ISO 9001:2015 Overview: Revisions & Impact - Part 1

DQS-ULManagementSystemsSolutions©
1
ISO9001:2015 Overview
Welcome
Revisions & Impact

2
Jawaid.Mansour@us.dqs-ul.com
Joe Mansour
Lead Auditor/ISO9001:2015
Program Manager
760-458-3879 (office/cell)

3
www.ul-dqsusa.com
http://ul-dqsusa.com/iso-90012015/

Today’s Presentation - ISO9001:2015
4
• Highlight Changes since October 2014
• Review Clause 0 of the Standard. Establish timeline for
three more webinars, each covering various sections of
the Standard
• Overall structure of the Standard
• Provide UL DQS’s transition plan for all registered clients
• Provide UL DQS’s Client Internal Auditor Training/
Certification Plan details.

Roadmap ISO 9001:2015
Initial Release:
based on
BS5750
1994: element
based - 20
sections.
2000: Radical
Change:Process
Based
2008: Minor
Revisions
2015200019941987
Significant
Changes

Changes Since October 2014
6
• Development is on track for FDIS in June/July 2015.
• Standard to be published by September 2015.

High Level Structure
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards; some
subclauses mandated as well.
Based on 7 Quality Management Principles
7

8
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

Notable Changes
9
- Quality Manual
- Management Representative
- Preventive Action

Notable Changes
10
If a quality manual is currently written to reflect the ISO
9001:2008 standard, does it have to be re-written to
reflect the now 10 instead of 8 sections?
No, assuming that the Quality Manual does not provide any
contradictory information concerning the requirements of
ISO9001:2015. However, the requirements of the two
standards are significantly different. Upgrading the Quality
Manual to comply with the requirements of the new standard
may be a valuable effort to better identify the deficiencies
within the organization and to have them addressed prior to
the upgrade audit. Renumbering of the pages and/or
sections is not essential as the new standard does not
even require that a Quality Manual be maintained.

Notable Changes
11
If a company has a manual based on standard
requirements, won’t they need to update to reflect process
approach?
There is no requirement for a quality manual in the draft for
2015. The new standard also requires that the processes be
identified and that their interaction be defined. The internal
audit process must use the “process approach”. The process
approach requirement has not changed. However, although
the “Process Approach” was noted in the ISO9001:2008
standard, the new standard explicitly requires the use of the
“Process Approach” when implementing the Quality
Management System.

Notable Changes
12
If a company has a manual based on standard
requirements, won’t they need to update to reflect
process approach?
……….. Furthermore, the new standard requires the top
management to demonstrate leadership and commitment by
promoting awareness of the “Process Approach” within the
organization. Since a Quality Manual is no longer required,
the “documented information” required by the standard may
be in any media or format.

Notable Changes
13
- Quality Manual
- Preventive Action

Notable Changes
14
You mentioned that a management representative is
not required any more. How about MRM?
Although the requirement for having a management
representative has been removed, the new standard
now allows for multiple individuals to be responsible for
different aspects of the quality management system
(Process owners, instead of just one person for the
entire system). Management is now required to identify
the responsibility and authority of the personnel affecting
quality. Section 9.3 of the Standard clearly defines the
requirements for the Management Review Process. It is
an essential part of the PDCA cycle for performance
evaluation.

Notable Changes
15
- Quality Manual
- Preventive Action

Notable Changes
16

Notable Changes
17
PROCESSINPUT OUTPUT
P-D-C-A
ISO9001:2008 Preventive
Action

Notable Changes
18
PROCESSINPUT OUTPUT
P-D-C-A
ISO9001:2015
Risk Based Thinking

Notable Changes
19
PROCESSINPUT OUTPUT
P-D-C-A
ISO9001:2015
Risk Based Thinking

Notable Changes
20
- New additions:
- “Documented Information” = Documented Procedure
(appears 17 times)
- “Documented Evidence” = Quality Records

Notable Changes
21
- New additions:
- The explicit need to have the QMS use the Process
Approach (implement, maintain and audit the value-
added activities as a process)
- Managing the processes using the Plan-Do-Check-
Act cycle Using Risk-based thinking for
“establishment, implementation, maintenance and
continual improvement” of the quality management
system,

Notable Changes
22
- New additions:
- Understanding the needs of the organization and
expectations of their interested parties and
stakeholders.
- Actions to address Risks and Opportunities. A formal
Risk Based program, such as the one defined in
ISO31000 may be suitable for some organizations,
but not mandated.

Notable Changes
23
- New additions:
The overall emphasis on the stakeholders is
to ensure long term business success.
Internally, organizations can benefit from
these requirements as well by considering
the guidance set forth in ISO 9004.

