What is Quality in Health Administration?
Quality improvement has become the fundamental strategy in both the corporate and international business of the 1990s. However, there has been little agreement between managers and professionals specialized in the field, regarding meaning of the word "quality".
The ISO Standard E 8402: 1994 of the International Organization for Standardization defines quality as: "The totality of features and characteristics of a product or service, which entail the ability to satisfy pre-established or implicit needs".
Even if all those “needs” could be identified and adequately defined, what would happen to the so-called “acceptable quality level” (AQL) which is the maximum percentage of failed service units or products that could be considered as acceptable for the average process ?.
In other words, how many mistakes can you make and still be producing a "quality" service or product?
An error of 0.1%, which is 1 in 1000, in the industry might be acceptable; but a nurse whose job is to hold babies, even dropping 1 newborn out of 1,000 is obviously unacceptable.
Perhaps the simplest definition of Quality is inspired by the work of W. Edwards Deming, a pioneer of the movement towards Quality in the industry. In its most basic statement, providing good quality means: "Doing the right things the right way." In Health care it also means offering a range of services that are safe and effective and meet the needs and expectations of clients.
The World Health Organization trying to cover the perspective of the different groups involved (Clients, Suppliers, Planners, Sanitarians), defines quality as:
"Quality in Health Care consists of the proper execution (according to standards) of interventions of proven safety, which are economically accessible to the population in question, and which have the capacity to produce a positive impact on mortality, morbidity, disability and malnutrition. "
Throughout the present we will try to provide and expand the concepts on regulations, quality management and international standards that try to delineate the operation and accreditation of clinical laboratories.
Ensuring Quality in Health
Principles of Good Quality
Quality assurance
According to ISO E 8402: 1994, Quality Assurance is defined as the “set of pre-established and systematized activities applied to the quality system, which have been shown to be necessary to give adequate confidence that a product or service will satisfy the requirements for quality ”.
The characteristic of Health Care differs from the Industry (Producer - Consumer) in two important features: First, most clients lack the knowledge to technically judge the quality of the Health Service provided; second, not only satisfaction and excellence could depend on the quality of the service, but also physical and mental health, and sometimes life itself.
A modern approach to the topic of Quality in Health is often represented by a triangle, which reflects the management concepts developed by Joseph Juran (see Figure 1). The three corners of the triangle - Quality Design, Quality Control and Quality Improvement - are related, essential components and mutually reinforce Quality Assurance.
Quality Design: It is planning and developing the process. The process design defines the organization's mission, including its customers and services. This provides the means and resources and determines the standards to be applied in the provision of the service.
Quality Control: Consists of monitoring, supervision and evaluation that ensures that each worker and each work unit reaches those standards and consequently provides good quality services.
Quality Improvement: Aims at increasing quality and promoting standards through continuous problem solving and process improvement.
Client-centered Health Care provides what clients anywhere wants: respect, understanding, honesty, accurate information, competence, convenience, and results.
Adopting a client-centered essay often requires a twist or change in attitudes. Even while trying to provide good quality services, most service providers and their staff have assumed that they, because they are qualified for health care, know or suppose that it is in their best interests. A customer-oriented orientation recognizes as a premise that customer concerns and preferences are also valid and important.
Customer orientation also provides a new perspective on management programs. The needs and wishes of the staff must also be considered in order to motivate them and consequently provide good care. In this way the "internal customer" arises.
Many health organizations and institutions, both public and private, have historically viewed their clients as passive recipients of services and products.
Being the experts, the managers and directors of health have placed themselves at the top of a hierarchical pyramid, while the patients would be the broad and numerous base.
Conversely, organizations and institutions with client-oriented programs invert this pyramid and place the client at the top (see Figure 2).
Basically the difference between traditional management and total quality management is noted here.
What is ISO?
The International Organization for Standardization (ISO) is a worldwide federation made up of national standardization bodies from 130 countries, one for each country.
ISO is a non-governmental organization established in 1947. ISO's mission is to promote the development of standardization and related activities in the world with the aim of facilitating the exchange of services and goods, and to promote cooperation in the sphere of the intellectual, scientific, technological and economic.
All work carried out by ISO results in international agreements which are published as International Standards.
Where does the ISO name come from?
Many people will have noticed the mismatch between the Organization's alleged English acronym and the word "ISO". So it would be, but ISO is not the acronym.
Indeed, "ISO" is a word, which derives from the Greek "isos", which means "equal", which is the root of the prefix "iso" which appears in infinity of terms.
