Proposed Structure ISO 9001:2015 (Final Release Date Approx. October 2015)

Towards the end of 2015, ISO 9001:2015 version should be released. This update will see a re-write of the standard where the existing 8 sections of the ISO 9001:2008 are extended to 10 sections. There is currently a DRAFT version available, which the following information is based on.

Below is Plan, Do, Check, Act model identifying the 10 new sections:

  • Section 4 – Context of the Organisation
  • Section 5 – Leadership
  • Section 6 – Planning
  • Section 7 – Support

Clauses

Changes

Plan and Establish

4. Context of the organisation

  • 4.1 Understanding the organization and its context
  • 4.2 Understanding the needs and expectation of interested parties
  • 4.3 Determining the scope of the quality management system
  • 4.4 Quality management system and its processes

New Clauses

4.1. Determine what will affect purpose and strategic direction organization to achieve intended operationg results.

4.2 Determine relevant interested parties and their requirements affecting customer requirements and customer satisfaction.

4.3 Determine and document scope QMS, including exclusions.

4.4. Determine QMS, using “process approach and risk approach.

5. Leadership

  • 5.1 Leadership and commitment
  • 5.2 Quality Policy
  • 5.3 Organizational roles, responsibilities and authorities

5.1 Altered description. And additional requirements.

5.2 Establish and communicate policy, also available to interested parties.

5.3 Additional requirements.

6. Planning

  • 6.1 Actions to address risks & opportunities
  • 6.2 Objectives and planning to achieve them
  • 6.3 Planning of changes

New Clauses

6.1 When conducting activities consider risks and nessecary actions.

6.2 Establish objectives and planning, including requirements they have to meet.

6.3 Changes carried out in a planned and systematic manner..

7. Support

  • 7.1 Resources
  • 7.2 Competence
  • 7.3 Awareness
  • 7.4 Communication
  • 7.5 Documented information

Described differently  to exising clause 6.3

7.1. Determine, provide and maintain resources (internal, external, knowledge).

7.2. Emphasis competence.

7.3. Emphasis Awareness.

7.4. Comunication Combined.

7.5 Documented information shall be controlled, can exist of “documents” and “records.

Implement and Operate

8. Operation

  • 8.1 Operational planning and control
  • 8.2 Determination of requirements for products & services
  • 8.3 Design & development of products & services
  • 8.4 Control of externally provided products & services
  • 8.5 Production & service provision
  • 8.6 Release of products and services
  • 8.7 Control of nonconforming process outputs, products and services

Described differently  to exising clause 7

8.1. Operational planning and control, including changes and outsourced processes.

8.2. Determine requirements of goods and services and review requirements related to products and services.

8.3 Design and Development.

8.4.1 Different description of 4.1 External Process.

8.4.2 Different control to 4.1 External Process.

8.4.3 Different documents asked for controlling 4.1 External Process.

New clause

8.6. Control release of production goods and provision services.

8.7. Control non-conforming products and services.

Monitor and Review

9. Performance Evaluation

  • 9.1 Monitoring, measurement, analysis & evaluation
  • 9.2 Internal audit
  • 9.3 Management review

Described differently

9.1 Determine and implement monitoring and measurement, customer satisfaction,   analysis and evaluation data.

9.2.1 Plan and establish internal audit process, emphsis on risk based auditing.

9.2.2 Plan and establish internal audit process, emphsis on importance of process.

9.3 Plan and review management system.

Maintain and Improve

10. Improvement

  • 10.1 General
  • 10.2 Non conformity and corrective action
  • 10.3 Continual Improvement

Described differently

10.1 Process nonconformity and corrective actions.

10.2 Process nonconformity and corrective actions.

10.3 Improvement process,review the outputs of analysis and evaluation, management review.