ISO 9001
Quality System Requirements
Produced by: Qualitivity, Inc.
Written by: Christopher Bohler
Technical Editing: Mark Jacobs
Qualitivity, Inc.
Copyright © 2012
ISO 9001 Quality System Requirements
Qualitivity, Inc.
Purpose: This Presentation Describes the ISO 9001
Quality Management System Requirements.
Objectives:
- Overview of the ISO 9001 Series Standard
- Specific Requirements of the ISO 9001 Series Standard
- International Trade and the ISO 9001 Series Standard
- Involvement with the ISO 9001 Series Standard
- Conclusions
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Definition of Quality
ISO 9000 Definition
“Degree
Degree to which a set of inherent
characteristics fulfills requirements”
Note:
N t requirements
i
t can be
b stated
t t d or implied.
i li d
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ISO 9001 Standard
Used to Assure Quality
Qualitivity, Inc.
What you would get from 99.9% suppliers:
At least 20,000 wrong
g prescriptions
p
p
per
p year.
y
Unsafe drinking water one hour per month.
No electricity, water or heat for 8.6 hours per year.
No phone service for 10 minutes each week.
Two crashes at each major airport per day.
500 incorrect surgical operations per week.
2,000 lost articles of mail per hour.
Original source unknown
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The ISO 9001 Standard
• Overviews Quality System Guidelines
• Internationally Recognized Quality Standards
• Applicable to All Organizations in All
Industry/Service Areas
• Allows for Certification by a Third Party
• Identifies Required Quality Policy and Procedures
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ISO 9001
Series Standard assures
assures...
Qualitivity, Inc.
That all business processes are:
Strategically planned and documented
with .... properly maintained records
with ... immediate corrective action
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Benefits of
ISO 9001 Standard
Qualitivity, Inc.
• Promotes International Trade
• Prevents Trade Barriers
• Translates to a Common Q
Quality
alit Lang
Language
age
• Establishes Consistent Quality Disciplines
• Minimizes Customer Audits
• Provide Contractual Documents
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When is ISO 9001 Required?
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• Regulatory Requirements - International regulations, laws or agreements may
require ISO 9001.
• Customer Requirements - Prefer to deal only with certified suppliers
- Must use only certified suppliers to manufacture
products to be sold in ISO participating countries.
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ISO 9001 Comparison
ISO 9001 and Other
Quality System Criteria
Meet Specs
ISO 9001
Standards
Quality Award
Criteria
World
Class
Cl
Quality
System
No
Quality
System
Military
Standards
ISO 9001 plus
I d t S ifi
Industry-Specific
standards
Beyond
y
Quality
Award
Criteria
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ISO 9001 Comparison
From MIL-SPECS to the
ISO 9001 Standard
MIL-STD-45208A
MIL-Q-9858
Management Responsibilities, Continual Improvement,
Installation and Service
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ISO 9001 Comparison
From the ISO 9000 Series Standard
to the Malcolm Baldrige
National Quality Award
Malcolm Baldrige National Quality Award would be nice to
have.
ISO 9000 International Standards for Quality Management
is often required to do business.
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International Trade
Use the ISO 9001 Standard as a Means to
Begin Entry Into International Trade as
Well as to Provide Recognition for the
Quality
y System
y
of Your Organization.
g
Companies Must:
• Understand ISO 9001
• Understand the Internal Situation
• Have a Work Team Strategy
• Have Flow Charts and Required Procedures
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What is ISO?
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- International Organization for Standardization
- Founded in 1946
- Goal to Develop Harmonized Standards in Support
of International Trade
- Based in Geneva, Switzerland
- Who are Members? ((aprox.
p
90 countries))
- Member Nations Promote Harmonized Standards
- United States Representative is the American
National Standards Institute (ANSI)
- Greek Prefix (iso) Means Equal
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What is the ISO 9001 Standard?
International Standards for Quality Management and
Quality Assurance.
Assurance
ƒF
Follows
ll
a Generic
G
i Approach
A
h Not
N t Specific
S
ifi to
t any
Product, Service or Industry.
