Following on from my last blog, here is what you need to do to meet the requirements of the second section on design for which the standard says –

7 Product Realization
7.3 Design and Development
7.3.2 Design and Development Inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.

The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

Designing is a process. The design and development process (clause 7.3) is the manner in which we transform design inputs (clause 7.3.2) into design outputs (clause 7.3.3). If you are going to design a good product or service then you need to know, before you start designing it, the requirements it must fulfil. These might be statements about:

  • How it will function
  • How it will perform
  • How it will look
  • What size it should beHow reliable it must be
  • How robust or durable it must be
  • How it will be maintained
  • How it will be packaged
  • Its lifespan
  • Safety factors
  • Regulations it must comply with
  • Earlier, similar designs you have done
  • What it should cost

Information on how the product or service should be designed may come from customer contracts, drawings, specifications. your own database of previous design projects, competitor analysis, industry standards, feedback from suppliers, field data, process performance data, codes of practice, acts & regulations of parliament, and so on.

Before commencing the design process the Standard asks us to check that these inputs provide the information needed to complete the assignment – do you have all the information you need, is the information clearly understood by everyone involved, and is it free from conflicting requirements.

Do you need it?

The clause on design is the one most frequently excluded by organisations. If you design and develop new products and services (regardless whether you buy the designs, outsource the design process, or actually do design and development yourself) then you need to include this clause.

If you supply the same services or manufacture the same products, even if you modify them within known parameters, then you can exclude this clause.

If you manufacture strictly from customer provided engineering drawings and specifications you can exclude this clause.

Here is guidance on exclusions straight from the horse’s mouth, the International Organization for Standardization.

If you’d like some guidance or need a sounding board please email me at Alternatively, visit my website where you’ll find my Top 5 Essential Tips and free ISO 9001 procedures.