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How do I document the Design & Development Process for ISO 9001:2015


If your organisation operates a design and development process, whether it’s for a product or service, then you may need to document the process for your ISO 9001 Quality Management System.

This template procedure and process example can be adapted to meet your organisation’s needs.

Can you Exclude Design and Development from ISO 9001?

Some organisations decide to exclude the Design and Development clauses of ISO 9001 from their Quality Management System.

if you do not undertake this activity, it can be justifiably excluded from the QMS Scope. The reasons for excluding these controls should be documented through, for example as part of your scope statement.

Including Design and Development

If you have decided to include design and development, you will need to document the process to the requirements of ISO 9001:2015 and provide evidence of compliance to back this up.

Some organisations find they need to tweak their process to become compliant.

This FREE Design and Development Process will help you understand the requirements and document your arrangements.

Design & Development Process Template

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