Note that the vote to proceed to FDIS was 79% in favor. With dissenting votes from US, Canada, Japan and other western countries....Anyone know why the US dissented? (too busy making war?
)
Source Omnex Navigator Winter 2015 edition Changes:
• 4.1 Understanding the Organization and
its Context –
New.
• 4.2 Understanding the Needs and
Expectations of Interested Parties -
New.
• 4.3 Scope - removal of exclusions.
• 5.1 Leadership and Its Commitment - tying
together quality policy and objectives
with strategic direction and context of
organization.
• 6.1 Actions to Address Risks and
Opportunities - running change and
addition of risk in multiple locations.
• 6.2 Quality Objectives and Planning to
Achieve Them - Clarifications.
• 7.1.4 Environment for the Operation of
Processes (and not work environment) -
Clarifications.
• 6.3 Planning of Changes and 8.5.6 Control of
Changes - New Manage the Change Process.
• 7.1.6 Organizational Knowledge -
New.
• 7.5 Documented Information -
New.
• 8.1 Operational Control - removal of
statistical techniques.
• 8.3 Design and Development of Products
and Services - removal of sub clauses
Design Verification and Design Validation.
Removal of Preventive Action.