What’s a Pre-assessment?

Andy Nichols

As the East Coast Regional Sales Manager for NQA, USA I’m frequently asked, by new clients to the ISO Registration process, what a “pre-assessment” is and what value it brings to an organization seeking ISO registration.

A pre-assessment or preliminary assessment is offered by NQA as a service in addition to the regular ‘Stage 1’ and ‘Stage 2’ audits of the actual Management System Registration process. It’s usually conducted by the same auditor that will perform the registration audit.

It’s recognized that a lot of work has gone into designing and developing a Management System which meets the various requirements of a standard like ISO 9001, ISO 13485, ISO/TS 16949 and ISO 14001. In many instances, the implementation of a Management System is a new venture for an organization and there is, naturally, some trepidation inside that organization as the Registration Audit approaches. There may be questions that cannot be satisfactorily answered by the people themselves; have we done enough to satisfy the requirements? Will this be enough to pass the audit? What will the auditor think of this? A pre-assessment is an opportunity to answer these.

In many ways, all the practice and preparation leading up to a Registration Audit is like the practice and development we – or our children - have gone through when learning to dance, or play an instrument etc. There comes a time when those skills and what’s been learned must be demonstrated, often in front of somebody! Maybe, a recital or a show of some kind is planned. In the days before that recital or show, it’s quite normal to go through a ‘dress rehearsal’, where the final touches are put to the performance. It’s not meant to be identifying anything really radically different, just putting a ‘polish’ on the overall performance; knowing where each person must stand on the stage, timing the lighting cues, last minute costume fixes etc.

Your organization can use a pre-assessment in the same way as a dress rehearsal for your Registration Audit. Unlike the ‘Stage 1’ and ‘Stage 2’ audits, there is no defined duration for the assessment, so you can choose how long you think you need. What’s more, as the customer, you get to decide what you want the auditor to review during the visit. The agenda is yours to define! An organization may decide to have the auditor focus on a few aspects, or take a sweep of the entire Management System. In selecting a smaller focus, customers often are interested in those aspects of the Management System which may be new to the organization, e.g. a calibration system, where none was formally defined or implemented before. Often a broad view of the status of the system as a whole can validate for the management team that their efforts are, indeed, ready to undergo the more detailed scrutiny of the Registration Audit.

Other benefits include:

• Observing how the assigned NQA auditor goes about performing the audit;
• Although the organization will have conducted internal audits, it’s always good to know how the NQA auditor does things.
• How they interact with the various people they interview;
• Each NQA auditor is different and they have ways of establishing good communications with the people they interact with. It helps to ‘break the ice’ if you know this ahead of time.
• Allowing the various people of the organization to experience their role as auditees;
• As before, although internal audits will have been performed, not everyone will have had a role in those. Some people might be natural candidates to be audited by the NQA auditor and it’s a great time to give them that experience
• Uncovering a potential weakness in the system before the ‘Stage 2’ audit is very useful, of course;
• The auditor who did the pre-assessment will be very aware the actions you took to rectify the situation found, which also builds confidence in the commitment to an effective system.
• The pre-assessment can be timed with the ‘Stage 1’ audit.
• This allows for some continuity of understanding for the auditor since they will have been able to study your system documentation and, while that knowledge is still ‘fresh’ take a look at aspects of the implementation too. It also helps to cut down on your expenses!
• The results of the pre-assessment can be a useful input to the ‘Management Review’ as a formal indicator of the ‘suitability and effectiveness’ of the Management System, in the days leading up to the Registration Audit.

One word of clarification: When an organization starts out on the road of implementing a Management System to meet an ISO based standard, it’s often useful to perform a ‘Gap Assessment’. This shouldn’t be confused with the pre-assessment described above. The timing, objective and outcomes are completely different.

In conclusion, if you intend to register your Management System, the management of your organization should fully weigh the benefits of having a pre-assessment performed. Just like a dress rehearsal, it doesn’t matter if it’s the local high school or the New York Symphony, they wouldn’t consider putting on a show without doing one!