ISO9001 System Document Package (7) | Quality Policy and Quality Objectives Management Procedure (5.2/6.2)

Document Description: This procedure corresponds to ISO 9001:2015 Clause 5.2 "Quality Policy" and Clause 6.2 "Quality Objectives and Planning to Achieve Them." It is a core procedure document for the "top-level design" of the quality management system (QMS) and is classified as a second-level document. This procedure transforms the quality policy from a mere slogan on the wall into an executable, measurable, and assessable management mechanism: it standardizes the formulation, approval, release, dissemination, and review and revision process of the quality policy, and establishes a closed-loop for the decomposition, monitoring, evaluation, and updating of quality objectives at three levels (company, department, and position). This ensures that the policy aligns with the organization's strategic direction and that the objectives are consistent with the policy and are measurable. This procedure is applicable to all enterprises that need to obtain ISO 9001 certification or have established a QMS, especially small and medium-sized manufacturing and service enterprises where the policy and objectives are often disconnected or where objectives diminish at each level. It can be directly applied and then revised according to the actual situation of the enterprise.

1. Purpose

To standardize the formulation, approval, release, dissemination, review, revision, and monitoring and assessment processes for the company's quality policy and quality objectives, ensuring:

1. The quality policy is consistent with the organization's purpose and strategic direction, includes a commitment to meeting applicable requirements and to the continuous improvement of the QMS, and provides a framework for setting and reviewing quality objectives.
2. Quality objectives are consistent with the quality policy, established at relevant functions, levels, and processes, and are measurable, achievable, and related to product and service conformity and customer satisfaction.
3. The achievement of quality objectives is regularly monitored, measured, analyzed, and evaluated, and unmet objectives are subject to cause analysis and improvement, forming a "Plan-Do-Check-Act" (PDCA) closed loop.

2. Scope of Application

This procedure applies to the full lifecycle management of the quality policy within the scope of the company's QMS, as well as the establishment, decomposition, implementation, monitoring, evaluation, and updating of quality objectives at all levels (company, department, and position). This includes, but is not limited to:

1. Formulation, approval, release, dissemination, review, and revision of the quality policy.
2. Setting and approval of annual quality objectives and their decomposed indicators.
3. Decomposition and deployment of quality objectives to departments and processes.
4. Statistics, analysis, assessment, and improvement of the achievement of quality objectives.
5. Adjustment of the quality policy and objectives in response to changes in internal and external environments.

This procedure does not apply to the comprehensive management of business and financial indicators (such as sales and profit), which are managed according to the company's business management system. However, indicators related to product quality and customer satisfaction should be included in the quality objectives system for coordinated management.

3. Responsibilities

1. General Manager: Approves and releases the quality policy; approves company-level quality objectives; chairs management reviews to evaluate the ongoing suitability of the quality policy; provides necessary resources for the realization of the policy and objectives; makes decisions on major unmet objectives.
2. Management Representative (System Responsible Person): Organizes the drafting of the quality policy and company-level quality objectives; reviews the decomposition plans of quality objectives at all levels; organizes the dissemination and training of the quality policy; supervises the implementation and assessment of quality objectives in each department; reports the overall status of policy and objectives management to the General Manager.
3. Quality Department (System Management Department): Compiles and revises this procedure; manages the release, dissemination, and archiving of the quality policy; compiles the annual "Quality Objectives Decomposition Table" and "Quality Objectives Achievement Statistics Table"; organizes the analysis and evaluation of objective achievement; retains relevant records.
4. Department Heads: Organize the decomposition and implementation of quality objectives in their departments; break down departmental objectives to teams/positions; report objective achievement data on a regular basis; conduct cause analysis and formulate corrective actions for unmet objectives; cooperate with the dissemination and review of the policy and objectives.
5. Human Resources Department: Incorporates the quality policy and quality objectives into the new employee onboarding training and annual training plan; cooperates in integrating objective achievement into departmental and individual performance evaluations.
6. All Employees: Understand and implement the quality policy; be aware of the quality objectives related to their positions and the personal indicators they are responsible for; record and report data according to procedures.

4. Work Procedures

(1) Formulation of the Quality Policy

1. Formulation Timing: During the initial establishment of the QMS; when the system undergoes significant changes (such as strategic adjustments, organizational restructuring, mergers, or acquisitions); when the management review deems the existing policy unsuitable.
2. Formulation Inputs:
   • The organization's purpose, mission, vision, and strategic direction.
   • Results of organizational environment analysis (4.1), including internal and external environments, industry characteristics, and market competition.
   • Stakeholder requirements and expectations (4.2), particularly customer requirements and legal and regulatory requirements.
   • Historical quality performance, customer satisfaction, and continuous improvement needs.
3. Policy Content Requirements (ISO 9001:2015 Clause 5.2.1):
   • Consistent with the organization's purpose and environment.
   • Provides a framework for setting and reviewing quality objectives.
   • Includes a commitment to meeting applicable requirements (including product and service conformity, customer requirements, and legal and regulatory requirements).
   • Includes a commitment to the continuous improvement of the QMS.
4. Formulation Method: The Management Representative organizes the drafting of the quality policy draft, which can be done through specialized seminars, soliciting opinions from various departments, etc. The draft should be concise, easy to understand and remember, and generally not exceed 3-5 sentences. The wording should avoid vague slogans and should guide the setting of objectives, such as "Customer demand-oriented, process control as a guarantee, continuous improvement as a driving force, providing customers with safe and reliable products and high-quality services."
5. Policy Review and Approval: The Management Representative organizes the review of the draft by relevant departments, focusing on "consistency with strategy, understandability, and guidance for objective setting." After revisions, the draft is submitted to the General Manager for approval.

(2) Approval, Release, and Dissemination of the Quality Policy

1. Approval and Release: After the quality policy is approved and signed by the General Manager, the Quality Department releases it in a controlled manner through channels such as controlled document distribution, office system announcements, bulletin board postings, and employee handbooks.
2. Dissemination and Training:
   • Incorporate the quality policy into the mandatory content of new employee onboarding training.
   • Organize at least one company-wide dissemination session annually (which can be combined with the annual management review or quality month activities).
   • Publicize the quality policy in prominent locations in the office and production areas.
   • Managers at all levels should explain the policy and its relevance to their positions during departmental meetings.
   • Retain evidence of dissemination through training sign-in sheets and dissemination records.
3. Accessibility: Ensure that the quality policy is communicated and understood at all levels within the organization and is available to stakeholders (customers, suppliers, regulatory bodies, etc.) when needed.

(3) Review and Revision of the Quality Policy

1. Review Timing: Annually during the management review, and at any time when there are significant changes in the organizational environment or stakeholder requirements.
2. Review Content:
   • Whether the policy remains consistent with the organization's purpose and strategic direction.
   • Whether the commitments in the policy are still valid and being practiced.
   • Whether the policy still provides an effective framework for setting quality objectives.
   • The level of understanding and implementation of the policy by employees.
3. Review Output: The review conclusions are recorded in the "Management Review Report" or "Quality Policy Review Record," including "Maintain" or "Revise" and revision suggestions, signed by the Management Representative.
4. Revision and Version Control: The revision of the policy is organized by the Management Representative, who drafts the revised version. After approval by the General Manager, it is released and the version is updated according to the "Document Control Procedure" (e.g., A/0 → A/1). The old version is recalled and invalidated to ensure that all locations use the effective version.

