Clause 7: "Support"

Question 1

Resources - general:

Answer 1

The organization shall
- determine and
- provide
the resources needed for the n establishment,
- implementation,
- maintenance and
- continual improvement
of the quality management system.
The organization shall consider:
- the capabilities of, and
- constraints on,
- existing internal resources;
- what needs to be obtained from external providers.

Question 2

Resources - People

Answer 2

The organization shall
- determine and
- provide
the persons necessary for the effective implementation of its quality management system and for the
- operation and 
- control 
of its processes.

Question 3

Resources - Infrastructure

Answer 3

The organization shall n determine,
- provide and
- maintain
the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

Question 4

Resources – Environment for the operation of processes

Answer 4

• The organization shall n determine,
• provide and
• maintain
  the environment necessary for the operation of its
  processes and to achieve conformity of products and
  services.

Question 5

Monitoring and measuring resources

Answer 5

The organization shall
- determine and
- provide
the resources needed to ensure 
- valid and
- reliable
results when monitoring or measuring is used to verify the conformity of its products and services to requirements.

Question 6

Monitoring and measuring resources

Answer 6

The organization shall ensure that the resources provided:
- are suitable for the specific type of monitoring and measurement activities being undertaken;
- are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriately documented information as evidence of fitness for purpose of the monitoring and measurement resources.

Question 7

Monitoring and measuring resources – Measurement traceability

Answer 7

When measurement traceability
- is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results,
measuring equipment shall be
- calibrated or verified, or both, at specified intervals,
- or prior to use,
against measurement standards traceable to international or national measurement standards;
When no such standards exist, the basis used for calibration or verification shall be retained as documented information;
- Measurement equipment shall be identified in order to determine their status.
- Measurement equipment shall be safeguarded from adjustments, damage or deterioration.

Question 8

Monitoring and measuring resources – Measurement traceability

Answer 8

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose.
If the validity of previous results has been adversely affected, the organization shall take appropriate action as necessary.

Question 9

Resources – Organizational knowledge

Answer 9

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
This knowledge shall
- be maintained and
- be made available
to the extent necessary.
When addressing
- changing needs and
- trends,
the organization shall consider its current knowledge and determine how to acquire or access
- any necessary additional knowledge and
- required updates.

Question 10

Organizational knowledge can be based on:

Answer 10

• internal sources
  (knowledge gained from experience, lessons learned from failures and successful projects, capturing and sharing undocumented knowledge and experience, results of improvements in processes, products and services…)
• external sources
  (standards, specialist books, academia, conferences, gathering knowledge from customers or external
  providers,…)

Question 11

Competence

Answer 11

The organization shall:
- determine the necessary competence for person(s) doing work under its control that affects the performance and effectiveness of the quality management systems;
- ensure that these persons are competent on the basis of appropriate
- education,
- training, or
- experience;
- where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken;
- retain appropriate documented information as evidence
of competence.

Question 12

Awareness

Answer 12

The organization shall ensure that persons doing work
under the organization‘s control are aware of:
- the quality policy;
- relevant quality objectives;
- their contribution to the effectiveness of the quality management system, including
- the benefits of improved performance;
- the implications of not conforming with the quality
management system requirements.

Question 13

Communication

Answer 13

The organization shall determine the internal and external communications relevant to the quality management system, including:

• on what it will communicate;
• when to communicate;
• with whom to communicate;
• how to communicate;
• who communicates.

Question 14

Documented information – General

Answer 14

The organization‘s quality management system shall
include:
- documented information required by ISO 9001:2015;
- documented information determined by the organization as being necessary for the effectiveness of the quality management system.

Question 15

Documented information – Creating and updating

Answer 15

When creating and updating documented information, the organization shall ensure appropriate:

• identification and description (e.g. title, date, author, or reference number),
• format (e.g. language, software version, graphics) and media (e.g. paper, electronic),
• review and approval for suitability and adequacy.

Question 16

Control of documented information

Answer 16

Documented information shall be controlled to ensure:

• it is available and suitable for use, where and when it is needed;
• it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

For the control of documented information, the organization shall address the following activities, as applicable:
- distribution, access, retrieval and use;
- storage and preservation, including preservation of
legibility;
- control of changes (e.g. version control); n retention and disposition.

Question 17

Control of documented information

Answer 17

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations.