Quality: The Basic Tool Kit

ASQ Section 1213 and Calumet College of St. Joseph

Quality Management Standards:

ISO 9001 and ISO/TS 16949
Presented by
Chuck Richardson
Performance Quality Systems, Inc.
502-491-0313
chuck@performancequalitysystems.com
www.performancequalitysystems.com
January 21, 2011
 Session topics

• Background of ISO 9001 and ISO/TS 16949

• The registration process and growth
• Quality management principles
• Steps to meeting the requirements
• Internal auditing
• Quality management system requirements
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 What is ISO?
• It’s the International Organization for
Standardization.
• An organization based in Geneva, Switzerland
with representation from 163 countries.
• ISO develops many standards most of which are
very specific to a product or process.
• ISO is not an acronym. "ISO", derived from the
Greek isos, meaning "equal".

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What is ISO 9001 and its purpose?
• It’s an quality management standard embraced
by about 1 million organizations worldwide.
• It is probably the best known ISO standard.
• Its purpose is to define good business practices
so an organization can:
– Consistently meets customer requirements.
– Continually improves its operations & customer
satisfaction.

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 History of ISO 9001
• During World War II, manufacturing problems in Britain
led to development of BS 5750, a standard for
managing manufacturing processes.
• With BS 5750 as its foundation, ISO 9001 was first
published in 1987.
• Revised in 1994, 2000, and amended in 2008.
• Since 1987, manufacturers have taken the lead in
applying ISO 9001, but many service businesses and
government agencies and have also implemented ISO
9001 based management systems.
• The year 2000 revision shifted the emphasis from
documentation to planning, performance, and
improvement.
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 ISO/TS 16949
• Issued in 1999, revised in 2002 and 2009
• Developed by the International Automotive Task
Force (IATF) with support form ISO/TC 176
– IATF members include: BMW, Daimler AG, Chrysler,
Fiat, Ford, GM, PSA Puegeot-Citroen, Renault SA, and
Volkswagen
• Includes all the ISO 9001 requirements plus
additions required by the automotive industry
• Replaced QS-9000 in 2006
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 Applicability
• ISO 9001 applies to any operation seeking to
consistently meet customer requirements and
enhance customer satisfaction.

• ISO/TS 16949 applies only to sites where

automotive-related production and/or service parts
are manufactured.(includes assembly, welding, heat
treating, plating, painting, or other finishing
services)

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 What is certification?
What is registration?
According to the International Organization for Standardization (ISO):

• “Certification” refers to the issuing of written assurance (the certificate)

by an independent external body that it has audited a management
system and verified that it conforms to the requirements specified in the
standard.

• “Registration” means that the auditing body then records the certification
in its client register. So, the organization’s management system has been
both certified and registered.

• Therefore, in the ISO 9001 context, the difference between the two terms
is not significant and both are acceptable for general use. “Certification” is
the term most widely used worldwide, although registration is often
preferred in North America, and the two are used interchangeably.
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 The registration process
ISO 9001 ISO/TS 16949
International Automotive
Accreditation Bodies Task Force
(ANAB, RvA, etc.)
International Automotive
Oversight Bureau (IAOB)
Certification Bodies
(Registrars)
Certification Bodies
(Registrars)
Auditors
Auditors
Organization seeking
registration Organization seeking
registration 9
Growth in worldwide certifications

8% increase

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Source: ISO Survey of Certifications 2009
Top five industrial sectors for ISO 9001
certificates 2009

1 Construction 116672
2 Basic metal & fabricated metal 107253
products
3 Electrical and optical 85357
equipment
4 Machinery and equipment 63523
5 Wholesale & retail trade; 63015
repairs of motor vehicles,
motorcycles & personal &
household goods

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Source: ISO Survey of Certifications 2009
 If aggregated services is the number one
industrial sector with 302,108 certificates
 
• Services includes:
• Publishing companies • Wholesale & retail trade;
• Printing companies repairs of motor vehicles,
• Electricity supply motorcycles & personal &
• Gas supply household goods
• Hotels and restaurants
• Water supply • Transport, storage and
• Wholesale & retail trade; communication
repairs of motor vehicles, • Financial intermediation, real
motorcycles & personal & estate, rental
• Information technology
household goods • Other Services
• Hotels and restaurants • Engineering Services
• Transport, storage and • Education
communication • Public administration
• Health and social work
• Financial intermediation, • Other social services
real estate, rental
• Information technology
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Source: ISO Survey of Certifications 2009
 Quality management principles
• Customer focus • Continual
improvement
• Leadership

• Factual approach to
• Involvement of people decision making

• Process approach
• Mutually beneficial
supplier relationships
• System approach to
management

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 Where to begin?
Commit to continual improvement
“Ongoing activity to increase the ability to fulfill requirements.”

