| 7.1 |
General requirements |
| previous |
Elements
4.3/4.4/4.6/4.7/4.8/4.9/4.11/4.12/4.15/4.19 |
| new: |
Detailed planning of the
necessary processes to realize the required product and / or service and
their sequence and interaction considering the outputs from quality
planning (see 5.5.2) |
| 7.2 |
Customer-related processes |
| 7.2.1 |
Identification of customer
requirements |
| previous: |
Element 4.3 |
| new: |
Identifying customer
requirements (completeness, fitness for purpose, obligations and legal
requirements, availability, delivery, support) |
| 7.2.2 |
Review of customer requirements |
| previous: |
Element 4.3 |
| new: |
No modification |
| 7.2.3 |
Customer communication |
| previous: |
Element 4.3 |
| new: |
Arrangements for
communication with customers, with the aim of meeting customer
requirements. (Product and / or service information, inquiry and
order handling - including amendments, customer complaints and actions
relating to nonconforming product and / or service, customer responses
relating to performance of product and / or service) |
| 7.3 |
Design and development |
| 7.3.1 |
General requirements |
| previous: |
Elements 4.4.1/4.4.2/4.4.3 |
| new: |
No modification |
| 7.3.2 |
Design and development inputs |
| previous: |
Element 4.4.4 |
| new: |
Legal and environmental
requirements and requirements from previous similar designs. |
| 7.3.3 |
Design and development outputs |
| previous: |
Element 4.4.4 |
| new: |
No modification |
| 7.3.4 |
Design and development review |
| previous: |
Element 4.4.6 |
| new: |
Aim of the review: |
|
- evaluate the capability to fulfil
requirements for quality
|
|
- identify problems, if any, and
propose the development of solutions
|
| 7.3.5 |
Design and development
verification |
| previous: |
Element 4.4.7 |
| new: |
No modification |
| 7.3.6 |
Design and development validation |
| previous: |
Wherever applicable,
validation shall be defined, planned and completed prior to the delivery
or implementation of the product and / or service. Where it is
impossible to undertake full validation prior to delivery or
implementation, partial validation the design or development outputs shall
be undertaken to the maximum extent practical. |
| 7.3.7 |
Design and development changes |
| previous: |
Element 4.4.9 |
| new: |
Additionally determine
the effect of changes on: |
|
- the interaction between the
elements of the design and / or development,
|
|
- the interaction between the
component parts of the resulting product and / or service,
|
|
- existing products and / or
services and upon post delivery product and / or service operations,
|
|
- the need for carrying out
re-verification or re-validation for all or part of the design and /
or development outputs.
|
| 7.4 |
Purchasing |
| 7.4.1 |
General requirements |
| previous: |
Elements 4.6.1/4.6.2 |
| new: |
The type and extent of
methods to control these processes shall be dependent on the effect of the
purchased product and / or service upon the final product and / or
service. |
| 7.4.2 |
Purchasing information |
| previous: |
Element 4.6.3 |
| new: |
Simplification of the
necessary purchasing information: |
|
a) requirements for
approval or qualification of product and / or service, procedures,
processes, equipment and personnel. |
|
b) any management
system requirements. |
| 7.4.3 |
Verification of purchased product
and / or services |
| previous: |
Element 4.6.4 |
| new: |
No modification |
| 7.5.2 |
Identification and Traceability |
| previous: |
Elements 4.8/4.12 |
| new: |
No modification |
| 7.5.3 |
Customer property |
| previous: |
Element 4.7 |
| new: |
All property of the
customer. |
|
Includes information
provided in confidence. |
| 7.5.4 |
Handling, packaging, storage,
preservation and delivery |
| previous: |
Element 4.15 |
| new: |
Includes parts and
components. Product release and / or service delivery shall
not proceed until al the specified activities have been satisfactorily
completed. |
| 7.5.5 |
Validation of processes |
| previous: |
Element 4.9 |
| new: |
Supplementation of the
validation of processes for products where the resulting output cannot be
validated completely and definition of arrangements that shall address: |
|
a) processes to be
qualified prior to use, |
|
b) qualification of
equipment and / or personnel, |
|
c) use of specific
procedures and / or records, |
|
d) re-validation. |
| 7.6 |
Control of measuring and
monitoring devices |
| previous: |
Element 4.11 |
| new: |
Knowledge of the
measurement uncertainty of the measuring and monitoring devices and
consistency with the required measurement capability. |
