ISO 9001 (2015) & IATF 16949 (2016) Requirements Awareness (For Upload)

JP Power Horizon Sdn Bhd
(901998-H)
Consultancy, Training & Auditing Services
Basic Understanding of
ISO 9001:2015 & IATF 16949:2016
Requirements Awareness
By
Stephen Lim (Ed.D)

0122145412 / jp.power.stephen@gmail.com
History of ISO 9001
(Sejarah ISO 9001)
• ISO 9001:1987 => 1 st edition (edisi pertama)
• ISO 9001:1994 => 2nd edition (edisi kedua)
• ISO 9001:2000 => 3rd edition (edisi ketiga)
• ISO 9001:2008 => 4th edition (edisi keempat)
• ISO 9001:2015 => 5th edition (edisi kelima)
NEW
jp.power.stephen@gmail.com 2
History of IATF 16949
(Sejarah IATF 16949)
• ISO/TS 16949:1999 => 1 st edition (edisi pertama)
• ISO/TS 16949:2002 => 2nd edition (edisi kedua)
• ISO/TS 16949:2009 => 3rd edition (edisi ketiga)
• IATF 16949:2016 => 1st edition (edisi pertama)
NEW
BASIC UNDERSTANDING THE
ISO 9001:2015 & IATF 16949:2016
REQUIREMENTS
(KEFAHAMAN ASAS TENTANG KEHENDAK
ISO 9001:2015 & IATF 16949:2016)
ISO 9001:2015 Structure
The following are the Requirements of the ISO 9001:2015 Standard. The ISO
9001:2015 Standard shall be used as one of the compulsory requirements in new
IATF 16949:2016.
 Section 4 Context of the organization

o 4.1 Understanding the organization and its context
o 4.2 Understanding the needs and expectations of interested parties
o 4.3 Determining the scope of the quality management system
o 4.4 Quality management system
 Section 5 Leadership
o 5.1 Leadership and commitment
o 5.2 Quality policy
o 5.3 Organizational roles, responsibilities and authorities
jp.power.stephen@gmail.com /
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9001:2015 Standard shall be used as one of the compulsory requirements in new IATF
16949:2016.
 Section 6 Planning
o 6.1 Actions to address risks and opportunities
o 6.2 Quality objectives and planning to achieve them
o 6.3 Planning of changes
 Section 7 Support
o 7.1 Resources
o 7.2 Competence
o 7.3 Awareness
o 7.4 Communication
o 7.5 Documented information
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IATF 16949:2016.
 Section 8 Operation
o 8.1 Operational planning and control
o 8.2 Determination of market needs and interactions with customers
o 8.3 Development of goods and services
o 8.4 Control of external provision of goods and services
o 8.5 Production of goods and provision of services
o 8.6 Release of goods and services
o 8.7 Nonconforming goods and services
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IATF 16949:2016.
 Section 9 Performance evaluation

o 9.1 Monitoring, measurement, analysis and evaluation
o 9.2 Internal Audit
o 9.3 Management review
 Section 10 Continual improvement