Upcoming Webinars
1. Scope
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.
24
And, one more after FDIS is issued to discuss the changes. .

Introduction “Forward” Section
25
- 0.1 General
-
- 0.2 The ISO Standards for Quality Management
- 0.3 Process Approach
- 0.4 Plan-Do-Check-Act Cycle (PDCA)
- 0.5 “Risk-Based Thinking”
- 0.6 Compatibility with other management system
standards.

Introduction
0.1 – General
The adoption of a quality
management system ought to be a
strategic decision for an
organization.
26

0.1 – General
27
a) its specific objectives
b) the risks associated with its context and
objectives
c) the needs and expectations of its customers and
other relevant interested parties
d) the products and services it provides
e) the complexity of processes it employs and
their interactions
f) the competence of persons within or working on
behalf of the organization
g) its size and organizational structure
Design & Implementation of QMS is influenced by the
context of the organization
Determine the issues and requirements that can impact on the planning of
the Quality Management System.

0.2 - Additional Sections
28
0.2 – The ISO standards for quality management
• ISO9001:2015 Standard (one of the 3 core standards)
• ISO9000 – Fundamentals and vocabulary
• ISO9004 – Managing for the sustained success of an
organization (lead to continual
improvement of the organization)
• - ISO10000 numbered standards

0.2 - ISO 10000 numbered standards
29
0.2 – GUIDELINES
.
ISO10001 Customer Satisfaction
Guidelines
ISO10012 Management of
measurement processes
ISO10002 Customer Satisfaction –
handling complaints
ISO10013 QMS Documentation
ISO10003 Customer Satisfaction –
External Dispute
ISO10014 Realizing financial and
economic benefits
ISO10004 Monitoring and Measuring
Customer Satisfaction
ISO10015 Guidelines for Training
ISO10005 Guidelines for Quality Plans ISO10017 Guidance on Statistical
Techniques
ISO10006 Guidelines for Quality
Management in Projects
ISO10018 Guidance on People
Involvement & Competence
ISO10007 Guidelines for Configuration
Management
ISO10019 Guidelines for the selection
of QMS consultants
ISO10008 Guidelines – Electronic
Commerce
ISO19011 Guidelines for auditing
management systems

0.3 – Process Approach
30
“set of interrelated or interacting
activities which transforms inputs
into outputs”
Document: ISO/TC 176/SC 2/N544R3
Guidance on the Concept and Use of the Process Approach
(http://www.iso.org/iso/04_concept_and_use_of_the_pr
ocess_approach_for_management_systems.pdf )

0.3 - Benefits of Process Approach
31
Benefits of the process approach are:
• Integration and alignment of processes to enable achievement of
desired outcomes
• Ability to focus effort on process effectiveness and efficiency.
• Provision of confidence to customers, and other interested
parties, about the consistent performance of the organization.
• Transparency of operations within the organization.
• Lower costs and creation of shorter cycle times, through the
effective use of resources.
• Improved, consistent and predictable results.
• Provision of opportunities for focused and prioritized
improvement initiatives.
• Encouragement of the involvement of people and the clarification
of their responsibilities.

0.3 - Definition of Process
32
PROCESSINPUT OUTPUT
• Production Processes (stamping, welding, painting)
• Management Processes (administration, audits, CAR, HR)
• Support Processes (maintenance, warehouse, purchasing)
• Customer Processes (sales, customer satisfaction)
activities which transforms inputs into
outputs”

0.3 - Identification/Interaction of Processes
33

34
0.3 - Process Map - Example

35

36

37

0.3 - NOT A PROCESS MAP
38

39

40

41

0.3 - Definition of Process
42
PROCESSINPUT OUTPUT
• Production Processes (stamping, welding, painting)
• Management Processes (administration, audits, CAR, HR)
• Support Processes (maintenance, warehouse, purchasing)
• Customer Processes (sales, customer satisfaction)
activities which transforms inputs into
outputs”

0.3 - Process Approach
43
From Section 0.3:
This International Standard promotes
the adoption of a process approach
when developing, implementing and
improving the effectiveness of a quality
management system, to enhance
customer satisfaction by meeting
customer requirements.

0.4 – Plan-Do-Check-Act Cycle
44
PROCESSINPUT OUTPUT
P-D-C-A

45
Plan
STAMPING

46
PROCESS
(DO)
INPUT OUTPUT
Plan
STAMPING

47
PROCESS
(DO)
INPUT OUTPUT
Plan
Check
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality -
rework
STAMPING
Process
Effectiveness
Internal Process
Efficiency
Internal Process
Efficiency
Internal Process
Efficiency

48
PROCESS
(DO)
INPUT OUTPUT
Plan
Check
Act
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality -
rework

49
PROCESS
(DO)
INPUT OUTPUT
Plan
Check
Act

0.5 – “Risk Based Thinking”
0.5 – Risk-based thinking
- concept has always been implicit
in ISO9001:2008
- ISO9001:2015 makes it more
explicit
50

Notable Changes
51
PROCESSINPUT OUTPUT
P-D-C-A

52
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.

