More Related Content Similar to ISO 9001:2015 webinar Part 3 - UL DQS Inc (20) ISO 9001:2015 webinar Part 3 - UL DQS Inc3. DQS-ULManagementSystemsSolutions©
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 .
6. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
6
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.
7. DQS-ULManagementSystemsSolutions©
7
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
8. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
8
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.
13. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
13
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
14. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
14
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
15. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
15
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
16. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
16
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.
17. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
17
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.
18. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
18
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
19. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
19
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..
20. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
20
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.
25. DQS-ULManagementSystemsSolutions©
Section 6 – Planning for QMS
25
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.
27. DQS-ULManagementSystemsSolutions©
Section 6 – Planning for QMS
27
• 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.
30. DQS-ULManagementSystemsSolutions©
6.1 – Actions – Risks & Opportunities
30
Addressing Risks/Opportunities
Determine Risks
and
Opportunities
per sections 4.1
and 4.2
Actions to
Address Risks
Establish Quality
Objectives
Manage QMS
Change
32. DQS-ULManagementSystemsSolutions©
Section 6 – Planning for QMS
32
• Build a strong knowledge base
• Establish a proactive culture of
improvement
• Assure consistency of quality
• Improve customer confidence and
satisfaction.
35. DQS-ULManagementSystemsSolutions©
Section 6 – 7 R’s of Risk Management
35
Recognition of Risks
Ranking or Evaluation of Risks
Responding to Significant Risks
Resourcing Controls
Reaction Planning
Reporting and Monitoring
Reviewing Framework
47. DQS-ULManagementSystemsSolutions©
Section 6 - Risk Management
47
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
52. DQS-ULManagementSystemsSolutions©
Section 6 – Planning for QMS
52
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.
53. DQS-ULManagementSystemsSolutions©
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
54. DQS-ULManagementSystemsSolutions©
Section 6 – Planning for QMS
54
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
55. DQS-ULManagementSystemsSolutions©
55
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
59. DQS-ULManagementSystemsSolutions©
Section 6 – 7 R’s of Risk Management
59
Recognition of Risks
Ranking or Evaluation of Risks
Responding to Significant Risks
Resourcing Controls
Reaction Planning
Reporting and Monitoring
Reviewing Framework