ISO 9001 system, ISO 14001 system, ISO 45001 system

The three-system certification is also called three-standard system certification or integrated three standards, including the ISO 9001 Quality Management System, the ISO 14001 Environmental Management System, and the ISO 45001 Occupational Health and Safety Management System.Based on national laws and regulations such as the Product Quality Law, Standardization Law, and Metrology Law, as well as product standards (including national, industry, and enterprise standards). Through the establishment of organizational structures, the setting of positions, the division of job responsibilities, and the formulation of job regulations and procedures, effective operation and control are carried out in aspects such as personnel, workplace, equipment and facilities, business items, and environmental impact, so as to achieve personnel safety, quality assurance, environmental protection, customer satisfaction, and enterprise benefits — a macro-level management philosophy.

Similarities and differences in implementing the three management system standards: ISO 9001, ISO 14001, and ISO 45001:

1. Similarities in implementing the three ISO standards:

1. The overall policy and objectives for implementing management in the organization are the same.

2. The three standards use a common process pattern structure, which is similar in structure for ease of use.

3. The principles of all systems are the PDCA (Plan-Do-Check-Act) cycle.

4. All require a documented management system.

5. All clearly require a documented division of responsibilities.

6. All have proposed achieving continuous improvement through system operation.

7. All have made commitments to comply with regulations and other requirements.

8. All propose using internal audits and management reviews to evaluate the effectiveness, suitability, and conformity of system operation.

9. All require management review of non-conformities and strengthening of training and education.

10. All require the organization‘s top management to appoint a management representative responsible for establishing, maintaining, and implementing the management system.

2. The biggest difference in implementing the three ISO standards is that they target different objects:

1. The quality management system established in accordance with the ISO 9001 standard has the customer as its object.

2.The environmental management system established in accordance with the ISO 14001 standard has society and interested parties as its objects.

3. The occupational safety and health management system established in accordance with the ISO 45001 standard has employees as its object.

Documents required for ISO 9001 certification audit:

1. Latest organizational chart and quality manual;

2.List of latest procedure documents, list of third-level operational documents, and list of fourth-level records;

3.Product process flow chart, QC engineering chart;

4. List of external documents;

5.List of organizational knowledge;

6.Organizational risk and opportunity management control list (2015 new version);

7.Monitoring and review form for the organization‘s internal and external environment and interested parties (2015 new version);

8.Latest internal audit plan, checklist, non-conformity reports, and summary report;

9.Latest management review plan, report, and quality objective achievement statistics table;

10.List of Qualified Suppliers and Initial Evaluation Form, Annual Review Form (Including Outsourced Parties);

11.Latest Customer Satisfaction Survey Form and Analysis Report;

12.Complete set of design and development planning, input, output, review, verification, and validation documentation for the past year for products within the certification scope of the certificate;

13.Customer complaint handling statistical report, 8D report;

14.List of production equipment and testing instruments (must include annual external calibration reports);

15.Business orders and contract review documents for the past year within the certification scope of the certificate;

16.Inspection records (IQC, IPQC, OQC, QA), first article inspection records, nonconforming product handling records, corrective and preventive actions, and records of continual improvement;

17.Daily production report, production schedule, consistency between SOP training and learning for production process steps and actual operations, equipment maintenance and check sheet, special process validation record;

18.Annual training plan, training assessment records, special operator training and assessment, and qualification certificates/work permits.

Documents required for ISO 14001/ISO 45001 certification audit:

1.Latest organizational chart, EHS manual, procedure documents, and list of third-level documents;

2.Latest list of environmental aspects and hazard sources for each department;

3.EHS objectives, targets, and program management table;

4.Organizational risk and opportunity management list;

5.Monitoring and review form for the organization‘s internal and external environment and interested parties;

6.Latest list of EHS laws, regulations, and other requirements, along with evaluation form;

7.Latest internal audit plan, checklist, non-conformity reports, and summary report;

8.Latest management review plan, report, and statistics table on EHS objective achievement;

9.Emergency plans and drill records for fire drills, leakage drills, and environmental protection equipment failure drills;

10.Environmental impact assessment report, approval documents, and "three simultaneities" acceptance report;

11.Latest monitoring reports for wastewater, exhaust gas, and boundary noise (consistent with environmental approval requirements, such as whether there are generators, canteens, etc.), hazardous waste transfer contracts and manifests;

12.Annual training plan, special operator training assessment records, and special operator qualifications;

13.Chemical warehouse safety signs, protective equipment, MSDS control sheet, eyewash stations, etc.;

14.Resource and energy (water, electricity, oil) consumption statistics table, EHS system expense input detail table;

15.On-site waste sorting control and signage, especially hazardous chemical warehouse signs and inventory list;

16.Fire equipment inspection ledger and emergency evacuation route map (with contact person names and phone numbers);

17.Fire organization chart and emergency command chart;

18.Building fire safety acceptance report and secondary renovation fire safety acceptance report;

19.Evidence of EHS influence on interested parties, such as letters to visitors and EHS agreements;

20.Occupational health and safety affairs representatives (employee representatives), first-aider qualifications;

21.External calibration reports and certificates for pressure vessels, and whether there are special equipment qualification certificates for cranes, etc.;

22.Evidence of social insurance, work injury insurance, and commercial accident insurance purchase;

23.Testing reports for indoor air, noise, and other occupational hazard workplaces, drinking water testing reports;

24.Occupational disease medical examination reports for employees in hazardous positions, annual physical examination reports for all employees;

25.First aid kit is provided on site;

26.Evidence of EHS operational control inspections.

ISO system certification process:

1.Preliminary preparation work

A documented quality management system has been established for more than three months; at least one internal quality management system audit and management review have been conducted, and the internal audit has covered all locations and standard clauses; provide the quality manual and procedure documents;

2.Communication

Exchange information with relevant parties, gain mutual understanding through personnel visits, telephone calls, faxes, electronic correspondence, etc., and determine the preliminary intention and feasibility of implementing certification.

3.Submit certification application

The interested applicant organization fills out the "Quality Management System Certification Application Form" and its attachment "Certification Information Survey Form." After the certification body reviews and approves the application, it will further contact the applicant organization, conduct an on-site visit if necessary, understand the basic situation of the auditee and the establishment and implementation of the quality management system, and issue a written quotation.

4.Sign the contract

After obtaining a clear intention to sign a contract from the applicant organization and completing the contract review, both parties sign the "Quality Management System Certification Service Contract". The certification body will designate an audit team leader who shall be responsible for carrying out and implementing the audit activities from the effective date of the contract.

Purpose of ISO Three-System Certification:

1. Implementing the ISO three-system standards can help enterprises achieve energy conservation and consumption reduction, optimize costs, and improve corporate image.

2. Strengthen quality management, improve enterprise efficiency; enhance customer confidence, expand market share.

3. Obtaining ISO three-system certification has become a pass to break down international green barriers and enter European and American markets, and has gradually become one of the essential conditions for organizations in their production, business activities, and trade.

4. Optimizing the internal quality structure management of the enterprise saves the effort and cost of audits on production service management across various processes.

5. Remain invincible in product quality competition, and facilitate international economic cooperation and technical exchange.

6. Mandatory bonus item in bidding, securing more development opportunities.