o 10.1 Nonconformity and corrective action
o 10.2 Improvement
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IATF 16949:2016 Structure
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Overview IATF 16949:2016
• IATF 16949:2016 follows the high structure of ISO
9001:2015
• IATF 16949:2016 must be used in conjunction with ISO
9001:2015
– 2 separate documents must be used to have all requirements
– IATF 16949 cannot be used as a stand-alone requirements
document
– Conclusion: An organization is required to conform to both
ISO 9001:2015 and IATF 16949:2016 Standards in order to be
third party certified to IATF 16949:2016.
• IATF 16949:2016 has 282 shalls / 16 shoulds (compare
with ISO/TS 16949:2009 of 292 shalls/16 shoulds)
• The main focus of IATF 16949:2016 are
– Increased focus on operational performance and customer
feedback (customer scorecards/metrics)
– Contains many IATF OEM Customer Specific Requirements
(CSRs)
– OEMs are raising the bar regarding expectations for audits to
reflect systemic weaknesses that affect supplier/client
performance
– Prevent problems before they occur
New/Modified/Carryover Requirements of IATF
16949:2016
The following are the requirements of new IATF
16949:2016, which incorporate “new” additional
requirements as well as requirements “modified” from ISO
9001:2015 and ISO/TS 16949:2009. Some requirements
remain unchanged (known as “carryover” from ISO/TS
16949:2009, ISO 9001:2015, etc).
Understanding the Changes in
IATF 16949:2016
 Section 4
o 4.1 Understanding the organization and its context
o 4.2 Understanding the needs and expectations of interested parties
o 4.3 Determining the scope of the quality management system
 Section 4.3.1 (Modified): Determining the scope of the quality management
system – supplemental
 Section 4.3.2 (New): Customer specific requirements
o 4.4 Quality management system
 Section 4.4.1.1 (New): Conformance of products and processes
 Section 4.4.1.2 (New): Product safety
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IATF 16949:2016
 Section 5
o 5.1 Leadership and commitment
 Section 5.1.1.1 (New): Corporate responsibility
 Section 5.1.1.2 (Modified): Process effectiveness and efficiency
 Section 5.1.1.3 (New): Process owners
o 5.2 Quality policy
o 5.3 Organizational roles, responsibilities and authorities
 Section 5.3.1 (Modified): Organizational roles, responsibilities and authorities –
supplemental
 Section 5.3.2 (Modified): Responsibility and authority for product requirements and
corrective action
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IATF 16949:2016
 Section 6
o 6.1 Actions to address risks and opportunities
 Section 6.1.1: follow ISO 9001:2015
 Section 6.1.2: follow ISO 9001:2015
 Section 6.1.2.1 (Modified): Risk analysis
 Section 6.1.2.2 (Modified): Preventive action
 Section 6.1.2.3 (Modified): Contingency plans
o 6.2 Quality objectives and planning to achieve them
o Section 6.2.1: follow ISO 9001:2015
o Section 6.2.2: follow ISO 9001:2015
 Section 6.2.2.1 (Modified): Quality objectives and planning to achieve them –
supplemental
o 6.3 Planning of changes
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IATF 16949:2016
 Section 7
 Section 7.1: follow ISO 9001:2015
 Section 7.1.1: follow ISO 9001:2015
 Section 7.1.3.1 (Modified): Plant, facility, and equipment planning
 Section 7.1.4.1 (Carryover): Environment for the operation of processes –
supplemental
 Section 7.1.5.1: follow ISO 9001:2015
 Section 7.1.5.1.1 (Modified): Measurement system analysis (MSA)
 Section 7.1.5.2.1 (Modified): Calibration/verification records
 Section 7.1.5.3.1 (Modified): Internal laboratory
 Section 7.1.5.3.2 (Modified): External laboratory
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IATF 16949:2016
 Section 7
 Section 7.2: follow ISO 9001:2015
 Section 7.2.1 (Modified): Competence - supplemental
 Section 7.2.2 (Modified): Competence – on-the-job training
 Section 7.2.3 (Modified): Internal auditor competency
 Section 7.2.4 (New): Second-party auditor competency
 Section 7.3: follow ISO 9001:2-15
 Section 7.3.1 (Modified): Awareness – supplemental
 Section 7.3.2 (Carryover): Employee motivation and empowerment
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IATF 16949:2016
Section 7
Section 7.4: follow ISO 9001:2015
Section 7.5: follow ISO 9001:2015
Section 7.5.1: follow ISO 9001:2015
Section 7.5.1.1 (Modified): Quality management system documentation
Section 7.5.2: follow ISO 9001:2015
Section 7.5.3.1: follow ISO 9001:2015
Section 7.5.3.2: follow ISO 9001:2015
Section 7.5.3.2.1 (Modified): Record retention
Section 7.5.3.2.2 (Modified): Engineering specifications
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IATF 16949:2016
 Section 8
 Section 8.1: follow ISO 9001:2015
 Section 8.1.1 (Modified): Operational planning and control – supplemental
 Section 8.1.2 (Carryover): Confidentiality
 Section 8.2: follow ISO 9001:2015
 Section 8.2.1: follow ISO 9001:2015
 Section 8.2.1.1 (Modified): Customer communication
 Section 8.2.2.1 (Modified): Determining the requirements of product and services –
supplemental
 Section 8.2.3.1.1 (Modified): Review of the requirements of product and services –
supplemental
 Section 8.2.3.1.2 (Carryover): Customer-designated special characteristics
 Section 8.2.3.1.3 (Modified): Organization manufacturing feasibility
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IATF 16949:2016
Section 8
Section 8.3: follow ISO 9001:2015
Section 8.3.1: follow ISO 9001:2015
Section 8.3.1.1 (Modified): Design and development of products and services – supplemental
Section 8.3.2.1 (Modified): Design and development planning – supplemental
Section 8.3.2.2 (Carryover): Product design skills
