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This paper presents the highlights of many technical standards, as established by International Organization for Standardization (ISO) through International Classification for Standards (ICS) and British Standards (BS), and quality standards and practices as governed by some international, regional or national institutes in promoting patients rights and safety control in medical sciences and healthcare facilities. The paper draws attention to adopt these standards in Pakistan.

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International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1087 | P a g e

Technical and Quality Standards and Practices in

Healthcare Facilities

Muhammad Tasleem1* , Nawar Khan2 , Syed Tasweer Hussain Shah3 , Asim Nisar4

1,2&3National University of Sciences and Technology, Islamabad, Pakistan

4Centers of Excellence in Science and Applied Technologies, Islamabad, Pakistan

m.tasleem@ceme.nust.edu.pk1

*Corresponding author

Abstract - This paper presents the highlights of many technical standards, as established by International Organization

for Standardization (ISO) through International Classification for Standards (ICS) and British Standards (BS), and quality

standards and practices as governed by some international, regional or national institutes in promoting patients rights and

safety control in medical sciences and healthcare facilities. The paper draws attention to adopt these standards in Pakistan.

Keywords- Standards; healthcare; quality; technical; ISO

1. INTRODUCTION

Quality Control and Management concepts and practices

have been rapidly progressed almost in all industrial

sectors since last two decades. The one of the major

reason is the establishment and expansion of ISO 9000

standards series. ISO 9001 is generic standard and can be

adopted by any type of trade. International Organization

of Standardization (ISO) has developed many technical

standards or specifications as well in parallel to quality

guidelines. The standard of each category contributes

value in the chain in the form of process efficiency,

product or service effectiveness, customer's satisfaction

and confidence and system improvement. The other major

reason is the effectiveness of international and national

quality awards across the world. In the service area, the

quality is very superficial and subjective, and thus it is

difficult to evaluate precisely or control the service (Yoo,

1996)[12]. According to Parasuraman et al. (1985)[6]

quality is an elusive and abstract construct that is difficult

to define. Quality can be described in terms of

effectiveness and efficiency, and can also refer to

characteristics of and the pursuit of excellence (Huber,

2000)[3]. Technical and quality standardization and

practices in medical sciences and health care facilities

become vital due to intensive caring services. There are

number of technical standards as generated by technical

committee of ISO, International Classification for

Standards (ICS) and British Standards Institute (BSI). The

mentioned organizations have introduced very specific

technical standards concerning to medical procedures and

operations. Some major are highlighted in section 2.

There are other quality standards and guidelines which

have been developed and regulated by international,

regional or national institutions or agencies (Tasleem et

al., 2014)[3] and have been adopted and implemented by

medical healthcare facilities to effectively maintain

expected level of services and to reduce and control

clinical errors. These are introduced in section 3 .

This paper sheds light on the introduction and importance

of technical and quality standards related to medical and

healthcare facilities. In a world undergoing accelerated

technological, cultural and socio-economic changes,

healthcare organizations have to adopt appropriate

organizational improvement policies to be able to fulfill

their responsibilities while maintaining an economically

viable and sustainable development (Reza et al., 2012)[7].

It has been reported that top quality care and new

technology solutions helped Colombian hospital attract

patients from all over the world (Agfa HealthCare, 2012).

2. TECHNICAL STANDARDS

There are numerous technical standards concerning to

medical procedures, operations and equipments. Some of

them are highlighted as established by International

Organization of Standardization (www.iso.org) and

British Standards Institute (www.bsigroup.com).

2.1 ISO Standards

2.1.1 Anesthetic and Respiratory Equipments

ISO 18082:2014 provides dimensions of non-

interchangeable screw-threaded low-pressure connectors

for medical gases.

ISO 26825:2008 gives requirements for labels which the

user attaches to syringes so that the contents can be

identified just before use during anesthesia. It covers the

color, size, design and general properties of the label and

the typographical characteristics of the wording for the

drug name.

