| name | iso-9004 |
| description | Managing for the sustained success of an organization - a quality management approach. Use when going beyond ISO 9001 requirements, building organizational maturity, or pursuing sustained success. Triggers: sustained success, ISO 9004, organizational maturity, self-assessment, innovation, balanced scorecard, key performance indicators, benchmarking, learning organization. |
ISO 9004:2009 - Managing for Sustaned Success
Follow ISO 9004:2009 for achieving sustained success through a quality management approach. This standard provides guidance BEYOND ISO 9001 requirements.
Core Concept: Sustaned Success
Definition: Ability of an organization to achieve and maintain its objectives in the long term.
Achieved by:
- Consistently meeting needs & expectations of customers & all interested parties
- Balanced approach over the long term
- Effective management of the organization
- Awareness of the organization's environment
- Learning & improvement/innovation
Quality Management Principles (Annex B)
1. Customer Focus
- Understand current & future customer needs
- Link objectives to customer needs
- Communicate needs throughout organization
- Measure & monitor satisfaction
- Manage relationships with customers
2. Leadership
- Establish unity of purpose & direction
- Create & sustain shared values, fairness, ethical models
- Establish culture of trust & integrity
- Inspire, encourage, recognize contributions
- Provide resources, training, authority to act
3. Involvement of People
- Understand contribution & role in objectives
- Promote collaboration & open discussion
- Empower people to determine constraints & take initiatives
- Recognize & acknowledge contributions
- Enable self-evaluation of performance
4. Process Approach
- Define & manage interrelated processes as system
- Understand system interactions
- Focus on key processes & opportunities
- Achieve effective process performance
- Improve processes based on evaluation
5. System Approach to Management
- Identify, understand & manage interrelated processes as system
- Improve system effectiveness & efficiency
- Enhance ability to focus effort & resources
6. Continual Improvement
- Apply to organization-wide objectives
- Provide people with training in improvement tools
- Make improvement everyone's responsibility
- Establish & deploy improvement projects
- Track, review, audit improvement projects
- Integrate improvement into development
- Recognize & acknowledge improvement
7. Factual Approach to Decision Making
- Ensure data/information accurate, reliable, secure
- Make data available to relevant people
- Analyze & evaluate using suitable methods
- Base decisions on analysis balanced with experience
8. Mutually Beneficial Supplier Relationships
- Determine relevant interested parties
- Prioritize relationships to manage
- Establish collaborative development
- Share information, expertise, resources
- Enhance improvement initiatives
- Encourage & recognize improvements
Clause 4: Managing for Sustaned Success
4.1 General
Organization should develop QMS to ensure:
- Efficient use of resources
- Decision making based on factual evidence
- Focus on customer satisfaction & interested party needs
4.2 Sustaned Success
Achieved by:
- Consistently meeting needs & expectations of interested parties (balanced way, long term)
- Monitoring & analyzing organization's environment constantly
- Identifying, assessing, managing risks
- Engaging interested parties & keeping informed
- Establishing mutually beneficial relationships with suppliers/partners
- Using negotiation, mediation to balance competing needs
- Identifying short & long-term risks, deploying overall strategy
- Anticipating future resource needs (including people competence)
- Assessing compliance with plans & taking corrective/preventive actions
- Ensuring learning opportunities for people
- Establishing & maintaining innovation & continual improvement processes
4.3 The Organization's Environment
- Ever-changing, regardless of size/activity/type
- Monitor constantly to identify, assess, manage risks related to interested parties
- Top management should make timely decisions for organizational change & innovation
4.4 Interested Parties, Needs & Expectations
Interested Parties: Individuals/entities that add value or are interested/affected by organization's activities.
| Interested Party | Needs & Expectations |
|---|
| Customers | Quality, price, delivery performance |
| Owners/Shareholders | Sustaned profitability |
| People in organization | Good work environment, job security, recognition |
| Suppliers & Partners | Mutual benefits, continuity |
| Society | Environmental protection, compliance |
Clause 5: Strategy and Policy
5.1 General
Top management should set strategy & policies clearly to get mission, vision, values accepted & supported.
