iso-9004

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.

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:

1. Define scope (parts of organization, type of assessment)
2. Identify who responsible & when carried out
3. Determine how carried out (team vs. individuals, appoint facilitator)
4. Identify maturity level for each process (compare to examples, mark elements being applied, start at Level 1)
5. Consolidate results into report (record progress, facilitate communication)
6. Assess current performance, identify areas for improvement/innovation
7. Assign responsibilities, estimate/provide resources, identify benefits/risks
8. Use results to stimulate comparisons, share learning, benchmark, monitor progress, identify/prioritize improvement areas

Maturity Levels (Table A.1)

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