We determine the products and/or services that they make or provide and assist them in writing a Quality policy, which states the aims of the organization. Quality objectives are determined. These are the measurable business and quality goals that implement the Quality policy against which we will measure performance.
Then we assist the organization in documenting, in a series of procedures, their quality processes: those processes that need to be performing consistently in order to produce their product(s). These processes also include requirements of the standard, such as management's responsibilities, what the organization wants to monitor and measure to ensure the achievement of the goals, how they will handle the internal auditing function and what they will do with product/service that isn't 'perfect' (called non-conforming product), and how they will perform corrective and preventive actions so that a problem, or a mistake never happens twice. This is one of the ways that the quality management system brings about continual improvement.
Work instructions and/or standard operating procedures may be required for an organization if the lack of instructions may result in a problem. So, we determine with the implementation team whether or not work instructions are needed.
If any forms are used in the business, they must also be included in the documented system so that they are also controlled. This is to prevent inadvertent use of obsolete forms (a problem in the governmental and healthcare areas).
Next, we perform a GAP Analysis, to ascertain if there are any gaps between this quality management system and the standard's requirements. When all the loops are closed, the gaps filled, we train the workforce in their roles and responsibilities and train an internal audit team.
The internal audit team then begins their auditing function, to make sure that we are doing what we say we are doing in our procedures, and to find opportunities for improvement.
At this point, the quality management system is in operation. To be certified means that a third party Registrar audits the operation in relation to the requirements of the standard. If the organization is meeting the criteria of the standard, they receive ISO 9001:2000 Certification. The Registrar provides ongoing surveillance to ensure that the system is continuing to perform. It is the way the marketplace is assured that product produced by this business will consistently conform to the requirements of the customer.
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