5.2 Strategy & Policy Formulation
Process should:
- Monitor & analyze organization's environment (customers, competitive situation, new technologies, political, economic, sociological)
- Identify & determine needs & expectations of interested parties
- Assess current process capabilities & resources
- Identify future resource & technology needs
- Update strategy & policies
- Identify outputs to meet needs & expectations
Consider: Customer/regulatory demands, organization's strengths/weaknesses, opportunities/threats.
5.3 Strategy & Policy Deployment
To implement, establish & maintain processes that:
- Translate strategy/policies into measurable objectives for all levels
- Establish timelines & assign responsibility/authority
- Evaluate strategic risks & define counter measures
- Provide resources for activities
- Execute activities to achieve objectives
5.4 Strategy & Policy Communication
- Meaningful, timely, continual
- Operate vertically & horizontally
- Tailored to recipients' needs
- Include feedback mechanism & review cycle
- Proactively address changes in environment
Clause 6: Resource Management
6.1 General
- Identify internal & external resources for short & long-term objectives
- Policies & methods consistent with strategy
- Processes to provide, allocate, monitor, evaluate, optimize, maintain, protect resources
- Periodically review availability & suitability (including outsourced)
- Use reviews as inputs to strategy/objectives/plans
6.2 Financial Resources
- Determine financial needs for current & future operations
- Establish & maintain processes for monitoring, controlling, reporting
- Report to determine ineffective/inefficient activities
- Initiate improvement actions
- Improve effectiveness/efficiency → positive financial results:
- Internally: reduce failures, eliminate waste of materials/time
- Externally: reduce product failures, compensation costs, lost customers/markets
6.3 People in the Organization
6.3.1 Management of People
- Create & maintain shared vision, values, internal environment
- Encourage personal growth, learning, knowledge transfer, teamwork
- Ensure people understand importance of contribution & roles
- Empower people to: translate objectives into individual goals, identify constraints, take ownership, assess performance, seek competence enhancement, promote teamwork, share information/knowledge/experience
6.3.2 Competence of People
Establish & maintain "people development plan":
- Determine competences currently available & gaps
- Implement actions to improve/acquire competences
- Review & evaluate effectiveness
- Maintain acquired competences
6.3.3 Involvement & Motivation
- Motivate people to understand significance of responsibilities/activities
- Develop process to share knowledge & use people's competence (ideas for improvement)
- Introduce recognition/reward system (based on individual evaluations)
- Establish skills qualification & career planning
- Review satisfaction, needs & expectations of people
- Provide mentoring & coaching opportunities
6.4 Suppliers & Partners
6.4.1 General
When developing partnerships, consider:
- Provide information to maximize contributions
- Support partners (information, knowledge, expertise, technology, processes, shared training)
- Share profits/losses
- Improve partner performance
6.4.2 Selection, Evaluation & Improvement
- Establish & maintain processes to identify, select, evaluate suppliers/partners
- Consider: contribution to activities, ability to create value, potential for continual improvement, enhancement of own capabilities through cooperation, risks in relationships
- Seek continual improvement of quality, price, delivery, management system effectiveness
- Review & strengthen relationships (balance short & long-term objectives)
6.5 Infrastructure
- Plan, provide, manage effectively & efficiently
- Periodically assess suitability to meet objectives
- Consider: dependability (availability, reliability, maintainability, maintenance support), safety/security, infrastructure elements related to products/processes, efficiency/cost/capacity/work environment, impact on work environment
Identify & assess risks, establish contingency plans.
6.6 Work Environment
Provide & manage suitable work environment:
- Social: non-discriminatory, calm, non-confrontational
- Psychological: stress-reducing, burnout prevention, emotionally protective
- Physical: temperature, heat, humidity, light, airflow, hygiene, noise
Encourage: productivity, creativity, well-being. Ensure compliance with statutory/regulatory requirements (environmental, OH&S).