• True commitment to continual improvement

should lead to:
– Planning of processes so problems are prevented.
– Planning of new jobs so problems are prevented.
– Effective corrective action so problems are
solved, and don’t keep happening.

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 Identify your business processes
Process: “Set of interrelated or interacting activities
which transforms inputs into outputs”

Customer
Customer
receives the
Inquiry
product

Examples include: Estimating, Human Resources, Project

Planning, Purchasing, Product Design, Production,
Warehousing, Shipping, Installation, Servicing

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 What are your processes?

Customer
Inquiry

Customer
receives the
product
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Take the Plan-Do-Check-Act approach
• Plan: “Establish the objectives and processes necessary
to deliver results in accordance with customer
requirements and the organization's policies.”

• Do: “Implement the processes.”

• Check: “Monitor and measure processes and product

against policies, objectives and requirements for the
product and report the results.”

• Act: “Take actions to continually improve process

performance.”

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 Plan and implement what
is needed for each process
Procedure
(Specified way to carry out an
activity or a process – may be
documented or not)

Input Process Output

Examples include: (Set of interrelated or
Examples include:
•Materials interacting activities)
•Materials
•Products •Products
•Information •Information
•Equipment
Monitoring & Measurement •Equipment
•Resources •Resources
opportunities
(Before, during, and after the
process) 18
 Manage processes
effectively, typically this means:
• There is a process owner.
• The process is defined.
• The process is documented as appropriate.
• Process linkages (or handoffs) of the process are
established.
• The process is monitored, analyzed, and improved.
• Records are maintained.

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 How can you measure
or monitor your processes?
Process Method of Process Method of
Monitoring Monitoring

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 Train and empower
your internal auditors
• An audit is a systematic, independent, and
documented process to evaluate the extent to which
policies, procedures, or requirements are fulfilled.
• An excellent tool for evaluating your quality
management system’s implementation and
effectiveness.
• Auditors must be trained and have the qualities to be
successful auditors.
– Desire
– Able to “Think on your feet”
– Good communication skills (speaking and listening)
– Observant
– Able to analyze and assess situations
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ISO 9001 & ISO/TS 16949 requirements
• Quality management system
– Quality manual
– Control of documents
– Control of quality records
• Management Responsibility
– Management commitment
– Quality policy
– Customer focus
– Management review
• Resource management
– Human resources
– Infrastructure
– Work environment

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 ISO 9001 & ISO/TS 16949 requirements
(continued)
• Product realization
– Customer related processes
– Design & development
– Purchasing
– Production and service
provision
– Control of monitoring and
measuring devices
• Measurement, analysis
and improvement
– Customer satisfaction
– Internal audit
– Monitoring and measuring
product & processes
– Control of nonconforming
product
– Analysis of data
– Continual improvement
– Corrective action
– Preventive action
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 Continual improvement of the
quality management system

Management
responsibility
Customer
Customer Act
Plan
Resource Measurement,
Satisfaction
management analysis, &
improvement
Check
Do
Product Output
Requirements Product
realization

Value adding activities Information flow

Model of a process-based quality management system 24
 ISO/TS 16949 additions
• Has the goals of defect prevention, reduction in variation,
and waste
• Expanded training requirements
– Process for motivating employees and measuring
awareness of impact on quality
• Expanded quality planning requirements
– Core tools: APQP, PPAP, FMEA, SPC, MSA
• The only exclusion is product design, not manufacturing
process design
• Supplier development requirements
• Requires evaluating manufacturing process capability
• Requires use of error-proofing methods
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 Quality planning tools
ISO/TS 16949
Automotive
Core Tools

APQP/ FMEA SPC MSA

PPAP

• APQP – Advanced Product Quality Planning

• PPAP – Production Part Approval Process
• FMEA – Failure Mode and Effects Analysis
• SPC – Statistical Process Control
• MSA – Measurement Systems Analysis 26
 ISO/TS 16949 additions continued

• Must be understood in light of additional documents

• ISO/TS 16949 Automotive Certification Scheme-Rules
for Achieving IATF Recognition
• Customer specific requirements (CSR)

• Companies must demonstrate readiness for the

registration audit by presenting data
• 12 months of audit results, management review results,
and performance data

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