PMA APSC 042617 Cathy · PDF file · 2017-04-26and VDA 6.1 in 1990s Ø1stISO/TS 16949 QMS 3rdparty auditor in US Ø1stto learn about new IATF 16949:2016 requirements in September,

Knowledge + Action = Results ©2017 Quistem, LLC www.Quistem.com

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ISO 9001:2015 IATF 16949:2016

International QMS StandardISO 9001:2008 ISO 9001:2015

Automotive QMS StandardISO/TS 16949:2009 IATF 16949:2016

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Transition deadline:September 14, 2018

(only 70 weeks!)

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6 months >$25,000


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» Audit nonconformances» More complex &

confusing QMS» Dis-satisfied customers


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Your QMS Transition was:» Fast» Worry-free» Made your business

money, and» Kept your

customers happy!


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Your Automotive QMS Expert:Cathy Fisher

Ø Over 30 years Automotive industry QMS expertise

Ø Automotive QMS involvement since introduction of QS 9000 and VDA 6.1 in 1990s

Ø 1st ISO/TS 16949 QMS 3rd party auditor in US

Ø 1st to learn about new IATF 16949:2016 requirements in September, 2016

Ø Leader of “Future of Automotive Core Tools” initiative

Knowledge + Action = Results www.Quistem.com

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» Your organization is currently registered to ISO 9001:2008?

» Your organization is currently registered to ISO/TS 16949:2009?

» Your organization must transition your QMS to maintain business with your Automotive customers?

» You want information on how to accomplish your QMS transition efficiently and effectively?

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» Share as much as I can in the short time we have together today

» Answer all your questions about your QMS transition

» Provide you with additional resources to support your organization’s QMS transition effort

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1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers

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» Routine review of ISO standards every 5 years

» Significant changes in QMS application, (especially in Automotive)

» Technology changes impacting organization’s operations, (the way we do business!)

» Quality as a strategic driver for business14


Business Ladder

System Processes = Policies, Objectives & Practices(how an organization does business)

Planning Processes apply Systemto fulfill customer requirements

(how do we meet customer requirements?)

Producing Processes to accomplish Plans(are we making the product correctly?)

Products/Services = output of producing Processes(does product meet customer requirements?)

Satisfied Customers!


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Innovation & Opportunity

QMS = Strong Foundation/Roots


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» Renumbering your QMS documentation to align with the ISO 9001/IATF 16949 standards

» Re-writing your Quality Manual to regurgitate the ISO 9001/IATF 16949 standards

» Creating QMS documentation for every individual requirement, (or “shall”), of the ISO 9001/IATF 16949 standards

» Generating more paperwork to show the auditor that does not directly support your organization’s processes 18


» Assessing what is currently working well in your organization’s QMS

» Recognizing business processes essential to fulfilling customer requirements and enhancing customer satisfaction

» Determining where opportunity exists to enhance your current QMS to better support your organization’s strategic direction

» Involving everyone in your business in creating a proactive Quality culture using your QMS 19


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ISO 9001:2015» Context of

Organization» Leadership » Risk-based thinking» Externally-provided

products, processes and services

» Change management

IATF 16949:2016» Corporate responsibility» Auditor competencies» Embedded software» Product

safety/traceability» Control of external

provision» Manufacturing feasibility» Warranty management» Customer-specific

requirements

» Interrelation of sections 4, 5, 6 requirements» External provider requirements, (8.4)» Product safety & traceability, (4.4.1.2, 8.5.2.1)» Embedded software, (8.3.2.3, 8.4.2.3.1)» Process changes, (6.3, 8.1, 8.5.6, 8.5.6.1,

8.5.6.1.1)» Auditing: 1st & 2nd party, (7.2.3, 7.2.4,

8.4.2.4.1, 9.2.2.1, 9.2.2.2, 9.2.2.3, 9.2.2.4)» Nonconformance, (8.7.1.1, 8.7.1.4, 8.7.1.5,

8.7.1.7, 10.2.5)» Requirements: CSRs, statutory/regulatory 22


» Avoid viewing new/modified requirements in isolation

» Process-approach emphasizes recognition of process interactions

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PDCA Cycle

PLAN

DOCHECK

ACT

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$$$

Customer Requirements

Business Planning

Resources

Evaluation

Improvement

Money-Making Process

Strategic

Planning/Improvement

Efficiency

On-Going Improvement

Customer Feedback

Effectiveness

!