6.7 Knowledge, Information & Technology
6.7.1 General
Establish & maintain processes to manage knowledge, information, technology as essential resources:
- Identify, obtain, maintain, protect, use, evaluate need
- Share with interested parties as appropriate
6.7.2 Knowledge
Assess how organization's current knowledge base is identified & protected:
- Learn from failures, near-miss situations, successes
- Capture knowledge/experience of people (tacit & explicit)
- Gather knowledge from customers, suppliers, partners
- Ensure effective communication at supply/production chain interfaces
- Manage data & records
6.7.3 Information
Establish & maintain processes to gather reliable/useful data & convert to information for decision making:
- Storage, security, protection, communication, distribution to all relevant parties
- Ensure integrity, confidentiality, availability of performance/improvement/progress information
6.7.4 Technology
Consider technological options to enhance performance:
- Product realization, marketing, benchmarking, customer interaction, supplier relations, outsourced processes
- Assess: current technology levels (inside/outside), economic costs/benefits, risks of changes, competitive environment, speed to react to customer requirements
Clause 7: Process Management
7.1 General
- Processes specific to organization, vary by size/maturity
- Determine & adapt activities to organization's features
- Proactive management of ALL processes (including outsourced)
- Adopt "process approach": establish processes, interdependencies, constraints, shared resources
- Review processes regularly, take improvement actions
- Manage as SYSTEM: create & understand networks, sequences, interactions
- Describe process map (Figure 1 extended model)
7.2 Process Planning & Control
Determine & plan processes, define functions to provide products that meet needs & expectations:
- Analyze organization's environment
- Short & long-term market forecasts
- Needs & expectations of interested parties
- Objectives to be achieved
- Statutory & regulatory requirements
- Potential financial & other risks
- Process inputs & outputs
- Interactions with other processes
- Resources & information
- Activities & methods
- Records required/desired
- Measurement, monitoring, analysis
- Corrective & preventive actions
- Improvement &/ior innovation activities
Include: develop/acquire new technologies, new products/product features for added value.
7.3 Process Responsibility & Authority
- Appoint process manager ("process owner") with defined responsibilities/authorities
- Recognize throughout organization
- Ensure people have competences needed
Clause 8: Monitoring, Measurement, Analysis & Review
8.1 General
Regularly monitor, measure, analyze, review performance in ever-changing environment:
- Identify & understand present/future needs & expectations of ALL interested parties
- Assess strengths, weaknessses, opportunities, threats
- Determine need for alternative/competitive/new product offerings
- Evaluate current/emerging markets & technologies
- Anticipate changes in statutory/regulatory requirements
- Understand labour market & effect on people loyalty
- Understand social, economic, ecological trends, local cultural aspects
- Determine need for natural resources & protection (long term)
- Assess current organizational/process capabilities (Annex A)
8.2 Monitoring
Establish & maintain processes for monitoring:
- KPIs (Key Performance Indicators): Quantifiable, enable setting measurable objectives, identify/monitor/predict trends, take corrective/preventive/improvement actions
- Methods: Interviews, questionnaires, surveys (customer satisfaction), benchmarking, performance reviews (suppliers/partners), monitoring/recording process variables & product characteristics
KPIs should consider:
- Needs & expectations of customers & interested parties
- Importance of individual products
- Effectiveness & efficiency of processes
- Effective & efficient use of resources
- Profitability & financial performance
- Statutory & regulatory requirements
8.3 Measurement
8.3.1 General
Assess progress against mission, vision, policies, strategies, objectives at all levels & functions.
8.3.2 Internal Audit
- Effective tool for compliance level & understanding/analyzing/improving performance
- Conducted by people NOT involved in activity examined (independent view)
- Assess implementation & effectiveness of management system
- Can audit against multiple standards (ISO 9001, ISO 14001, etc.)
