The ISO management system certification follows a closed-loop logic of “Plan-Establish-Audit-Maintain.” The entire process is divided into four core stages, with tasks and outputs clearly corresponding to each stage, as detailed in the table below:

Stage 1: Preparation & Planning – Laying the Certification Foundation

The core objective of this stage is to establish a common understanding, define clear goals, and ensure all subsequent activities are carried out accurately and efficiently, thereby avoiding any waste of resources.

• Decision & Objective Setting: Top management must define the core value of certification (e.g., improving quality control, meeting customer requirements), set quantifiable objectives, and commit to providing necessary resources (human, financial, etc.), formalized in a Certification Objective Confirmation Document.

• Forming the Core Implementation Team: Establish a cross-departmental team (covering key departments like production, R&D, sales, administration), appoint a dedicated Management Representative, and clearly define their authority and responsibility for “coordinating the establishment and maintenance of the system,” ensuring departmental collaboration.

• In-depth Standard Training: Organize specialized ISO standard training for the implementation team and key employees (recommended in conjunction with authoritative institutions), focusing on mastering the core clauses, the logical framework of the standard, and how it integrates with business operations.Maintain complete training attendance records, assessment scores, etc.

• System Gap Analysis & Plan Development: Led by the implementation team, conduct a comprehensive review of existing company systems and processes against the ISO standard requirements, resulting in a System Gap Analysis Report. Based on the gaps, develop the System Implementation Plan, specifying tasks, responsible persons, timelines, and acceptance criteria for each stage. Publish and execute upon approval by top management.

Stage 2: System Establishment & Trial Run – Achieving Standard Implementation

This stage is the critical phase for translating ISO standards into actionable company systems. Ensure documents are “practical and operable,” avoiding a “disconnect between documentation and practice.”

• Tiered Documentation Development: Build the documentation system based on a four-tiered structure: “Policy – Process – Operation/Instruction – Evidence”, ensuring cohesion between levels:

  • Level 1 Documents (Manual): Define the system scope, policy, objectives, organizational structure, and departmental responsibilities, providing the framework for system operation.

• Level 2 Documents (Procedure Documents): Standardize cross-departmental process flows (e.g., Purchasing Control, Control of Nonconforming Product), clarifying process steps, responsible departments, and interface requirements. 

  • See Attachment Form 1: ‘Control of Nonconforming Purchased Product Procedure’

• Level 3 Documents (Work Instructions): Develop work instructions for specific roles (e.g., Equipment Operation Procedures, Inspection Standards) to ensure standardized operations. 

  • See Attachment Form 2: ‘100T Punch Press Safety Operation Procedure’

• Level 4 Documents (Forms & Records): Design supporting forms (e.g., production reports, inspection records) to provide traceable evidence of system operation.

  •  See Attachment Form 3: ‘Bulk Goods Inspection Report’

Document Review & Release: Organize document reviews with department heads, focusing on conformity (meets standard requirements), applicability (fits company reality), and compatibility (avoids inter-departmental process conflicts). After review and approval, authorize release by top management, specifying effective dates and management requirements (e.g., revision, obsolescence process).

System Trial Run & Verification: Initiate a full-scope trial run upon the effective date of the documents (lasting at least 3 months) and comprehensively gather operational records.During this period, complete at least 1 Internal Audit (verifying system conformity) and 1 Management Review (assessing system effectiveness). Promptly optimize documents and processes based on findings.

Stage 3: Certification Audit – Undergoing Independent Assessment

This stage consists of independent audits conducted by a third-party certification body and represents a critical part of the certification process, requiring thorough preparation and active cooperation from the company.

• Select a Compliant Certification Body: Choose a body accredited by the Chinese National Accreditation Service for Conformity Assessment (CNAS), verify its scope of accreditation covers the company’s industry, evaluate the body’s industry reputation and service quality to ensure the certificate’s broad acceptance and credibility.

• Submit Complete Application Materials: Submit the Application Form and supporting documents to the certification body, including business license, system documents (manual & procedures), trial run records, internal audit report, management review report, etc. Ensure materials are authentic and complete.

• Stage 1 Audit (Document Review): The audit team confirms whether the system documentation meets ISO standard requirements through document review and an initial site visit, assesses the trial run status, and defines the focus, scope, and schedule for the Stage 2 audit. The company must cooperate by providing supplementary information to ensure the audit team gains a comprehensive understanding of the company’s operations and context.

• Stage 2 Audit (On-site Audit): The audit team conducts an on-site audit, verifying through interviews, observation, and sampling of records whether the system operates according to the standard and documented procedures. The audit scope covers all system-related departments and activities. The company should assign escort(s) to guide the auditors, promptly provide access to requested information, and address any queries.

• Correction & Verification: For nonconformities identified during the audit (categorized as major or minor), the company must complete the closed-loop process of “root cause analysis – corrective action – effectiveness verification” within the specified timeframe: Major nonconformities require immediate correction; minor ones require a correction plan completed on schedule. Submit the Correction Report with evidence. The certification process can only continue after the audit team has verified the effectiveness of the corrections.

• Certification Decision & Issuance: The certification body’s technical committee comprehensively assesses the complete audit findings and the effectiveness of all corrective actions taken. Companies meeting requirements receive the certification certificate (valid for 3 years). If unresolved issues exist, supplementary corrections and re-assessment are required as specified.

Stage 4: Post-Certification Maintenance – Maintaining Certification Validity

After certification, the organization must continuously maintain the system to ensure its ongoing effectiveness and the validity of the certification.

• Cooperate with Annual Surveillance Audits: During the certificate’s validity period, the certification body conducts annual surveillance audits (covering core system elements and previous year’s corrective actions). The company mustmaintain the system in daily operation, have records readily available, and facilitate a seamless audit process.

• Complete Recertification on Time: Apply for recertification 3-6 months before the certificate expires. The recertification audit scope aligns with the initial certification. Comprehensively review system operation and supplement materials for changes over 3 years (e.g., process optimization, product upgrades). A new certificate is issued after passing the audit.

• Management of System Changes: When significant changes occur (e.g., organizational restructuring, relocation, core product changes), promptly update the system documentation and formally notify the certification body without delay (typically within 30 days, as required).

The essence of ISO management system certification is to drive continuous improvement in organizational management, not merely to obtain a certificate. Companies must embody three core elements:

• 1) Top Management Commitment, ensuring resource allocation and direction;
• 2) Company-wide Participation, integrating system requirements into routine tasks;
• 3) Practicality, avoiding “certification for certification’s sake” and letting the system truly serve business improvement.

Through practical implementation, companies can not only achieve certification efficiently but also build a robust, standardized management system, laying a solid foundation for sustainable growth and enhanced competitiveness.