$$$ DOING

PLANNING

CUSTOMER REQUIREMENTS4.2 Needs & expectations of interested parties

5.1.2 Customer focus8.2 Requirements for products/services

BUSINESS PLANNING: (Management)4 Context of the Organization

4.1, 4.2, 4.3 scope, 4.4 QMS processes5 Leadership: 5.1, 5.2, 5.3

6 Planning6.1 Risks & Opportunities

6.2 Quality Objectives6.3 Planning of changes

7.1 Resources

RESOURCE PROVISION: (Management)7 Support

7.1 Resources7.2 Competence7.3 Awareness

7.4 Communication7.5 Document information

CHECKINGEVALUATION: (Management)

4.4.1 g) evaluate QMS processes6.2.1 e) monitor quality objectives

7.2 c) evaluate effectiveness of actions taken8.5.1 c) Control of production and service

provision8.7 Control of nonconforming outputs

9 Performance evaluation9.1 Monitoring, measurement, analysis and

evaluation9.2 Internal audit

ACTINGIMPROVEMENT: (Management)

10 Improvement10.1 Opportunities for improvement

10.2 Nonconformity & corrective action10.3 Continual improvement

PRODUCT REALIZATION8 Operation

8.1 Operational planning and control8.2 Requirements for products & services

8.3 Design & development of products & services8.4 Control of Externally provided processes,

products, services8.5 Production & service provision

8.6 Release of products and services

Strategic

Planning/Improvement

Continual Planning

Measures of Efficiency

On-Going Improvement

ISO 9001:2015Managed Activities/Process System

9.3 Management Review

Customer Feedback8.2.1 c) obtain customer feedback

9.1.2 Customer satisfaction

Measures of Effectiveness



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Customer-oriented, (COPs) (product

realization)» Market analysis» Bid/tender» Order/request» Product/process design» Product/process

verification/validation» Product production» Delivery» Payment» Warranty/service» Post sales/customer

feedback

Support» Document control» Record control» Alignment of

process/output goals with organization quality objectives

» Training/competency requirements

» Communication with interfaces

» Methods used for analyzing process/output performance

» Application of improvement action processes

» ISO 9001:2015 does not specify name or nature of your organization’s QMS processes, (you decide!)

» IATF 16949:2016 supplements ISO 9001:2015 with additional QMS requirements where processes must be defined

» IATF 16949:2016 even indicates which of these processes must be documented! 28



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QMS Processes Required in IATF 16949 ISO 9001

IATF 16949

Requirement Your Process

4.4.1 Processes of QMS

4.4.1.2 Documented process for

management of product-safety

related products and

manufacturing processes

5.1.1.2 Product realization and support

processes

6.1.2.2 Process to lessen impact of

negative effects of risk

6.1.2.3d) Notification process to customer

7.1.5.2.1 Documented process for

managing

calibration/verification records

7.2.1 Documented process for

identifying training needs,

achieving competence of

personnel

7.2.3 Documented process to verify

internal auditors are competent

7.3.2 Documented process to

motivate employees to achieve

quality objectives, etc.

7.5.1.1b) Documented processes for

QMS

7.5.1.1c) Organization’s processes

7.5.3.2.2 Documented process

describing review, distribution

and implementation of all

customer engineering

standards/specs

ØISO 9001:2015 +ØIATF 16949:2016 automotive sector

supplemental requirements +ØCustomer-specific requirements +ØPart & process approval, (PPAP) +ØAutomotive Core Tools, (APQP,

FMEA, Control Plan, SPC, MSA) Ø (NOTE: these are all separate documents)


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» QMS Scope» QMS processes» Organizational

QMS Gap Analysis» Schedule QMS

Transition audit with your registrar

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» ISO 9001:2015 4.3» IATF 16949:2016

4.3.1, 4.3.2» Must be documented

information, (4.3)» Included in your

Quality Manual, (7.5.1.1)

» More than just the Scope statement on your QMS registration certificate! 34


QMS Scope Review

Knowledge + Action = Results ©2015 Quistem LLC

www.Quistem.com

Current QMS scope: (can be found on QMS registration certificate or your organization’s quality manual) *Your organization’s products/services: Primary activities/processes of your business: (e.g. design, manufacture, assembly, processing, warehousing, distribution, delivery, servicing, etc.)

