| A process for quality assurance for products with internally developed embedded software is req.
Software development assessment methodology is required to assess the process
Records of a software development capability self-assessment using risk prioritization
| Design and development planning includes all affected stakeholders (Include supply chain, where appropriate)
Examples include, but are not limited to:
Project management (for example, APQP or VDA-RGA)
Product and manufacturing process design activities (DFM, DFA, alternative designs & Mfg processes)
Design FMEAs, design risk analysis – including risk reduction
| The requirements of ISO 9001, Section 8.3.1 applies to product and manufacturing process design and development and focuses on error prevention rather than detection.
Documented design and development process is required
|Manufacturing feasibility analysis now includes the following changes:
Requiring a multidisciplinary approach to analyze feasibility,
Considering all engineering and capacity requirements specified
Feasibility analysis for any manufacturing or product technology new to the organization and any changed manufacturing process or product design.
Should validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate
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- S035 - Section 188.8.131.52: Customer communication — supplemental
- S034 - Section 8.1.1: Operational planning and control — supplemental
- S033 - Section 184.108.40.206.2: Engineering specifications