Doc Edition Section Question Answer

The design requirements of 5.4 shall not apply if the product is production activities,
servicing, storage, distribution, or logistics (see 3.1.17)
Q1 10th Clause 5.4.1
Background: My organization’s product is one of the activities described above (e.g.
servicing) for which the activity has designs. However, the Specification uses the words
“shall not apply” as it relates to performing design.
Question 1: Does clause 5.4.1 require the organization to exclude Design if the
No
organization’s product is one of the activities described in 5.4.1?
Question 2: Is it acceptable for my organization to perform design if my organization’s
Yes
product is one of the activities described in 5.4.1?

The procedure shall address the following: determination and implementation of

manufacturing acceptance criteria (MAC)

Background: There are requirements in the standard that reference MAC. The definition
Q1 10th Clause 5.6.1(a)
of MAC states: Requirements applied to characteristics or combinations of those
characteristics, of materials, products, or components to achieve conformity to DAC (see
3.1.7) and other product manufacturing requirements. My organization does not identify
or reference DAC (required by 5.4.4 (c)) for some or all of our products and services
because our product or service does not require design or because design is excluded.
Question: When an organization does not perform design for some or all products or
services, is it possible to determine and implement MAC if DAC is not identified or Yes
referenced in accordance with 5.4.4(c)?

The organization shall establish and maintain identification throughout product

realization, including applicable delivery and post-delivery activities.
Q1 10th Clause 5.6.5(a)
Background: Identification of a tangible product (e.g. valve) is well understood, however,
when an organization’s product is a service (e.g. project management services), it is not
possible to apply identification marks on or attached to the “product”.
Question: When the organization’s product is a service, can identification be maintained
Yes
through other methods?
 The organization shall maintain a documented procedure describing the methods used
to preserve the product and component parts throughout product realization and
delivery. The procedure shall address the following a) identification and traceability
marking; b) storage, including the use of designated storage areas or stock rooms; c)
assessment of condition at intervals specified by the organization; d) transportation; e)
Q1 10th Clause 5.6.8
handling; f) packaging; and g) protection.

Background: My organization’s product is a service (e.g. project management services).

The product does not have any requirements for identification markings, storage,
transportation, packaging, etc.

Question: When an organization’s product is a service and that service does not have
any requirements for 5.6.8(a)-(g), is the organization still required to develop a Yes
procedure per 5.6.8?