Topic 2 - QSS

Framework for QMS involves fulfilling the requirements in managing risk and opportunity, action plans in achieving quality objective and managing the changes is the intent referring to:

• Clause 8 Operation

• Clause 6 Planning

• Clause 4 Context of the organisation

• Clause 7 Support

Meaningful data that is required to be controlled and maintained by an organisation through a selected medium is definition for:

• Documented information

• Interested parties

• Top management

• Risks

Characteristics of persons having an impact on an object under consideration is definition of:

• Context of the organisation

• External providers

• Top management

• Human factors

Below are the example of external issues, EXCEPT:

• Political

• Financial

• Economy

• Legal

Below are the example of internal issues, EXCEPT:

• Competency

• Social

• Operation

• Infarstructure

The scope should be established based on:

• Products and services provided by the organisation

• Requirements of top management

• Availability of documented information

• Internal issues only

_______________________ provides an overall sense of direction to the business. It consists of statements of the organisation regarding its intentions in relation to its quality performance.

• Manual Quality

• Quality objective

• Quality policy

• Management review meeting

Top management will need to establish specific Responsibilities and authorities for the roles and ensure that employees in the organisation understand and are aware of their assignments through effective communication activities is refer to :

• Clause 5.1

• Clause 4.4

• Clause 4.1

• Clause 5.3

The purpose of planning for change is:

• Assist in the cancellation or postponement of a service

• To ensure that the organisation has the ability to continue to provide conforming products and services during the change

• Help to avoid negative consequences such as rework

• Result in positive consequences such as the reduction of nonconforming outputs or reduced incidents of human error

To ensure that the organisation has the facilities, equipment and services needed to consistently provide conforming products and services to its customers, is refer to:

• Clause 6.2

• Clause 7.1.2

• Clause 7.1.3

• Clause 6.3