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Home  > ISO Certification & Standards > iso9001

ISO 9001

 

Requirements of ISO 9001:2008 and ISO 9001:2015

The major changes in ISO 9001:2015 from ISO 9001:2008 are as below;

  • Introduction of HLS, defined at Annex SL of ISO Directive
  • Risk-based thinking
  • Introduction of documented information
  • More applicability to service industry
  • Requirements to QMS boundary
  • Emphasis on organizational context
  • More requirements for leadership
 

ISO 9001 requirements

ISO 9001:2008

ISO 9001:2015

1. Scope

2. Normative reference

3. Terms and definition

4. Quality management system
  4.1 General requirements
  4.2 Documentation requirements
   - 4.2.1 General
   - 4.2.2 Quality manual
   - 4.2.3 Control of documents
   - 4.2.4 Control of records

5. Management responsibility
  5.1 Management commitment
  5.2 Customer focus
  5.3 Quality policy
  5.4 Planning
   - 5.4.1 Quality objectives
   - 5.4.2 Quality management system planning
  5.5 Responsibility, authority and communication
   - 5.5.1 Responsibility and authority
   - 5.5.2 Management representative
   - 5.5.3 Internal communication
  5.6 Management review
   - 5.6.1 General
   - 5.6.2 Review input
   - 5.6.3 Review output

6. Resource management
  6.1 Provision of resources
  6.2 Human resources
   - 6.2.1 General
   - 6.2.2 Competence, training and awareness
  6.3 Infrastructure
  6.4 Work environment

7. Product realization
  7.1 Planning of product realization
  7.2 Customer-related processes
   - 7.2.1 Determination of requirements related to the product
   - 7.2.2 Review of requirements related to the product
   - 7.2.3 Customer communication
  7.3 Design and development
   - 7.3.1 Design and development planning
   - 7.3.2 Design and development inputs
   - 7.3.3 Design and development outputs
   - 7.3.4 Design and development review
   - 7.3.5 Design and development verification
   - 7.3.6 Design and development validation
   - 7.3.7 Control of design and development changes
  7.4 Purchasing
   - 7.4.1 Purchasing process
   - 7.4.2 Purchasing information
   - 7.4.3 Verification of purchased product
  7.5 Production and service provision
   - 7.5.1 Control of production and service provision
   - 7.5.2 Validation of processes for production and service provision
   - 7.5.3 Identification and traceability
   - 7.5.4 Customer property
   - 7.5.5 Preservation of product
  7.6 Control of monitoring and measuring equipment

8. Measurement, analysis and improvement
  8.1 General
  8.2 Monitoring and measurement
   - 8.2.1 Customer satisfaction
   - 8.2.2 Internal audit
   - 8.2.3 Monitoring and measurement of processes
   - 8.2.4 Monitoring and measurement of product
  8.3 Control of nonconforming product
  8.4 Analysis of data
  8.5 Improvement
   - 8.5.1 Continual improvement
   - 8.5.2 Corrective action
   - 8.5.3 Preventive action

1. Scope

2. Normative Reference

3. Terms and Definition

4.Context of the Organization
  4.1 Understanding the organization and its Context
  4.2 Understanding the needs and expectations of interested parties
  4.3 Determining the scope of the quality management system
  4.4 Quality management system and its processes

5. Leadership
  5.1 Leadership and Commitment
  5.2 Policy
  5.3 Organizational roles, responsibilities and authorities

6. Planning
  6.1 Actions to address risks and opportunities
  6.2 Quality objectives and planning to achieve them
  6.3 Planning of changes (Only QMS)

7. Support
  7.1 Resources
  7.2 Competence
  7.3 Awareness
  7.4 Communication
  7.5 Documented information

8. Operation
  8.1 Operational planning and control
  8.2 Requirements for products and services
  8.3 Design and development of products and services
  8.4 Control of externally provided processes, products and services
  8.5 Production and service provision
  8.6 Release of products and services
  8.7 Control of nonconforming outputs

9. Performance evaluation
  9.1 Monitoring, measurement, analysis and evaluation
  9.2 Internal Audit
  9.3 Management Review

10. Improvement
  10.1 General
  10.2 Nonconformity and corrective action
  10.3 Continual improvement

 

KEYPOINT's to establish ISO 9001 system

Enhanced commitment & support of management
Advertisement of certification & its effect
Training for common understanding
Correct establishment of Quality Management System
Active implementation for goal achievement
Proper use of experts and their advice
More than certification : A tool for quality management to establish management system and improve the system

Benefits of ISO 9001 certification

To meet the customer requirements (customer satisfaction)
To establish systematic management
To evaluate company's image and to create PR effect
To enhance marketing capacity
To increase profitability by reducing quality cost
To improve employees’ awarness
To reduce quality defetives

General of Quality management system

ISO 9001:2008 adopts process approach, which is based on PDCA (Plan-Do-Check-Act) cycle. This shows product or service cycle and management cycle. The following is the 4 major processes out of 20 requirements.