From "equal" to "standard" it is easy to follow this line of thought which led to choosing "ISO" as the name of the Organization.
ISO Standards
How does ISO develop its standards?
The International Organization for Standardization stipulates that its standards are produced according to the following principles:
1) Consensus: The views of all stakeholders are taken into account: manufacturers, sellers, users, consumer groups, analysis laboratories, governments, specialists and research organizations.
2) Global Industrial Application: Global solutions to satisfy global industries and customers.
3) Voluntary: International standardization is market driven and therefore based on the voluntary commitment of all market stakeholders.
What are the standards?
A standard could be defined very briefly as: the qualitative or quantitative norm that serves as a measurement standard for the object to be evaluated.
Although this definition is applicable to different general concepts, it lacks content in relation to International Quality Standards.
Taking into account international regulations, the standards are: “Documented agreements, approved by consensus, containing technical specifications or other precise criteria to be used consequently as rules, guidelines, or definitions of characteristics that ensure that materials, structures, products, processes, results and services are tailored to your purposes. "
Thus, all ISO Standards are the product of committees that, together and after exhaustive analysis, by international agreement and consensus, document the agreed standards in written form.
This establishes, as an indispensable characteristic for the success of any Standard that must be used for the purposes of an accreditation, the need for it to be previously approved and accepted as valid by the institutions that submit to it, and not simply as an imposition of different standards designed by different accrediting bodies.
Also arises as necessary, for the purposes of consensus and the applicability of the norm, the “non-delegable” intervention of the State, through its Normalizing Organizations (IRAM), which in turn intervened with delegations in the creation of the aforementioned Norms ISO.
ISO 9000 standards
The existence of non-harmonized standards for similar technologies in different countries could contribute to the so-called "technological barriers to trade".
The quality of a product depends on many variables, such as the caliber of the components or materials used; the type of equipment used in the design, production, handling, installation, testing, and shipping; the calibration equipment and maintenance procedures used; the training and experience of production and supervisory personnel; as well as the environmental conditions of production.
The ISO 9000-1987 Standard defines "Quality System" as: "the organization, structure, responsibilities, procedures, processes and resources to implement quality management".
The conformity of a product to the ISO 9000 Standards is also being required as a specification and purchase condition more and more frequently.
This is how the market in search of quality and overcoming trade barriers, adopts these regulations for its products, having become a symbol of quality that many manufacturers show in their products, as can be seen in Figure 3.
Quality in Health Administration
Figure 3.
What are ISO 9000, ANSI / ASQC Q90, and CEN / CENELEC EN 29000?
In 1987, the ISO published a series of five international standards (ISO 9000, 9001, 9002, 9003 and 9004), developed by the Technical Committee on quality systems TC 176. This series together with the terminology and definitions contained in the Standard ISO 8402 provide a guide for selecting the right quality program.
The ISO 9000 Standards were designed to spontaneously serve as a guide and advice, applicable primarily for use in a two-party contractual situation or for internal audits. However, the standards are currently used under a much wider range of conditions and circumstances.
ISO 9000 Standards have been adopted in the United States as ANSI / ASQC Q 9000 (A merican N ational S tandards I nstitute / A merican S ociety for Q uality C ontrol)
In Europe, they have been adopted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) as the European Standards Series (EN) 29000.
It is worth mentioning regarding Laboratories in general that the ISO / DIS 17025 standard known as ISO 25 is applied worldwide, which in the European Community has its equivalent in EN 45001.
Within ISO, the Technical Committee 212 Working Group 1 (ISO / TC 212 WG1), working on aspects of quality management in medical laboratories produced a document that serves as a guide, based on ISO / DIS 17025 (ISO 25), and which is known as the ¡Error! The self-reference to the marker is not valid. Quality Management in the Medical Laboratory, which we will deal with later.
What type of information does each ISO 9000 Standard contain?
ISO 9001, 9002, and 9003 include the need for: an effective Quality System; ensure measurements are valid by regularly calibrating measuring and testing instruments; the use of appropriate statistical techniques; have a product identification and monitoring system; maintaining a process registration system; have an adequate handling, packaging, storage, preservation and delivery system; have an adequate inspection and audit system as well as a process for the treatment of non-conforming units; ensure the education and training of personnel.
ISO 9000 (ANSI / ASQC Q90)
Quality Management and Quality Assurance Standards - Guidelines for selection and use, explains the fundamental concepts of quality; define key terms; and provides a guide for the selection, use and adaptation to ISO 9001, 9002, and 9003.
