QMS ISO 9001:2015 INTERNAL AUDITORS REFRESHER COURSE

Planning for a QMS audit requires:

An audit plan is:

All of the following are the definition of an Audit Client expect

The primary purpose of an opening meeting is to

The following are all part of the Auditors responsibility during an Audit process except

Conducting an audit can accomplish all of the following EXCEPT

Internal audits are used to verify that:

The output from management reviews of a QMS based on ISO 9001 should lead to decisions or actions
related to:

The number of auditors assigned to an audit and their related experience and qualifications should be
dependent on:

In which of the following phases will an Auditor agree corrective action with the Auditee?

The following questions are designed to enhance your understanding and application of ISO 9001:2015
Standard and to aid you in becoming an effective and efficient auditor. Answer to the best of your
knowledge:

Question:

ISO 9001:2015 is based on some Management principles. List them

An audit cycle is completed only after an audit process goes through a number of phases. State these
phases.

List and briefly explain the three audit types in the Management System Auditing

List the Auditing principles governing Auditors during the conduct of Management Systems audits.

Clearly outline the steps that an auditee organization may take in responding effectively to corrective actions on nonconformities raised during a third party QMS audit according to ISO 9001:2015. State the relevant clauses

Instruction:

Identify any nonconformance for each case below. If there is a nonconformance, using the format below determine the root causes of the NCs you have identified, the corrective actions to be taken to prevent a future re-occurrence and the applicable ISO 9001:2015 clause (20MKS)

Question

The Risk register captured the Business process risks across various departments; however, it was observed that Production and IT departments did not have treatment plans on how these risks are evaluated. Also no evidence to show that the risks have been reviewed since the past 12 months as required by the Risk procedure- QSP/RM/04

A copy of ISO 9001:2015 awareness slides was found in the HR and Admin Department. The department had carried out regular training in ISO documentation and audit for workers. However only the training records were maintained in the staff files.

The Business Development Manager claimed that he did not need to record any customer order as he can remember well all the customer orders. Therefore, he dismissed the need for a written record for contract review and did not provide the Auditors any evidence to customer order and/or customer requirements reviews

Management Review Meeting is required to be conducted once every 12 months. When asked, the auditee replied that the review was not carried out for the past 18 months due to company expansion and able to produce record on good customer service. In addition, a nonformal management review was carried out verbally 6 months ago and no records was maintained due to ongoing expansion and restructuring

The Store Manager claimed that there is no need to label the materials and their batch number in the store as the store keeper knows how to identify them, since he is responsible for the storage and arrangement of all the raw materials and goods in the store. Two items were also found at outgoing store has no identification of inspection being carried out.