Automotive Customers served: Other interested parties/requirements: Physical boundaries, (sites, locations): Primary: Support:

Outsourced processes: *IATF 16949:2016 reqs. Not Applicable + Justification: Updated QMS Scope statement: Reviewed with registrar by: Date: (NOTE: * items must be reflected in QMS Scope statement)

» Recognize shared QMS processes, (especially with corporate/sister divisions and other “interested parties”)

» Supporting functions, (both on-site or remote); e.g. design centers, corporate headquarters, distribution centers, etc.

» Customer-specific requirements, (need to name your automotive customers!)

» Identify ALL Outsourced processes, (and consider as part of 8.4 External Provision)

» Determine what new IATF 16949:2016 requirements do not apply to your organization’s QMS

» Get clear on product design ownership; exclusion for product design limited to specific IATF 16949 sub-requirements 35


» Evaluation of current processes and evidence in your organization related to general QMS requirement topics

» Top-level view of your QMS

» Set of open-ended questions related to QMS topics

» Designed to promote dialogue about QMS


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Organizational QMS Gap Analysis

Knowledge + Action = Results ©2015 Quistem LLC

www.Quistem.com

ISO Ref Question Process Owner Response Process Evidence 4.1 How is your QMS

considered during business planning?

Top Management

4.2 What groups of interested parties

does your organization interact

with?

Top Management

4.3 What activities of your business directly impact satisfying

customers?

Top Management

4.4 How are processes of your organization

identified?

Top Management

5.1 How does your organization

demonstrate customer focus?

Top Management

5.2 How is success of your business

measured?

Top Management

» Highlights what your organization already has in place that is working

» Prevents overwhelm of trying to fit interpretations of new ISO 9001:2015 & IATF 16949:2016 requirements into your business

» Avoids prescribing specific solutions» Involves process owners across your

organization» Gets people talking about your QMS from a

strategic perspective 38


» Confirm transition audit dates

» Auditor availability!» QMS Scope review» Documentation review» Structure for QMS

transition audit» Registrar requirements» Duration same as re-

registration audit 39


» October 1, 2016: IATF 16949:2016 release» January 1, 2017: IATF 16949:2016 3rd party

Transition audits begin» January 1 thru September 30, 2017: Voluntary

IATF 16949:2016 QMS Transition audit at regularly scheduled surveillance/re-certification audit

» October 1, 2017 thru September 14, 2018: Mandatory IATF 16949:2016 QMS Transition audit at regularly scheduled surveillance/re-certification audit

» Up to May 15, 2018: “safe window” for transition to allow 120 days to clear potential audit nonconformances

» September 14, 2018: ISO/TS 16949:2009, (and ISO 9001:2008) expires!

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IATF 16949:2016 QMS Transition Plan Action Responsible Date Status

Determine transition date Schedule transition audit with

registrar

Get copy of ISO 9001:2015, IATF 16949:2016, (optional:

IATF Rules 5th, ISO 9000:2015)

Review QMS scope Conduct Organizational QMS

Gap Analysis

Confirm QMS processes to IATF 16949:2016

requirements

Identify new/revised QMS processes & process owners

Define detailed QMS Transition time & action plan

Update internal auditor competencies

Management briefing on IATF 16949:2016

All-employee awareness training of IATF 16949:2016

Conduct internal audits of updated QMS

Management review of updated QMS

Prepare QMS vs. IATF 16949:2016 mapping

QMS Transition audit prep

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Operational consistency!

PredictableSuccess

Preventive/detectiverisk control strategy

Stable/capable processes

0-4 dppm (internal) No customer complaints

Never Recalls!


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Get certified to IATF 16949:2016!

1. Compliance to ISO 9001 through 2nd party audits2. Certification to ISO 9001 through 3rd party audits;

maintain 3rd party certification issued by an IAF accredited member where accreditation body’s main scope includes management systems certification to ISO/IEC 17021

3. Certification to ISO 9001 with compliance to other customer-defined QMS requirements, (e.g. AIAG CQI-19), through 2nd party audits

4. Certification to ISO 9001 with compliance to IATF 16949 through 2nd party audits

5. Certification to IATF 16949 through 3rd party audits, (by IATF-recognized certification body)”

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This is a progression to accomplish over time!


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QMS Transition Resources» QMS cross-reference» QMS scope worksheet» QMS Transition plan» Cathy’s book

“Worry-Free QMS Transition”


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Documents

PMA APSC 042617 Cathy · PDF file · 2017-04-26and VDA 6.1 in 1990s Ø1stISO/TS 16949 QMS 3rdparty auditor in US Ø1stto learn about new IATF 16949:2016 requirements in September,