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DIS ISO9001:2015 Overview
Welcome
Sections 8-10Revisions & Impact
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Joe MansourISO9001:2015 Program Manager
Lead Auditor
760-458-3879 (office/cell)
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Today’s Presentation ISO9001:2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015
10. ImprovementISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
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… Final Webinar on July 29, 2015 .
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www.ul-dqsusa.com
http://ul-dqsusa.com/iso-90012015/
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Questions?
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Please send your questions to:
Next Webinar: July 29, 2015
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Questions From The Last Webinar
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Q38: In 7.1.5, it is noted to do assessment if an equipment is found to be “defective”. Would this include out of tolerance conditions as well.
Defective is defined in 3.40 as “a nonconformity related to an intended or specified use”.
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Questions From The Last Webinar
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Q39 Do you feel audits will take longer due to evaluation of risk
assesment evidence?
The overall number of audit-days will most likely not change significantly.
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Questions From The Last Webinar
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Where is the documnt N-1222 located? on the ULDQS wbsite?
This document is not available on our website. Please refer to question C3 on how it could be accessed.
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Questions?
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Please send your questions to:
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Sections 8, 9, 10
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8 Operation
9 Performance Evaluation
10 Improvement
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Sections 8 – Operation
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8.1 – Operational
Planning8.2
Determination of
requirements
8.3 Design and
Development
8.4 Control of External Sources
8.5 Production/ Service
Provision
8.6 Release of Products
8.7 Control of Nonconformity
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Sections 8 – Operation
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a) Determining Requirements
b) Establishing Criteria
c) Determining Resources
d) Implementing Controls
e) Retaining documented Information
8.1 - OPERATIONAL PLANNING AND CONTROL
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Sections 8 – Operation
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8.2.1 – Customer Communication
8.2.2 – Requirements for Products/Services
8.2.3 – Review of Requirements
8.2 – DETERMINATION OF REQUIREMENTS FOR PRODUCTS AND SERVICES
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Sections 8 – Operation
8.3.1 General
8.3.2 Planning
8.3.3 Inputs
8.3.4 Controls
8.3.5 Outputs
8.3.6 Changes
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8.3 – Design and Development Products and Services
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Sections 8 – Operation
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8.4.1 - General
8.4.2 – Type and Extent of Control
8.4.3 – Information for External Providers
8.4 – Control of ExternallyProvided Products and Services
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Sections 8 – Operation
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8.5.1 Control of Production
8.5.2 Identification / Traceability
8.5.3 Customer Property
8.5.4 Preservation
8.5.5 Post-delivery
8.5.6 Control of Changes
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Sections 8, 9, 10
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8.6 Release of Products and
Services
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Sections 8 – Operation
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• 8.7 - Control of Nonconforming outputs, products and services
• - Correction
• - Segregation, Containment, Return or Suspension
• - Informing the Customer
• - Obtaining Authorization For Release
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Sections 8, 9, 10
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8 Operation
9 Performance Evaluation
10 Improvement
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Section 9 – Performance Evaluation
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9.1.3 – Analysis and EvaluationDemonstrate Conformity, Enhance Customer Satisfaction…
9.1.2 – Customer SatisfactionMonitor Customer Perception
9.1.1- GeneralWhat, Methods, When and How
9 – Performance Evaluation
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Sections 8, 9, 10
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9.2 – Internal Audits
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9.2.1 - Planned Audits
1- Organization’s Requirements
2- Requirements of ISO9001
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9.2 – Internal Audits
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a- Plan, Establish, Maintain with defined Frequency, method, responsibilities, reporting
b- Define the criteria and scope
c- Use of Independent Auditors
d- Reporting of Results to Management
e- Taking Actions Without Undue Delay
f- Maintain and Retain Documented Information
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9.2 – Internal Audits
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For Internal Audits, see
ISO19011 for Guidance
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4.4 - QMS and its Processes
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9.2 – Internal Audits
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Process When Shift 4.1 4.2 4.3 4.4 5.1 5.2 5.3 6.1 6.2 6.3
Sales 9-4-15 1
Engineering W 45 1,2
Planning Jan. 1
Production 1
Q1 1,2,3
Production 2
Q2, Q3
1,2,3
Pack and Ship
Q4 1
HR Dec. 2
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9.2 – Internal Audits
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Process When Shift 4.1 4.2 4.3 4.4 5.1 5.2 5.3 6.1 6.2 6.3
Sales 9-4-15 1
Engineering W 45 1,2
Planning Jan. 1
Production 1
Q1 1,2,3
Production 2
Q2, Q3
1,2,3
Pack and Ship
Q4 1
HR Dec. 2
Primary Secondary
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9.2 – Internal Audits
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Process-oriented auditing with focus on results and effectiveness (4.4)
Responsibilities, Authorities, Ownership
Risks, Opportunities, Undesired Effects
Activities, Methods Of Operation, Documented
Information, People Involved.
Results, Measurements,
Records, Performance Indicators, Control
Des
ired
Out
put
Imp
rove
me
nt O
ppor
tuni
ties
Inpu
t R
esou
rces
Interaction with other processes, external providers
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9.2 – Internal Audits
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Process-oriented auditing with focus on results and effectiveness (4.4)
Responsibilities, Authorities, Ownership
Risks, Opportunities, Undesired Effects
Activities, Methods Of Operation, Documented
Information, People Involved.