(4) Formulation of Quality Objectives

1. Formulation Basis: Quality objectives should be established based on the framework of the quality policy, be consistent with the policy, and consider:
   • Key performance indicators related to product and service conformity and customer satisfaction.
   • Applicable legal and regulatory requirements and industry standards.
   • The organization's strategic planning, annual business plan, and resource allocation capabilities.
   • Historical performance data, process capability, and improvement opportunities.
   • Results of risk and opportunity assessments (in conjunction with the "Risk and Opportunity Management Procedure").
2. Formulation Principles (SMART Principles):
   • Specific: The objective description is clear and unambiguous, such as "Incoming inspection batch pass rate" rather than "Improve incoming material quality."
   • Measurable: There are clear statistical criteria, calculation formulas, and data sources, allowing for quantifiable evaluation.
   • Achievable: The objectives can be achieved with effort under existing resources and conditions, avoiding unrealistic high targets.
   • Relevant: The objectives are directly related to the quality policy, product conformity, and customer satisfaction, not unrelated indicators.
   • Time-bound: The statistical period and assessment deadline are clearly defined, such as "annually" or "each quarter."
3. Objective Categories: Company-level quality objectives generally include, but are not limited to: first-time pass rate of products, customer satisfaction and complaint handling timeliness, on-time delivery rate, quality cost loss rate, timely closure rate of nonconformities from internal and external audits, and the number of major quality incidents.
4. Objective Value Setting: Baseline data from history is used, combined with industry benchmarks and improvement needs. The objective values should be reviewed and confirmed as feasible, and each objective should specify the responsible department, statistical frequency, and data source.

(5) Decomposition and Deployment of Quality Objectives

1. Decomposition Principles: Company-level objectives are decomposed to relevant departments based on the principle of "who executes, who is responsible, and measurability." Departmental objectives are further decomposed to teams/positions, forming a three-level objective chain (company-level, department-level, position-level). Each company-level objective should have at least one responsible leader, and each departmental objective should have at least one responsible department head.
2. Decomposition Method: A goal deployment table (matrix table) can be used to break down the company-level objectives into departmental process indicators and supporting indicators, ensuring a clear support relationship. For cross-departmental objectives, the main responsible department and supporting departments should be clearly defined to avoid "everyone is responsible, but no one is accountable."
3. Upward and Downward Communication (Catchball): The Quality Department compiles the "Quality Objectives Decomposition Table (Draft)" and communicates it with each department for confirmation. After review by the Management Representative and approval by the General Manager, the table is released in a controlled manner. Each department then formulates its implementation plan based on the approved table.
4. Objective Commitment: Department heads sign off on the objectives they are responsible for. Key position objectives can be included in individual performance contracts when necessary, linking objectives to performance.

(6) Monitoring and Measurement of Quality Objectives

1. Statistical Responsibility: Each objective should specify a unique statistical responsibility department and statistical period. Data sources should be traceable (based on inspection records, statistical reports, system data), and estimation without basis is prohibited.
2. Statistical Frequency: Regular objectives are typically monitored monthly or quarterly, with annual objectives summarized semi-annually and at year-end. Objectives with high variability and high customer attention (such as on-time delivery rate and customer complaint rate) should be monitored monthly.
3. Monitoring Methods:
   • The responsible department fills out the "Quality Objectives Achievement Statistics Table" on a periodic basis, including data source explanations.
   • The Quality Department compiles a company-level objective achievement ledger, and alerts for abnormal fluctuations.
   • For unmet or deteriorating objectives, the responsible department conducts cause analysis and corrective actions according to Section (7) of this procedure.
   • Objective statistical data serves as important input for management reviews, data analysis, and evaluation (9.1.3).

