ISO 9001 Requirements Clause
ISO 9001 Requirements Clause 8.3.3 Design and development inputs
In defining the specifications for a new or revised PS, your DD process must consider the requirements essential for each new PS to be designed and developed. These considerations include:
Functional and performance requirements :
· Functional requirements refer to the capabilities (what does the PS do?) of PS it will be designed to provide during its use or operation (provide value to the user), e.g. for a watch – tell time; for a car – provide transportation; for a copier – make color or enlarged images; for metal product – resist bending; for a computer – manipulate and process data; for tax services – prepare and file tax return; for investment services – provide advice on stocks, bonds, etc. It answers the question – Has the PS been designed to meet customer and business requirements and intended use?
· Performance requirements refer to how well the PS will perform its functional capability (provide criteria for), e.g. watch – accuracy; car – reliability, fuel efficiency; etc; tax services – accuracy and timeliness; etc. It answers the question – How well do the capabilities designed into the PS satisfy the customer or users needs and expectations?
These requirements can originate from many sources and may include:
1. Customer provided specifications and requirements;
2. Information from previous similar DD activities;
3. Statutory and regulatory requirements;
4. Industry standards and codes;
5. Specifications from providers of external products, services and processes;
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article on this clause discusses in detail the specific controls to address each of the specific requirements of clause 8.3.3.a-e.