ISO 9001 (ANSI / ASQC Q 91)
Quality Systems - Model for quality assurance in design and development. Production. Installation and service. It is the broadest series standard. ISO 9001 covers all the elements listed in ISO 9002 and 9003. Additionally, design, development and service capacities are established.
ISO 9002 (ANSI / ASQC Q 92)
Quality Systems - Model for quality assurance in Production and Installation, establishing the prevention, detection and correction of problems during production and installation. It is more extensive and sophisticated than ISO 9003.
ISO 9003 (ANSI / ASQC Q 93)
Quality Systems - Model for quality assurance in Final Inspection and Testing. It is the least wide standar. It establishes requirements for the detection and control of problems during the final inspection and testing.
ISO 9004 (ANSI / ASQC Q 94)
Quality Management and Elements of the Quality System - Guidelines: provides a guide to the supplier in order to use it in the development and implementation of a Quality System and in determining the extent to which each element of the quality system is applicable.
ISO 9004 examines each of the elements of the Quality System in great detail and can be used for internal and external audit purposes.
Comparative table of ISO 9000 Standards.
The following table shows and compares the elements contained in ISO 9001, 9002 and 9003:
| REQUEST | 9001 | 9002 | 9003 |
| Management responsibility | X | X * | X ** |
| Quality system | X | X * | X ** |
| Contract review | X | X | |
| Design Control | X | ||
| Document and data control | X | X | X ** |
| Purchases | X | X | |
| Product provided to the buyer | X | X | |
| Identification and Tracking | X | X | X ** |
| Process control | X | X | |
| Inspection and Testing | X | X | X ** |
| Control of Inspection Instruments | X | X | X ** |
| Inspection and Test Status | X | X | X ** |
| Control of nonconforming product | X | X | X ** |
| Corrective and preventive actions | X | X | |
| Handling, Packaging, Storage, Preservation and Delivery | X | X | X ** |
| Quality Records Control | X | X | X ** |
| Internal Quality Audits | X | X * | |
| Training | X | X * | X ** |
| Service | X | ||
| Statistical techniques | X | X | X ** |
* The requirements are less stringent than those of ISO 9001
** The requirements are less stringent than those of ISO 9002
The list of the requirements that correspond to the ISO 9000 Standards in general is observed in this table. They are fully compliant in the ISO 9001 Standard, but they would not be as strict in the 9002 Standard, and even less in the 9003 Standard.
Quality Management in the Clinical Laboratory.
Treatment of the problem.
Each country in particular has its own characteristics and requirements that differentiate it from the others in terms of the regulations and standards adopted for its health services, which makes it difficult to unify criteria, even in areas as developed in this area as the Economic Community. European.
Likewise, for addressing the problems of Quality Systems, applied to Clinical and Microbiological Analysis Laboratories, the particular characteristics of this type of laboratory should not be ignored either. Only if the aspects common to all of them are taken into account, instead of the differences, it is possible to project a harmonized scheme of the Quality System that covers different laboratories from different fields of work.
In this way, any Quality System proposed for Clinical Laboratories, whether national or international, could be divided into four levels according to what was proposed by JC Libeer in figure 4:
Quality for Clinical Laboratories
We see in this diagram, that the first two levels that would be common to all types of laboratories, can be covered and considered by ISO 9000 and ISO / DIS 17025, which covers many aspects and elements contained in ISO 9000, as well as others corresponding to clinical laboratories in particular.
A third level reaches the professional and personal aspects, while the fourth level reaches the regulations of the country or region.
Considering the first three levels, ISO / CD 15189 would serve as a complete guide to cover these three levels in the Quality Systems of Clinical Laboratories worldwide and as a reference for the purposes of accreditation.
As emerges from this diagram, the ISO 9000 Standards by themselves do not cover the necessary quality requirements and to be taken into account in Medical Laboratories.
Is the Clinical Laboratory different from other laboratories?
Clinical analysis laboratories have a long and long history of applying both external and internal quality control of their results.
However, and taking into account that its results have implications on the health of patients, it is obvious that the consequences of failures in the quality system of a laboratory that produces petrochemicals would be different from that of a clinical laboratory that produces valuable results. diagnosis.
