Adoption of Voluntary standards should be a business decision with a cohesive business cost-benefit plan. Can we afford to adopt the standard? Can we afford to maintain the standard? Will the standard pay for itself over time? Perform a Gap Analysis 3. Perform a Gap Analysis W. Prepare the Laboratory 4. Prepare the Laboratory Organizational Culture 1.
A measurable pattern of such collective behaviors and assumptions that people share within an organization. The meanings that the people attach to their actions 3.
Organization values, visions, norms, working language, systems, symbols, beliefs and habits. Organizational culture affects the way people and groups interact with each other, with clients, and with stakeholders. The pattern of behaviours and values that are taught to new organization members. Prepare the Laboratory As you go through the process of preparation consider: 1. If you are running a successful laboratory, you likely only need fine tuning rather than an overhaul.
Develop an Implementation Plan There are a number of laboratory domains that will likely need revisions: 1. Policies, Mission, Vision 2. Quality Indicators Measurement tools 3. Document Creation and Document Control 4. Supply Management 5. Physical Plant 6.
Equipment 7. Quality Control routines including Measurement Uncertainty 8. Personnel training and competencies 9. Proficiency testing Management Review Steps to Adoption 5. Develop an implementation plan 5. Start with the Major Deficiencies on the Gap Analysis. Determine your state of readiness What is a Gap Analysis? When is your laboratory Ready for Quality? On a process level Going to full accreditation mode is not a major or immediate priority.
Steps to Adoption 8. Make the Accreditation decision 8. Do you want Quality or Accreditation or Both? Laboratory Accreditation can be a valuable asset but is NOT the only choice. Commit to the standard 9. The goal of process is not the receipt of a certificate; it is the confidence that the laboratory provides better and safer care with fewer errors and continuous focus on improvement.
Workshop Exercise In the next phase of this workshop we will look at a number of clauses within ISO, and discuss: 1. What is the purpose off the clause 2. How would you implement the clause 3. How would you accomplish the clause 4. How would you document the activity. All laboratory staff shall have access to and be instructed on the use and application of the quality manual and the referenced documents. For a copy of the Internal Audit Master form visit www.
The methods for obtaining and using this information shall include cooperation with users or their representatives in monitoring the laboratorys performance, provided that the laboratory ensures confidentiality to other users. Records shall be kept of information collected and actions taken.
The process of monitoring quality indicators shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement. The indicators shall be periodically reviewed, to ensure their continued appropriateness. For a copy of the Quality Indicator Worksheet visit www. Reassessment shall take place at regular intervals. Retraining shall occur when necessary. Open navigation menu. Close suggestions Search Search.
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Guidelines for the Medical Technology Internship Program 1. Jump to Page. Search inside document. Eddie Mendoza. Certification Consultancy. The laboratory shall evaluate and determine the sufficiency and adequacy of the space allocated for the performance of the work.
ISO Facility maintenance and environmental conditions Laboratory premises shall be maintained in a functional and reliable condition. Work areas shall be clean and well maintained. Attention shall be paid to factors such as light, sterility, dust, noxious or hazardous fumes, electromagnetic interference, radiation, humidity, electrical supply, temperature, sound and vibration levels and workflow logistics, as appropriate to the activities concerned so that these do not invalidate the results or adversely affect the required quality of any examination.
The laboratory shall provide a quiet and uninterrupted work environment where it is needed. Increasing presence in newer geographic regions?
Increasing Clinical Relevance for the broadening community? Why is ISO a special standard 1. It is a single document that can be used by medical laboratories around the world to unify efforts to improve patient care. ISO publishes the document in multiple languages. It can be used by authorized accreditation organizations anywhere. How ISO laboratory accreditation assures patient safety?
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