ISO 9001 Awareness

What is ISO Quality Audit?

• Audit the Quality Manual, Standard Operating Procedures

• Audit the Quality Management System

• Audit the quality of the products and services

• Audit the quality of the organisation and people

• All of above

Quality System noncompliance (e.g. detected during internal audits)

• Supplier Product Inspection

• Supplier Product Inspection

• Customer complaint

• Serious and/or recurring non-conforming product or service

• All of above

What is the new emphasis in the latest version of ISO9001:2015?

• System approach

• Process approach

• Risk-based thinking

• Preventive action

• Customer Focus

Risks and Opportunities can be derived from

• The needs and expectation of the interested parties of an organisation

• External issues of an organisation

• Process within an organisation

• Internal issue of an organisation

• All of above

Documented information can include..

• Market Survey

• Job Description

• Financial Reports

• Company Profile

Who are the potential Auditees to be audited in QMS regarding material quality?

• Suppliers

• Workers

• Managers

• Top management

Which one is NOT TRUE about risk assessment process?

• Risk Assessment required in ISO9001:2015

• Risk Assessment required in ISO9001:2008

• Risk Assessment to be conducted at process Level

• Risk Assessment to be conducted at company Level

Which one is NOT TRUE on infrastructure?

• Audit on Infrastructure shall be performed at the process level

• Audit on Infrastructure shall be performed at the company level

• Infrastructure includes computer software and hardware and networking system

• Infrastructure includes Process Equipment, Building, and associated M&E infrastructure, Logistic and telecommunication system

Monitoring of performance can be included the following, EXCEPTED for..

• Customer Satisfaction Survey

• Customer Complaint

• Progress of Risk Control

• Supplier internal audit result

• Internal failed rate

One of the below statement is TRUE about the management review process.

• The assigned Manager shall ensure the management review is to be conducted as per schedule

• The organization shall conduct meetings to review the QMS to demonstrate conformity.

• Management review is completed when the decision is made on the input of the review item

• QMS and operation are discussed in separate issues.