As we have observed, the regulations do not cover all aspects of a laboratory with such characteristics for the following reasons:
- Technical suitability is not enough. Professional suitability with all its implications is also necessary. Constant updating of both instruments and analytical techniques is necessary to keep up with medical requirements. Biosecurity aspects are key in a laboratory that receives infected patients and infectious materials and / or contaminated. Both patients and professional, technical and auxiliary personnel, and the environment are exposed to both biosafety and dangerous or radioactive substances. A medical request can be formulated as a specific detail of determinations or the Specific search for a specific pathology. For the purposes of correct sampling, it is necessary to consider the pre-analytical phase, which includes preparation of the patient, sampling,transport and conservation of the same. Derivation of samples and determinations is common use under the responsibility of the primary laboratory. The validity of the results must satisfy not only the analytical aspects but also the diagnostic and therapeutic utility. The reports produced by clinical laboratories They have particularities and requirements that are not common to other laboratories. The results produced must not have diagnostic interpretation. Ethics and confidentiality of the results are of vital importance.The reports produced by clinical laboratories have particularities and requirements that are not common to other laboratories. The results produced must not have diagnostic interpretation. Ethics and confidentiality of the results are of vital importance.The reports produced by clinical laboratories have particularities and requirements that are not common to other laboratories. The results produced must not have diagnostic interpretation. Ethics and confidentiality of the results are of vital importance.
All these aspects detailed here led to the production within the Technical Committee 212 of a document that covered all this problem, thus generating the Error! The self-reference to the marker is not valid.
ISO / CD 15189 standard.
The ISO / CD 15189 Standard is in the study and adaptation stage in the Clinical Analysis Subcommittee of the Argentine Institute for Standardization (IRAM).
The requirements of this International Standard are relevant and useful for the purposes of Clinical Laboratory Management.
As a warning, this regulation clarifies that: “although the document was not intended as a guide for accreditation, it could be used for such purposes by governments, professionals or another authority. The document focuses on the characteristic features and requirements of medical laboratories. ”
Normative references.
It is interesting to list the sources of ISO 15189, since anyone who requires a more punctual and / or exhaustive study of a certain aspect covered by the standard can turn to the corresponding regulations.
The following references have been used as a source of the referred norm, being valid for that produced within ISO / TC 212 / WG1 N38. June 1998.
ISO / IEC Guide 2: 1996, General terms and their definitions concerning standardization and related activities.
ISO / DIS 17025, General requirements for the competence of testing and calibrating laboratories.
ISO / IEC Guide 43: 1996, Development and operation of laboratory proficiency testing comparisons.
ISO / IEC Guide 58: 1993, Calibration and testing laboratory accreditation system - General requirements for operation and recognition.
ISO 8402: 1994, Quality management and quality assurance - Vocabulary
ISO 31: 1992, Quantities and units.
ISO 3534-1: Statistics - vocabulary and symbols, Part 1 - Probability and general statistical terms.
ISO 3534-2: Statistics - vocabulary and symbols, Part 2 - Statistical quality control.
ISO 3534-3: Statistics - vocabulary and symbols, Part 3 - Design of experiments.
ISO / WD 15190, Clinical laboratory safety
International vocabulary of basic and general terms in metrology (VIM): 1993, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML.
Guide to the expression of uncertainty in measurements: issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML.
Contents of ISO 15189.
The general content of the standard is detailed below, as it will be observed, it is very broad and covers all aspects of quality management as well as the direction and administration of a Clinical Laboratory:
- Introduction. Reference regulations. Definitions. Management System Requirements. Quality Management System. Quality Improvement. Administration of instruments, reagents, and analytical systems. Quality Manual. Organization and Management. Document control. Choice of Derivation Laboratories. External Services and Supplies. Control. of Non-Conforming Analysis, Advisory Service, Corrective Actions, Preventive Actions, Records of technical and quality controls, Internal Audit, Management review. Resources and Technical Requirements. Personnel Environmental and labor conditions. Laboratory equipment. Pre-analytical procedures. Analytical procedures. Quality assurance in analytical procedures. Reporting results. Annex A: Informational Laboratory Computerized Systems Annex B: Informational Ethics in the Medical LaboratoryIntroductionGeneral PrinciplesGetting InformationCollection of SamplesDevelopment of the ExamsReports and ResultsReservation and Archiving of Medical RecordsAccess to Medical recordsFinancial arrangements. Annex C: Bibliography.
Synthesis of Content
Given the length of this ISO 15189 Standard, the aspects and points considered most interesting of it have been chosen here according to the previously listed content.
Definitions.
