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DIS ISO9001:2015 Overview
Welcome
Sections 1-5
Revisions & Impact
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Joe MansourISO9001:2015 Program Manager
Lead AuditorBSEE, MSEE, MBA
760-458-3879 (office/cell)
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www.ul-dqsusa.com
http://ul-dqsusa.com/iso-90012015/
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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.
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… Final Webinar on July 29, 2015 .
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Questions?
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Please send your questions to:
Next Webinar: April 29, 2015
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Questions From The Last Webinar
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Q1 What is the current difference between element approach and process approach?
Explanation of Process Approach was included in slides 30-49. ISO9001:2015 requires all Processes (value-added activities of the organization) be identified and managed as a process.
Element-based standards just outline the requirements.
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Questions From The Last Webinar
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Q2 What do you mean by the standard now requires min 17 "documented information"
“Retain Documented Information“ appears 17 times in the Standard. Namely, in sections 4.4, 6.2.1, 7.1.5, 7.2, 8.1.e), 8.2.3, 8.3.5, 8.3.6, 8.4.1, 8.5.2, 8.5.6, 8.6, 8.7, 9.1.1, 9.2.2, 9.3.2 and 10.2.2.
This is equivalent to the current Quality Records requirement, where the information can be in any media or format. For clarification, please note that “Maintain documented information“ is equivalent to the current “Documented Procedure“ requirement.
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PROCESS
(DO)INPUT OUTPUT
Plan
Check
Act
Questions From The Last Webinar
Q3 What does PDCA stand for?
Slides 15-19.
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Questions From The Last Webinar
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Q4 How do I obtain training in Risk Management? Will numbering align with ISO14k and the OHSAS18k?
We will be covering Risk Management as part of our April 20 Webinar.
TS16949, AS9100, TL9000 have already indicated that they will update .
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Questions From The Last Webinar
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Please refer to slides 56-63 and FAQ question A5.
Q6 What will be the deadline to update documentation to the 2015 standard after release?
If we just got re-certified, will we have to do it again, or can we do it at the next 3 year cycle?
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Questions From The Last Webinar
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http://isotc.iso.org/livelink/livelink/open/tc176SC2public. As of March 25, 2015, the link is still active.
Q7 The ISO 176 link is no longer valid. Can you supply the new link?
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Q8 Can you provide the FAQ location again?
http://ul-dqsusa.com/iso-90012015/
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Questions From The Last Webinar
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Q12 You showed several examples of "not a process map" and one bad process map. Could you explain what a good process map looks like, requires, etc.?
ISO9001:2015 requires all processes to be identified. Furthermore, clause 4.4b requires the “sequence and interaction of the process“ be defined”.
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Questions From The Last Webinar
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Q16 So we will have to re-do our internal auditor
certifications that we currently have?
Not necessarily. Please see FAQ
questions B1, B2 and B3.
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Questions From The Last Webinar
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ISO committee is made up of 163 member countries, each with a single vote. All ISO standards are normally
reviewed every five years to assure that they are still relevant and adequate in an ever changing world.
Q17 Why change to ISO 9001:2015, just stay at ISO 9001:2008.
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Questions From The Last Webinar
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Q26 For family owned companies, involvement of management is very rare and the real actions are really limited to the doers in the company. I am afraid that we will not be able to implement the new requirements
On the contrary, the new requirements have been defined so as to make them easier to implement in smaller organizations. With reduced need for documentation, the ISO9001:2015 is less prescriptive.
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Sections 1-5
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1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
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Sections 1-5
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1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
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Section 1- Scope
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• Needs to demonstrate its ability to meet customer/statutory/regulatory requirements
• Aims to enhance customer satisfaction
This Standard specified
requirements for a quality management system where
an organization
All requirements are generic and intended to be applicable to all types of organizations, regardless
of type, size and product (or service) provided.
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Sections 1-5
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1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
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Section 2
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2 Normative References.
There are no normative references for DIS ISO9001:2015.
This section is included to maintain clause numbering alignment with other ISO
management system standards.
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Sections 1-5
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1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
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Section 3 – Terms & Definitions
3.02 – INTERESTED PARTY
Person or organization (3.01) that can affect, be affected by, or perceive themselves to be affected by a decision or activity.
