Escolar Documentos
Profissional Documentos
Cultura Documentos
Prepared by
Rand E Winters, Jr.
Senior ASR Lead Auditor
March 2014
Objective of Revisions
Enhance an organizations ability to satisfy
customers.
Whats New?
Risk management is being added with focus on risk-based
thinking. Identification of risk and risk control now a
requirement.
Structure Re-organized
8. Operation includes planning & control, determine market
needs, interaction w/customers, planning process, control of
external provisions of goods/services, production of goods,
provision of services, release of goods/services, non-conforming
goods/services
9. Performance Evaluation includes monitoring, measurement,
analysis & evaluation, internal audit, management review
Structure Outlined
10. Improvement addresses non-conformity & corrective
action, improvement
2014
2015
June 2013 CD
(Committee Draft)
April 2014 DIS
(Draft International Standard)
July 2015 FDIS
(Final Draft International Standard)
September 2015
(Published International Standard)
2016
2017
2018
September 2015
Published International Standard
Considering Risk
Risk Control
OPTION analysis
Implementation of measures
RESIDUAL RISK evaluation
Overall RISK acceptance
Risk Evaluation
RISK acceptability decisions
RISK ASSESSMENT
Post Production
Information
Post-production experience
Review of RISK MANAGEMENT
experience- customer use
Take appropriate actions
Risk Continued
6.3 Planning and Controlling Changes
a) identification of risk and control measures associated with
product
8.4 Control of External Processes or Products- evaluation
based on risks and risk control
8.5.1 Design and Development, define c) risk
8.5.3 Implement c) risk control measures
8.6 Execution/Implementation 8.6.1h) implementation of
risk controls
9.3 Management Review b) determined risks
Thank you