- Identify problems/risks/nonconformities, monitor progress closing them
- Identify good practices for use in other areas, improvement opportunities
- Outputs: compliance info, nonconformities, improvement opportunities
- Present to management, use as input for management review
- Establish process to review all audit reports, identify trends, take corrective/preventive actions
8.3.3 Self-Assessment (Annex A)
- Comprehensive, systematic review of activities & performance (degree of maturity)
- Determine strengths/weaknesses, best practices (overall & individual processes)
- Prioritize, plan, implement improvements/innovations
- Support continual improvement, progress toward sustained success, innovation, learning
- Communicate results to relevant people, share understanding & future direction
- Use as input to management review
8.3.4 Benchmarking
- Measurement & analysis methodology to search for best practices (inside/outside organization)
- Types: Internal (within organization), Competitive (vs. competitors), Generic (vs. unrelated organizations)
- Success depends on: Top management support, methodology, benefits vs. costs, understanding characteristics for correct comparison
- Methodology: Define scope, choose partners, define indicators, collect/analyze data, identify gaps, establish improvement plans, incorporate experience into knowledge base
8.4 Analysis
- Analyze information from monitoring
- Identify risks & opportunities
- Establish plans to manage them
- Monitor & maintain relevant information
- Analyze potential impacts on strategy & policies
Consider: Changing needs & expectations of interested parties, existing products/activities providing most value, new products/processes needed, evolving demands, influence of emerging technologies, new competences needed, changes in statutory/regulatory requirements, labour markets, other resources
8.5 Review of Information
- Systematic approach to reviewing available information
- Use data from: monitoring, measurements (KPIs), assessments of integrity/validity, internal audit, self-assessment, benchmarking, risk assessment, feedback from customers/interested parties
- Evaluate results against objectives
- Indicate adequacy of resources, how effectively used
- Use for benchmarking (internally & externally), show trends over time
- Present in format facilitating implementation of process improvement activities
Clause 9: Improvement, Innovation & Learning
9.1 General
Improvement (small-step continual) & Innovation (breakthrough change) necessary for sustained success.
Apply to: Products, processes & interfaces, organizational structures, management systems, human aspects/culture, infrastructure/work environment/technology, relations with interested parties.
Fundamental: Ability & enablement of people to make informed judgments based on data analyses & incorporate lessons learned.
9.2 Improvement
- Define objectives for improvement of products, processes, organizational structures, management system
- Follow structured approach (PDCA methodology)
- Ensure continual improvement becomes part of organizational culture:
- Provide opportunities for people to participate (through empowerment)
- Provide necessary resources
- Establish recognition & reward systems
- Continually improve effectiveness/efficiency of improvement process itself
9.3 Innovation
9.3.1 General
Changes in environment may require innovation to meet needs & expectations.
Organization should:
- Identify need for innovation
- Establish & maintain effective/efficient innovation process
- Provide related resources
9.3.2 Application
Apply innovation to:
- Technology/Product: Respond to changing needs, anticipate potential changes, product lifecycles
- Processes: Improve methods for product realization, improve stability, reduce variance
- Organization: Innovate constitution & organizational structures
- Management System: Ensure competitive advantage maintained, utilize new opportunities, respond to emerging changes
9.3.3 Timing
- Balance urgency of need vs. resources available
- Use process aligned with strategy to plan & prioritize
- Support innovation initiatives with resources
9.3.4 Process
Establish, maintain, manage processes for innovation considering:
- Urgency of need, innovation objectives & impact on products/processes/structures
- Organization's commitment to innovation
- People's willingness to challenge/change status quo
- Availability/emergence of new technologies
9.3.5 Risks
Assess risks related to planned innovation activities:
- Potential impact on organization
- Prepare preventive actions to mitigate risks
- Establish contingency plans where necessary
9.4 Learning
Organization should encourage improvement & innovation through learning.
"Learning as an organization": Collect information from internal/external events/sources (success stories & failures), gain insights through in-depth analyses.
"Learning integrating individual capabilities with organization":
- Combine knowledge, thinking patterns, behavior patterns of people with organization's values
- Support initiatives in learning, demonstrate leadership through behavior
- Stimulate networking, connectivity, interactivity, sharing of knowledge
- Maintain systems for learning & sharing knowledge
- Recognize, support, reward improvement of people's competence
- Appreciate creativity, support diversity of opinions
Rapid access to & use of knowledge enhances ability to manage & maintain sustained success.
