Norms and Accreditation Flashcards
This is done to confirm that an establishment follow rules and standards.
Assessment
These personnel are responsible for having the initiative to accredit a laboratory.
Laboratory Director
These personnel are usually medical technologists and they do tasks up to standard and are aware of the assessment process.
Laboratorians
These are documents that provides rules, guidelines or characteristics for activities or their results.
Normative Documents
These are documents established by consensus and approved by a recognized body.
Standard Documents
These are any form of standard that is mandated by a governmental agency or authoritative body.
Regulation
In the Philippines, this is the organization that manages regulations.
Department of Health
These are developed accreditation requirements to be used in owned agencies, organizations, or regions.
Self-developed Standards
These are some of the advantages of Self-developed Standards.
Optimized locally, progressive, and possible international recognition.
These are the weaknesses of Self-developed Standards.
Can be biased and may not be recognized.
These are the 4 standard bodies.
- ISO (International Organization for
Standardization)
2.CLSI (Clinical Laboratory Standardization Institute) - CEN (Comite Europeen de Normalisation or European Committee for Standardization)
- WHO (World Health Organization)
These are the number of countries that is included in the ISO.
157 countries
This is the world’s largest developer and publisher for international standards.
International Organization for Standardization (ISO)
This is the percentage of ISO personnel who needs to be in favor for a new standard to be developed.
75%
This is a global, non-profit organization that promotes healthcare guidelines and documents developed by experts.
Clinical Laboratory Standard Institute (CLSI)
This is a national standard body in Europe and includes openness, transparency, consensus, and integration in its general terms.
European Committee for Standardization (CEN)
This is an organization that has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, and measles.
World Health Organization (WHO)
This is the number of samples annually processed in polio laboratories.
150 samples
These are standards that are based internationally and are adapted to the culture and general condition of the country.
Country-specific Standards
These are only supplements to the ISO standard with laboratory technical guidance such as addressing specific kinds of tests.
Guidelines
These are procedures by which a third party gives a written assurance that a product, process, or service conforms to specific requirements.
Certification (ISO/IEC 17000)
These are procedures by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks
Accreditation (ISO 15189)
This is defined as granting of ability to practice provided most often by a local governmental agency, usually based on demonstrated knowledge, training and skills.
Licensure
These are the 4 elements of an accreditation process.
Accreditation Body, Standards, Assessors, and User Laboratory.
These are examples of Certification Standards.
ISO 9001:2000 and ISO 14000
These are examples of Accreditation Standards.
ISO 17025 and ISO 15189
These are examples of Regulations.
US CLIA Regulation, GBEA, and UN Transport of Dangerous Goods Regulation.
These are examples of National Standards.
GBEA (France), BLQS (Thailand), and CLIA (US)
This ISO document encompasses tests calibration sampling.
ISO 17025
This ISO document encompasses requirements for competency in order to be confirmed or recognized.
ISO 15189
These are the order of laboratory recognition.
Licensure, Certification, then Accreditation
This term represents a general agreement in the absence of strong and compelling objection.
Consensus
This term is required and essential for standardization and includes the word “shall.”
Normative Statement
This term often includes a ‘note’ that may be for explanatory, cautionary, or exemplary purposes.
Informative Statement
This term meets both text and spirit of a requirement.
Compliance
This term is the failure to fulfill a requirement specified by process, structure, or service.
Non-conformity
This term is the confirmation by examination of evidence.
Verification of Conformity
This must be done before every patient sample.
Quality Control
These are tests given to reference laboratories to test their accuracy.
Proficiency Testing
True or False; Accreditation guarantees success and is the only requirement for the whole quality journey.
False, accreditation does not guarantee success and is only one step along the quality journey.
True or False: Accredited laboratories tend to perform better in proficiency testing and have a working quality system management.
True
True or False: Accreditation is viewed as the achievement.
False, accreditation is only an accomplishment, and the real achievement is maintaining accreditation.
This is the meaning of IEC.
International Electrotechnical Commission
These are the required personnel in the CEN and where it located.
30 National Members, 7 Associates, 2 Councilors and is located in Brussels, Belgium
This element of the accreditation process sets the standard.
Accreditation Body
This element of the accreditation process are the ones that you must comply with to become accredited.
Standards
This element of the accreditation process seeks to establish compliance with standards through giving assessments.
Assessors
This element of the accreditation process must comply with the set of standards by being assessed.
User Laboratory
This characteristic of an accrediting body must require their own accredited status via national or international.
Approved
This characteristic of an accrediting body must be knowledge and skilled in the standard against they accredit.
Knowledgable
This characteristic of an accrediting body states that they are established in standards.
Standard-based
This characteristic of an accrediting body is based on evidences rather than impression and people cannot write their own rules.
Objective
This characteristic of an accrediting body must have trained and skilled staff and maintained via professionalism.
Competent
This process of accreditation states that the path towards meeting standards and recognition is rarely straightforward.
Commitment
This process of accreditation states the path towards accreditation takes time.
Planning
This process of accreditation states that application standards require knowledge of the standards and how to interpret them.
Knowledge
This process of accreditation states that the process of accreditation may require reorganization, restructuring, trained staff, and additional equipment.
Resources
This is important so that clients can have confidence and have claims about quality, performance, and reliability.
Value of Accreditation
This is a valuable tool to determine the effectiveness of the quality management systems.
Accreditation
