Summary Checklist of Preparation Materials Before ISO System Certification Audits!

 

When auditing various ISO systems, preparing the necessary materials is a headache for many quality personnel. Below, we list and explain the materials that need to be prepared during system certification audits for your reference. Quality personnel can adjust according to their company's actual situation.

ISO9001:2015 Quality Management System

 

1. Management of Documents and Records:  

1.  The office should have a complete list of blank forms for all documents and records;  

2.  List of external documents (related to quality management, product quality standards, technical documents, materials, etc.), especially documents of mandatory national laws and regulations and records of their distribution control;  

3.  Document distribution records (each department must have them)  

4.  Controlled document list for each department, including: quality manual, procedure documents, supporting documents of each department, external documents (national, industry standards, etc.; materials affecting product quality, etc.);  

5.  Quality record list for each department;  

6.  Technical document list (drawings, process regulations, inspection procedures, and distribution records);  

7.  All types of documents must be reviewed, approved, and dated;  

8. All quality record signatures must be complete;  

2. Management Review:  

9.  Management review plan;  

10.  Management review meeting "sign-in sheet";  

11.  Management review records (reports from management representatives, discussions or written materials from participants);  

12.  Management review report (contents are in the "procedure documents");  

13.  Rectification plans and measures after management review; records of corrective, preventive, and improvement actions.   

14.  Follow-up verification records.  

3. Internal Audit:  

15.  Annual internal audit plan;  

16.  Internal audit plan and schedule  

17.  Appointment letter of internal audit team leader;  

18.  Copy of internal auditor qualification certificates;  

19.  First meeting records;  

20.  Internal audit checklist (records);  

21.  Final meeting records;  

22.  Internal audit report;  

23.  Nonconformity reports and verification records of corrective actions;  

24.  Relevant records of data analysis;  

4. Sales:  

25.  Contract review records; (order review)  

26.  Customer ledger;  

27. Customer satisfaction survey results, customer complaints, grievances, and feedback information, ledgers, records, and statistical analysis to determine if quality objectives are met;  

28.  After-sales service records;  

5. Procurement:  

29. Qualified supplier evaluation records (including subcontractor evaluations); and materials evaluating supplier performance;  

30. Qualified supplier quality ledger (how much material was purchased from a supplier, whether it is qualified), procurement quality statistical analysis, and whether quality objectives are met;  

31. Procurement ledger (including subcontracted product ledger)  

32.  Procurement list (should have approval procedures);  

33.  Contracts (should be approved by department heads);  

6. Warehouse and Logistics Department:  

34.  Detailed ledgers of raw materials, semi-finished products, and finished products;  

35.  Identification of raw materials, semi-finished products, and finished products (including product identification and status identification);  

36.  Inbound and outbound procedures; management of first-in, first-out.  

7. Quality Department

37.  Control of nonconforming measuring instruments and tools (scrapping procedures);  

38.  Measuring instrument calibration records;  

39. Completeness of quality records in each workshop

40.  Detailed tool ledger;  

41.  Detailed measuring instrument ledger (should include calibration status, calibration date, re-calibration date) and preservation of calibration certificates;       

8. Equipment:  

41.  Equipment list;  

42.  Maintenance plan;  

43.  Equipment maintenance records;

44.  Special process equipment approval records;  

45.  Identification (including equipment identification and equipment integrity status identification);    

9. Production:  

46. Production plan; and records of planning for production and service process realization (meetings); 

47.  List of completed production plan projects (ledger);  

48.  Nonconforming product ledger;  

49.  Records of nonconforming product handling;  

50.  Inspection records and statistical analysis of semi-finished and finished products (whether the pass rate meets quality objectives);  

51.  Various regulations, markings, and safety measures for product protection and storage;  

52.  Training plans and records for each department (business technical training, quality awareness training, etc.);  

53.  Operation documents (drawings, process regulations, inspection procedures, operation procedures on site);  

54.  Key processes must have process regulations;  

55.  On-site markings (product markings, status markings, equipment markings);  

56.  Uncalibrated measuring tools must not appear on the production site;  

57.  Each type of work record in each department should be bound into volumes for easy retrieval;  

10. Product Delivery:  

58.  Shipping plan;  

59.  Shipping list;  

60.  Evaluation records of the carrier (also part of qualified supplier evaluation);  

61.  Records of customers receiving goods;  

11. Human Resources and Administration Department:  

62.  Job position requirements;  
63.  Training needs of each department;  

64.  Annual training plan;  

65.  Training records (including: internal auditor training records, quality policy and objectives training records, quality awareness training records, quality management system document training records, skills training records, inspector on-the-job training records, all should have corresponding assessment results)  

