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01. Awareness ISO9000 - 9001 2015

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Awareness and Use of
ISO 9000:2015:
Quality management systems —
Fundamentals and vocabulary
Purpose and scope
For use by the public in providing training on the
importance of ISO 9000:2015 when it comes to:
Understanding the significant differences
between ISO 9001:2008 and ISO 9001:2015
Auditing and implementing ISO 9001:2015
2
Normative references = “indispensable”
ISO 9001:2015 identifies only one document as
“normatively referenced” and “indispensable
for its application”:
ISO 9000:2015
Quality management systems —
Fundamentals and vocabulary
3
“indispensable”
Merriam-Webster Dictionary:
adjective in·dis·pens·able \ˌin-di-ˈspen(t)-sə-bəl\
– extremely important and necessary
1: not subject to being set aside or neglected
– <an indispensable obligation>
2: absolutely necessary: Essential
– <an indispensable member of the staff>
Oxford Dictionary
4
/ˌɪndɪˈspɛnsəbl/
too important to be without
SYNONYM essential
Cars have become an indispensable part of our lives.
indispensable to somebody/something
She made herself indispensable to the department.
indispensable for something/for doing something
A good dictionary is indispensable for learning a foreign language.
ISO 9000 series
Three standards in the series:
ISO 9000
ISO 9001
New Revisions released together in 2015
5
ISO 9004
Currently under revision
ISO 9000 series
6
ISO 9000
ISO 9001
ISO 9004
Quality management
systems—
Fundamentals and
vocabulary
Quality management
systems—
Requirements
Managing for the
sustained success of
an organization—
A quality management
approach
Essential background for
the proper understanding
and implementation of
ISO 9001
Requirements aimed
primarily at giving confidence
in the products and services
an organization provides,
thereby improving
customer satisfaction
Guidance for organizations
that choose to progress
beyond ISO 9001
requirements to address
a broader range of topics
that can lead to continual
improvement of the
organization's overall
performance
ISO 9001 provides common ground
Quality management systems (QMS) standards for which ISO
9001 is a normative reference also require use of ISO 9000.
SAE
AS9100C:2009
ISO TS
16949:2009
ISO
13485:2003
QUEST
TL9000
Aerospace
Automotive
Med. devices
Telecom
ISO 9001
ISO 9000
7
ISO 9000 table of contents (continued)
2.3 Quality management principles
2.3.1 Customer focus
2.3.2 Leadership
2.3.3 Engagement of people
2.3.4 Process approach
2.3.5 Improvement
2.3.6 Evidence-based
decision making
2.3.7 Relationship management
8
• No requirements
• Ideas useful in guiding
organizations’ actions
• Used as a basis for
developing ISO 9001
ISO 9000 table of contents (continued)
2.4 Developing the QMS using fundamental
concepts and principles
2.4.1 QMS model
2.4.2 Development of a QMS
2.4.3 QMS standards, other management systems and
excellence models
9
ISO 9000 table of contents (continued)
3 Terms and definitions
Terms related to …
3.1 person or people
3.2 organization
3.3 activity
3.4 process
3.5 system
3.6 requirement
3.7 result
3.8 data, information and document
3.9 customer
3.10 characteristic
3.11 determination
3.12 action
3.13 audit
Required definitions of terms used in
10
requirements standards such as ISO 9001
ISO 9000 table of contents (continued)
Annex A
Concept relationships and
their graphical representation
Bibliography, Alphabetical index of terms
11
Concept diagrams
aid in understanding
of interrelationships
among terms and
concepts
Properly using ISO 9000—an example
Clause 10.2.1d in
ISO 9001:2015
states that the
organization shall …
“review the effectiveness
of any corrective action
taken”
12
Substituting
“effectiveness” and
“corrective action” with
definitions from ISO
9000, this becomes:
“review the extent to
which planned activities
are realized and planned
results are achieved
of any action to eliminate
the cause of a
nonconformity and to
prevent recurrence”
Definitions and fundamental concepts in ISO 9001:2015
Examples of new, revised or removed terms of ISO 9001
Interested party
New
Risk
New
Risk-based thinking
New
Provider
New
Documented information New
Effectiveness
Revised
Competence
Revised
13
Output
Revised
Information
Revised
Information system Revised
Verification
Revised
Validation
Revised
Corrective action
Revised
Preventive action
Removed
New “terms” in clauses 1-6 of ISO 9001:2015
1.
