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Design and development topics

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Guest user Created:   Feb 05, 2019 Last commented:   Feb 05, 2019

Design and development topics

"I am working as QMS M.R., facing difficulties in design and development clause as it was not in my previous working organization. Need help in the same for developing records, conducting reviews and risk analysis. additionally, will you be able to provide new work instruction formats content (points to be mentioned in WI format).”
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Carlos Pereira da Cruz Feb 05, 2019

Answer:
I like to see design and development as a journey. https://www.screencast.com/t/reXnDk1dzHK

At the beginning of that journey, your organization at step 1 collects all the requirements that a new product or service must comply with. These requirements can be performance specifications; compliance specifications; timing specifications; production or provision constraints, …

During step 3 your organization creates the product or service prototype, or the first samples. With that prototype or samples, a verification is made by comparing actual performance with all the constraints and performance established as inputs at step 4.

At step 5 the product or service is tested by the customer to val idate its performance in real life conditions.

Remember that in the end, your organization should have:

Product or service specifications;
Production process or service provision specifications and instructions;
Purchasing specifications; and
Documented information specifications.

The following material will provide you with more information about design and development:
- How to deal with design and development changes in the technology sector using ISO 9001 - https://advisera.com/9001academy/blog/2017/02/28/how-to-deal-with-design-and-development-changes-in-the-technology-sector-using-iso-9001/
- Specific use of ISO 9001 design and development in the machining process - https://advisera.com/9001academy/blog/2017/03/14/specific-use-of-iso-9001-design-and-development-in-the-machining-process/
- The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- About records required by ISO 9001 about design and development consider - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
- About conducting design and development reviews consider - ISO9001 Design Verification vs Design Validation - https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
- ISO 9001:2015 Foundations Course - https://training.advisera.com/course/iso-9001-foundations-course/
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Feb 05, 2019

Feb 05, 2019

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