International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1088 | P a g e

2.1.2 Surgery

ISO/TR 11991:1995 provides guidance on airway

management during laser surgery of upper airway and

intends to minimize the risk of an airway fire when using

a laser.

2.1.3 Sterilization and Disinfection

ISO 25424:2009 specifies requirements for the

development, validation and routine control of a Low

Temperature Steam and Formaldehyde (LTSF)

sterilization process for medical devices.

ISO 11135:2014 specifies requirements for the

development, validation and routine control of an

ethylene oxide sterilization process for medical devices.

ISO 11138-2:2006 provides specific requirements for test

organisms, suspensions, inoculated carriers, biological

indicators and test methods intended for use in assessing

the performance of sterilizers and sterilization processes

employing ethylene oxide gas as the sterilizing agent.

2.1.4 Medical Laboratory

ISO 15189:2012 specifies requirements for quality and

competence in medical laboratories. This standard can be

used by medical laboratories in developing their quality

management systems and assessing their own

competence. It can also be used for confirming or

recognizing the competence of medical laboratories by

laboratory customers, regulating authorities and

accreditation bodies.

ISO 15190:2003 specifies requirements for safe practices

in the medical laboratory.

ISO/TR 22869:2005 provides guidance to medical

laboratories describing how a medical laboratory can

meet the specific technical and quality requirements in

ISO 15189:2003.

ISO/TS 22367:2008 characterizes the application for

reducing laboratory error and improving patient safety by

applying the principles of risk management, with

reference to examination aspects, especially to pre- and

post-examination aspects, of the cycle of laboratory

medical care.

ISO/DTS 17518 provides guidance for users of reagents

for staining in biology in medical laboratories.

2.1.5 Dentistry

ISO 1942:2008 provides definitions for a number of

concepts specific to dentistry in the interest of facilitating

development and comprehension of standards.

ISO 3950:2009 provides a system for designating teeth or

areas of the oral cavity using two digits.

ISO/CD 18845 provides guidance on test methods and

marking for the accuracy of machined indirect

restorations.

2.1.6 Hospital equipment

IEC 60601:2009: applies to the basic safety and essential

performance of medical beds intended for adults.

IEC 80601:2009: establishes particular basic safety and

essential performance requirements, which minimize

hazards to patients, and operators for heating devices

using blankets, pads or mattresses and intended for

heating in medical use and specifies tests for

demonstrating compliance with these requirements.

2.1.7 Medical Textiles

ISO 10282:2014 specifies requirements for packaged

sterile rubber gloves intended for use in surgical

procedures to protect the patient and the user from cross-

contamination.

ISO 11193-1:2008 specifies requirements for packaged

sterile, or bulked non-sterile, rubber gloves intended for

use in medical examinations and diagnostic or therapeutic

procedures to protect the patient and the user from cross-

contamination.

ISO 22609:2004 describes a laboratory test method for

measuring the resistance of medical face masks to

penetration by a splash of synthetic blood.

2.1.8 Medical Devices

ISO/IEC Guide 63:2012: provides guidance to include

safety aspects in the development of medical device.

ISO 10781:2009 describes the content and means of

functioning of the electronic health record system of the

HL7 EHR Work Group.

2.1.9 Medical Plastic wares

ISO 12771:1997 specifies requirements for the

development and use of disposable serological pipettes.

ISO 8362-4:2011 specifies the shape, dimensions and

capacities of glass vials for injectable preparations. The

standard applies to colourless or amber glass containers

moulded from borosilicate or soda-lime glass, with or

without an internal surface treatment, and intended to be

used in the packaging, storage or transportation of

products intended for injection.

ISO 8536-1:2011 specifies the dimensions, performance

and requirements of infusion glass bottles necessary to

ensure functional interchangeability. It is applicable only

to infusion bottles for single use.

ISO 11418-1:2005 specifies the design, dimensions,

material and requirements of drop-dispensing glass

bottles. Drop-dispensing glass bottles are applicable to

primary packs used in direct contact with a drug.