It would be very extensive to list all the definitions (they are more than 100) that have been applied for the purposes of ISO 15189. However, it is useful to detail some of them:
Laboratory Management: It is the collective body of people who conduct the laboratory activities and which is headed by its Director.
Clinical Laboratory: It is the resource for the biological, microbiological, serological, chemical, immunochemical, hematological, biophysical, cytological, pathological analysis, or other examination of materials derived from the human body with the purpose of providing information for diagnostic purposes, prevention, treatment of any disease or impairment and contribute to the health of human beings.
Pre-analytical procedures.: These are the steps that start in chronological order by the medical requirement, including the request for analysis, preparation of the patient, collection of the primary sample, transportation to and in the laboratory of the same, ending when the process Analytical examination begins.
Analytical Procedures: Ways to carry out an analysis.
Quality System: It is the organization of structure, procedures, processes and resources necessary to implement quality management..
Quality management system
At this point the Standard establishes that it is the responsibility of the Laboratory Management:
- Establish implement and maintain quality system. Establish quality policies and objectives. Make quality policies and objectives in writing and available to all personnel. Develop and implement quality indicators. Provide access to training and continuing education for personnel. Participation in external quality evaluation programs Define a program to control and evaluate the correct calibration and operation of instruments, reagents and analytical systems
Quality Manual
The standard establishes with respect to the content of the "Quality Manual" that:
"It must describe the Quality System, technical procedures and the structure of the documentation used in the quality system."
The Quality Manual may also contain a list of the specific procedures that allow the fulfillment of its objectives.
Organization and Management.
The Laboratory or the organization to which it belongs must be legally identifiable.
The Laboratory Management has the maximum responsibility in the design, establishment, maintenance and implementation of the Quality System.
Documentary control
The Standard defines at this point as “document” all information or instructions, including the Quality Manual itself, definitions of quality policies, books, procedures, specifications, calibration curves and tables, memoranda, graphs, examination procedures, etc.
All the Quality System documents must be reviewed and approved by the responsible and authorized personnel periodically before being made available for consultation.
Choice of the Derivation Laboratory
According to the Standard, the Laboratory or the Organization to which it belongs must take into account the following points:
- Evaluate and select laboratories to derive samples. Demonstrate that the Laboratory to which it refers has the capacity and the means to carry out the requested. Contractual agreements with receiving laboratories must be reviewed periodically. Keep a record of all derived samples and their results.
External supplies and services.
The Standard establishes that the Laboratory Management must define and document the directives and procedures to select and use external services, equipment, supplies and consumable supplies that may affect the quality of its provision.
There must be procedures and criteria for inspection, acceptance, rejection and storage of supplies and consumables.
The equipment and supplies purchased that affect the quality of the system should not be used until verification and compliance with the specifications and quality requirements previously defined by the laboratory.
Control of Non-Conforming Analysis.
The Standard establishes that the Laboratory should have instructions and procedures to follow when it is detected that any aspect of an analysis or determination does not conform, does not conform to its own controls, or does not comply with the requirements of the requesting physician.
For this, the Standard suggests the following as necessary:
- Appoint responsible personnel to solve the problem. Define the actions to be taken. Evaluate the clinical and medical importance of the non-conformity and inform the requesting physician appropriately. Stop the determinations and retain the results if necessary. Take action Corrective immediately. Non-compliant results that have been reported should be identified and returned if necessary. Define responsibility for the resumption of examinations. For the purposes of preventive actions, each episode of non-conformity should be recorded.
Internal audit.
The Standard suggests that internal audits should be carried out at time intervals defined by the quality management of the laboratory (it is suggested to complete one a year), to verify that all the operations continue to comply with the quality requirements of the Quality Management System. The results of the same must be sent for the revision of the Direction.
Pre-analytical procedures.
1) There must be and be available a "Sample Collection Manual", which must include:
a) Copies of standard documents for:
i) Inform consent
ii) Instructions to give patients regarding their own preparation prior to sample collection.
b) Procedures to be followed by medical or nursing personnel to:
i) Patient preparation
ii) Collection of samples with the description of the necessary elements and additives.
c) Instructions for:
i) Type and quantity of sample to be obtained.
ii) Special needs for collection times.
iii) Special transportation needs from collection to reception.
iv) Requirements for identification and labeling of samples.
v) Diagnostic information requirements.
vi) Detailed identification of the patient to be sampled
vii) Identification of the personnel who collected the sample.
viii) Disposal of the materials used for the sampling.
ix) Instructions to complete the analysis request.
