How to prepare for an ISO 9001 audit ?

ISO 9001 Audit

Being audited is daunting enough for a business that has all its systems in place, no paper trails, and no worries about the quality of its products and services. In short, a business that has already attained the highest standards of ISO 9001 certification is an ideal candidate for the standard’s third-party external audit process. For others, however, the prospect of an audit is nothing less than a nightmare.

Leading practitioners of the standard have their own ways of approaching an audit. A service company will probably be approached by its client’s customers to conduct the audit. The company will organize the audit according to its internal procedures, which it may well impose on its clients as part of their contractual commitments. In this way, it can maintain control over the process and keep up its reputation for quality and integrity. The company will also probably insist that its staff conduct the audit.

An inspection company will probably do exactly what its name suggests: it will organize an independent inspection of your premises and operations. The company may well have its own internal procedures, which may be imposed on the companies whose ISO 9001 certification it is inspecting. It too will be eager to maintain a reputation for quality and integrity. It is unlikely to insist that its staff conduct the audit but will opt instead for third parties, whose independence and integrity it can rely on.

A certification company will probably also choose to arrange an independent inspection of your premises and operations. It may well insist that its staff conduct the inspection. It will be equally eager to foster a reputation for quality and integrity.

The size and nature of your business will also influence the type of audit you are offered. A large, multinational company will probably opt for an inspection company’s services; it can expect to receive a full team of independent auditors who will arrive in force, with all the latest gadgets and instruments. A small or medium-sized company, on the other hand, will look for a service company to undertake the audit. It will probably have to settle for less of a show: one or two auditors whose arrival may not be announced.

Audits can be a daunting prospect, especially if you’re not sure what to expect. Luckily, there are some things you can do to prepare and make the experience go as smoothly as possible.

Here are a few tips on how to prepare for an ISO 9001 audit:

1. Know the requirements inside and out. Be familiar with all the requirements of the standard so that you can easily answer any questions that come up during the audit.

2. Understand your organization’s procedures. Know how your organization operates and be able to explain its procedures to the auditor.

3. Be prepared to answer questions about your quality management system. The auditor will want to know how your system works and how it benefits your organization.

4. Be prepared to show evidence. The auditor will likely ask to see examples of your quality management system in action. Be sure to have plenty of documentation on hand to support your claims.

5. Have a positive attitude. Show the auditor that you’re open to feedback and willing to make improvements to your system.

By following these tips, you can ensure that your ISO 9001 audit goes smoothly and that you’re prepared for anything that comes up. With a little bit of preparation, you can make the experience much less stressful and more productive.

The cost of an audit is also likely to vary according to the complexity of your business and the size and status of your organization. A service company may charge some $10,000 for a comprehensive single-point assessment or $15,000 for an internal assessment; a multinational certification body charged up to $200,000 for its latest ISO 9001 Internal Audit Package covering thousands of items spread over dozens of business units worldwide.

After the audit, your business will receive a report and a certificate. Each auditor has his or her own style. Some will be brief, giving you a copy of the report on the spot and handing you your certificate at the end of the meeting; others will want to give you plenty of opportunities to ask questions before issuing both.

One last point: although most auditors are thoroughly familiar with ISO 9001, they may not let on that they are, in case they prejudice you against them. Ask them directly about their knowledge of the standard, or play safe by asking for an ISO 9001 auditor to conduct your audit.