(7) Evaluation, Assessment, and Update of Quality Objectives

1. Evaluation Cycle: Before the annual management review, the Management Representative organizes a comprehensive evaluation of the annual objective achievement. Mid-year evaluations can be combined with business analysis meetings.
2. Handling of Unmet Objectives: For unmet objectives, the responsible department conducts cause analysis using methods such as "5Why" or fishbone diagrams, formulates corrective actions, and specifies responsible persons and completion deadlines. These actions are tracked and verified according to the "Nonconforming and Corrective Action Procedure." If unmet due to resource shortages or other systemic reasons, the Management Representative coordinates solutions or requests a management review decision.
3. Assessment Application: The achievement of objectives is linked to departmental and individual performance evaluations, serving as a reference for awards, promotions, and salary adjustments. For objectives that are consistently unmet, the Management Representative organizes a special analysis and adjusts strategies.
4. Update Timing: When the quality policy is revised; when there are significant adjustments to the organization's strategy or business plan; when there are significant changes in the market, regulations, or customer requirements; when the management review suggests adjustments. The update process must be re-performed, including "drafting, reviewing, approving, and releasing," to maintain control.

(8) Flowchart (Text Version)

Start
  │
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Formulation Inputs: Strategic Direction, Organizational Environment, Stakeholder Requirements, Historical Performance
  │
  ▼
Management Representative Organizes Drafting of Quality Policy Draft (5.2)
  │
  ▼
Relevant Departments Review → General Manager Approves → Controlled Release
  │
  ▼
Dissemination and Training (Onboarding Training/Annual Dissemination/On-site Publicity) + Retain Evidence
  │
  ▼
Formulate Company-Level Quality Objectives Based on Policy (SMART, 6.2)
  │
  ▼
Objective Decomposition: Company-Level → Department-Level → Position-Level (Catchball Communication and Confirmation)
  │
  ▼
General Manager Approves "Quality Objectives Decomposition Table" → Controlled Release
  │
  ▼
Departments Implement, Statistically Report Objective Achievement Data on a Regular Basis
  │
  ▼
Quality Department Compiles Monitoring → Cause Analysis of Unmet Items → Corrective Actions (10.2)
  │
  ▼
Management Review: Policy Suitability Review + Objective Achievement Evaluation (9.3)
  │
  ├──── Suitable/Achieved ────► Maintain, Enter Next Cycle
  │
  └──── Unsuitable/Major Changes ──► Revise Policy/Update Objectives → Re-Approval and Release
  │
  ▼
End

5. Related Records

Form Filling Instructions:

• Quality Policy Review Record: Record the review time, participants, current policy status, review points (consistency with strategy, commitment effectiveness, framework guidance), review conclusions (maintain/revise), and revision suggestions, signed by the Management Representative.
• Quality Objectives Decomposition Table: List company-level objectives (objective name, objective value, statistical criteria, main responsible department) vertically and departmental承接 indicators (department, decomposed indicators, objective value, statistical frequency, responsible person) horizontally, ensuring each company-level objective is fully decomposed.
• Quality Objectives Achievement Statistics Table: Each objective is listed in a row, filling in the statistical period, actual value, objective value, achievement rate, brief description of unmet causes, improvement measures, and tracking status, signed by the responsible person of the statistical responsibility department.
• Quality Objectives Change Application Form: Fill in the name of the objective to be changed, the original value, the proposed value, the reason for the change (such as strategic adjustments, market changes, resource limitations), and the impact assessment, which becomes effective after review by the Management Representative and approval by the General Manager.

6. Related Documents

1. Quality Manual (QM-01) Chapters 5 and 6.
2. Document Control Procedure (QP-3).
3. Record Control Procedure (QP-4).
4. Organizational Environment and Stakeholder Management Procedure (QP-5).
5. Risk and Opportunity Management Procedure (QP-6).
6. Human Resources Management Procedure (QP-8).
7. Data Analysis and Evaluation Procedure (QP-24).
8. Management Review Procedure (QP-26).
9. Nonconforming and Corrective Action Procedure (QP-27).