2) All the primary samples, as well as their fractions, must be clearly labeled and identified.
a) Samples without proper identification or an accompanying order request should not be accepted or processed by the laboratory.
b) In case of urgency, the laboratory may choose to process the sample but without issuing the result until and until the requesting doctor and / or the person who took the sample is responsible for the identity of the sample or provides the information adequate.
c) If this rule is violated for any reason, the person responsible should be identified in the protocol of the result.
3) All primary samples must be transported to the laboratory:
a) Within a scheme according to the nature of the sample and the examination requested.
b) At the temperature and with the additives specified in the Sample Obtaining Manual.
c) Ensuring compliance with local and / or international biosafety standards in order to protect the person who transports it and the general public.
4) The analysis request must contain enough information to identify the patient, the applicant, the location, as well as the diagnostic data.
There must be documented criteria to accept or reject samples.
Analytical Procedures.
The Laboratory must use analytical procedures, including those for obtaining samples, that meet the needs of the client and preferably those published in scientific journals and texts or recommended methods nationally, regionally or internationally.
Analytical procedures must also meet medical and diagnostic needs, and before being selected for use, their results must be satisfactorily tried and tested.
All procedures must be documented and available to all personnel in the workplace. These must be reviewed initially and then annually by the Laboratory Management.
Documented procedures must have the following characteristics:
I. Purpose of the analysis.
II. Principles of the analytical method and procedure.
III. Performance specification: linearity, reproducibility, detection limit, systematic error, sensitivity and specificity.
IV. Types of samples, collection material and additives.
V. Required equipment and reagents.
SAW. Calibration procedures.
VII. Temperature.
VIII. Analysis steps.
IX. Quality control procedures.
X. Interferences.
XI. Principle of calculation of the result.
XII. Biological reference intervals.
XIII. Critical alert values (maximum and minimum)
XIV. Medical interpretation.
XV. Biosecurity precautions.
XVI. Potential sources of variability.
Also acceptable as a component of the procedures is a manufacturer's manual for the instruments or reagents used, written in language accessible to the personnel performing the procedure. Any modification must be documented.
The biological reference ranges should be periodically reviewed. If the Laboratory for some reason considers and determines that a range of values is no longer appropriate for the reference population, it must take the corresponding corrective actions. This review will also be carried out in case of changing the analytical or pre-analytical procedures.
Conclusions
Throughout the present the following fundamental concepts are outlined:
- The importance of the implementation of the Quality Management System in Health Services The possibility of applying and adapting International Standards to Management in Health Services The need to complete the regulations to adapt it to Clinical Laboratories The specialization and differentiation, due to its special characteristics, Quality Management in the Clinical Laboratory. The application of ISO 15189 as a valid tool for Accreditation of Clinical Laboratories. The need to translate and adapt it to national requirements, transforming it into an official application document for the purposes of accreditation.
Extensive application of this regulation brings with it the following benefits for the Clinical Laboratories that adopt it:
- a) Improve the quality of services and results produced b) Improve contractual conditions compared to other providers c) Improve the return on investment produced by reducing costs d) Improve the legal situation against lawsuits by adjusting to regulations e) Prevent the appearance of clandestine laboratories with unqualified personnel f) Improve orientation and service to the patient and doctor g) Improve working conditions and biosafety h) Improve the educational and scientific level compared to their peers i) Incorporate ethical professional concepts to healthcare activity.
Finally, it is important to remember what is stated in ISO 15189 Annex B Ethics in the Clinical Laboratory, General Principles:
"The general principle of medical ethics is that the patient's well-being is a priority"
Bibliography
- Breitemberg Maureen A.: “Questions and Answers on Quality, the ISO 9000 Standard Series, Quality System Registration, and Related Issues”, US Department of Commerce National Institute of Standards and Technology Standards Code and Information Program Office of Standards Services, July 1992. International Organization for Standardization (ISO): “Introduction to ISO”, October 1999. The Johns Hopkins University School of Public Health, Population Reports: “Family Planning Program: Improving Quality”, Series J, Number 47, November 1998. Population Information Program Center for Communication Programs. Libeer J. C: "Total Quality Management for medical Laboratories: a European point of view", Scientific Institution of Public Health - Louis Pasteur, Brussels, Belgium, February 1998 ISO / CD 15189: "Quality Management in the Medical Laboratory", International Organization for Standardization, ISO / TC 212 / WG 1, June 1998. Fundación Bioquímica Argentina: “Manual of Laboratory Accreditation - MA2”, March 1999
