the project meets the requirements of the delivery inspection items specified in the standard)