UPDATED ACTUAL Exam Questions and
CORRECT Answers
Every organization has different processes, so there will always be some exclusions in the ISO
9001 requirements of its QMS. T/F - CORRECT ANSWER - False.
Not every organization has exclusions of the ISO 9001 requirements in its QMS scope.
Top management needs to define the responsibilities for the relevant roles of the QMS and
document them. t/f - CORRECT ANSWER - False.
ISO 9001 doesn´t require companies to document responsibilities and authorities in the QMS - it
requires that responsibilities and authorities are assigned and communicated, which can be done
without documenting them.
Organizational knowledge can be maintained through up-to-date work instructions, procedures,
training, and so on. t/f - CORRECT ANSWER - True.
Organizational knowledge is the knowledge necessary for the organization to have for the
operation of its processes and to achieve conformity of products and services, and it can be
maintained by work instructions, procedures, training, etc.
According to ISO 9001, the organization should have evidence that employees have the
appropriate training and experience by:
1. Writing a procedure that specifies the needs and actions taken for the competence and training
of the employees
2. Train all the employees at least once a year without the need of keeping any records
3. Keeping records showing that the employees really have these competences, such as
certificates, recommendations, proof of attendance at training courses, etc.
, 4. Writing a training plan - CORRECT ANSWER - 3. Keeping records showing that the
employees really have these competences, such as certificates, recommendations, proof of
attendance at training courses, etc.
Methods for quality management awareness-raising include occasional email newsletters,
presentations or short online courses, discussions at meetings, and other events/gatherings. t/f -
CORRECT ANSWER - True
Regarding the communication with internal and external third parties, ISO 9001 requires the
companies to define:
1. The needs for internal and external communication, as well as what should be communicated
and when, by and with whom it will be communicated
2. A formal format to communicate that fulfills ISO 9001 requirements
3. A mandatory procedure for communication with third parties
4. Specific quality objectives related to communication with third parties - CORRECT
ANSWER - 1. The needs for internal and external communication, as well as what should
be communicated and when, by and with whom it will be communicated
Documented information from internal and external origins should be protected if it is relevant
for the QMS. t/f - CORRECT ANSWER - True
The organization should follow the criteria established by ISO 9001 to determine the significant
risks. t/f - CORRECT ANSWER - False.
ISO 9001 does not provide any criteria to determine the significant risks of an organization.
Validation activities are always conducted, even in situations when the conformity of the product
can be verified after production. t/f - CORRECT ANSWER - False.
Validation activities are conducted in situations when the conformity of the product cannot be
verified after production