admin Staff asked 9 years ago
We were asked in audit to represent the H/W Inputs/Outputs.
How can QPACK assist us in preparing such document (having the HRS requirements already in QPACK)
ISO 13485: 2003
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, performance and safety requirements, according to the intended use,
- b) applicable statutory and regulatory requirements,
- c) where applicable, information derived from previous similar designs,
- d) other requirements essential for design and development, and
- e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.3 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the
design and development input and shall be approved prior to release.
Design and development outputs shall
- a) meet the input requirements for design and development,
- b) provide appropriate information for purchasing, production and for service provision,
- c) contain or reference product acceptance criteria, and
- d) specify the characteristics of the product that are essential for its safe and proper use.
Records of the design and development outputs shall be maintained (see 4.2.4).
NOTE Records of design and development outputs can include specifications, manufacturing procedures,
engineering drawings, and engineering or research logbooks.