66.  List of special types of work (approved by relevant responsible persons for on-the-job, and related certificates);  

67.  List of inspectors (appointed by relevant responsible persons, with defined duties and authorities);  

12. Safety Management:  

68.  Various safety regulations (relevant national, industry, and company laws and regulations, etc.);  

69. Firefighting equipment and facility list;  

ISO14001:2015 Environmental Management System

 

1. Documents proving compliance with mandatory laws and regulations 

1. Environmental impact assessment and approval 

2. Pollution discharge monitoring report (must be qualified) 

3. "Three Simultaneities" acceptance report (if necessary) 

4. Pollution discharge permit 

5. Fire safety acceptance report 

6. Hazardous waste disposal contracts and transfer forms (must not be omitted, mainly 5-part forms; regular waste disposal must also be recorded, including lamps, toner, waste oil, waste paper, scrap iron, etc.) 

2. Documents proving system compliance 

7. List of environmental factors and significant environmental factors 

8. Target indicator management plan 

9. Monitoring records of target indicator management plan 

10. List of applicable environmental laws, regulations, and other requirements (the list must include all laws and regulations related to the company's products; for electronics companies, pay attention to EU ROHS and China ROHS, and update all laws and regulations to the latest versions; if local regulations exist, please collect them.) 

11. System monitoring records (regular 5S or 7S inspection records) 

12. Compliance assessment of laws/regulations and other requirements 

13. Environmental training plan (including training plans for key positions) 

14. Emergency facility files/lists 

15. Emergency facility inspection records 

16. Emergency drill plans/reports 

17. Mandatory inspection reports for special equipment and safety accessories (forklifts, cranes, elevators, air compressors, air tanks and pressure gauges/safety valves, overhead cableways, boilers and pressure gauges/safety valves, pressure pipelines, other pressure vessels, etc.) 

18. Special equipment use permits (forklifts, elevators, cranes, air tanks, etc.) 

19. Special operation personnel qualification certificates or copies 

20. Internal audit and management review related records. 

21. Calibration of measuring equipment 

22. Plans and records (photos) of fire safety, production safety, first aid, anti-terrorism drills, etc.

ISO45001:2018 Occupational Health and Safety Management System

1. Business license of the enterprise

2. Organization code certificate

3. Production safety license

4. Production process flowchart and description

5. Company profile and scope of system certification description

6. Occupational health and safety management system organizational chart

7. Appointment letter of occupational health and safety management system management representative

8. Company employees' participation in occupational health and safety management

9. Employee Representative Appointment Letter and Election Records

10. Company Plant Layout Plan (Pipeline Network Map)

11. Company Electrical Circuit Layout Plan

12. Emergency Escape Plans and Personnel Safety Assembly Points for Each Floor of the Company

13. Company Hazard Source Location Map (indicating important locations such as generators, air compressors, oil depots, hazardous material warehouses, special work posts, and other locations generating exhaust gas, noise, dust, and other hazards)

14. Occupational Health and Safety Management System Related Documents (Management Manual, Procedure Documents, Work Instruction Documents, etc.)

15. Formulation, Understanding, and Promotion of Occupational Health and Safety Management System Policy

16. Fire Safety Acceptance Report

17. Safety Production Law Compliance Certificate (required for high-risk production enterprises)

18. Internal/External Information Feedback Forms (Raw Material Suppliers, Transportation Service Units, Canteen Contractors, etc.)