Usage Instructions

1. How to Modify According to the Actual Situation of the Enterprise

• Organizational Structure Adaptation: Replace "Management Representative" with the actual quality responsible position in your company (such as Quality Director or Quality Vice President). In small enterprises, the General Manager can directly assume this responsibility, merging the "drafting—reviewing—approving" levels into "General Manager direct approval." However, the dissemination evidence and objective statistical closed loop must be retained and not omitted.
• Objective Indicator Adaptation: Manufacturing enterprises are advised to retain indicators such as "first-time pass rate of products, on-time delivery rate, and quality loss rate." Service enterprises can replace these with "customer complaint rate, service response time, customer satisfaction, and first-time resolution rate." Project-based enterprises can add "first-time project acceptance rate" and "timely document delivery rate." It is advisable for each type of enterprise to select 5-8 key indicators, as too many can lead to a loss of focus, and too few can result in inadequate coverage.
• Statistical Criteria Adaptation: The objective decomposition table must specify the calculation formula (numerator/denominator definition) and data source form for each indicator, such as "Incoming inspection batch pass rate = number of qualified batches ÷ total number of inspected batches × 100%, data from the 'Incoming Inspection Record.'" This avoids statistical discrepancies due to inconsistent criteria.
• Assessment Cycle Adaptation: Manufacturing enterprises should statistically report monthly and assess quarterly. Project-based enterprises can report at project milestones. Research and development organizations can have a more relaxed statistical cycle, but annual evaluations must be synchronized with management reviews.

2. Audit Focus Points (Certification Auditors Typically Check)

• Whether the quality policy is documented and approved, and whether employees can understand the policy's meaning (auditors will randomly ask frontline employees, "What is your company's quality policy, and how does it relate to your position?").
• Whether quality objectives echo the policy and whether employees can articulate which part of the policy supports specific objectives.
• Whether objectives are measurable: Auditors will request a demonstration of the statistical data source and calculation process for a specific objective. Objectives without statistical evidence will be marked as nonconformities.
• Whether objectives are established at relevant functions, levels, and processes: Objectives that only reach the company level and are not decomposed to departments and positions are common nonconformities.
• Whether the policy has review records: The management review report should reflect the evaluation of the policy's suitability, not just the achievement of objectives.
• Whether unmet objectives have cause analysis and corrective actions: Unmet objectives without any analysis or improvement records are typical issues that auditors will check.

3. Common Mistakes

• Vague Policy Slogans: Writing the policy as "Quality First, Customer Supreme" without specific commitments or guidance for objective setting, which does not meet the requirements of Clause 5.2.1. The correct approach is to include commitments to "meeting requirements" and "continuous improvement" and to establish a traceable link to the objectives.
• Disconnection Between Policy and Objectives: The policy states "pursuing excellence," but the objectives are set as "pass rate ≥ 95%," lacking logical consistency. Auditors often review the "policy—objectives—indicators" chain to check the logical consistency of the system.
• Unmeasurable Objectives: Phrases like "improve employee quality awareness" or "strengthen process control" that cannot be quantified. Any objective that cannot provide a statistical criteria and value cannot be used as a quality objective.
• Layered Objectives That Become Unrealistic: Company-level objectives of 95% are decomposed to 99% at the department level and 100% at the team level, leading to statistical fraud or unrealistic objectives. Decomposition should maintain logical consistency and be confirmed through upward and downward communication (Catchball).
• Setting Objectives Without Monitoring the Process: Objectives are set at the beginning of the year and assessed at the end, with no monitoring or early warning in between, making it impossible to remedy unmet objectives. The procedure should clearly specify monthly/quarterly statistical and abnormal early warning mechanisms.
• Policy and Objectives Being Separate: The policy is displayed on the wall, and the objectives are locked in file cabinets, with employees unaware and not responsible. Ensure the policy and objectives are implemented through onboarding training, annual dissemination, on-site publicity, and position-level objective responsibility.

Policy sets the direction, objectives are measurable, and the closed loop promotes improvement.

Knowledge code: 2.3.1

Version: v20260809

Author: Quality Think Tank Quality Think Tank is dedicated to providing systematic professional knowledge, methodologies, and practical tools to quality management practitioners, helping enterprises continuously improve their quality capabilities.