Section 8.3.2.3 (New): Development of products with embedded software
Section 8.3.3.1 (Modified): Product design input
Section 8.3.3.2 (Modified): Manufacturing process design input
Section 8.3.3.3 (Modified): Special characteristics
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IATF 16949:2016
Section 8
Section 8.3.4.1 (Modified): Monitoring
Section 8.3.4.2 (Modified): Design and development validation
Section 8.3.4.3 (Modified): Prototype programme
Section 8.3.4.4 (Modified): Product approval process (PPAP related)
Section 8.3.5.1 (Modified): Design and development – supplemental
Section 8.3.5.2 (Modified): Manufacturing process design output
Section 8.3.6.1 (Modified): Design and development changes – supplemental
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IATF 16949:2016
Section 8
Section 8.4.1.1 (Modified): General – supplemental (under Control of externally provided processes,
products and services)
Section 8.4.1.2 (Modified): Supplier selection process
Section 8.4.1.3 (Modified): Customer-directed sources also known as “direct-buy”)
Section 8.4.2.1 (Modified): Type and extent of control – supplemental
Section 8.4.2.2 (Modified): Statutory and regulatory requirements
Section 8.4.2.3 (Modified): Supplier quality management system development
Section 8.4.2.3.1 (New): Automotive product-related software or automotive products with embedded
software
Section 8.4.2.4 (Modified): Supplier monitoring
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IATF 16949:2016
Section 8
Section 8.4.2.4.1 (New): Second-party audits
Section 8.4.2.5 (Modified): Supplier development
Section 8.4.3.1 (Modified): Information for external providers – supplemental
Section 8.5.1.1 (Modified): Control plan
Section 8.5.1.2 (Modified): Standardized work – operator instructions and visual standards
Section 8.5.1.3 (Modified): Verification of job set-ups
Section 8.5.1.4 (New): Verification after shutdown
Section 8.5.1.5 (Modified): Total productive maintenance (TPM)
Section 8.5.1.6 (Modified): Management of production tooling and manufacturing, test,
inspection tooling and equipment
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IATF 16949:2016
Section 8
oSection 8.5.1.7 (Modified): Production scheduling
oSection 8.5.2: follow ISO 9001:2015
oSection 8.5.2.1 (Modified): Identification and traceability – supplemental
oSection 8.5.4.1 (Modified): Preservation – supplemental
oSection 8.5.5.1 (Modified): Feedback of information from service
oSection 8.5.5.2 (Modified): Service agreement with customer
oSection 8.5.6.1 (Modified): Control of changes – supplemental
oSection 8.5.6.1.1 (New): Temporary change of process controls
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IATF 16949:2016
Section 8
Section 8.6.1 (Modified): Release of products and services – supplemental
Section 8.6.2 (Modified): Layout inspection and functional testing
Section 8.6.3 (Modified): Appearance items
Section 8.6.4 (Modified): Verification and acceptance of conformity of externally provided products and
services
Section 8.6.5 (Modified): Statutory and regulatory conformity
Section 8.6.6 (Carryover): Acceptance criteria
Section 8.7.1.1 (Modified): Customer authorization for concession
Section 8.7.1.2 (Modified): Control of nonconforming product – customer specified process
Section 8.7.1.3 (Modified): Control of suspected product
Section 8.7.1.4 (Modified): Control of reworked product
Section 8.7.1.5 (Modified): Control of repaired product
Section 8.7.1.6 (New): Customer notification
Section 8.7.1.7 (Modified): Nonconforming product disposition
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IATF 16949:2016
 Section 9
∞ Section 9.1: follow ISO 9001:2015
∞ Section 9.1.1: Follow ISO 9001:2015
∞ Section 9.1.1.1 (Modified): Monitoring and measurement of manufacturing processes
∞ Section 9.1.1.2 (Modified): Identification of statistical tools
∞ Section 9.1.1.3 (Modified): Application of statistical concepts
∞ Secion 9.1.2: follow ISO 9001:2015
∞ Section 9.1.2.1 (Modified): Customer satisfaction – supplemental
∞ Section 9.1.3.1 (Modified): Prioritization
∞ Section 9.2.2.1 (Modified): Internal audit programme
∞ Section 9.2.2.2 (Modified): Quality management system audit
∞ Section 9.2.2.3 (Modified): Manufacturing process audit
∞ Section 9.2.2.4 (Modified): Product audit
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IATF 16949:2016
 Section 9
∞ Section 9.3.1.1 (Modified): Management review – supplemental
∞ Section 9.3.2.1 (Modified): Management review inputs – supplemental
∞ Section 9.3.3.1 (Modified): Management review outputs – supplemental
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IATF 16949:2016
 Section 10
$ Section 10.1: follow ISO 9001:2015
$ Section 10.2.1: follow ISO 9001:2015
$ Section 10.2.2: follow ISO 9001:2015
$ Section 10.2.3 (Modified): Problem solving
$ Section 10.2.4 (Modified): Error-proofing
$ Section 10.2.5 (New): Warranty management systems
$ Section 10.2.6 (Modified): Customer complaints and field failure test analysis
$ Section 10.3.1 (Modified): Continual improvement – supplement
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ANNEX A: CONTROL PLAN
Differences between IATF 16949:2016 & ISO/TS 16949:2009
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ISO 9001 (2015) & IATF 16949 (2016) Requirements Awareness (For Upload)

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ISO 9001 (2015) & IATF 16949 (2016) Requirements Awareness (For Upload)

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JP Power Horizon Sdn Bhd

Consultancy, Training & Auditing Services

Stephen Lim (Ed.D)

 Section 4 Context of the organization

 Section 9 Performance evaluation

 Section 10 Continual improvement

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