2.
3.
4.
4.1
4.2
4.3
Scope of standard
Normative references
Terms and definitions
“Context of the organization”
Understanding the organization and its “context”
Understanding the needs and expectations of “interested parties”
Determining the scope of the quality management system….
b) the requirements of relevant “interested parties”
4.4 Quality management system and its processes….
4.4.1 f) address the “risks”
5. “Leadership”
6. “Planning”
6.1 Actions to address “risks and opportunities”
14
Understanding “context”
From ISO 9000:2015:
2.2.3 Context of an organization
“Understanding the context of the organization is a process. This process
determines factors which influence the organization’s purpose, objectives
and sustainability.”
3.2.2 context of the organization
“combination of internal and external issues that can have an effect on an
organization’s approach to developing and achieving its objectives.”
15
Understanding “interested parties”
When determining the scope of the organization, we shall consider
the expectations of “relevant interested parties.”
All of the following can be "interested parties”:
16
Person having an
interest in the
success of an
organization
Person that can affect
an activity
Organization that
perceives itself to be
affected by a decision
Stakeholder
Person having an
interest in the
performance of an
organization
Providers’ regulators
Competitors
Opposing pressure
group
There are more!
Understanding “risk”
The term “risk” has been added to ISO 9001:2015 and is noted in
many places throughout the standard.
From ISO 9000:2015, clause 3.7.9:
risk
effect of uncertainty…positive or negative….
Often characterized by reference to potential events….
Often expressed in terms of the consequences of an event …
and the associated likelihood of occurrence
This may apply, for example, to a product, service,
process, provider, customer, consumer, environment,
employee, and the competition.
17
Assisting organizations
ISO 9000 terms are broken down by category to
promote international understanding and
increase confidence in the global market
18
Assisting organizations
The PDF version of ISO 9000 includes click-on
numerical links for defined terms:
19
Reference links for additional Information
• “ISO 9000:2015—What’s Normative, Anyway?” by Paul Palmes
www.insidestandards.com/iso-90002015-whats-normative-anyway/
• Standards Connection newsletter
asq.org/standardsconnection/
• Learn About Standards
asq.org/learn-about-quality/learn-about-standards/
• ASQ Standards Channel
videos.asq.org/asq-standards-channel
• ISO 9000 Series overview
asq.org/learn-about-quality/iso-9000/overview/overview.html
• ISO/FDIS 9000:2015 “NOTE Guidance on some additional frequently used
words in the QMS standards developed by ISO/TC 176, and which have an
identified dictionary meaning, is provided in a glossary available at:
www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf”
20
ISO-9001:2015
Where we have been and where we are
going
21
Transition – Key to success
1) Understand the requirements
2) Conduct a gap analysis
3) Don’t let concerns with auditability and documented
information drive bureaucracy into your quality
management system.
4) Implement changes that add maximum value to
your organization.
22
Agenda
• Context of the Organization
• Process Approach and Risk Based Thinking
23
Context of the Organization
24
Context of the Organization
• The new requirement reads: “The
organization shall determine external and
internal issues that are relevant to its
purpose and its strategic direction and that
affect its ability to achieve the intended
result(s) of its quality management system.”
25
Decision making and ISO-9001:2015
•
The first is a quality principle quoted from ISO 9000:2015, namely “evidence-based decision making.” It is not
hard to understand that better decisions are made when they are based on evidence rather than by conjecture.
