I need some help with my existing ISO system!

Some ISO management systems were designed in the “Dilbert Style”– “Honking great binders that nobody read and were off-loaded to the nearest passer-by.” These systems were often compliant but often overly documented, overly bureaucratic, and not well focused on the needs of the business. If your system suffers
from these symptoms, it's time to overhaul it!

Alternatively your system is perfect, and you need some external resources to keep things going.

Either way, we can help!

Upgrade to 2000 – The new version of ISO 9001:2000 is not new to us. We have always used a process approach in the development and documentation of processes. Additionally, we are members of the ISO technical committees and have been giving training classes since the beginning of 1999 on the 2000 version of the standard (Yes that's 2 full years before it was published!). The standard only requires procedures for 6 of its sections; although, we would rarely recommend this – documents are the best way for processes to be defined as management wants them communicated to allow auditing. The key is to make them efficient and keep the business focused. Read more about the new standard. We can help you optimize your system. We can help with training, documentation, gap analysis, or full service consulting.

More Info on Upgrading to 2000

Document Review – Has it been a while since anyone audited your procedures objectively? Your registrar hasn’t done it since the registration audit and that’s if they even read it then!

More Info on Document Review

Pre-Assessment – How about a full blown, independent, professional audit by qualified lead auditors – better yet, because they are not your own auditors, they can offer advice. Think about that - objective and subjective advice!

More Info on Pre-Assessment

Internal Auditing – if you are too busy to conduct your own internal audits, if you find them time consuming and wasteful, or if your auditors all left the company – we can help! We are professional auditors and consultants. We will be objective in ensuring your conformance to the standard, but as consultants we may just have lots of good ideas to simplify your system and improve your processes.

Training – We can conduct a variety of training to bring your organization up to date with the latest ISO management system thinking or to simply hone your skill. Public courses or in-house, customized to your needs and specifically designed for your organization.

More Info on Training

Temporary or Contract Quality Manager – Do you need short term help, or do you simply not have the resources to hire full-time staff to operate your quality system. We can step in and complete all of the tasks necessary for you to maintain your registration; including document control, internal auditing, nonconformance and corrective action reporting, management review meetings, interface with the registrar, analysis, and improvement of your system. How about a single day a month? Whatever you need.

Authorized Representative – Are you a medical device manufacturer? Do you manufacture Class 1 Medical devices for sale in Europe? If so, we have an office in Europe and can provide you with the services of an Authorized European Representative. Perhaps we can do it cheaper than your Lawyer, and we are certainly more independent than your distributor. Email us with information about your product range and we’ll provide you with a quote.

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