8.2.2 Determining requirements related to products and services
For our products and services have we determined the following requirements:
(a) applicable statutory and regulatory
(b) those we feel are necessary
Can we meet the claims for the products and services we offer?
8.2.3 Review of requirements related to products and services
Before committing to supply do we ensure can we meet:
(a) requirements specified by the customer
(b) requirements necessary for intended use
(c) requirements specified by us
(d) statutory and regulatory requirements
(e) contract or order requirements
Do we
(a) ensure that contract or order requirements differing from those previously defined are resolved
(b) confirm requirements before acceptance of the order
(c) retain documented information as applicable describing the results of the review, including any new or changed requirements for the products and services
8.2.4 Changes to requirements for products and services
Have we
(a) ensured that documented information is amended and that relevant personnel are made aware of the changed requirements when requirements for products and services are changed
8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES
8.3.1 General
Have we have a design and development process for products and services that is appropriate
8.3.2 Design and Development planning
In determining the stages and controls for design and development, have
we considered:
(a) the nature, duration and complexity of the activities
(b) stages including review
(c) verification and validation
(d) responsibilities and authorities
(e) internal and external resources
(f) involvement of customer and user groups
(g) the subsequent production process
(h) documented information required