What's New In ISO 9001:2015, Call [phone]

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ISO 90012015Whats new about it?
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Contents

• Change in principles
• Change in clauses
• Change in terminology
• Key changes in Documentation Requirements
• Key changes in clauses and what they mean?
• Whats good about - Annexure A
• - no requirements for Organization's QMS
  documentation to mirror that of this documented
• -no requirements for using some terms
• What about exclusions?

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Changes in Principles
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Change in clauses
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Change in Terminology/New Terminology

• Product replaced by Product and Services
• Documented Information
• Design and Development
• Interested Party
• Context of the organization
  
  
  
• Traceability

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Product and Services

• ISO 90012008 used the term product to include
  all output categories whereas ISO 90012015 uses
  products and services
• The term product and services includes all
  output categories such as hardware, services,
  software and processed materials.

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Documented Information

• The terms documented procedure and record
  have been replaced by Documented Information
• Where ISO 90012008 uses the term documented
  procedures ( to define, control or support a
  process) whereas ISO 90012015 uses the term
  Documented Information.
• ISO 90012008 uses the term records but ISO
  90012015 uses Documented information.

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Design and Development

• Set of processes that transforms requirements for
  an object into more detailed requirements
• Note- to entry The requirements (3.03)forming
  input to design and development can be expressed
  in a broader, more general sense

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Interested party

• Person or organisation that can affect, be
  affected by, or perceive themselves to be
  affected by a decision or activity.
• Example Customers , owners, people in an
  organisation, suppliers, bankers, unions,
  partners or society that may include competitors
  or opposing pressure groups.

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Context of the organisation

• There are two new clauses relating to the
  context of the organisation
• 4.1 Understanding the organisation and its
  context
• 4.2 Understanding the needs and expectationsof
  interested parties.

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Traceability

• Ability to trace the history, application or
  location of an object.
• When considering a product or a service,
  traceability can relate to
• The origin of materials and parts
• The processing history
• The distribution and location of the product or
  service after delivery.

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