ISO STANDS ISO

As the certification of different organizations became more common, its applicability in services and, more specifically, in clinical laboratories, was finally understood.

ISO STANDS ISO

This is one of the reasons why ISO guidelines had been labeled as вЂњproduct manufacturing standardsвЂќ for a long time. ISO StandardsДЄlthough very well known in manufacturing industries, ISO standards are relatively new in healthcare and service organizations. The ISO 9001 standard, as a Quality Management System, also went through these steps: The old 1994 version (ISO 9001:1994) used a QA-related approach, while its most recent version, the current ISO 9001:2000, has adopted a TQM-related approach. In fact, QC, QA and TQM can be considered evolutionary steps of the Quality concept. It states that the different areas have responsibilities in assuring and maintaining quality as a вЂњwork philosophyвЂќ, a вЂњlife styleвЂќ for business purposes. TQM can be defined as the use of quality concepts in every process of a company. QA, in turn, can be seen as part of a wider system called Total Quality Management (TQM). Understanding Quality Assurance as a major and wide system allows us to see QC вЂ“ and its more specific focus - as part of QA, although the opposite is not true. Specific standards usually divide QA in three phases: pre-analytical (pre-examination procedures), analytical (examination procedures) and post-analytical (post examination procedures). Quality assurance (QA) is a process to aid companies in improving the reliability, quality, and the overall performance of the organizations, helping them to develop a systemic approach of processes and interfaces. QC can be considered part of the operational control of processes, being extremely useful for detecting and correcting real and potential deviations. Quality control (QC), according to the definition from some accrediting bodies, is a process where known samples are tested routinely, in a systematic way, in order to confirm the reliability and precision of analytical procedures. So, for ISO purposes, companies that were found to meet the requirements specified in international standards are called certified, and not accredited, since the certifying company is the one that is supposed to be accredited. The process by which a company is audited by the certifying body is called Certification and compliance is usually demonstrated by written assurances (the certificates). In the ISO system, the independent certifying company is the one that is accredited, meaning that this company must be checked and recognized by other specialized authority bodies in order to be considered capable to certify other companies. Usually, accreditation processes are more focused on the technical aspects of the services provided. It is a means of showing confidence in an organizationвЂ™s performance. Accreditation can be defined as a voluntary process by which organizations are certified by an independent company that they comply with specific requirements. An accredited institution is one that can be believed. The word accredit is related to the same root word as credible, or believable. Some concepts must be clearly understood to gain the proper perspective on the ISO approach: This essay has the intention to present some basic concepts related to ISO System вЂ“ making a clear distinction with accreditation processes - and to clarify the approach for applying ISO standards in clinical laboratories. But what are the differences between these processes? Is laboratory accreditation the same as ISO certification? Are ISO standards really valuable for medical laboratories? One of the most recent ISO publications вЂ“ ISO15189:2003 вЂ“ was developed as a guideline for the implementation of quality systems in medical (clinical) laboratories, complementing the ISO9001:2000 international standard. But the ISO System is catching the attention of more and more labs in the last few years. CAP, JACHO, COLA and other institutions have a very well established know-how in the field. Westgard, Ph.D., FACBДЄccreditation processes are widely known in clinical laboratories and medical services worldwide. About the authors and their institution.A final clarification on our perspective and approach What you can expect (and not expect) from ISO standards and Rogerio Rabelo, MD, FACB, present the basic ideas and concepts of ISO standards and how they apply to the clinical laboratory. What is ISO? What is ISO accreditation? Guest authors Daniel Perigo, R.Ph.

Iso stands