Student Learning Objective 6
Apply the commonly used quality systems and standards.
Learning Objective D
Construct ISO 9001 documentation.
Content
This module presents documentation requirements for ISO 9001 and introduces other sector-specific quality standards based upon ISO 9001.
Slide 18
Slide 19: Quality Management System Documentation
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Quality Policy
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Quality Manual
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Quality Objectives
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Quality Procedures
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Forms, records, etc.
Slide 20: Documentation Pyramid
Source: Besterfield (2003)
Slide 21: Sector-Specific Standards
Sector-specific applications of ISO 9001
ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
ISO 13485 - Medical Devices ISO 17582 - Electoral organizations at all levels of government ISO 18091 - Local government ISO/TS 22163 - Business management system requirements for rail organizations ISO/TS 29001 - Petroleum, petrochemical and natural gas industries ISO/IEC 90003 - Software engineering
Source: Sector-Specifice Applications of ISO 9001
Slide 22: Automotive Sector
IATF 16949:2016 vs ISO 9001:2015
IATF 16949:2016 is not a stand-alone quality management standard but is implemented as a supplement to, and in conjunction with ISO 9001:2015.
IATF 16949:2016 does not contain the ISO 9001:2015 text. The contains only the automotive specific additional requirements; however, organizations are still required to comply with ISO 9001:2015
The IATF 16949 requirements are fully aligned with the ISO 9001:2015 high-level structure.
Source: IATF 16949:2016 versus IOS 9001:2015
Slide 23: 16949 Tools
What are the Quality Core Tools
The Quality Core Tools are defined as five supplemental techniques and/or methods which support the expectations of IATF 16949. These tools are documented separately through the publication of five manuals available through Automotive Industry Action Group (AIAG). The traditional five core tools are listed in their order of use when designing products or processes:
- Advanced Product Quality Planning (APQP)
- Failure Modes and Effects Analysis (FMEA)
- Measurement Systems Analysis (MSA)
- Statistical Process Control (SPC)
- Product Part Approval Process (PPAP)
Source: What are the Quality Core Tools (IATF 16949)
Slide 24: APQP
What is Advanced Product Quality Planning
Advanced Product Quality Planning (APQP) is a tool box of methods and techniques which are used to assure product quality by communicating requirements, specifications and risks. APQP is a structured approach to product and process design which facilitates communication between suppliers, design communities and customers. APQP supports the never ending and relentless continuous improvement intent of IATF 16949.
Source: What are the Quality Core Tools (IATF 16949)
Slide 25: PPAP
What is Production Part Approval Process (PPAP)
Production Part Approval Process (PPAP) is a standardized process in the automotive and aerospace industries. PPAP demonstrates through documentation that as manufactured, the product and process perform as specified by design intent and purchasing requirements. The elements of PPAP are related to APQP in that they are created at key times during product and process design. The evidence of conformance is collected and provided as validation of proper planning. PPAP promotes a clearer understanding of the requirements to manufacturers and suppliers. PPAP also helps to ensure that the processes selected to manufacture parts can consistently reproduce the parts at planned production volumes. For automotive industry suppliers, the PPAP process is currently governed by the PPAP manual published by the Automotive Industry Action Group (AIAG).