Results, Measurements,
Records, Performance Indicators, Control
Des
ired
Out
put
Imp
rove
me
nt O
ppor
tuni
ties
Inpu
t R
esou
rces
(e)(f)
(c)
(c)
(a 1)(d
)
(a 2)(c
,h)
Interaction with other processes, external providers
(b)
8.4
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9.2 – Internal Audits
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Process-oriented auditing with focus on results and effectiveness (4.4)
Responsibilities, Authorities, Ownership
Risks, Opportunities, Undesired Effects
Activities, Methods Of Operation, Documented
Information, People Involved.
Results, Measurements,
Records, Performance Indicators, Control
Des
ired
Out
put
Imp
rove
me
nt O
ppor
tuni
ties
Inpu
t R
esou
rces
(e)(f)
(c)
(c)
(a 1)(d
)
(a 2)(c
,h)
Interaction with other processes, external providers
(b)
8.4
1
2
3
4
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4.4 - QMS and its Processes
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4.4 - QMS and its Processes
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Risks and Opportunities
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4.4 - QMS and its Processes
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Risks and Opportunities
W.O.Sheet Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented Information
Press, Dies, Inspection Tools Set-Up Lead,
Operator, Supervisor
Finished Products
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4.4 - QMS and its Processes
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Risks and Opportunities
W.O.Sheet Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented Information
Press, Dies, Inspection Tools Set-Up Lead,
Operator, SupervisorInspectors
Finished Products
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2
3
4
1
6
7
5
Interactions with other processes
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4.4 - QMS and its Processes
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Risks and Opportunities
W.O.Sheet Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented Information
Press, Dies, Inspection Tools Set-Up Lead,
Operator, SupervisorInspectors
Finished Products
5.2, 6.1, 6.2, 7.5, 8.5, 8.7,
9.1
5
2
3
4
1
6
7
5
Interactions with other processes
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Section 6
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Section 6
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Section 9.3 – Management Review
9.3 Management Review
9.3.1- Inputs
9.3.2- Outputs
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Section 9.3 – Management Review
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Reviews at Planned Intervals
Ensue its continuing suitability, adequacy and effectiveness
a) Status of actions from previous reviews
b) Changes / Strategic DirectionMan
agem
ent
Rev
iew
In
pu
ts
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Section 9.3 – Management Review
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c) Information on Quality Performance • Nonconformities and CARs• Monitoring and
Measurement Results• Audit Results• Customer Satisfaction• Issues with Relevant Parties
/External Providers• Adequacy of resources• Process Performance• Conformity of Products
Man
agem
ent
Rev
iew
In
pu
ts
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Section 9.3 – Management Review
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a) Continual Improvement Opportunitiesb) Any change needed for QMS, including resources
Retain document information as evidence of results of management review.
Man
agem
ent
Rev
iew
O
utp
uts
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Sections 8, 9, 10
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8 Operation
9 Performance Evaluation
10 Improvement
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Sections 8, 9, 10
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10.1- General
10.2- Nonconformity and Corrective Action
10.3 Continual Improvement
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Section 10- Improvement
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10.1 a) Improve to prevent occurrence
10.1 b)
Improve products and services to meet known and predicted requirements
10.1 c)Improve Quality
Management System Results
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Section 10 – Improvement
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NCMR, CAR
React
Take Action, Control, Correct Deal with it
Evaluate Action for
Cause
Review the NCMR
Determine Cause
Impact on others
Implement Action
Needed
Review for effectiveness
Make changes
10.2.2 – retain documented information as evidence of nature of
NC and result of Corrective Action taken.
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Section 10- Improvement
Continually Improve the Suitability, Adequacy,
Effectiveness
Consider the Outputs Of
Analysis And Evaluation
Consider Outputs Of
Management Review
Utilize Methodologies
For Investigation
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Today’s Presentation ISO9001:2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015
10. ImprovementISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
47
… Final Webinar on July 29, 2015 .
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Transition Plan
UL DQS TRANSITION
PLANISO9001:2008 TO ISO9001:2015
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Transition Plan
September 2015: Start of 3 years transition period to September 2018
2018201720162015
September 2015: Published International Standard
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as part of its scheduled
Recertification Audit;
- in a planned manner through the Continuous
Assessment process with additional audit
time, or
- through a Special Transition Audit.
Transition Plan
An organization may be
upgraded:
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2008 to 2015 Transition
Identification of Interested Parties and their requirements.
Identification of Gaps and actions needed
Identification of Risks and Opportunities
Identification of Processes
Context of the Organization and Leadership Requirements
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2008 to 2015 Transition
Review of one round of process-based Internal Audits to ISO9001:2015
At least one management review after the completion of the audits.
Ensure Understanding of the Requirements
Deployment of Process-based Management System
Stage 1 to be done about eight weeks prior to Stage 2.
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2008 to 2015 Transition
Please let your Customer Service Representative know well in advance of your audit when you are ready to
upgrade.
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2008 to 2015 Transition
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Customize
d On Site Presentations
ISO9001:2015 Transition Process and Requirements
Availability of Gap Assessments
ISO9001:2015 Available Services Services
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2008 to 2015 Transition
Please let your Customer
Service Representative know should
be interested in these services.
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2008 to 2015 Transition
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Questions?
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Please send your questions to:
Next Webinar: July 29, 2015
DQ
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Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
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Please send your questions to:
Next Webinar: July 29, 2015
