ISO 9001:2015 webinar Part 3 - UL DQS Inc

DQS-ULManagementSystemsSolutions©
1
DIS ISO9001:2015 Overview
Welcome
Sections 6-7
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.
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… 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: May 26, 2015

Questions From The Last Webinar
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Q27: Slide 8 of the presentation
material for part 1 cross-referenced
ISO9001:2008 sections to 2015
sections. I found many errors. You
may want to revisit it.
The references are as
outlined in document
N1224 by TC176/SC2.

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ISO
9001:2008
ISO/DIS 9001
ISO
9001:2008
ISO/DIS 9001
ISO
9001:2008
ISO/DIS 9001
ISO
9001:2008
ISO/DIS 9001
4 4 5.5.3 7.4 7.2.3 8.2.1 7.5.4 8.5.3
4.1 4.4 5.6 9.3 7.3 8.5 7.5.5 8.5.4
4.2 7.5 5.6.1 9.3.1 7.3.1 8.3, 8.3.1, 8.3.2 7.6 7.1.5
4.2.1 7.5.1 5.6.2 9.3.1 7.3.2 8.3.3 8 9.1
4.2.2 4.3, 7.5.1, 4.4 5.6.3 9.3.2 7.3.3 8.3.5 8.1 9.1.1
4.2.3 7.5.2, 7.5.3 6 7.1 7.3.4 8.3.4 8.2 9.1
4.2.4 7.5.2, 7.5.3 6.1 7.1.1, 7.1.2 7.3.5 8.3.4 8.2.1 9.1.2
5 5 6.2 7.2 7.3.6 8.3.4 8.2.2 9.2
5.1 5.1, 5.1.1 6.2.1 7.2 7.3.7 8.3.6 8.2.3 9.1.1
5.2 5.1.2 6.2.2 7.2 , 7.3 7.4 8.4 8.2.4 8.6
5.3 5.2 6.3 7.1.3 7.4.1 8.4.1,8.4.2 8.3 8.7
5.4 6 6.4 7.1.4 7.4.2 8.4.3 8.4 9.1.3
5.4.1 6.2 7 8 7.4.3 8.6 8.5 10
5.4.2 6, 6.1, 6.3 7.1 8.1 7.5 8.5 8.5.1 10.1, 10.3
5.5 5 7.2 8.2 7.5.1 8.5.1, 8.5.5 8.5.2 10.2
5.5.1 5.3 7.2.1 8.2.2 7.5.2 8.5.1 8.5.3 Clause removed
5.5.2 5.3 7.2.2 8.2.3 7.5.3 8.5.2 see 6.1
ISO9001:2008 vs. ISO/DIS 9001

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Q28 Can we assume the terms of
definitions in the draft of ISO9001:2005 will
be the definitions in ISO9000’s next revision.
ISO9000 Vocabulary is currently under revision
as well. The next update is expected to include
the definitions currently included in
ISO9001:2015.
ISO9000-2005 currently does not include all the
definitions currently included in DIS
ISO9001:2015.

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Q29 The corrective action must eliminate
the “cause”. If the cause is an operator do we
need to get rid of the operator?
Yes and No.
Please consider Deming’s 85/15 Rule.

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Tester
Reject

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Tester
Reject

12
Tester
Reject

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The definition for corrective action has not changed. The
intent is to eliminate the root cause and prevent problems
from happening. The corrective action requirements apply
to all internal and external nonconformities.
Q30 Will this new definition for corrective action
imply that the bar will be raised by auditors on the
results expected on the determination of the cause of
each nonconformity detected internally and/or
externally

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With respect to the context of the organization, the
Quality Management System requirements are to be
considered in meeting customer requirements.
Furthermore, those requirements will have to be
integrated into the Business Management System of the
organization. (Section 4.1)
Q31 Is the Context Of The Organization
directed only towards the Quality
Management System or the Entire Business
Management System

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Q32 At what level of the
organization will the standard expect
that the 4.1 requirements of
understanding of the organization
and the context can be explained to
an external or internal auditor?
Determining the Context of the
Organization is a Leadership responsibility
and is noted under Section 4.0

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Q33 Are you suggesting that the company
will now need process maps for each identified
process?
A process map is not required, but is a good way of
identifying the processes and showing their
sequence and interaction.

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Q34 Can the
processes be
grouped? with
generic inputs,
outputs, measures,
responsibilities,
etc. or does each
specific process
need to have each
item listed in clause
4.4.
Items a-h of section
4.4 has to be
addressed for all
processes.

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The turtle diagrams and process maps were all
examples of how the requirements of the standard may
be met. Other methods will equally meet the
requirements of the standard as long as items
Q35 We have the processes explained in written
documents where the information required by 4.4
can be found. Do we have to go to a more graphic
approach for process definition as the turtle
diagram or equivalent when we certify to
ISO9001:2015

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Q36 Is the ISO9001:2015 standard still on track
to be released by this September.
The current timeline for FDIS publication is July 15,
2015 and for the final Standard by September 2015..

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Q37 If the company has multiple
sites in which sections are excluded,
can those sites lose certification if
main company don’t maintain those
exclusions.
That may depend on the type of
certification being sought. Single Site vs.
Corporate Registration.