ISO 11418-1:2005 is applicable to drop-dispensing glass

bottles used in pharmacy. Together with the

corresponding closure systems, they serve for packaging

of pharmaceutical preparations which are not intended for

parenteral use.

2.1.10 Blood transfusion, infusion and injection

ISO/ASTM 51939:2013 outlines irradiator installation

qualification, operational qualification, performance

qualification and routine product processing do symmetric

procedures to be followed in the irradiation of blood and

blood components by the blood-banking community.

ISO 1135-4:2011 specifies requirements for single-use

transfusion sets for medical use in order to ensure their

compatibility with containers for blood and blood

components as well as with intravenous equipment.

In some countries, the national pharmacopoeia or other

national regulations are legally binding and take

precedence over ISO 1135-4:2011.

International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1089 | P a g e

ISO 21649:2006: applies to safety and performance and

testing requirements for single-use and multiple-use

needle-free injection systems intended for human use in

clinics and other medical settings and for personal use by

patients.

The dose chamber of the injection system is often

disposable and intended to be replaced after either a

single use or a limited number of uses. It is sometimes

separable from the injection mechanism and often termed

a "cartridge", "ampoule", "syringe", "capsule" or "disc".

In contrast, the dose chamber also may be a permanent

internal chamber designed to last through the claimed life

of the device.

ISO 8362-2:2008 specifies the shape, dimensions,

material, performance requirements and labeling of

closures for injection vials covered by ISO 8362-1 and

ISO 8362-4.

ISO 28620:2010 specifies essential requirements and

related test methods for non-electrically driven portable

infusion devices. It applies to devices designed for

continuous (fixed or adjustable) flow and/or for bolus

application.

2.2 British Standards

BS 8432:2005 gives guidance on the design of spinal

orthoses.

BS 13779:2008 specific to implants for surgery, chemical

analysis and characterization of crystallinity and phase

purity.

BS 25539:2009 is specific to cardiovascular implants,

endovascular devices and vascular stents.

BS 7206:2008 specific to implants for surgery of partial

and total hip joint prostheses and provides classification

and designation of dimensions.

BS 5832:2007 is specific to implants for surgery with use

of metallic materials and wrought stainless steel.

BS 8835:2010 is specific to inhalational anesthesia

systems and transfer and receiving systems of active

anesthetic gas scavenging systems.

BS 10651:2009 is specific to lung ventilators for medical

use and defines particular requirements for basic safety

and essential performance.

BS 8185:2009 specifies guidance on respiratory tract

humidifiers for medical use and specifies requirements for

respiratory humidification systems.

BS 8359:2009 specifies safety requirements for oxygen

concentrators for medical use.

BS 18778:2009 defines particular requirements for

respiratory equipment and infant monitors.

BS 5366:2009 specifies tracheostomy tubes and

connectors for use in anesthetic and respiratory

equipments for adults.

BS 60601:2008 specific to medical electrical equipments

and particularly specify requirements for the basic safety

and essential performance of external cardiac pacemakers

with internal power source

BS 55011:2009 defines limits and methods of

measurement of radio-frequency disturbance

characteristics of medical equipments

3. QUALITY STANDARDS

3.1 ISO Standards

ISO 9001:2008: An ISO 9000 implementation gives a

basic road map for integration of all functions involved in

total health care services, for ensuring a better quality of

service to the patients. The last version, the ISO

9001:2008, is very relevant to the Healthcare Services

Sector as it focuses on fulfilling customer (patient)

expectations, improving the quality of an organization's

business and management processes, so that when a job is

done it is done well, first time, every time.

ISO 9001 is based on famous Deming's Plan -Do-Check-

Act (PDCA) cycle. The major clauses include clause 5.0 -

management responsibility, clause 6.0 - resource

management, clause 7.0 - product realization (service

provision) and clause 8.0 - monitoring, measurement and

analysis (customer satisfaction and continual

improvement).

