ISO- 9001-2015 to be Release.

ISO- 9001:2015 Change Release is Scheduled for September 2015 and as of Feb.1st
2015 is on schedule.

If you contract with the government, you must meet certain quality standards which will vary based on the product or service that you are providing. International standards may apply and U.S. quality assurance standards are part of contract terminology.
A Certificate of Conformance, instead of source inspection, may be permitted at the discretion of the contracting officer.

FAR part 46 Quality Assurance

The government makes use of industry-specific standards created in the private sector.
Subcontractors, as well as prime contractors, must adhere to government-mandated quality standards.

First published in 1987, ISO 9000 has been ISO’s most popular series of standards.

ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems,
is busy laying the groundwork for the next generation of quality management standards.

ISO 9001 revisions since beginning 1987
1994, 2000, 2008, and now the 2015 Revision is underway.

ISO 9001, Quality management systems, give a base-level confidence in an organization’s ability to provide conforming products.

Latest ISO 9000 series:
ISO9001:2008 is a Quality management systems
ISO9004:2017 is Managing for the sustained success of an organization – A quality management approach

ISO- 9001:2015 Revision of Quality Pricciples
Basic Principles are revisited.

  • Customer Focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • evidence based decision making
  • Relationship management

10 Clauses

  1. Scope
  2. Normative references
  3. Terms and definitions
    • 3.01. Organization
    • 3.02. Interested Party (preferred term)
    • 3.03. Requirement
    • 3.04. Management System
    • 3.05. Top management
    • 3.06. Effectiveness
    • 3.07. Policy
    • 3.08. Objective
    • 3.09. Risk
    • 3.10. Competence
    • 3.11. Documented information
    • 3.12. Process
    • 3.13. Performance
    • 3.14. Outsource
    • 3.15. Monitoring
    • 3.16. Measurement process
    • 3.17. Audit
    • 3.18. Conformity
    • 3.19. Non-conformity
    • 3.20. Correction
    • 3.21. Corrective Action
    • 3.22. Continual improvement
  4. Context of 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
      • 4.4.1. General
      • 4.4.2. Process Approach
  5. Leadership
    • 5.1 Leadership & Commitment
    • 5.2 Quality Policy
    • 5.3 Organizational Roles, Responsibilities & Authorities
  6. Planning
    •  6.1 Actions to address risks & opportunities
    • 6.2 Quality objectives & planning To achieve them
    •  6.3 Planning of changes
  7. Support
    • 7.1 Resources
    • 7.2 Competence
    • 7.3 Awareness
    • 7.4 Communications
    • 7.5 General Creating & Updating, Control of Documented Information.
  8. Operations
    • 8.1 Operational Planning & Control
    • 8.2 Determination of Market needs & interactions with customers
    • 8.3 Operational Planning process
    • 8.4 Control of external Provision of Goods & Services
    • 8.5 Development of Goods & Services
    • 8.6 Production of goods and provision of services
    • 8.7 Release of goods and services
    • 8.8 Nonconforming goods & services
  9. Performance Evaluations
    • 9.1 Monitoring, measurement , analysis and evaluation
    • 9.2  Internal Audit
    • 9.3 Management Review
  10. Improvement
    • 10.1 Nonconformity and Corrective Action
    • 10.2 Improvement Clause

The new clause 8 is covered the requirements of clause 7 in last version. vClause 7.3 design & development in previous versions is simplified to clause 8.5 development of goods and services. The new standard resolved many problems related to design and development

Clause 9. Performance evaluation . 9.2. 9.3.  9.1.1.General, 9.1.2.customer satisfaction, 9.1.3. Analysis & evaluation of data

 

 


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