ISO/TS 16949 - Second Edition

Chad Kymal - OmnexOMNEX

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May 20, 2001

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What is ISO/TS 16949, Second Edition?

• Eagerly awaited ISO 9001:2000 based QS-9000 update

• Harmonized U.S., European and Asia - Pacific OEM standard

• Accepted in lieu of QS-9000, Third Edition

• Technical specification accepted by ISO/TC-176

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Implication of ISO/TS16949, Second Edition

• Based on the following facts:– ISO 9001:2000 registered organizations have 3

years to upgrade (until December 2003).– QS-9000 will not be upgraded.

• Note: It is based on ISO 9001:1994.

– Only ISO/TS 16949 is getting upgraded to ISO 9001:2000

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ISO/TS 16949 Facts

• Only 33 Registrars worldwide can audit this standard.

• Has 90% to 95% QS-9000 content (First edition)

• Accepted instead of QS-9000, AVSQ, VDA or EAQF

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ISO/TS 16949, Second Edition Standard Structure

• Note: The standard incorporates the structure of ISO 9001:2000

Example: • Scope1.1 General1.2 Applicability

• Normative References• Terms and Definitions• Quality Management System

4.1 General Requirements4.2 Documentation Requirements

4.2.1 General4.2.2 Quality manual4.2.3 Control of Documents

4.2.3.1 Engineering Specifications

4.2.4 Control of Records4.2.4.1 Records Retention

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ISO/TS 16949, First Edition Additions

• 25 additions at sub-element level– For example, 4.1.4

• 74 additions lower than sub-element level– For example, 4.1.1.2 Objectives or 4.2.4.9.2

Process Design Inputs

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Summary of Changes

• A majority of additions to First Edition migrate to 7.0 Product Realization, 8.0 Measurement, Analysis and Improvement and 6.0 Resources in Second Edition.

• Just 2 additions from 1st edition to 2nd edition - 6.5 Sourcing, 7.1.2 Change Control

• Changes have not been made in 17 areas• A change is made to the language of almost every

requirement, whether a change to the wording or removal of a term

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Any Surprises?

• ISO 17025 is not required for internal laboratories.• External laboratories could have customer or second

party concurrence or assessment• 7.3 Design and development includes Product and

Manufacturing Design• Addition of requirements to 7.4 Purchasing that at a

minimum, “the supplier shall be compliant to ISO 9001:2000”

• Undecided about direction on documentation “parking lot issue”

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Any Surprises? Continued...

• Sanctioned Interpretations, added as notes to First Edition, is virtually missing in Second Edition.

• Many small edits including:– No requirement for 100% on-time delivery

(4.15.6 Delivery)– No mention of linearity, bias and discrimination

(4.11.4)

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What ISO/TS 16949 First Edition Additions Were Removed?

• 4.1.4 Business Plan• 4.1.6 Employee Satisfaction (please note change)• 4.1.7.1 Product Safety - Significantly reduced• 4.1.7.2 Regulations - Added as note• 4.2.4.3 Review Cycle - incorporated into 7.3.4

Design and development review• 4.2.4.9 Management of Process Design - General• 4.3.2.2 Review - Supplemental

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What ISO/TS 16949 First Edition Additions Were Removed?

• 4.5.2.1 Document and Data Approval and Issue- Note

• 4.6.1.1 General - Note

• 4.10.1.1 General - Note

• 4.15.4.2 Customer Packaging Standards

• 4.15.4.3 Labeling

• 4.15.6.4 Electronic Communication

• 4.15.6.5 Shipment Notification

• 4.19.1 Servicing - Note

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Be Cautious on Changes!!

• Many requirements not present in the second edition may very well become customer specific requirements

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What Was Added?

• 6.5 Sourcing

• 7.1.2 Change Control (note change)

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Impact on QS-9000 Implementation

• Process Approach– Process versus elements– Impact on documentation

• Customer Focus

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The Hierarchical Organization vs. The Process Focus

• How do you document your system?H

uman

Res

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Man

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anag

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Process Mapping

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Process Documentation

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Customer Focus

ProcessShipment

ShipmentAccuracy

% Downtime

ProcessMaintenance

100% On-Time Delivery Customer Need andExpectation (5.2)

100% of shipments received bycustomer on scheduled day Goal and Objectives (5.4)

% On-Time (on day required) Result Measurable (5.4)

ProcessTraining

Setup JobsFilled

Key Processes (4.1)

ProcessMeasurables (8.2.3)

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What to Do Now?

• The impact on QS-9000 is really ISO 9001:2000.– Upgrade your QS-9000.– Implement ISO/TS 16949, Second Edition.

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Proposed SAC Quality System Standard

SAC Quality System Standard = ISO 9001 + ISO 9004 + ISO/TS 16949 +

QS-9000 Semiconductor Supplement + SAC

Value added practices

SAC Requirements

ISO 9004:2000 +

TS-16949

ISO 9001:2000