ISO 9001 Lead Auditor Training

Module 6 Conducting On-site Activities 

6.1.5.7 Audit Team Meeting
An audit team meeting should be held after the auditing process completes so the team leader can plan the closing meeting in detail, and ensure the team knows what is going to be presented to the organization in the way of nonconformities and a summary.

The team leader chairs the audit team meeting and has some points that must be covered:
a) To complete the recording of all nonconformities with supporting audit evidence
b) To review the audit findings, and any other appropriate information collected during the audit, against the audit objectives
c) To agree on the audit conclusions, taking into account the uncertainty inherent in the audit process
d) To prepare the Audit Summary Report
e) To prepare recommendations, if specified by the audit objectives and
f) To discuss audit follow-up, if included in the audit plan

ISO 9001 Auditor Training - The team meeting needs to be at least an hour before the closing meeting, or less if some of the work has already been previously completed (for example, the night before).

Some auditors try to “squeeze in” a bit more auditing at this point. The law of diminishing returns applies and very little will be gained by trying to rush through some more auditing.

There is no set rule about who presents the information. The team leader may present everything all nonconformities and the summary or the team members may be asked to present the nonconformities they found. The review of nonconformities is important and members should be rigorous in their review of one another's statements. Are all the facts there? Is it clear it is a nonconformity? Can it be read easily? Is it grammatically correct?

As a result of the “review team” findings, the team leader prepares an audit summary. This summary reflects the degree to which a company is conforming to its own documented quality management system and the ISO 9001 standard.
As a suggestion, a team leader should answer three questions asked about the quality management system in any audit:

1. Is there a documented (and defined) system addressing the clauses of ISO 9001?
- to what extent? (audit of documentation)
2. Has this documented system been put into practice?
- to what extent? (audit of implementation)
3. Is the quality management system achieving objectives?
- to what extent? (audit of effectiveness).
- Are nonconformities being prevented by the existing controls?
To answer these questions, the nonconformities raised will give some guidance.
Further questions may be answered by the summary:
4. Do the nonconformities indicate weakness in any particular department, process or, ISO 9001 clause within the audit scope?
5. Do the nonconformities indicate weakness in any particular part of the QMS?

ISO 9000 Training - The team leader also prepares an agenda for the closing meeting and arranges, either through a team member or a guide, for copies of all nonconformities to be passed over to the company's management at the appropriate time. It is ideal, but no means possible on every audit, for the team leader to organize the seating arrangements for the closing meeting. This is not for any underhand reason, but they should try to ensure that the arrangements suit the purpose and no one is in an awkward position. Often, the closing meeting is in the very room the auditors used for their team meeting.

6.1.5.8 Audit Conclusions – QMS Effectiveness
As the audit comes towards the end, the auditors should be gradually building up a picture of the organization’s QMS strengths and weaknesses. This is the composite picture the auditors are required to present at the closing meeting and in their written report.

The team leader has the responsibility for generating this composite picture as their audit conclusion of the degree to which working systems conform to stated requirements and objectives (and the Standard), after consideration of all audit findings. This information comes from the findings during the audit, but it is necessary to “sort” this so that a reasonable conclusion can be reached (assuming nonconformities have been found):

• number of major nonconformities raised
• number of nonconformities raised during the audit of defined processes and documentation (intent)
• number of nonconformities raised during the audit of implementation (practices)
• number of nonconformities related to the effectiveness of the system
• number of nonconformities raised against each clause of the Standard
• number of nonconformities in each department or area of responsibility
• The capability of the management review process to ensure the continuing suitability, adequacy, effectiveness and improvement of the management system

ISO 9001 Auditor Training - Based on this, a picture emerges of the kinds of failure found, relative frequency, where found in the company, and the quality management system requirement (clause of the standard) that is weakest. However, this is not the only information the auditor should be considering. A further picture can emerge from examining the following:

Internal failures How many modifications to drawings, specifications, or purchase orders were made that should have been avoided? How much avoidable product scrap, rework, and concessions or waivers occur?

External failures How often do customers complain and/or return product? Is there a large Returns department?

Past Audits Have recent internal and external audits established many nonconformities?

Trends Do they consider any or all the above in reviews to establish how their quality management system should be changed to prevent such events in the future? Is the number of nonconformities rising, static, or falling?

Corrective action Has there been any evidence to show that a strong and consistently effective system operates to correct things that are wrong and monitor it to ensure it stays that way? What techniques are used to establish the causes? Are they shown to work?

Management attitude Does top management know the results of audits, the level of product defects, and the cost of poor quality? Are they involved rather than only stated to be committed? What evidence is there, if any, that top management takes an interest in the quality management system? Are they proud of their system?

Staff attitude to management Are the employees positive about their management? Is there an open or closed-door style? Did the management representative have easy access to various managers during the audit? Does the staff have to “dress up” nonconformities for presentation to management? If auditors find information that indicates a distinct lack of management support for the system, then they should say so in their report. Their task is to collate the evidence as fairly and objectively as they can and highlight areas of the greatest risk and least assurance.

As usual, there is no substitute for experience, and even experienced team leaders are very careful about their conclusions, and about the way they present them. 

If you are interested in taking formal accredited ISO 9001 Lead Auditor training, call me at 905-593-8867 or email me at artjlewis@rogers  to get details of the scheduled dates, locations and cost for the best recognized training course providers. Another option would be to contact some of the training providers listed on this page and see if they offer the accredited ISO 9000 lead auditor course at a time and place you prefer.

Related ISO Lead Auditor Training Resources:

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

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