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1
DIS ISO9001:2015 Overview
Welcome
Sections 6-7
Revisions & Impact
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2
Joe Mansour ISO9001:2015 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. 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/
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Questions?
5
Please send your questions to:
Next Webinar: May 26, 2015
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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Tester Reject
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Questions From The Last Webinar
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Tester Reject
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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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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Questions From The Last Webinar
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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.
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Questions?
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Please send your questions to:
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Sections 6-7
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6 Planning For the Quality Management System
7 Support
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Sections 6-7
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6 Planning For the Quality Management System
7 Support
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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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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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WHAT IS
RISK-BASED THINIKING?
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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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10 - Improvement
Improve by responding to change in Risk
9 - Performance
Monitor, Measure, Analyze
8 - Operation
Implement Processes
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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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Section 6 – Planning for QMS
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WHY USE
RISK-BASED THINIKING?
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Section 6 – Planning for QMS
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• Build a strong knowledge base
• Establish a proactive culture of improvement
• Assure consistency of quality
• Improve customer confidence and satisfaction.
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Section 6
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1 ISO31000
2 Document N1222 “Risk In ISO9001:2015”
3 Examples
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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
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Section 6 – 4 T’s of Risk Management
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Tolerate
Treat
Transfer
Terminate
Re
sp
on
din
g T
o
Sig
nif
ican
t R
isks
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Section 6
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1 ISO31000
2 Document N1222 “Risk In ISO9001:2015”
3 Examples
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Section 6 – Planning for QMS
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HOW DO I USE
A RISK-DRIVEN APPROACH IN MY ORGANIZATION?
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Section 6 – Planning for QMS
Identify The Risks
Analyze & Prioritize
Plan Actions to address
Take Action Check
Effectiveness Learn & Improve
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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Section 6 – Planning for QMS
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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
Ris
k-B
ased
Th
inkin
g
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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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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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Section 6 – Planning for QMS
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6.2.1 Quality Objectives
Be Monitored
Be Communicated
Be Updated as appropriate
Retain Documented Information on the Objectives
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Section 6 – Planning for QMS
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6.2.2 Quality Objectives
What will be done.
What resources will be required.
Who will be responsible.
When it will be completed.
How the results will be evaluated.
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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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Section 6 – Planning for QMS
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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
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Section 6 – Failure-Mode-And-Effect (FMEA)
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RPN= Severity * Occurrence * Detection
RPN= Risk Priority Number
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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
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Sections 6-7
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6 Planning For the Quality Management System
7 Support
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Section 7 – Support
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7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
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Section 7 – Support
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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
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Section 7 – Support
7.2 Competence
Determine competence needed
Ensure Competence
Acquire Competence
Retain Evidence
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Section 7 – Support
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Quality Policy Quality
Objectives
Contributions Implications
7.3 - Awareness
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Section 7 – Support
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What When
With Whom
How
7.4 - Communication
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Section 7 – Support
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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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Section 7 – Support
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Distribution, Access, Retrieval, Use
Storage, Preservation
Control of Changes
Retention and Disposition
7.5.3.2
Documented
Information
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Questions?
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Please send your questions to:
Next Webinar: May 26, 2015
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Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
69
Please send your questions to:
Next Webinar: May 26, 2015