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Specific Requirements of ISO 9001
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ISO 9001 Requirements Detail
40
4.0
4.1
4.2
5.0
5.1
5.2
5.3
5.4
5.5
5.6
6.0
61
6.1
6.2
6.3
6.4
7.0
7.1
71
7.2
7.3
7.4
7.5
7.6
8.0
8.1
8.2
8.3
8.4
85
8.5
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Quality Management System
General
Documentation Requirements
Management Responsibilities
Management Commitment
Customer Focus
Quality Policy
Planning
Responsibility, Authority and Communication
Management Review
Resource Management
P
Provision
i i off Resources
R
Human Resources
Infrastructure
Work Environment
Product Realization
Planning of Product Realization
Customer Related Processes
Design and Development
Purchasing
Production and Service Provision
g and Measuring
g Devices
Control of Monitoring
Measurement, Analysis and Improvement
General
Monitoring and Measurement
Control of Nonconforming Product
Analysis of Data
Improvement
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4.0 Quality Management System
ƒ General Requirements
ƒ Documentation
D
t ti Requirements
R
i
t
ƒ Mandatory Procedures
y Control of Documents 4.2.3
y Control of Records 4.2.4
y Internal Audits 8.2.2
y Control of Nonconforming Product 8.3
y Corrective Action 8
8.5.2
52
y Preventive Action 8.5.3
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4.1 General Requirements
ƒ Identify Processes and Applications
ƒ Determine Sequence and Interaction
ƒ Determine Operation and Control Criteria and
Methods
ƒ Ensures Availability
y of Resources
ƒ Monitor, Measure and Analyze
ƒ Implement Process and Improvements
ƒ Manage and Control Outsourced Processes
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4.2 Documentation Requirements
ƒ Quality
Q lit Manual
M
l
ƒ Quality Policy and Objectives
ƒ Procedures as Required
ƒ Control of Records
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5.0 Management Responsibility
ƒ Management Commitment
ƒ Customer Focus
ƒ Quality Policy
ƒ Planning
ƒ Responsibility,
Responsibility Authority and
Communication
ƒ Management Review
ƒ Management Representative
ƒ Internal
I t
l Communication
C
i ti
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6.0 Resource Management
ƒ Provision of Resources
ƒ Human Resources
ƒ Infrastructure and Maintenance
ƒ Work Environment
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7.0 Product Realization
ƒ Planning of Product Realization
ƒ Customer-related
Customer related Processes
ƒ Design and Development
ƒ Purchasing
ƒ Production and Service Provision
ƒ Control of Monitoring and Measuring Devices
SPECIAL NOTE: The requirements
q
listed in Section 7
can be excluded from the audit if justified.
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7.1 Planning of Product Realization
ƒ Requires Determining the Following:
y Quality Objectives and Product Requirements
y Establishment of Processes, Documents and Resources
y Requirement for Verification, Validation, Monitoring,
Inspection and Test Activities
y Records Required
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7.2 Customer-Related Processes
ƒ Determine Requirement Related to Product
ƒ Statutory and Regulatory Requirements
q
Prior to Quotation
ƒ Review Requirements
ƒ Differences Resolved Before Order Acceptance
ƒ Customer Communication
ƒ Customer Feedback Including Complaints
ƒ Changes
Ch
tto C
Contract
t tN
Need
dC
Controls
t l
ƒ Records
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7.3 Design and Development
ƒ Design and Development Planning
ƒ Design and Development Inputs
ƒ Design and Development Outputs
ƒ Design and Development Review
g and Development
p
ƒ Design
Verification
ƒ Design and Development Validation
ƒ Control of Design and Development Changes
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7.4 Purchasing
ƒ Purchasing Process
ƒ Purchasing Information
ƒ Verification
V ifi ti off Purchased
P
h
d Product
P d t
ƒ Supplier Selection and Approval
ƒ Records
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7.5 Production and Service Provision
ƒ Control of Production and Service
ƒ Validation of Processes and Equipment
ƒ Approval of Equipment and Qualification of
Personnel
ƒ Defined
D fi d Criteria
C it i and
d Workmanship
W k
hi Standards
St d d
ƒ Identification and Traceability
ƒ Customer
C t
P
Property
t
ƒ Preservation of Product
ƒ Records
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7.5 Production and Service Provision
(continued)
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ƒ Control of Production and Service
ƒ Validation of Processes and Equipment
ƒ Approval of Equipment and Qualification of Personnel
ƒ Defined Criteria and Workmanship Standards
ƒ Identification and Traceability
ƒ Customer Property
ƒ Preservation of Product
ƒ Records
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7.5 Production and Service Provision
(continued)
