Standards 4u5n1r

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 [email protected] 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 2

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 form ISO/TC 176

– IATF 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 6

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 . So, the organization’s management system has been both certified and ed.

• Therefore, in the ISO 9001 context, the difference between the two

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. 8

The registration process ISO 9001 Accreditation Bodies (ANAB, RvA, etc.) Certification Bodies (Registrars) Auditors

ISO/TS 16949 International Automotive Task Force International Automotive Oversight Bureau (IAOB) Certification Bodies (Registrars) Auditors

Organization seeking registration

Organization seeking registration

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Growth in worldwide certifications 8% increase

Source: ISO Survey of Certifications 2009

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Top five industrial sectors for ISO 9001 certificates 2009 1

Construction

116672

2

Basic metal & fabricated metal products

107253

3

Electrical and optical equipment

85357

4

Machinery and equipment

63523

5

Wholesale & retail trade; repairs of motor vehicles, motorcycles & personal & household goods

63015

Source: ISO Survey of Certifications 2009

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If aggregated services is the number one industrial sector with 302,108 certificates  

• Services includes: • • • • • •

• • • •

Publishing companies Printing companies Electricity supply Gas supply Water supply Wholesale & retail trade; repairs of motor vehicles, motorcycles & personal & household goods Hotels and restaurants Transport, storage and communication Financial intermediation, real estate, rental Information technology

• Wholesale & retail trade; repairs of motor vehicles, motorcycles & personal & household goods • Hotels and restaurants • Transport, storage and communication • Financial intermediation, real estate, rental • Information technology • Other Services • Engineering Services • Education • Public istration • Health and social work • Other social services

Source: ISO Survey of Certifications 2009

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Quality management principles • Customer focus

• Continual

improvement

• Leadership • Involvement of people • Process approach • System approach to

• Factual approach to decision making

• Mutually beneficial

supplier relationships

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 Inquiry

Customer receives the product

Examples include: Estimating, Human Resources, Project Planning, Purchasing, Product Design, Production, Warehousing, Shipping, Installation, Servicing 15

What are your processes? Customer Inquiry

Customer receives the product 16

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 Examples include: •Materials •Products •Information •Equipment •Resources

Process

Output

(Set of interrelated or interacting activities)

Monitoring & Measurement opportunities (Before, during, and after the process)

Examples include: •Materials •Products •Information •Equipment •Resources 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. 19

How can you measure or monitor your processes? Process

Method of Monitoring

Process

Method of 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 22

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

Measurement, analysis, & improvement

Resource management

Satisfaction

Check Do Product realization

Requirements

Value adding activities

Product

Output

Information flow

Model of a process-based quality management system

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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 25

Quality planning tools ISO/TS 16949

Core Tools APQP/

Automotive

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

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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 27