Professional Documents
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Carmine Liuzzi
Industry Leader
SAI Global Assurance Services, Training & Improvement Solutions
Presenters
Carmine Liuzzi Glen Broomfield
Industry Leader National Sales Manager
Training & Improvement SAI Global
Solutions Assurance Services
- 20-year veteran with SAI Global
- Over 10 years of professional management
- Masters degree In polymer chemistry from Long system development, business to business
Island University and a bachelors in sales and sales team management experience
biochemistry from Manhattan College
- Bachelors Degree in Business Administration
- Areas of specialty include ISO 9001, ISO 14001, and Marketing, trained as an Exemplar Global
ISO/TS 16949 and OHSAS 18001, as well as certified ISO 9001 Lead Auditor and is also a
process improvement techniques Lean Six Sigma Black Belt
- RABQSA certified Lead Auditor for Quality and
Environmental Management Systems, - Cross continental working experience in
Automotive expert, including ISO/TS 16949, strategic planning, system development and
APQP, PPAP, FMEA, MSA sales team management
- Coaches clients in all aspects of developing, - Seasoned mentor for the US sales team in
implementing and integrating management developing appropriate solutions and services
systems, and provides services that range from for customers
training and consulting support to leading
internal assessment teams
Webinar Objectives
#1 Customer #3 Engagement
#2 Leadership
Focus of People
The primary Leaders at all It is essential for
focus of quality levels establish the organization
management is unity of purpose that all people
to meet customer and direction and are competent,
requirements create conditions empowered and
and to strive to in which people engaged in
exceed customer are engaged in delivering value
expectations achieving the
quality objectives
of the
organization
Quality Management Principles
#6 Evidence-
#4 Process
#5 Improvement based Decision
Approach Making
Consistent and Successful Decisions based
predictable results organizations on the analysis
are achieved have an ongoing and evaluation of
more effectively focus on data and
and efficiently improvement information are
when activities more likely to
are understood produce desired
and managed as results
interrelated
processes that
function as a
coherent system
Quality Management Principles
#7 Relationship
Management
For sustained
success,
organizations
manage their
relationships with
interested parties,
such as suppliers
The new structure for ISO 9001
One of the big changes to Clause Description
come in the new version of 1 Scope
ISO 9001;2015 is its 2 Normative references
structure 3 Terms and Conditions
4 Context of the
There will now be 10 organization
sections (instead of 8) in the 5 Leadership
Standard; the requirements 6 Planning for the quality
themselves are set out in management system
Clauses 4 - 10 7 Support
8 Operation
9 Performance evaluation
10 Improvement
High Level View of Changes
Many requirements from the existing version are now
located differently
Process Approach is now embedded in requirements
Clause 4.4, not as before in the Introduction
For the most part these consist of requirements that
were already in 9001, but which have now been
brought together
Preventive action has been removed and replaced with
Risk management
Requirements for both Management Review and Internal
Audit are now under Performance Evaluation clause 9
Most of what is currently covered under Management
Responsibilities is now under clause 5 Leadership.
High Level View of Changes
10
4
6 9
7
Plan-Do-Check-Act Cycle
The methodology known as Plan-Do-Check-Act cycle can
be applied to all processes and the quality management
system as a whole
PDCA cycle which can be briefly described as follows:
Plan: establish the objectives of the systems and its
component processes and resources
Do: implement what was planned
Check: monitor and where applicable measure processes,
product and services against policies, objectives and
requirements, and report the results
Act: take actions to improve process performance, as
necessary
Plan-Do-Check-Act Cycle
Act Plan
Do
Check
0.5 Risk-based thinking
Risk is the effect of uncertainty on an expected
result and the concept of risk-based thinking has
always been implicit in ISO 9001
The Standard now makes risk-based thinking more
explicit and incorporates it in requirements for the
establishment, implementation, maintenance and
continual improvement of the quality management
system
0.6 Compatibility with other
Management System Standards
The Standard has adopted the high level structure
(i.e. clause sequence, common text and common
terminology) to improve alignment among all
International Standards for management systems
This enables an organization to use the process
approach:
with the PDCA methodology and risk-based
thinking
to align or integrate its quality management
system with the requirements of other
management system standards
Section 1 - Scope
to
Explanation:
Leadership takes accountability of the effectiveness of the
quality management system
Ensuring the integration of the quality management system
requirements into the organizations business processes
Quality Policy should align with the Strategic direction / plan
and the context of the organization.
Clause 6 - Planning for the Quality
Management System
Explanation:
We need to establish a planned and systematic
management of change process that evaluates the
effect / consequences of any changes to the management
system prior to implementation of the change.
This is further emphasized in Section 8.1 The
organization shall control planned changes and review the
consequences of unintended changes, taking action to
mitigate any adverse effects, as necessary.