Annex A: Self-Assessment Tool
A.1 General
- Comprehensive, systematic review of activities & results vs. chosen standard
- Provides overall view of performance & degree of maturity
- Identify areas for improvement/innovation
- Determine priorities for subsequent actions
- Identify improvement & innovation opportunities
- Set priorities & establish action plans for sustained success
- Show strengths/weaknesses, maturity level, progress over time
- Valuable input to management reviews
- Learning tool, provides improved vision of organization
- Promote involvement of interested parties
A.2 Maturity Model
Mature organization performs effectively & efficiently, achieves sustained success by:
- Understanding & satisfying needs & expectations of interested parties
- Monitoring changes in environment
- Identifying areas for improvement/innovation
- Defining & deploying strategies & policies
- Setting & deploying relevant objectives
- Managing its processes & resources
- Demonstrating confidence in its people → increased motivation/commitment/involvement
- Establishing mutually beneficial supplier/partner relationships
A.3 Self-Assessment of Key Elements
Performed periodically by top management to obtain overview of behavior & current performance.
A.4 Self-Assessment of Detailed Elements
Performed by operational management & process owners for in-depth overview.
A.5 Using Self-Assessment Tools
Step-by-step methodology:
- Define scope (parts of organization, type of assessment)
- Identify who responsible & when carried out
- Determine how carried out (team vs. individuals, appoint facilitator)
- Identify maturity level for each process (compare to examples, mark elements being applied, start at Level 1)
- Consolidate results into report (record progress, facilitate communication)
- Assess current performance, identify areas for improvement/innovation
- Assign responsibilities, estimate/provide resources, identify benefits/risks
- Use results to stimulate comparisons, share learning, benchmark, monitor progress, identify/prioritize improvement areas
Maturity Levels (Table A.1)
| Level | Focus | Approach |
|---|
| 1 - Base | Products, shareholders, some customers | Reactive, ad hoc, top-down instructions |
| 2 | Customers, statutory/regulatory | Reactive, structured reactions, managers at different levels |
| 3 | People, some additional interested parties | Continual improvement emphasized, proactive |
| 4 | Balancing needs of identified interested parties | Best-in-class performance, systematic improvement/innovation, learning-oriented |
| 5 - Best Practice | Balancing needs of emerging interested parties | Sustaned success over long term, proactive, empowerment at all levels |
Annex C: Correspondence with ISO 9001:2008
ISO 9004 complements ISO 9001. Can be used independently or together:
- ISO 9004: Guidance for sustained success (beyond requirements)
- ISO 9001: Requirements for QMS (certification, contractual)
Clause correspondence:
- Clause 4 (Managing for sustained success) ↔ ISO 9001 Clauses 4, 5
- Clause 5 (Strategy & policy) ↔ ISO 9001 Clause 5
- Clause 6 (Resource management) ↔ ISO 9001 Clause 6 (extended)
- Clause 7 (Process management) ↔ ISO 9001 Clauses 7, 8
- Clause 8 (Monitoring, measurement, analysis, review) ↔ ISO 9001 Clause 8, 9
- Clause 9 (Improvement, innovation, learning) ↔ ISO 9001 Clause 10
Integration with Other Standards
Core Standards (ISO/TC 176):
- ISO 9000: Fundamentals & vocabulary
- ISO 9001: Requirements (certification)
- ISO 9004: Guidance for sustained success (this standard)
Related Standards:
- ISO 10001-10019 series (customer satisfaction, quality plans, configuration management, people involvement, etc.)
- ISO 14001: Environmental management
- ISO 31000: Risk management
- ISO 19011: Auditing management systems
- ISO 50001: Energy management
- ISO/IEC 27001: Information security
When to Use ISO 9004 vs. ISO 9001
| Situation | Use |
|---|
| Need certification/contractual compliance | ISO 9001 |
| Want guidance beyond requirements | ISO 9004 |
| Building organizational maturity | ISO 9004 |
| Pursuing sustained success | ISO 9004 |
| Need structured QMS for customers | ISO 9001 |
| Want self-assessment tool | ISO 9004 (Annex A) |
| Integrating multiple management systems | Both |