3.2 Joint Commission International

Accreditation (JCIA)

Joint Commission International Accreditation is a division

of Joint Commission on Accreditation of Healthcare

Organization (JCAHO) in U.S.A. Joint Commission

International (JCI) is contributing to improve patient

safety and quality of health care in the international

community through standards and evaluation. It offers

different types of programs , for example, education,

publications, advisory, and international accreditation and

certification services including of primary care, medical

transport and ambulatory care in more than 100 countries

(www.jointcommisioninternational.com).

Figure 1. Gold Seal of Approval® by JCI

International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1090 | P a g e

The healthcare standard established by JCI is

comprehensive comprising 323 total standard numbers

and 1134 measurable elements and majorly focuses on

environment safety and infection control. A hospital with

an accreditation from JCI means that it provides patient-

centered quality care, focuses on patient safety, and

ensures patients' rights. There is only one hospital, Agha

Khan University Hospital Karachi, accredited from JCI in

Pakistan.

3.3 The International Society for Quality in

Health Care (ISQua)

ISQua is the International Society for Quality in Health

Care. The society provides standards, principles and

solutions covering entire continuum of care, ranging from

system and processes to quality and patient care and

performance and exchange through global network

(www.isqua.com). ISQua is involved in the accreditation

of national and regional health care facilities and is an

essential resource for policy makers, leading patient

safety agencies, health care workers and professionals

around the world.

3.4 International and National Quality

Awards

Almost all of the countries in the world have established

and implemented their own national quality awards which

are dated from different times. Mostly these award

systems have been established by some governmental

institution or other regulatory agency to lay down upmost

performance standards with fundamental principles and

values of quality and results. Malcolm Baldrige National

Quality Award (MBNQA) and European Foundation

Quality Management (EFQM) systems and criteria are the

most famous in the world.

3.4.1 MBNQA

It is U.S.A based quality award system established since

in 1987. There are five categories of the sectors including

a separate one for healthcare. Since 2002 there have been

17 healthcare facilities which won MBNQA in healthcare

category (www.nist.gov). The award criteria are non-

prescriptive and address following seven elements;

 Leadership and governance

 Strategic planning

 Health care and processes and operations,

 Customers

 Workforce

 Finance and markets

 Knowledge Management

The Health Care Criteria items and the scoring guidelines

can be used as competitive strategy in external

assessments or for identification of opportunities for

improvement in self-assessment.

Figure 2.Baldrige Healthcare Criteria Framework

3.4.2 EFQM

EFQM framework and criteria is European based

established since 1994. Hospitals, outpatient services,

acute care, rehabilitation clinics, primary care centers and

specialized services have used this approach (Moeller,

2001)[4]. Studies have shown that the EFQM approach

provides a broader framework for evaluation and

improvement of quality. In Germany 10-15% of total

hospitals are using EFQM approach (EFQM, 2003).[2]

International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1091 | P a g e

Figure 3. EFQM Criteria Framework

3.4.3 Prime Minister Quality Award (PMQA)

PMQA is based on MBNQA criteria has been prepared

and is under implementation by National Productivity

Organization (NPO) Pakistan.

3.5 Pakistan Standards

Pakistan's governmental and institutions and regulatory

bodies are marching to meet international benchmarks.

There have been initiatives to cope the advanced

requirements through Pakistan standards and the same is

true in standardizing healthcare practices in medical

facilities.

The formulation and or adoption of Pakistan Standards is

carried out in Technical Committees and endorsed by

National Standards Committee which include Pakistan

Standards and Quality Control Authority (PSQCA)

experts, intellectuals from related scientific institutions,

technical experts from relevant production units and

consumers.

Figure 4. Pakistan Standard Mark

Drafts of Pakistan standards for primary healthcare and

secondary have been prepared and are under scrutiny for

finalization and implementation in Pakistan.