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ƒ Control of Production and Service
ƒ Validation
V lid ti off Processes
P
and
d Equipment
E i
t
ƒ Approval of Equipment and Qualification of Personnel
ƒ Defined Criteria and Workmanship Standards
ƒ Identification and Traceability
ƒ Customer Property
ƒ Preservation of Product
ƒ Records
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7.5 Production and Service Provision
(continued)
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ƒ Control of Production and Service
ƒ Validation of Processes and Equipment
ƒ Approval
pp
of Equipment
q p
and Qualification of Personnel
ƒ Defined Criteria and Workmanship Standards
ƒ Identification and Traceability
ƒ Customer Property
ƒ Preservation of Product
ƒ Records
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7.6 Control of Monitoring and Measuring
Devices
ƒ Calibration
ƒ Identify Calibration Status
ƒ Safeguard
ƒ Protect From Damage
ƒ Record Validity of Measurements If Faulty Gage is
Found
ƒ Computer Software
ƒ Records
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8.0 Measurement Analysis and
Improvement
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ƒ General
ƒ Monitoring and Measurement
ƒ Control of Nonconforming Product
ƒ Analysis of Data
ƒ Improvement
p
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8.1 General
ƒ Demonstrate Product Meets Requirements
ƒ Ensure Quality Management System Meets ISO
9001 and Customer Requirements
ƒ Continual Improvement of Effectiveness
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8.2 Monitoring and Measurement
ƒ Customer Satisfaction
ƒ Internal Audit
ƒ Monitor and Measure Processes
ƒ Monitor and Measure Product
ƒ Product Cannot Be Released Until Process is
Complete
ƒ Records
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8.3 Control of Nonconforming Product
ƒ Identify and Control
ƒ Prevent Unintended Use or Delivery
ƒ Documented Procedure
ƒ Repair and Rework is Re-Inspected
ƒ Records
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8.4 Analysis of Data
ƒ Determine, Collect and Analyze Data
ƒ Customer Satisfaction
ƒ Product Conformity
ƒ Trends and Opportunities for Preventive Action
ƒ Suppliers
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8.5 Improvement
ƒ Continual Improvement
ƒ Corrective Action
ƒ Preventive Action
ƒ Documented Procedure
ƒ Records
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Process Based
Quality Management System
Continual Improvement of Quality Management System
Management
Responsibility
C
U
S
Measurement Analysis
and Improvement
Resource Management
T
O
M
E
R
Product
Realization
S
A
T
I
S
F
A
C
T
I
O
N
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Approach to Implementing
an ISO 9000 Series Program:
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• Management Accepts, Acknowledges and
Understands ISO 9001 Standard
• Management Commits to ISO 9001 Management
Responsibilities
• Provide Continuous Review and Audit of Quality
System
• Maintain a Quality
y Improvement
p
Plan
• Adhere to Quality System Requirements in Policy
and Procedures
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Implementing ISO 9001
Program (continued)
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Management Representative Coordinates Efforts
• Everyone Knows Quality Policy
Auditors of the certifying agency may ask all
employees questions regarding their role in the ISO
9001 program.
• Prepare for Semi-annual or Annual Audit
• Everyone
E
M
Mustt H
Have K
Knowledge
l d off Q
Quality
lit
• ISO Efforts Need to be Company-wide
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Why Implement ISO 9001?
• Market Advantage
• Product Quality Improvement
• Each Employee Will Benefit
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Implementation of the System
Implementation of the ISO 9001 Series Standard
requires trained and experienced personnel
empowered to get the job done.
Even if you are on the right track,
you’ll get run over if you just sit there.
Will Rogers.
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Worldwide Recognition
International Trade
and the ISO 9001 Series
Standard
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What is Driving ISO 9001 Forward?
• Global Competition
• The European Community
• Quality Competitive Advantage
• Quality Ensured by Third Party Registrar
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ISO 9001 Standard Maintenance
ƒ Revised Approximately Every Five Years
ƒ Comments From Users Encouraged
ƒ Future Revision Effective When Published
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Team Participation
Involvement With the
ISO 9001Standard
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ISO 9001 Implementation
Does Your Organization
Want to Become
Certified to ISO 9001?
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ISO 9001 Implementation
ISO 9001
After the Approval is
Received,
Received Can We Relax?
