ISO 9001:2015 Revision Overview: part 3

DQS-ULManagementSystemsSolutions©
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DIS ISO9001:2015 Overview
Welcome
Sections 8-10
Revisions & Impact

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Jawaid.Mansour@us.dqs-ul.com
Joe Mansour
ISO9001:2015 Program Manager
Lead Auditor
760-458-3879 (office/cell)

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. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
3
… Final Webinar on July 29, 2015 .

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www.ul-dqsusa.com
http://ul-dqsusa.com/iso-90012015/

Questions?
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ISO9001_2015_Questions@us.dqs-ul.com
Please send your questions to:
Next Webinar: July 29, 2015

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”.

7
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.

8
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.

Questions?
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Sections 8, 9, 10
10
8 Operation
9 Performance Evaluation
10 Improvement

Sections 8 – Operation
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8.1 –
Operational
Planning
8.2
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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a) Determining Requirements
b) Establishing Criteria
c) Determining Resources
d) Implementing Controls
e) Retaining documented Information
8.1 - OPERATIONAL PLANNING AND CONTROL

13
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

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

15
8.4.1 - General
8.4.2 – Type and Extent
of Control
8.4.3 – Information for
External Providers
8.4 – Control of Externally
Provided Products
and Services

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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

Sections 8, 9, 10
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8.6 Release of
Products and
Services

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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

Sections 8, 9, 10
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8 Operation
10 Improvement

Section 9 – Performance Evaluation
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9.1.3 – Analysis and Evaluation
Demonstrate Conformity, Enhance Customer Satisfaction…
9.1.2 – Customer Satisfaction
Monitor Customer Perception
9.1.1- General
What, Methods, When and How
9 – Performance Evaluation

Sections 8, 9, 10
21

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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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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For Internal Audits, see
ISO19011
for Guidance

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4.4 - QMS and its Processes

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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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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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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
DesiredOutput
ImprovementOpportunities
Input
Resources
Interaction with other processes,
external providers

29
effectiveness (4.4)
Responsibilities,
Undesired Effects
Information, People
Involved.
Results,
Measurements,
Indicators, Control
DesiredOutput
Input
Resources
(e)
(f)
(c)
(c)
(a1)
(d)
(a2)
(c,h)
external providers
(b)
8.4

30
effectiveness (4.4)
Responsibilities,
Undesired Effects
Information, People
Involved.
Results,
Measurements,
Indicators, Control
DesiredOutput
Input
Resources
(e)
(f)
(c)
(c)
(a1)
(d)
(a2)
(c,h)
external providers
(b)
8.4
1
2
3
4
5
6
7

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32
Risks and
Opportunities

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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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Risks and
Opportunities
W.O.
Sheet
Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Documented
Information
Press, Dies,
Operator,
Supervisor
Inspectors
Finished
Products
5
2
3
4
1
6
7
5
Interactions with
other processes

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Risks and
Opportunities
W.O.
Sheet
Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Documented
Information
Press, Dies,
Operator,
Supervisor
Inspectors
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

Section 6
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Section 6
37

Section 9.3 – Management Review
9.3 Management
Review
9.3.1- Inputs
9.3.2- Outputs
38

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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 Direction
ManagementReview
Inputs

40
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
Management
Review
Inputs

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a) Continual
Improvement
Opportunities
b) Any change needed
for QMS, including
resources
Retain document
information as evidence
of results of
management review.
Management
Review
Outputs

Sections 8, 9, 10
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8 Operation
10 Improvement

Sections 8, 9, 10
43
10.1- General
10.2- Nonconformity and
Corrective Action
10.3 Continual Improvement

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

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.

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. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
47
… Final Webinar on July 29, 2015 .

Transition Plan
UL DQS
TRANSITION
PLAN
ISO9001:2008 TO ISO9001:2015
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Transition Plan
September 2015:
Start of 3 years transition period to September 2018
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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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.

Please let your Customer Service
Representative know well in advance
of your audit when you are ready to
upgrade.
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On Site
ISO9001:2015 Transition
Process and Requirements
Availability of Gap
Assessments
ISO9001:2015 Available Services
Services

Please let your
Customer
Service
Representative
know should
be interested in
these services.
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Questions?
56

Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
57

ISO 9001:2015 Revision Overview: part 3

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