•
The second is found in Clause 0.1, “Addressing risks and opportunities associated with its context and
objectives.” Addressing risks means proactively managing uncertainties. The simple meaning of “managing
uncertainties” is that decisions should be made with consideration of the possible positive and negative
consequences that the uncertain future may bring.
•
Finally, in Clause 5.1, entitled Leadership and Commitment, there is a requirement for top management: “Ensuring
that the quality policy and quality objectives are established for the quality management system and are
compatible with the context and strategic direction of the organization.” Top management’s most basic role is
strategic decision-making for the organization.
26
Decisions are to be made based on
evidence. Evidence is found in the
CONTEXT of the organization.
27
Internal Context
•
•
•
•
•
•
•
28
Vision
Mission
Strategic objectives and direction
Organizational Chart
SOPs
Resources
Culture
External Context
•
•
•
•
•
•
•
29
Legal
Social
Political
Regulatory
Financial
Economic
Market Trends
Examples
•
Customer pressures and complaints can force organizations to change policies such as product returns and customer and technical
support .
•
Technological changes can provide new and more effective ways to handle communications, operations, shipping and logistics.
•
Governments regulatory and trade policies can play a significant role in determining how businesses operate, especially in regard to
international trade, taxation, and regulations
•
The media, including social media, can have a huge impact on a company’s image and public relations. A bad news video or news
report can go viral pretty fast, and if your organization doesn’t provide an acceptable response, the negative publicity and effects
can last a long time.
•
Sociological forces often drive what, where and how consumers buy product and services. There is an increasing trend in the
number of consumers purchasing products online and reading reviews before making a purchase.
•
The multinational and multicultural trend in workforce composition can cause significant changes in hiring and retention of
30
competent human resources.
Risk Based Thinking
Examples and Ideas
• Purchasing
• Design and Development
• Process
31
Purchasing
Supplier Approval and Re-Evaluation
• Do all raw materials create the same risk for your final
product?
• Do all suppliers bring the same risk to your business?
Does your current QMS account for these differences?
32
Design and Development
• Design FMEA – for actual design
• Risk Registers – for project risks
33
The Process Approach and
Risk Based Thinking
• Assign a Process Owner
• Define the process
• Identify the inputs and outputs
• Define measures of effectiveness and efficiency
• Identify risks and opportunities
• Report on the status of each process
34
Materials
Suppliers
(By whom)
35
Measures
Inputs
PROCESS
Methods
(How)
Machine
(With what)
Manpower
(Training/Skills)
Outputs
Environment
(Conditions)
RISK!
Customer
(For Whom)
Process Definition
• Should include: Process Owner, Inputs
and Outputs, Process, Process Metrics
and RISK
36
Process Review
• Should include: Inputs and Outputs,
Process, Process Metrics and RISK
37
Process Owner’s Meetings
•
•
•
•
•
•
Owner/Co-Owner Reporting
Process Metrics
Current State
Recent Updates
Plans moving forward
Audit Nonconformance's (Internal and
External)
• Dashboard
• RISK
38
Purchasing
Measurable: # Supplier Nonconformance's
Process Owner:
Goals 2016: 10% Reduction from ’15
Risk: Production interruptions due to material shortages
Risks and Opportunities:
Supplier Nonconformances - 2015
100
80
60
40
20
0
Jun
Sep
July Aug
Oct Nov Dec
e
t
64 24 56 20 66 43 26 47
Jan Feb Mar Apr May
Series1 32
78
45
36
Supplier Nonconformances - 2015
250
200
150
100
50
0
Dimensional
39
Damaged
Functional
Aesthetics
Wrong
Product
Risk – This rate of supplier rejects has resulted in 280
hours of line shut downs in 2015, and the trend is
not improvement moving into 2016.
Opportunity: IF the shipping damage issues could be
solved, we could eliminate 24 % of the
nonconforamnces and 20% of the hours of line
interruption
Task
Responsibility Target Date
Corrective Action Plans:
Quarterly Business Reviews
(Management Representative and Process Owners)
• Review of identified risk within each key process
• Has the risk changed?
