ISO 9001 Lead Auditor Training

MODULE 5  Audit Activities
The extent audit activities are applicable depend on the scope and complexity of the specific audit and intended use of the audit conclusions. The planning and conducting of audit activities involve the following process flow or lifecycle:

5.1 Initiating The Audit
5.1.1 Appointing the audit team leader
5.1.2 Defining audit objectives, scope and criteria
5.1.3 Determining the feasibility of the audit
5.1.4 Selecting the audit team
5.1.5 Establishing initial contact with the auditee
 
5.2 Conduct Document Review
 
5.3 Prepare For On-Site Audit Activities
5.3.1 Determining Audit Strategies
5.3.2 Preparing the audit plan
5.3.3 Assigning work to the audit team
5.3.4 Preparing work documents

5.1 Initiating The Audit
5.1.1 Appointing the audit team leader
ISO 9000 Lead Auditor Training -Those assigned the responsibility for managing the audit program should appoint the audit team leader for the specific audit. Where a joint audit is conducted, agreement should be reached between the audit organizations, before the audit commences on the specific responsibilities of each organization, particularly with regard to the authority of the team leader appointed for the audit.

Registrars have defined rules and guidelines for audit planning derived from Guide 62 and ISO 19011. The leader has responsibility for planning, conducting, and reporting the audit, following these rules and guidelines. The leader is briefed on the objectives and scope of the audit and is then required to specify the resources necessary to carry out the audit, in terms of staff days, and the number of auditors required, including any with special technical expertise.

This latter point about technical expertise merits some discussion. There are some schools of thought that say that an auditor does not need technical knowledge of the area they have to audit. The auditor needs knowledge of quality management systems and the Standard. This is, of course, partly true. However, auditors will be required to use all applicable senses during an audit. Familiarity with the kinds of processes going on around the audit will allow auditors to determine conformity, or otherwise, quicker and with probably less doubt, than if they have little experience of that industry.

ISO 9000 Training - With lack of knowledge or experience, it will take auditors longer to reach the same decision based on the same evidence than it would take an experienced auditor. The team leader may be chosen on the basis of particular experience or it may be decided to include a member in the team who has particular expertise.

5.1.2 Defining Audit Objectives, Scope And Criteria
Within the overall objectives of the audit program, an individual audit should be based on documented objectives, scope and criteria. The audit objectives define what is to be accomplished by the audit and may include the following:
a) Determining degree of conformity of the QMS, or parts of it with audit criteria
b) Evaluating the capability of the QMS to ensure compliance with statutory, regulatory and contractual requirements
c) Evaluating effectiveness of the QMS in meeting specified objectives
d) Identifying areas for potential improvement of the QMS

ISO 9000 Auditor Training The objectives can be many and diverse, but it is essential to be clear on the objectives at the beginning of the audit process. The client should define audit objectives.

The audit scope describes the extent and boundaries of the audit, such as:
• Applicable requirements of ISO 9001
• Physical locations - facilities, plants, offices
• Organizational activities - products, processes, departments, functions
• Date the quality management system was formally in effect

The Client initiates the audit (2nd and 3rd party) and decides the scope with help from the Lead Auditor. The Auditee may be contacted, if necessary. The Client, with help of the Lead Auditor, must determine what resources are needed and ensure that adequate resources are provided to achieve the objectives for the scope of the audit.
The client decides the frequency. Remember the client may be the auditee, customer, or registrar or regulatory body.

The audit criteria are used as a reference against which conformity is determined and may include:
• Applicable policies and procedures
• Standards, laws and regulations
• ISO 9001 and organization management system requirements
• Industry requirements
• Business sector codes of conduct

The audit scope and criteria should be defined between the audit client and the audit team leader in accordance with audit program procedures. The same parties should agree to any changes to the audit objectives, scope or criteria.
Where a combined audit is to be conducted, the audit team leader should ensure that the audit objectives, scope and criteria are appropriate to the nature of the combined audit.

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.