Questions?
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Sections 6-7
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6 Planning For the Quality
Management System
7 Support

Sections 6-7
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Management System
7 Support

Section 6 – Planning for QMS
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6.1 Actions to Address
Risks and Opportunities
6.2 Quality Objectives and
planning
6.3 Planning of Changes

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a) Incorporated in requirements for the
establishment, implementation, maintenance and
continual improvement of the QMS.
b) May Use ISO31000 - but not required.
c) Not all processes represent the same level of risk.
d) Considering Risk “qualitatively” to define the
QMS, processes and activities.
Risk is the effect of uncertainty on
an expected result.

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WHAT IS
RISK-BASED THINIKING?

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• Risk-based thinking is what we do
automatically.
• Risk-based thinking is already part of the
process approach.
• Risk is the negative side.
• Opportunity is the positive side.
• Opportunity not related to risk, but related to
objectives.

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6 - Planning
Take Action to Identify Risks
5 - Leadership
Ensure Clause 4 is Followed
4 - Context
Determine Risks

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10 - Improvement
Improve by responding to change in Risk
9 - Performance
Monitor, Measure, Analyze
8 - Operation
Implement Processes

6.1 – Actions – Risks & Opportunities
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Addressing Risks/Opportunities
Determine Risks
and
Opportunities
per sections 4.1
and 4.2
Actions to
Address Risks
Establish Quality
Objectives
Manage QMS
Change

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WHY USE
RISK-BASED THINIKING?

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• Build a strong knowledge base
• Establish a proactive culture of
improvement
• Assure consistency of quality
• Improve customer confidence and
satisfaction.

Section 6
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1 ISO31000
2 Document N1222
“Risk In ISO9001:2015”
3 Examples

Section 6
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Section 6 – 7 R’s of Risk Management
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Recognition of Risks
Ranking or Evaluation of Risks
Responding to Significant Risks
Resourcing Controls
Reaction Planning
Reporting and Monitoring
Reviewing Framework

Section 6 – 4 T’s of Risk Management
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Tolerate
Treat
Transfer
Terminate
RespondingTo
SignificantRisks

Section 6
37
1 ISO31000
2 Document N1222
“Risk In ISO9001:2015”
3 Examples

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HOW DO I USE
A RISK-DRIVEN APPROACH
IN MY ORGANIZATION?

Identify The
Risks
Analyze &
Prioritize
Plan Actions
to address
Take Action
Check
Effectiveness
Learn &
Improve
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Section 6 - Risk Management
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Is Not New
Something You Already Do
Is Continuous
Ensures Greater Knowledge
Increases Reaching Goal
Reduces Poor Results
Makes Prevention a Habit
Risk-Based
Thinking

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6.1.1 Consider Issues in 4.1 and 4.2
Give assurance QMS can achieve its
results
Prevent, or reduce, undesired effects
Achieve Continual Improvement

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6.1.2 The organization shall plan
Actions to address these Risks and
Opportunities
Integrate actions into its QMS processes
Evaluate the effectiveness

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6.2.1 Quality Objectives
Be consistent with the quality policy
Be measurable
Take into account applicable
requirements
Relevant to conformity of products

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Be Monitored
Be Communicated
Be Updated as appropriate
Retain Documented Information on the
Objectives

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What will be done.
What resources will be required.
Who will be responsible.
When it will be completed.
How the results will be evaluated.

4.4 – STAMPING Process Map
OBJECTIVE ACTUAL GOAL ACTION
PPM 25 50 Continue to
Monitor
Machine Up Time 82 % 95% Increase PM, have
spare parts
available, staffing
Parts Per Hour 235 215 Continue to
Monitor
Cost of Rework $496 <$500 per month Continue to
Monitor/consider
risk
Quality Objectives For The Stamping Process

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6.2.2 Planning of Changes
The Purpose and Consequence of
Change
The Integrity of the Quality Management
System
The Availability of Resources
The allocation/reallocation of
responsibilities

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SEVERITY
1 No relevant effect
2 Very Minor, no damage
3 Minor, low damage
4 Moderate
5 Critical (loss of primary
function)
6 Catastrophic
OCCURANCE
1 Extremely Unlikely
2 Remote
3 Occasionally
4 Reasonably Possible
5 Frequent
DETECTION
1 Certain
2 Almost Certain
3 High
4 Moderate
5 Low
6 Undetectable
Risk Priority Number
(RPN) =
Severity * Occurance *
Detection
FMEA - RPN

Section 6 – Failure-Mode-And-Effect (FMEA)
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RPN= Severity * Occurrence * Detection
RPN= Risk Priority Number

Section 6 - Risk Register
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Section 6 - Risk Management
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Section 6 – 7 R’s of Risk Management
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Recognition of Risks
Ranking or Evaluation of Risks
Responding to Significant Risks
Resourcing Controls
Reaction Planning
Reporting and Monitoring
Reviewing Framework

Sections 6-7
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Management System
7 Support

Section 7 – Support
61
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information

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7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring Resources
7.1.6 Organizational knowledge

7.2 Competence
Determine competence needed
Ensure Competence
Acquire Competence
Retain Evidence
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Quality Policy
Quality
Objectives
Contributions Implications
7.3 - Awareness

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What When
With
Whom
How
7.4 - Communication

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7.5.1 General
7.5.2 Creating and
Updating
7.5.3 Control of
Documented Information
7.5
Documented
Information

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Distribution, Access,
Retrieval, Use
Storage, Preservation
Control of Changes
Retention and
Disposition
7.5.3.2
Documented
Information

Questions?
68

Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
69

ISO 9001:2015 webinar Part 3 - UL DQS Inc

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