53
Document N1222 published by ISO/TC 176/SC2.
Document:ISO/TC176/SC2/N1222
Guidance on the Concept and Use of the Process
Approach
http://isotc.iso.org/livelink/livelink/open/tc176SC2public
Look for presentation on “ISO9001 and Risk” at the end of
section 7. Also, article N1221 in section 1.

0.6 – Compatibility
- ISO/IEC Directives, Part 1, Consolidated ISO
supplement, 2013, Annex SL,
High level structure and common text is public information and can be
found in Annex SL of the www.iso.org/directives
54
Organizations implementing multiple management
systems (e.g. quality, environmental, information
security) can achieve better integration and easier
implementation

High Level Structure
1. Scope
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards; some
subclauses mandated as well.
Based on 7 Quality Management Principles
55

Transition Plan
UL DQS
TRANSITION
PLAN
ISO9001:2008 TO ISO9001:2015
56

Transition Plan
September 2015:
Start of 3 years transition period to September 2018
2018201720162015
September 2015:
Published
International Standard

58
An organization may be upgraded to
ISO9001:2015
- 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

 The most cost-effective way is to
upgrade during the normally
scheduled Recertification Audit.
 Upgrade audits done as part of the
Continuous Assessment and Special
audits will be carried out for the same
number of days as a recertification
audit (including Stage 1 and Stage 2)
59
2008 to 2015 Transition

60
Topics to be verified during readiness review:
(in addition to verification of fulfillment of changed requirements)
Resonsibilities / actions
 Knowledge about the changed requirements
 Identification of gaps and action needs
 Action plan / responsible persons
 Awareness building in the organization
Focus:
Context of the organization, leadership, and planning

61
Is a complete MR and internal audit expected
before certification against ISO 9001:2015?
Yes; Management review and internal audit on the
basis of ISO 9001:2015 have to be completed before
a certificate on ISO 9001:2015 can be issued. Stage
1 (readiness review) can be carried out before
management review and a complete audit but the
need to complete it before stage 2 will be addressed
in the audit report.

62
Stage 1 Stage 2
Newly Implemented
< 3 years
Maintained / Monitored
Effective / Mature
(including Process Approach and
Risk-Based Thinking)
On Site
On Site
On Site On Site
Off Site On Site

Please let your Customer Service
Representative know well in advance
of your audit when you are ready to
upgrade.
63

64
Client Internal Auditor Training Plan
ISO9001:2008 to ISO 9001:2015

65
 On Site Overview
 Webinar
 Client Internal Auditor Certification
Program

66
 On Site Overview
 One Day on-site presentation
 Provide Overview of the Standard
 No Certificate Issued

67
 Webinars:
 Done By Cindy Soltis - October 2014
 February 18 2015 (provide update,
announce the transition plan, the
Internal Auditor Certification program
and section 0 of the Standard)

68
 Webinars: In-depth review of the
requirements
 March 25, 2015 Sections 1-6
 April 29, 2015 Sections 7-8
 May 26, 2015 Sections 9-10

Internal Auditor Certification Program
Internal Auditor Certification
Program
 Partner up with the clients
 Let you know what we know!
 Complete the UL DQS on line training
module and test.
69

Internal Auditor Certification Program
 Client Certification
 Attend a 2 day Training Session in
person (locations to be determined)
and participate in case studies.
 Get a Certificate of Training.
70

Please let your Customer Service
Representative know well in advance
if you are interested in receiving
Internal Auditor Training from
UL DQS
http://ul-dqsusa.com/iso-90012015-training
71

Questions?
72
ISO9001_2015_Questions@us.dqs-ul.com
Please send your questions to:
Next Webinar: March 25, 2015

Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
73
ISO9001_2015_Questions@us.dqs-ul.com
Please send your questions to:
Next Webinar: March 25, 2015

ISO 9001:2015 Overview: Revisions & Impact - Part 1

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to ISO 9001:2015 Overview: Revisions & Impact - Part 1

Similar to ISO 9001:2015 Overview: Revisions & Impact - Part 1 (20)

More from DQS Inc.

More from DQS Inc. (10)

Recently uploaded

Recently uploaded (20)

ISO 9001:2015 Overview: Revisions & Impact - Part 1