Meeting

Frequently Asked Questions

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More questions? E-mail dardenne@usit.net. We'll e-mail you the answer to your question, and post new questions here.

1. How long does it take to get certified?

It depends on two things:
  1. Your objectives for the Quality Management System. If you want the certificate, it will take a lot less time to obtain it than if you want the employees to buy in to the QMS so you develop a much stronger company in the long run.
  2. Where your company presently is vs. where it needs to be to meet the requirements of the standard. A well disciplined company that needs to add only a few procedures can be certified in six months, or less. A company starting from scratch that wants to establish an effective QMS, which includes employee buy-in will take 18-24 months. Other companies will take somewhere in between. In any case, the full support of executive management is a must to be successful. A three month history of your system working that includes a complete round of internal audits, CA/PA process, and management review is required.

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2. What is the cost to get certified?

This will vary greatly depending on the size of your company, the pre-ISO items you already have in place, the resources you have available, and the registrar you select. A good Baseline Analysis will determine this for you.

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3. Do we have to calibrate every instrument?

No, only those that are used to determine whether the quality of the product being produced meets the customer's specifications. However, personally owned equipment is included.

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4. How long do we have to keep our records?

This is determined by the organization (you). Typically, input is obtained from legal counsel. They need to be kept long enough to ensure that the customer's and statutory/regulatory requirements are being met.

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5. Do auditors have access to all records?

Generally, financial and personnel records are excluded- Training records, however, are included.

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6. Is it really necessary to do a Baseline Analysis?

A good Baseline analysis is highly recommended. It will focus your efforts, save a lot of time, and reduce system installation costs.

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7. What will my third party certification auditor expect to see to be able to recommend that my system be transitioned to ISO 9001:2008?

Typically your Third Party Auditor will determine whether the client has:
  • purchased a copy of the new standard
  • revised the Quality Manual
  • identified any needed changes
  • trained appropriate personnel
  • implemented any needed changes
  • audited the changes
  • conducted a Management Review of the changes

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