Clause 4 "Context of the organization".

Question 1

What topics does this clause 4 contain?

Answer 1

• Understanding the organization and its context
• Understanding the needs and expectations of
  interested parties
• Determining the scope of the quality management system
• Quality management system and its processes

Question 2

Explain: Understanding the organization and its context

Answer 2

The organization shall determine external and internal issues that are

• relevant to its purpose and
• its strategic direction and
• that affect its ability to achieve the intended result(s) of its quality management system.

Question 3

Examples for external issues:

Answer 3

External issues can include for example:

• legal environment
• technological environment n competitive environment
• market environment
• cultural environment
• social environment
• economical environment.

Question 4

Examples of internal issues:

Answer 4

Internal issues can include for example:

• values
• culture
• knowledge
• performance of the organization

Question 5

What to determine the scope of the quality management system?

Answer 5

The organization shall determine

• the boundaries and
• applicability of the quality management system
• to establish its scope.

Question 6

What shall the organization consider when determining the scope?

Answer 6

When determining this scope, the organization shall consider

• the relevant external and internal issues,
• the requirements of relevant interested parties,
• the products, and services of the organization.

Question 7

What ISO standards shall apply when determining the scope?

Answer 7

• The organization shall apply all the requirements of ISO 9001:2015 if they are applicable within the determined scope of its quality management system!
• The scope of the organization‘s quality management system shall be available and maintained as documented information!

Question 8

The scope shall:

Answer 8

The scope shall

• state the types of products and services covered, and
• provide justification for any requirement that the organization determines is not applicable.
• The requirements determined as not being applicable shall not affect the organization‘s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

Question 9

What shall the organization do when thinking about quality management and its processes?

Answer 9

The organization shall

• establish,
• implement,
• maintain and
• continually improve a quality management system,
• including the processes needed and their interactions!

Question 10

When deciding on the processes needed what shall the organization do?

Answer 10

The organization shall determine the processes needed for the quality management system and their application throughout the organization.
The organization shall
- determine the inputs required and the outputs
expected from these processes;
- determine the sequence and interaction of these
processes;
- determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
- determine the resources needed for these processes and ensure their availability;
- assign the responsibilities and authorities for these processes;
- address the identified risks and opportunities;

Question 11

The organization shall:

Answer 11

• evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
• improve the processes and the quality management system.
  To the extent necessary, the organization shall also
• maintain documented information to support the
  operation of its processes and
  n retain documented information.