19. Internal/External Information Feedback Data (with Suppliers and Customers)

20. Internal/External Information Feedback Data (with Employees and Government Agencies)

21. ISO45001 Occupational Health and Safety Awareness Training

22. Basic Knowledge of Occupational Health and Safety

23. Fire and Other Emergency Drill Exercises (Emergency Preparedness and Response)

24. Materials for Three-Level Safety Education

25. List of Personnel in Special Posts (Occupational Disease Posts)

26. Training Status of Special Work Types

27. On-site 5S Management and Safety Production Management

28. Hazardous Chemicals Safety Management (Usage and Protective Management)

29. On-site Safety Signage Knowledge Training

30. Personal Protective Equipment (PPE) Usage Knowledge Training

31. Knowledge Training on Laws, Regulations, and Other Requirements

32. Personnel Training on Hazard Identification and Risk Assessment

33. Training on Occupational Safety and Health Responsibilities and Authorities (Job Responsibility Descriptions)

34. Distribution of Major Hazard Sources and Risk Control Requirements

35. List of Applicable Health and Safety Laws, Regulations, and Other Requirements

36. Summary of Applicable Health and Safety Regulatory Provisions

37. Compliance Evaluation Plan

38. Compliance Evaluation Report

39. Departmental Hazard Identification and Evaluation Form

40. Summary List of Hazard Sources

41. List of Major Hazard Sources

42. Control Measures for Major Hazard Sources

43. Incident Handling Status (Four No-Release Principles)

44. Hazard Identification and Evaluation Form for Related Parties (Chemical Hazardous Material Carriers, Canteen Contractors, Vehicle Service Units, etc.)

45. Proof of Impact Imposed by Related Parties (Surrounding Factories, Neighbors, etc.)

46. Occupational Health and Safety Agreements with Related Parties (Chemical Hazardous Material Carriers, Transportation Service Units, Canteen Contractors, etc.)

47. List of Hazardous Chemicals

48. On-site Safety Labels for Hazardous Chemicals

49. Chemical Spill Emergency Facilities

50. Safety Characteristics Sheet of Hazardous Chemical Substances

51. Safety Inspection Checklist for Hazardous Chemical Warehouses and Oil Depot On-site Safety Inspection Checklist

52. Material Safety Data Sheet (MSDS) for Hazardous Chemicals

53. Overview of Occupational Health and Safety Management System Objectives, Indicators, and Management Plans

54. Checklist for Execution of Objectives/Indicators and Management Plans

55. System Operation Checklist

56. Regular Health and Safety Inspection Form for Work Sites

57. Safety Professional Inspection Checklist for High and Low Voltage Distribution Stations

58. Annual Health Professional Inspection Checklist for Generator Rooms

59. Safety Monitoring Plan for Engine Rooms

60. Records of Occupational Diseases, Work Injuries, Accidents, and Incident Handling

61. Occupational Disease Medical Examination and General Employee Medical Examination Status

62. Company Health and Safety Monitoring Reports (Water, Air, Noise, Dust, etc.)

63. Emergency Drill Record Forms (Firefighting, Escape, Chemical Spill Drills)

64. Emergency Plans (Fire, Chemical Spill, Electric Shock, Poisoning Accidents, etc.) and Emergency Contact Lists

65. Emergency Situation List/Summary

66. Emergency Team Leader and Member List or Appointment Letters

67. Fire Safety Inspection Record Forms

68. General Safety and Fire Inspection Checklist for Holidays

69. Firefighting Equipment Inspection Records

70. Escape Plans for Each Floor/Workshop

71. Records of Usage and Maintenance Updates for Safety Equipment (Fire Hydrants/Fire Extinguishers/Emergency Lights, etc.)

72. Safety Inspection Reports for Cranes and Elevators

73. Calibration Certificates for Safety Valves and Pressure Gauges of Boilers, Air Compressors, Air Tanks, and Other Pressure Vessels

74. Certification Status of Special Operation Personnel (Electricians, Boiler Operators, Welders, Crane Operators, Pressure Vessel Operators, Drivers, etc.)

75. Safety Operating Procedures (Cranes, Pressure Vessels, Motor Vehicles, etc.)

76. Audit plans, attendance sheets, audit records, non-conformance reports, corrective actions and verification materials, audit summary reports

77. Management review plans, review input materials, attendance sheets, review reports, etc.

78. Workshop on-site environmental safety management

79. Machine and equipment safety management (poka-yoke management)

80. Canteen management, vehicle management, public area management, personnel business trip management, etc.

81. Hazardous waste recycling sites must have containment containers with clear labeling

82. Chemical use and storage areas equipped with corresponding MSDS sheets

83. Chemical storage equipped with related fire-fighting facilities and leak prevention facilities

84. Warehouses have ventilation, sun protection, explosion-proof lighting, and temperature control facilities

85. Warehouses (especially chemical warehouses) have fire-fighting equipment, leak prevention, and emergency leak response facilities

86. Identification and isolated storage of chemically incompatible or reactive chemicals

87. Status of safety facilities at production sites: protective barriers, guards, dust removal equipment, silencers, shielding facilities, etc.

88. Safety status of auxiliary equipment and facilities: power distribution rooms, boiler rooms, water supply and drainage facilities, generators, etc.

89. Management status of chemical hazardous goods warehouses (types stored, quantities, temperature, protection, alarm devices, leak emergency measures, etc.)

90. Fire-fighting equipment availability: fire extinguishers, fire hydrants, emergency lights, fire escape routes, etc.

91. Whether on-site operators wear personal protective equipment

92. Whether on-site employees operate according to safety operating procedures

93. High-risk industries should confirm whether sensitive areas exist around the enterprise (e.g., schools, residential areas, etc.)

ISO22000:2018 Food Safety Management System

1. Copies of legal and valid proof of legal status documents (business license or other legal status proof documents, organization code, etc.);

2. Copies of legal and valid administrative license documents and filing certificates (if applicable), such as permits, etc.;

3. The management system must have been in operation for no less than 3 months, and provide current valid management system documents;

4. List of applicable laws, regulations, standards, and norms complied with during production, processing, or service in China and the importing country (region);

5. Description of processes, products, and services involved in the system or product, process flowcharts, process descriptions;

6. Organizational chart and description of responsibilities;

7. Organizational layout plan, plant location map, floor plan;

8. Processing workshop floor plan;

9. Food hazard analysis, operational prerequisite programs, HACCP plans, and evaluation checklists;

10. Description of processing production lines, HACCP project implementation, and shifts;

11. Description of food additive usage, including names of additives used, amounts, applicable products, and limit standards;

12. List of applicable laws, regulations, standards, and norms complied with during production, processing, or service in China and the importing country (region);

13. When products implement enterprise standards, provide a copy of the product standard text stamped by the local government standardization administrative department;

14. List of main production and processing equipment and inspection equipment;

15. Description of outsourced processing (if important food safety-related production processes are outsourced, please provide additional pages explaining:

(1) Name, address, and number of personnel of the outsourcing organization;

(2) Specific outsourced processes;

(3) Whether the outsourcing organization has obtained food safety management system certification or HACCP certification; if certified, provide a copy of the certificate; if not certified, WSF will arrange on-site audits of the outsourced processing;

16. Relevant evidence that products meet hygiene and safety requirements; if applicable, provide evidence from qualified inspection agencies that water, ice, and steam in contact with food meet hygiene and safety requirements;

17. A self-declaration committing to comply with relevant laws, regulations, certification body requirements, and the authenticity of provided materials.

ISO/IEC27001:2013

1. Organization's legal proof documents, such as business license and annual inspection certificate copies (with official seal);

2. Copies of organization code certificate and tax registration certificate (with official seal);

3. Proof documents of effective operation of the applicant organization's information security management system (such as system document release control forms, timestamped records, etc.);

4. Introduction of the applicant organization:

4.1 Organization introduction (about 1000 words);

4.2 Main business processes of the applicant organization;

4.3 Organizational chart or functional description documents;

5. System documents of the applicant organization, including but not limited to (can be combined):

5.1 Information Security Management System (ISMS) policy document;

5.2 Risk assessment procedures;

5.3 Statement of applicability;

5.4 Risk treatment procedures;

5.5 Document control procedures;

5.6 Record control procedures;

5.7 Internal audit procedures;

5.8 Management review procedures;

5.9 Corrective and preventive action procedures;

5.10 Procedures for measuring the effectiveness of control measures;

5.11 Functional role assignment table;

5.12 The entire system document structure and list.

6. Explanation of the correspondence between the applicant organization's system documents and the requirements of GB/T22080-2008/ISO/IEC27001:2005;

7. Proof materials of internal audits and management reviews of the applicant organization;

8. Confidentiality or sensitivity declaration records of the applicant organization;

9. Other supplementary materials required by the certification body for the applicant organization.