3.5.1 Primary health care facility

Primary healthcare facility standard covers following

requirements;

 Primary care management committee

 Patient information

 Notifiable diseases

 Provision of utilities facilities and monitoring of

equipment

 Water supply

 Waiting area

 Latrine Facility

 Work area

 Operability of the procedures and guideline

 Availability of Staff

 Health and Safety

 Emergency cases

 Privacy

 Patient feedback

 Complaint Handling

 Continual Improvement

3.5.2 Secondary health care facility

Secondary healthcare facility standard covers following

requirements;

 Patient Rights

 Care Continuum

 Operation Theatre Department

 Casualty Department

 Intensive Care Unit

 Resuscitation

 Maternity Services

 Laboratory Services

International Journal of Management Excellence

Volume 9 No.2 August 2017

©TechMind Research Society 1092 | P a g e

 Radiology

 Pharmacy Services

 Infection Control

 Sterile Supplies

 Cleanliness and Sanitation

 Waste Management

 Health and Safety

 Safe and Appropriate Facilities

Each requirement area covers service management,

procedures and policy, facilities and equipments and

measurable criteria to establish.

4. CONCLUSION

As many technical and quality standards and practices

have been introduced and implemented across the world,

there is constant need to adopt and cope with the

benchmarks by medical sciences and healthcare facilities

in Pakistan. These standards are important in better

patient care, safety control and continual improvement.

Acknowledgment

Cooperation of physicians and medical consultants of

medical facility at Centers of Excellence in Science and

Applied Technologies (CESAT), Islamabad, Pakistan is

acknowledged.

5. REFERENCES

[1] "Customer case - Agfa HealthCare" Mortsel –

Belgium,5TPSF GB 00201202, 2012.

[2] EFQM. Introducing Excellence. Brussels: European

Foundation for Quality Management 2003.

[3] Huber, D., Leadership and Nursing Care

Management, second ed. Saunders, Philadelphia,

2000.

[4] Moeller, J. " The EFQM Excellence Model German

Experiences with EFQM approach in health care,"

International Journal for Quality in Health Care,

volume 13, ppt. 45-49, 2001.

[5] Tasleem, M. Nisar, A., and Ahmed, E., "Self-

Assessment for operational performance through

TQM Award Model: A Case Study," International

Convention on Quality Improvement (ICQI), 2014.

[6] Parasuraman, A., Zeithaml, V. A., Berry, L. L., "A

conceptual model of service quality and its

implications for future research,", Journal of

Marketing, volume 4, pp. 41–50, 1985.

[7] Reza Dehnavieh, HosseinEbrahimipour,

SomayehNouriHekmat, AzadehTaghavi, Mehdi

JafariSirizi, Mohammad Hossain

Mehrolhassani,"EFQM-based Self-assessment of

Quality Management in Hospitals Affiliated to

Kerman University of Medical Sciences,"

International Journal of Hospital Research, volume

1(1): pp. 57-64, 2012.

[8] www.bsigroup.com

[9] www.iso.org

[10] www.isqua.org

[11] www.jointcommissioninternational.org

[12] www.nist.gov

[13] Yoo, D.K., "A study on quality perceptions and

satisfaction for medical service marketing," Journal

of Korea Academy Nursing Administration, volume

2 (1), pp. 97–114, 1996.

ResearchGate has not been able to resolve any citations for this publication.