• Have high risk issues been addressed?
• Does performance to objectives reflect risk
mitigation?
40
Integrated Systems and RISK
• ISO-9001
• ISO-14000
• FSSC- 22000, SQF, BRC (Food Standards)
41
Hazard Analysis for food safety
Hazard Analysis - Food Safety
42
List each
process
step from
the Process
Flow
Diagram
Does this process step
INTRODUCE or INTENSIFY a
potential food safety hazard?
If YES identify the hazard(s).
Assess probability, severity
and risk per columns 4, 5 and
6.
(4) (5) (6)
(7)
(8)
(9)
(10)
Justification of Risk Level
Assessment
List the support programs that
CONTROL or ELLIMINATE this
hazard. Do the support program(s)
control the hazard to an acceptable
level? If yes, proceed to the next
process step. If no, proceed to
column 9.
Is this hazard CONTROLLED or
ELIMINATED (or reduced to an
acceptable level) at a subsequent
process step? If YES, this step is not
CCP or
a CCP. Identify the subsequent
oPRP
process step and proceed to the next
process step. If the hazard is not
controlled at this process step, go to
column 10 and assign a CCP number.
Risk
(3)
Severity
1
(2)
Likelihood
Process Step
(1)
B- Pathogen contamination
due to uncontrolled
transportation
L
M
2
Raw materials are received
covered and/or packaged,
Trailer Checks, Sealed Truck
Purchasing Program
Shipping and Receiving Program
Yes
No
C- Chemical contamination
due to uncontrolled
Receive raw transportation
materials
L
M
2
Raw materials are received
covered and/or packaged,
Trailer Checks, Sealed Truck
Purchasing Program
Shipping and Receiving program
Chemical Control Program
Yes
No
P- Physical contamination with
extraneous material due to
L
uncontrolled transpiration
L
1
Raw materials are received
covered and/or packaged,
Trailer Checks, Sealed Truck
Purchasing Program
Shipping and Receiving Program
Glass and Brittle Plastics Program
Metal and Blade Control Program
Yes
No
ISO-14000 Aspects and Impacts
Significant
environmental aspect
(Yes), (No) or (NA)
Water
NO
NO
Receiving C - none
Air
Land
Water
NO
NO
Air
Land
Water
NO
NO
P- Potential for Scrap
43
L
L
Risk
Land
Severity
Air
Aspects
Likelihood
B - none
Process Step
legal and
Other Requirements
Aspect and Impacts Risk Assessment - ISO-14000
2
Impact (Use notes to insert further
analysis)
Quality Risk Assessment
Risk Assessment - Quality
(1)
44
List each
process
step from
the
Process
Flow
Diagram
Does this process step
INTRODUCE or
INTENSIFY a potential
quality issue?Assess
Likelihood and severity
and risk per columns 4, 5
and 6.
Risk
(4) (5) (6) (7)
Severity
1
(3)
Likelihood
Process Step
(2)
Receive
raw
materials
Q-
L
M
2
(8)
(9)
(10)
Is this hazard CONTROLLED
List the support programs or ELIMINATED (or reduced to
that CONTROL or
an acceptable level) at a
ELLIMINATE this risk.
subsequent process step? If
Do the support program(s) YES, this step is not a QCP.
Justification of Risk
control the risk to an
Identify the subsequent process QCP
Level Assessment
acceptable level? If yes,
step and proceed to the next
proceed to the next process process step. If the risk is
step. If no, proceed to
controlled at this process step,
column 9.
go to column 10 and assign a
QCP number.
No
What should you do?
•
Identify what the risks and opportunities are in your organization – it depends
on context
•
Analyze and prioritize the risks and opportunities in your organization
– what is acceptable?
– what is unacceptable?
•
Plan actions to address the risks
– how can I avoid or eliminate the risk?
– how can I mitigate the risk?
45
•
Implement the plan – take action
•
Check the effectiveness of the actions – does it work?
•
Learn from experience – continual improvement
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