James O. Westgard, Ph. Our intention is to show that, when you understand the concepts behind this system, it becomes very clear how it can be applied to the clinical laboratory. We will also take you through the basic principles stated in ISO standards that, when implemented and maintained in a QMS, will help our clinical laboratories to meet the objectives of continual quality improvement and patient satisfaction. The ISO series is a collection of good management practices related to quality systems and composed of generic and specific standards.
In the case of clinical laboratories, many of these requirements are specified by customers and organizations must be able to achieve them. ISO is part of this series and is the standard applicable for certifying quality management systems. The version of the standard was originally divided in three guidelines:. According to the scope of certification, the organization could decide which standard should be implemented.
However, at the same time ISO was adopted by many companies worldwide, it also received many criticisms: it was too bureaucratic, too operational, departments-focused, without a systemic approach…The concept of quality assurance stated by the ISO in fact made it distant from management and closer to operational control.
It presents requirements to the implementation of quality management systems. A Management system is the set of interrelated or interacting elements that allow an organization to establish policies and objectives and to achieve those objectives.
The coordinated activities to direct and control an organization with regard to quality are what we call a Quality Management System QMS. These principles are presented in the standard as general topics, divided in subtopics. Requirements are presented from items 4 to 8, as shown in the table below:. The organization shall identify critical processes and elaborate controlled procedures, including a quality manual.
Status : Withdrawn. Publication date : Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks.
Close of voting. Proof returned by secretariat. In a business, ISO requires that individuals receive training to learn, understand, and be able to audit the standard. Certification can be done online with an easy-to-use training course. Using the link above, you can find training courses for both implementation and auditing, and complete ISO training online for free.
After completing the training courses, you can choose whether to go for the exam and pay for the certification. Advisera online certification is very reasonably priced compared to the costs of in-classroom training, and the travel costs associated with it.
As indicated above, the training videos can be viewed for free, and if you wish to purchase the certificate the prices for these ISO training courses are in the list as follows:. If you are going to work as an auditor for a certification body, being certified as an ISO lead auditor is mandatory; but, is it worthwhile for the other accreditations?
An important part of the ISO QMS is to identify the competence required of employees, and to ensure that they obtain this competence. By being certified, it is easy to show that these competence requirements are met — not only for yourself, but also for any customer, certification bodies auditors, or other interested parties that may need proof that you know what you are doing in your QMS. Along with other training organizations, Advisera issues the ISO certificate to students who pass the exam.
For the ISO Foundations, Internal Auditor, and Lead Auditor training courses, these certificates are accredited by Exemplar Global , which ensures the certificates are accepted worldwide. To find out how to get certified as an ISO lead auditor , see this article.
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