Section 7 - Support
7.1 Resources
7.1.3 Infrastructure
7.1.4 Environment for the operation of
processes
7.1.5 M onitoring and measuring resources
7.1.6 Organizational knowledge
Explanation:
To determine the knowledge necessary for the operation of its
processes and to achieve conformity of products and services
This knowledge shall be maintained, and made available to the
extent necessary
When addressing changing needs and trends there is a need
to consider current knowledge and determine how to acquire
or access the necessary additional knowledge
7.1.6 Organizational Knowledge
NOTES:
Organizational knowledge can include information such as
intellectual property and lessons learned
To obtain the knowledge required, the organization can
consider:
internal sources (e.g. learning from failures and
successful projects, capturing undocumented knowledge
and experience of topical experts within the organization)
external sources (e.g. standards, academia,
conferences, gathering knowledge with customers or
providers)
This discussion will likely be part of the Management
Review process in forward thinking organizations
Section 8 - Operation
Explanation:
Documented information of actions taken on nonconforming
process outputs, products and services, including on any
concessions obtained and on the person or authority that
made the decision regarding dealing with the nonconformity
must be retained
Clause 9 - Performance Evaluation
Explanation:
As before Internal Audits remain one of the key components that
measures the effectiveness of the quality management system
Internal audits must be conducted at planned intervals to provide
information on whether the quality management system conforms to:
the organizations own requirements for its quality
management system
the requirements of the Standard
Organization in which Internal Organization in which Internal
Audit makes a valuable Audit does not make a valuable
contribution contribution
Top management recognizes Top management is not interested
benefits of internal audit and in internal audit.
actively supports internal audit. Top management does not address
Top management commits to problems.
address all the problems. Top management ignores the truth.
Top management does not distort Top management approach to
the truth. internal audit accelerates
Good internal auditors are departments uncooperative
developed as internal audit is response to internal audit.
respected as precious information When being appointed as internal
source. Internal audit will become auditor, people try to find a reason
effective in providing information to decline the appointment.
that top management wants.
Clause 9 - Performance Evaluation
Explanation:
To be effective we need to plan, establish, implement and
maintain an audit program(s) including:
frequency, methods, responsibilities, planning
requirements and reporting, considering the quality
objectives and importance of the processes concerned
customer feedback, changes impacting on the
organization, and the results of previous audits
Clause 9 - Performance Evaluation
Explanation:
Essentials:
define the audit criteria and scope for each audit
select auditors and conduct audits to ensure objectivity
and the impartiality of the audit process
ensure that the results of the audits are reported to
relevant management
Clause 9 - Performance Evaluation
Explanation:
Essentials:
take necessary correction and corrective actions
without undue delay
retain documented information as evidence of the
implementation of the audit program and the audit
results.
Clause 9 - Performance Evaluation
Explanation:
The second key activity measuring effectiveness requires
Top Management to review the organization's quality
management system, at planned intervals, to ensure its
continuing suitability, adequacy, and effectiveness
The management review must be planned and carried out
taking into consideration:
actions from previous management reviews and
changes in external and internal issues that are relevant
Clause 9 - Performance Evaluation
Explanation:
information on the quality performance, including trends and
indicators for:
nonconformities and corrective actions
monitoring and measurement results
audit results
customer satisfaction
issues concerning external providers
Clause 9 - Performance Evaluation
Explanation:
adequacy of resources
process performance and conformity of products and
services
Planning must also consider the effectiveness of actions taken
to address risks and opportunities and new potential
opportunities for continual improvement
A proactive review not just reactive actions
Clause 10 Improvement
10.1 General
10.2 Nonconformity and
corrective action
10.3 Continual improvement
Explanation
The organization shall determine and select opportunities
for improvement and implement necessary actions to meet
customer requirements and enhance customer satisfaction
Improve processes to prevent nonconformities
Improve products and services to meet known and predicted
requirements
Improve quality management system results
Clause 10 Improvement
10.1 General
10.2 Nonconformity and
corrective action
Explanation: 10.3 Continual improvement
When a nonconformity occurs including those arising from
complaints
Take action to control and correct it and deal with consequences
Evaluate the need for action to eliminate the cause in order that is
does not recur or occur elsewhere
Determine if similar nonconformities exist or could potentially
occur
Corrective actions should be appropriate to the effects of the
nonconformities encountered
Retain documented information
Clause 10 Improvement
10.1 General
10.2 Nonconformity and
corrective action
10.3 Continual improvement
Explanation:
Organization shall consider:
Outputs of analysis and evaluation
Outputs of management review
To confirm if there are areas of underperformance or
