Clause 9 : "performance evaluation"

Question 1

Before the performance evaluation the organization shall determine:

Answer 1

• what needs to be monitored and measured;
• the methods for monitoring, measurement, analysis
  and evaluation;
• when the monitoring and measuring shall be performed;
• when the results of monitoring and measurement shall be analyzed and evaluated

Question 2

What shall the organization evaluate and retain?

Answer 2

The organization shall evaluate
- the performance and
- the effectiveness
of the quality management system.
The organization shall retain appropriate documented information as evidence of the results.

Question 3

What to monitor and determine when looking at customer satisfaction?

Answer 3

The organization shall monitor
- the customers‘ perception
- of the degree to which their
- needs and expectations have been fulfilled.
The organization shall determine n the methods for obtaining, monitoring and reviewing this information.

Question 4

What shall and organization evaluate?

Answer 4

The organization shall analyze and evaluate appropriate data and information, arising from monitoring and measurement.

Question 5

What can you evaluate with the results of the analysis?

Answer 5

The results of the analysis shall be used to evaluate:
- conformity of products and services;
- the degree of customer satisfaction;
- the performance and effectiveness of the quality management system;
- if planning has been implemented effectively;
- effectiveness of actions taken to address risks and
opportunities;
- the performance of external providers;
- the need for improvements to the quality management system.

Question 6

Why do you need an internal audit?

Answer 6

The organization shall conduct internal audits n at planned intervals to provide information on whether the quality management system conforms to

• the organization‘s own requirements for its quality management system;
• and the requirements of this International Standard.

Question 7

When planning an internal audit what shall be considered?

Answer 7

In doing so, it shall be considered: frequency of audits, methods, responsibilities, planning requirements and n reporting, which is dependent on:

• the importance of the processes concerned,
• changes affecting the organization and
• the results of previous audits.

Question 8

Why shall an internal audit be documented?

Answer 8

Documented information shall be retained

- as evidence of the implementation of the audit program - and the audit results.

Question 9

What shall the top management do?

Answer 9

Top management shall

• review the organization‘s quality management system,
• at planned intervals,
• to ensure its continuing suitability,
• adequacy and
• effectiveness and
• alignment with the strategic direction of the organization.

Question 10

what shall be considered when planning the management review?

Answer 10

The management review shall be planned and carried out, taking into consideration the following aspects (inputs):
- status of the actions from previous management
reviews;
- Changes in external and internal issues that are
relevant to the quality management system;

Question 11

What are the trends in the QMS?

Answer 11

• customer satisfaction and feedback from relevant
  interested parties;
• the extent to which quality objectives have been met;
• process performance and conformity of products and services;
• nonconformities and corrective actions;
• monitoring and measurement results;
• audit results;
• the performance of external providers

Question 12

What shall the output of the management review include?

Answer 12

The outputs of the management review shall include
decisions and actions related to:
- opportunities for improvement,
- any need for changes to the quality management system,
- resource needs.
Documented information shall be retained as evidence of the results of the management review.