3.01 – person or group of people that has its own functions (3.25) with responsibilities, authorities and relationships to achieve its objectives (3.08)
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Section 3 – Terms & Definitions
3.06 - EFFECTIVENESS
Extent to which planned activities are realized and planned results achieved.
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Section 3 – Terms & Definitions
3.08 –OBJECTIVE
Result to be achieved.
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Section 3 – Terms & Definitions
3.09 - RISK
Effect of uncertainty on an expected
result.
The effect can be positive or
negative consequence
- Risk is characterized by potential events and
consequences.
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Section 3 – Terms & Definitions
3.11 – DOCUMENTED INFORMATION
Information (3.50) required to be controlled and maintained by an organization (3.01) and
the medium on which it is contained.
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Section 3 – Terms & Definitions
3.12 – PROCESS
Set of interrelated or interacting activities
which transforms inputs into outputs
(3.46).
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Section 3 – Terms & Definitions
3.20 – CORRECTIVE ACTION
Action to eliminate the cause of a nonconformity (3.19) and to prevent recurrence.
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Section 3 – Terms & Definitions
3.24 – CONTEXT OF THE
ORGANIZATION (Business
Environment)
Combination of internal and
external factors and conditions that can have an effect on an organization’s approach to its
products, services and investments,
and interested parties.
- Business Environment, organizational environment or
ecosystem of an organization.
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Section 4 - Context Of The Organization
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4.1 Understanding the Organization and Its Context
4.2 Understanding The Needs And Expectations Of Interested Parties
4.3 Determining The Scope of The Quality Management System
4.4 Quality Management System And Its Processes
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Section 4 - Context Of The Organization
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4.1 Understanding the Organization and Its Context
4.2 Understanding The Needs And Expectations Of Interested Parties
4.3 Determining The Scope of The Quality Management System
4.4 Quality Management System And Its Processes
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4.1 – Understanding-Organization-Context
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UL DQS : Mission and values
We want to be the preferred partner for certification, auditing, and assessments of management systems.
Values – Our corporate values drive common attitudes:
Success -
We like to be successful, just like our customers.
Respect
We treat people with respect, always.
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4.1 – Understanding-Organization-Context
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Customer orientation
Customer needs come first – generate value for customers.
Employee orientation
Our employees, auditors, are our greatest success factor.
Mutual trust
Mutual trust enables cooperation in achieving goals.
Responsibility
Take responsibility for results and behavior
Integrity / credibility
Independence, competence and attitude to ensure integrity.
Reliability
Keep our promises. Trust us!
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4.1 – Understanding-Organization-Context
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The vision drives the development of UL DQS. It reflects the expectations of the essential stakeholders:
Preferred partner for certification, auditing, and assessments;
Recognized for our competence in
Supporting business success and organizational health of our customers.
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4.1 – Understanding-Organization-Context
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Other Internal Factors May Include
Management Strategy
Business Continuity
Work Environment
Employee Satisfaction
Overall Compensation
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4.1 – Understanding-Organization-Context
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4.1 The organization shall determine external and internal issues that are relevant to its purpose and its strategic decision and that affect its ability to achieve the intended results.
The organization shall monitor and review the information about these external and internal issues.
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4.1 – Understanding-Organization-Context
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Internal Environment
Society
External Environment
Government
OwnersFinancial
Customers
Suppliers
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4.1 – Understanding-Organization-Context
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Internal Environment
Society
External Environment
Government
OwnersFinancial
Customers
Suppliers
Socia
lC
ultura
lP
olit
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Dem
ogra
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Gro
wth
Facto
rs
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Section 4 - Context Of The Organization
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4.1 Understanding the Organization and Its Context
4.2 Understanding The Needs And Expectations Of Interested Parties
4.3 Determining The Scope of The Quality Management System
4.4 Quality Management System And Its Processes
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4.2 – Understanding Needs and Expectations
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Due to impact on organization’s ability to meet
customer, statutory and regulatory requirements, the
organization shall
Identify the interested parties that are relevant to the quality
management system.
Identify the requirements of these interested parties
Organization to monitor and review the information about these interested parties and their relevant requirements.