• Quality
Q
System
S
Basis is Continual
C
Improvement
• Need to Continue to Meet ISO 9001
• Approval
pp o a Agency
ge cy Comes
Co es Back
ac to Verify
e y Co
Compliance
p a ce
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Statistical Process Control
• Continual Quality Improvement
• Pareto Chart for Corrective Action
• Product and Process Quality Index
• Six Sigma Quality Methods
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ISO 9001 Implementation
g
How Do Registrars
Work?
• USA
• United Kingdom
• International
• European
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ISO 9001 Implementation
Auditor Attributes
ƒ Auditor Represents Management
ƒ Maintain Professional and Positive Attitude
ƒ Be Prepared for Audit
ƒ Maintain
M i i Control
C
l off Situation
Si
i
ƒ Ask Questions, Not Statements
ƒ Listen Attentively to Responses
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ISO 9001 Implementation
Auditor is a Fact Finder
Relax Person Being Audited
A id Arguments
Avoid
A
t
Do Not Offer Opinions
Avoid Suggestions
Gather The Information
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ISO 9001 Implementation
Person Being Audited
ƒ Maintain a Professional and Positive Attitude
ƒ Be
B P
Prepared
d for
f Audit
A dit
ƒ Know Work Instructions and Quality
Policy
ƒ Understand Corrective Action
ƒ Do Not Volunteer Information
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ISO 9001 Implementation
Conclusions
•
ISO 9001 Standard is Here to Stay
•
Customers are Demanding it
•
Understand
U d t d ISO 9001 International
I t
ti
l
Standards for Quality
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ISO 9001 Overview Test
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1. ISO stands for
a. The International Organization for Standardization.
b. The International Specifications Organization.
c. The International Opera.
d None of the above
d.
above.
2. Which of the following are requirements of 7.6
Control of Monitoring
g and Measuring
g Devices?
a. Calibration activities.
b. Identification of calibration status.
c. Computer software validation.
d. All of the above.
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Problem Solving Test
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3. ISO 9000:2000 defines quality as the degree to which
a set of inherent characteristics fulfills
a. Profitability.
b. Requirements.
c. Actions.
A ti
d. Reactions.
4.
4 For
F which
hi h off the
th following
f ll i activities
ti iti does
d
ISO
9001:2000 require a documented procedure?
a Control of Documents
a.
Documents.
b. Internal Audits.
c. Corrective Action.
d. All of the above.
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Problem Solving Test
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5. The auditor is a fact finder and during the audit
process they should do all of the following except
a. Relax
R l the
th person being
b i audited.
dit d
b. Argue aggressively to make sure a point is understood.
c Avoid suggestions
c.
suggestions.
d. Do not offer opinions.
6.
6 The person being audited is required to
a. Maintain a positive and professional attitude.
b Be prepared for the audit
b.
audit.
c. Understand corrective action.
d. All of the above.
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Problem Solving Test
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7. The ISO 9001 Standard is revised approximately
every
a. 3 years.
b. 7 years.
c year.
c.
year
d. 5 years.
8.
8 If justified,
justified requirements of ISO 9001 can be excluded
but only from
a. Section 4.
b. Section 5.
c. Section 7.
d. Section 8.
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Problem Solving Test
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9. All of the following are good auditor attributes
except
a. Listening
Li t i attentively
tt ti l tto responses.
b. Maintaining a professional and positive attitude.
c Being biased in judgment and becoming opinionated
c.
opinionated.
d. Being prepared for the audit.
10.
10 A benefit of the ISO 9001 Quality Management
System requirements includes
a. A common quality language.
b. Minimizing customer audits.
c. Consistent quality disciplines.
d. All of the above.
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EMPLAST QUALITY POLICY
QUALITY POLICY (Sample)
“We, the employees of the organization, through continual improvement of our quality
management
g
system
y
and objectives,
j
, commit ourselves to be qqualityy focused and customer
driven by striving to provide defect-free plastic products with the highest level of service,
on-time delivery, and customer satisfaction.”
Core Management Group
QUALITY OBJECTIVES
To ffulfill
f its internal organizational
g
ggoals,, the company
p y has established qqualityy objectives
j
to:
1. To maintain and continually improve the quality of our products and services.
2. To offer products and services that meets or exceeds our customers’ expectations for quality,
performance, dependability and overall value.
p
3. To reduce waste and inefficiencyy in our operations.
4. To meet the delivery requirements established by our customers.
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