Background and Objectives: There is a growing tendency in Iran's health sector for adoption of standard excellence models for improving quality in healthcare organizations. The European Foundation of Quality Management (EFQM) model is a widely used framework for continuous quality management within healthcare facilities. The purpose of this article is to extend the view of current status of quality management in Iran's hospital industry by reporting the details of an EFQM-based self-assessment of quality management in hospitals of Kerman University of Medical Sciences. Methods: A cross-sectional study was conducted over the period of October to December 2011 by enrolling heads of departments and chief executive officers of all the four university hospitals of Kerman, the capital of Kerman province in southern Iran (n = 69). The standard EFQM questionnaire was used to measure quality management. Reliability of the assessment tool was determined by calculating Chronbach's alpha coefficient. The data was analyzed using descriptive statistics. Findings: The criteria 'Process' and 'Customer results' scored above 60%, and other criteria scored within the range of 50% to 60%. While 'Process' gained the highest score of 62.9%, the lowest score of 52.1% was received by 'Key performance results'. Scores appeared to be overestimated compared to those gained by pioneer healthcare settings in developed countries. However, the scores were found more realistic in comparison with those in precedent domestic studies, suggesting a trend of gradual improvement of quality management knowledge and self-assessment skill. Conclusions: The data suggest that the criteria 'People' and 'Resource and Partnership' are of a high priority for improvement in order to reach satisfactory 'Key performance results'.

• J Möller

To expand on previous reports by illustrating experiences German health services organizitions made in their assessment against the European Foundation for Quality Management (EFQM) Excellence Model. To provide an evaluation of the EFQM method compared to peer auditing and accreditation concepts within health care. To indicate the EFQM method and scoring system and draft the process of self-assessment in health services organizitions. To refer to the experiences of German health care pioneers during their early assessments. Using the EFQM approach, an organizition can earn up to 1.000 points. More than 50% of German hospitals scored 200-300 points and not a single organizition achieved over 450 points. To make a comparison, the best score obtained in an industrial setting was between 650-750 points. In addition to the numbers, this report describes success factors and best practices of self-assessments, as well as limitations, barriers and lessons learned during the implementation phase. The Excellence Model is a systematic quality management approach to gain competitive advantage. It is non-governmental, non-financier driven, and generic enough to address health care issues. Having its foundation in industry, however, it is not specific enough to cover all areas relevant to health care. Integrating the management-smart method of self-assessment with clinical standards as delivered by peer auditing and accreditation systems generates the potential to deliver excellence in health care.

Brussels: European Foundation for Quality Management

EFQM. Introducing Excellence. Brussels: European Foundation for Quality Management 2003.

Self-Assessment for operational performance through TQM Award Model: A Case Study

• M Tasleem
• A Nisar

Tasleem, M. Nisar, A., and Ahmed, E., "Self-Assessment for operational performance through TQM Award Model: A Case Study," International Convention on Quality Improvement (ICQI), 2014.

A study on quality perceptions and satisfaction for medical service marketing

• D K Yoo

Yoo, D.K., "A study on quality perceptions and satisfaction for medical service marketing," Journal of Korea Academy Nursing Administration, volume 2 (1), pp. 97-114, 1996.

A conceptual model of service quality and its implications for future research EFQM-based Self-assessment of Quality Management in Hospitals Affiliated to Kerman University of Medical Sciences A study on quality perceptions and satisfaction for medical service marketing

• A Parasuraman
• V A Zeithaml
• L L Berry
• Dehnavieh
• Hosseinebrahimipour
• Somayehnourihekmat
• Mehdi Azadehtaghavi
• Mohammad Jafarisirizi
• D K Hossain Mehrolhassani Yoo

Parasuraman, A., Zeithaml, V. A., Berry, L. L., " A conceptual model of service quality and its implications for future research, ", Journal of Marketing, volume 4, pp. 41–50, 1985. [7] Reza Dehnavieh, HosseinEbrahimipour, SomayehNouriHekmat, AzadehTaghavi, Mehdi JafariSirizi, Mohammad Hossain Mehrolhassani, " EFQM-based Self-assessment of Quality Management in Hospitals Affiliated to Kerman University of Medical Sciences, " International Journal of Hospital Research, volume 1(1): pp. 57-64, 2012. [8] www.bsigroup.com [9] www.iso.org [10] www.isqua.org [11] www.jointcommissioninternational.org [12] www.nist.gov [13] Yoo, D.K., " A study on quality perceptions and satisfaction for medical service marketing, " Journal of Korea Academy Nursing Administration, volume 2 (1), pp. 97–114, 1996.

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