When you are first advised about the impending audit, ask the certification body for full details about the proposed auditors - who they are, whom they work for, their qualifications and suitability for the audit. Communicate this information to your senior and middle managers for their comments. (They may know something that you don't!) If any potential conflict of interest is identified, raise this immediately with the certification body.
Do a thorough document and process review to ensure that your system addresses all of the relevant requirements of the standard. Ensure that all the relevant documentation is controlled, up-to-date, and accessible to the people who use it.
Check the status of your internal audit programme. Arrange internal audits of the more important procedures and processes. Commence corrective action on any non-conformities discovered.
Arrange audits of all important management systems and technical records. Ensure that these are up-to-date, complete and readily accessible.
Advise all of your people of the impending audit. Brief them on how it will be conducted and what will be expected of them by the auditors. Brief them on how to respond to the auditors. Assure them of your total support and encourage them to approach the audit confidently.
Ensure that they are familiar with the documentation and records that relate to their activities, and that they can readily access these.
Ensure that you and your 'quality related' managers are thoroughly familiar with the requirements of the standard. You should all aim to know the standard as well as the auditors do!
Think ahead about what will be needed by the audit team:
Provide the audit team leader with clear directions on how to get to the organization, where to go when they arrive, and how to make contact with you. If the auditors will be travelling by car, do what you can to provide them with parking. If they are flying in from another city or country, offer to collect them at the airport.
Alert the audit team leader to any special site entry requirements, and be ready to provide the team with any personal protective equipment needed during their visit.
Set aside an office for their exclusive use as a team room for the duration of their visit.
Make arrangements to provide the auditors with a light on-site lunch (if this is acceptable in the culture and permitted by the certification body). Also make arrangements to provide refreshments (tea/coffee/water) during the opening meeting and the auditors' final team meeting.
Arrange for a room to be available for the opening and closing meetings with sufficient seating for everyone likely to be in attendance.
A day or two before the audit, tidy up the workplace areas but do not overdo it - it should look like a working organization. During this time, again reassure your people of your full support, respond to any concerns they have, and make certain that they are ready. (Spread the word: 'If there are deficiencies in our system, it's better for the auditors to find them rather than our customers!')
The key issue will be the relationship that you establish with the auditors:
As far as possible, maintain normal work patterns, but remove any avoidable distractions.
Provide senior people as guides for members of the audit team. Ensure that the guides understand that their role will be to facilitate the audit, not dominate it. They will be observers of what the auditors are discovering, and they should take detailed notes of the auditors' findings. They should periodically report to you on the progress of the audit, and immediately alert you if anything serious develops.
Approach the audit as a co-operative venture, not a confrontation. Treat the auditors with respect, but not with subservience. Avoid arguments and confrontation. Do not try any tricks, such as wasting time or distracting the auditors.
Maintain the relationship that you have established earlier.
Remember that the audit is an opportunity to inject fresh ideas into your organization. Be receptive to any ideas or suggestions that the auditors offer for improving your system or processes.
Listen non-defensively to any concerns that the auditors raise. Discuss the issues calmly and objectively. Ask the auditors to provide details of the evidence on which they are basing their findings, and exercise your right to respond to their concerns.
If you disagree with a finding, don't argue with the auditors - ask them to relate the issue back to the relevant requirement in the standard. If the auditors are merely expressing vague concerns, ask them to crystallize these concerns ('What exactly are you concerned about?' ). Remember that findings of an audit should be based on the requirements of the standard, not the personal opinion of an auditor.
Before the audit team leaves the organization, ensure that there is a common understanding between yourselves and the auditors on which items will be reported as mandatory actions and those that are merely recommendations or suggestions.
Don't ever try to falsify your records in the hope of covering up deficiencies. Experienced auditors are not easily fooled, and the consequences of detection will be disastrous to the whole outcome of the audit.
Believe it or not, an audit can be just as stressful and mentally demanding for the auditors as it is for the auditees. Everything, therefore, that you do to prepare your organization for the audit and anticipate the needs of the auditors will be appreciated by them and will reflect positively on their impression of your management skills.
Some of these suggestions relate directly to the technical preparedness of your system. Others are concerned with establishing the right relationship between yourselves and the auditors. Still others are simply matters of professional courtesy and common sense. All of them, however, reflect a professional approach that should go quite some way to achieving the best possible outcome to the audit of your QMS.
About the author
Ivan Waples recently retired after 27 years with the National Association
of Testing Authorities Australia (NATA). During this time, he participated
in nearly 500 laboratory assessments and ISO 9000 audits. At the time
of his retirement, he was an IRCA-registered lead auditor and the
principal presenter of NATA's QMS lead auditor training course.
Although now officially retired, he is still actively conducting training
courses in assessments of laboratories and audits of management systems.
He can be contacted at ivanwaples@iprimus.com.au