ISO 9001:2015 Awareness

"The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system." Which of the following is true about this statement?

• It is a requirement

• It is a recommendation

• It is a suggestion

• None of the above

ISO 9001 requires that organizations conduct internal audits at planned intervals. What intervals are recommended?

• Every 6 months

• Once a year

• Every 3-4 months

• The Standard does not recommended a specific interval

The organization shall conduct the Management Review at least twice a year.

• True

• False

Extent and boundaries of an audit are defined as

• Audit scope

• Audit criteria

• Audit evidence

• Audit schedule

Which of the following DOES NOT comply with the good storage requirements?

• Store on pallet or racking

• Mixed raw materials and finished product as long as all items are packed properly

• Label raw material

• Store room is clean and well ventilated

Auditor shall not audit their own works or area of responsibilities.

• True

• False

Which of the following tools can best be used to visually represent the interrelationship of processes?

• Work Instructions

• SOP

• Procedures

• Business process mapping

P-D-C-A stands for

• Plan-Do-check-Act

• Plan-Do-correct-Act

• Proceed-Do-check-Act

• Proceed-Do-correct-Act

Clause 4.4 Quality management system and its processes, requires the determination of:

• inputs and outputs of processes

• sequence and interaction of processes

• criteria and methods needed to control processes

• resources needed

• All of the above.

Clause 7.1 Resources, requires the determination of following resources.

• People, Infrastructure, Environment for operation, monitoring and measuring resources, and organization knowledge.

• People and infrastructure needed only.

• Infrastructure and knowledge only.