Different ISO 9000 comes out of a quality assurance tradition for the manufacture of hard goods, but software is strikingly different from hard goods like cars and nails. First, software is abstract . It is the same piece of software, whether it sits in memory, on a diskette, in a print-out, in a flow chart, or in any other form or medium. Second, software is intangible and non-material . If you make multiple copies of a program, you have not created new software.
Every copy is the program, in a sense.
If I find a diskette is defective, I can mark it with a red dot. Third, software is complex . It is not just complex in the sense that highway systems, or city infrastructures are complex. Software is many, many orders of magnitude more complex than any other thing that humans have created and learned to deal with successfully. Worse, we typically expect a single programmer to take responsibility for making it correct.