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4.2 – Understanding Needs and Expectations
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Corporate Policies of UL DQS governed by
Customers
Employees and Auditors
External Auditors, Business Partners
Shareholders
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4.2 – Understanding Needs and Expectations
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Employee expectations
UL DQS employees expect above-average working conditions and jobs that provide learning opportunities in the long term. They also expect an income commensurate with their performance, recognition for their achievements, and support for attractive professional development.
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4.2 – Understanding Needs and Expectations
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Employee Policy - Example
Employee commitment and competence is an essential principle of success for business activities. With attractive working conditions, performance-oriented culture, and respectful interaction with each other, the goal is to be an organization preferred by employees..
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Section 4 - Context Of The Organization
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4.1 Understanding the Organization and Its Context
4.2 Understanding The Needs And Expectations Of Interested Parties
4.3 Determining The Scope of The Quality Management System
4.4 Quality Management System And Its Processes
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4.3 - Determining Scope of QMS
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The scope shall be
available and be maintained
as a documented information stating the:
• Products and services covered by the quality management system
• Justification for any instance where a requirement of this international standard cannot be applied. .
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Section 4 - Context Of The Organization
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4.1 Understanding the Organization and Its Context
4.2 Understanding The Needs And Expectations Of Interested Parties
4.3 Determining The Scope of The Quality Management System
4.4 Quality Management System And Its Processes
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4.4 - QMS and its Processes
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The organization shall identify the processes and shall determine:
The inputs required and the outputs expected
The sequence and interaction of these processes
The criteria, methods, including
performance indicators
The resources needed
The assign of the responsibilities and authorities
The risks and opportunities
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4.4 - QMS and its Processes
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PROCESSINPUT OUTPUT
• Production Processes (stamping, welding, painting)
• Management Processes (administration, audits, CAR, HR)
• Support Processes (maintenance, warehouse, purchasing)
• Customer Processes (sales, customer satisfaction)
• Service Processes (Bank- deposit, withdrawal, loan
processing, mortgage application, monthly statements)
“set of interrelated or interacting
activities which transforms inputs into
outputs”
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4.4 - QMS and its Processes
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4.4 – QMS - and its Processes - Service
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PROCESS
(DO)INPUT OUTPUT
Plan
Check
Act
4.4 - QMS and its Processes
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality -
rework
STAMPING
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4.4 – STAMPING Process Map
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Inputs/Needs Process
Operations
Outputs/Results Responsibility
Work Order
Material
identified with
tag
Verify Schedule
Adjust setup
Supervisor
Set up for
Production
Run First off Set Up Lead
Inspect Q.C. Inspector
Set Up Lead
Update NCMR
database
Resume Full
ProductionOperator
N
Y
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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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4.4 - QMS and its Processes
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4.4 - QMS and its Processes
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The organization shall maintaindocumented information to the extent necessary to support the
operation of processes and retain documented information to
the extent necessary to have confidence that the processes
are being carried out as planned.
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Sections 1-5
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1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization
5 Leadership
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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Leadership
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Taking accountability
of Effectiveness
Ensure Quality Policy &
Objectives in place
Ensure QP is communicated
and understood
Integration of QMS with business
processes
Leadership and Commitment
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Leadership
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Promoting awareness /Process Approach
Availability of Resources
Communicate the
importance of effective QMS
Ensure QMS achieves intended results
Leadership and Commitment
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Leadership
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Engaging, directing and supporting
Promoting Continual
Improvement
Support other
management roles
Leadership and Commitment
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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5 - Leadership
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is appropriate to the purpose and context of
the organization
Provides a framework for setting and reviewing
quality objectives
Includes a commitment to continual improvement
of the quality management
Includes a commitment to satisfy applicable
requirements
Quality Policy
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5 - Leadership
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• 5.1.1 Leadership and commitment for the QMS
• 5.1.2 Customer Focus
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational roles, responsibilities / authorities
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5 - Leadership
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system conforms to
the requirements
of ISO
all processes are delivering their intended
results
reporting on the
performance
promotion of customer
focus
Organizational Roles and
Responsibilities
Maintain
Integrity
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Questions?
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Please send your questions to:
Next Webinar: April 29, 2015
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Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager
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Please send your questions to:
Next Webinar: April 29, 2015