opportunities that shall be addressed as part of continual
improvement
Select and utilize applicable tools and methodologies for
investigation of the causes of underperformance and for
supporting continual improvement
ISO 9001:2015 Timeline
May 2013 CD
(Committee Draft) + Transition period
for certification
May 2014 DIS (Draft
International
Standard)
September 2015 IS
Published (International
Standard)
Transition Period for Certification
September 2015
(Published International Standard)
September 2015
start of 3 year transition period
to September 2018
ISO 9001:2015 Revision Whats Next
A U S T RA L IA B A N GL A D E S H B R A ZI L C A N A DA C H I L E C H I NA C Z E C H E G Y P T F R A N C E G E O RG IA G E R M A N Y I N DI A
I N D O N E S IA I R E L A ND I T A L Y J A P A N K O R E A L E B A NO N M E X IC O N E W Z E A L A N D P O L A N D R U S S IA S O UT H A F RI CA
S P A I N S W E D E N T A I WA N T HA I L A N D T UN I S I E T U R K E Y U N I T ED K I N GD OM U N ITE D S TA TE S
Assurance Services
OHSAS 18001:2007
*SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions
Public training and improvement courses include:
ISO 9001 Quality Management System Training Course
ISO 9001 Understanding and Implementing Course for Senior
Management
Implementing a Quality Management System
Corrective and Preventative Action (CAPA) Course
Conducting and Leading Management System Audits
Process Mapping for Process improvement
Enhancing Management Representative Skills to Support
Organizational Success
Transitioning to ISO 9001:2015 Quality Management System
www.saiglobal.com/courses
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions Date Location
July 29, 2014 Toronto, ON
Transitioning to ISO 9001:2015 Quality Aug 1, 2014 Cleveland, OH
Management System Course Outline Aug 26, 2014 Vancouver, BC
(1-day) Aug 27, 2014 Toronto, ON
Sept 3, 2014 Chicago, IL
The purpose of this one-day course is to provide
Sept 11, 2014 Sudbury, ON
advance information on and interpretation of the
requirements of the Draft/DIS ISO 9001:2015 Sept 16, 2014 Montreal, QC
International Standard. Attendees will gain an Sept 26, 2014 Houston, TX
introduction to the potential changes in the Sept 30, 2014 Toronto, ON
upcoming revision and how these could affect
Oct 3, 2014 Cleveland, OH
their organizations quality management system.
The course will also explore the implementation Oct 28, 2014 Calgary, AB
timeframe and the impact on current Nov 14, 2014 St. Louis, MO
registrations. Nov 18, 2014 Vancouver, BC
Nov 28, 2014 Toronto
www.saiglobal.com/courses
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Upcoming Quality Training
10% Discount* Code:
United States Canada ISO9001REV10
Anaheim, CA Calgary, AB
*Valid for public training courses
Atlanta, GA Edmonton, AB
Baltimore, MD Halifax, NS
Boston, MA Montreal, QC
Charlotte, NC Toronto, ON
Chicago, IL Ottawa, ON
Dallas, TX Vancouver, BC
Houston, TX
Los Angeles, CA
Nashville, TN
Orlando, FL
St. Louis, MO
www.saiglobal.com/courses
Training & Improvement Solutions
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions
Consulting
Program review & development
Evaluate performance of current business systems to identify
improvement opportunities
Develop and implement management systems to meet business needs
/ requirements
Upgrade current management system to incorporate new / enhanced
requirements
Development and implementation of sustainable business excellence
models
Customize training and workshops to meet specific business needs
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions
Consulting
Gap Analysis This evaluation is critical to the development of an effective and
efficient project plan / implementation plan (basically establishes a starting point
and enables us to plot a straight line to the desired goal).
A gap analysis not only identifies gaps, but also areas where the systems are
conforming and where opportunities for improvement may exist
A detailed project plan identifying timing, task and responsibilities is created
This serves as the basis for development of a detailed customized project plan
for the implementation of the management system
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions
Consulting
Management System Development - The focus of a management system
implementation is on ensuring effectiveness (getting the right answer) and
efficiency (cost effective operations and use of resources) of an organizations
business processes
SAI Global translates the requirements from ISO speak into practical,
innovative effective business processes that help the organization
improve customer satisfaction. The organization then realizes savings
and sustainable profitability from these improved operations all while
meeting the registration requirement.
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Training & Improvement Solutions
Consulting
Kaizen Event Specific, focused event to identify potential process
improvements. Part classroom activities, part actual work on the selected
process.
Typically, the process selected by the organization will realize a 20%
improvement within 6 months or less*. Teaches process to participants
so they can expand improvement to other processes.
SAI Globals Improvement Solutions Business and Certification Services Business operate independently. Any audit
provided by our Certification Services Business is totally independent of any work we may have done through our
Improvement Solutions Business and will not provide our clients with any special treatment.
Assurance Services
ISO 9001
ISO 14001
OHSAS 18001
Responsible Care -- RC 14001 & RCMS
ISO 50001
BAN e-Stewards
Responsible Recycling (R2)
Recycling Industry Operating Standard (RIOS)
TS 16949
AS 9100, AS 9110, AS 9120
Request more information on
Training, Auditing, Consulting & Certification
www.saiglobal.com/assurance
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