International Standardization

in Blood Banking
Ms Sally Lam
Laboratory Director
Blood Services Group
Health Sciences Authority

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International Standardization ?
Products or services in a particular business or
industry sector conform to an agreed standards
achieved through consensus agreements between
national delegations (suppliers, users and, often,
governments.)
agreed on specifications and criteria to be applied
consistently in the classification of materials, the
manufacture of products and the provision of
services.
International Standards provide a reference
framework, or a common technological language,
between suppliers and their customers

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International Standardization : Benefits

A set of standards commonly
recognized & accepted worldwide
World-class quality systems
Increased business
opportunities globally
Increased productivity
Reduced inefficiencies
Quality services and products
Gained confidence from
suppliers, customers &
consumers
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Background

ISO ~ International Organization for Standardization

Greek word isos, referred to as equal or uniform
Founded in 23 Feb 1947
Based in Geneva, Switzerland
A Non-Government Organization, international
standards-setting agency
a network of the national standards institutes from
163 member countries

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Role of ISO
Worlds leading developer of
international standards
Set, publish & maintain international
standards for business, government &
society
ISO does not audit or issue certifications.
a network of the national standards
institutes of some 163 countries that
coordinates the system and publishes
the finished standards.
18,000 standards produced as of Nov
2010
Consist of Guidance and Conformance
standards
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ISO member countries ~ 163/203

3 categories of membership :
member bodies (green)
correspondent members
(black)
subscriber members (red)

Indonesia Badan Standardization Nasional (BSN)

Singapore SPRING Singapore

Extracted from ISO online (Nov 2010)

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ISO Standards : Classifications

Reference number - consists of a prefix, a serial number and
the year of publication. The prefix will usually be "ISO" to
indicate that the publication is an ISO International Standard.

ISO 1ISO 999

ISO 1000ISO 9999
ISO 9000 : Quality Management
ISO 10000ISO 19999
ISO 14000 : Environmental Management
ISO 15189 : Medical laboratories (Particular
requirements for quality and competence)
ISO 17025 : Test and calibration laboratories
(General requirements for competence)
ISO 2000ISO 29999
ISO 3000ISO 39999
ISO 80000
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ISO Standards : ISO 9000

International standards for good quality management
practices
First published in 1987, developed for war industry
Renamed as ISO 9000 for the civil version
It is organization / process oriented
Focus on quality management & quality assurance :
Management Responsibilities
Resource Management
Product Realization
Measurement, Analysis & Improvement

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ISO 9000 Series

Standard

Title

Edition

ISO 9000:2005

Quality management systems Fundamentals and vocabulary

3rd

ISO 9001:2008

Quality management systems

Requirements

4th

ISO 9004:2000

Quality management systems

Guidelines for performance
improvements

2nd

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ISO 9001 : 2008

a set of standardized requirements for a quality
management system
It is the only standard in the family against which
organizations can be certified
certification is not a compulsory requirement of
the standard.
a systematic approach to managing the
organization's processes so that they consistently
turn out product that satisfies customers'
expectations.

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Extracted from : http://www.iso.org

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ISO Standards : ISO/IEC 17025

Previously know as ISO/IEC guide 25
International standards for Testing & Calibration
Laboratories
e.g. Standards Reference Laboratories, Chemical Metrology
Laboratory, Forensic Science Laboratory

Commonalities to ISO 9000

Focus on the concept of competence ~ aimed at
improving the ability to consistently produce valid
results
- Management Requirements : operation and
effectiveness of the quality management system within
the laboratory
- Technical Requirements : factors which determines
the correctness and reliability of the tests and
calibrations performed in laboratory.

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ISO 15189 Medical Laboratory

Based on ISO 9001
Quality management systems for organizations

Based on ISO/IEC 17025

Testing & calibration laboratories

Emphasis is on technical notes relevant to

medical laboratories with focus on :
Pre-Analytical :
provision of advice to users of the laboratory service,
the collection of patient samples,

Analytical :
Quality controls & assurance, accuracy & reproducibility,
traceability
Provision of testing in medical emergency
Training & competency of staff

Post-Analytical :
interpretation of test results, results reporting
acceptable turnaround times,

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ISO in Blood Banking ?

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Blood Transfusion Chain

Supply Chain

GMP
GLP
VeinISO
to9001
- Vein

GMP

Integrated Quality Management System

Donor
Recruitment

Blood
Collection

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Blood
Processing
/Testing
/Storage

PreTransfusion
Testing

Issue
/Transfusion

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Countries

Quality System

Australia

NATA accreditation

Hong Kong

ISO 9001, ISO 14001, ISO 15189

Indonesia

National system

Japan

National system

Korea

ISO 9001

Malaysia

NATA accreditation

New Zealand

NATA accreditation

Singapore

AABB accreditation

Thailand

ISO 9001, ISO 15189

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ISO 9000
Management
Responsibilities

GMP

AABB

Quality Management

Organization

Documentation

Documents &
Records

Personnel

Personnel

Premises & Equipment

Equipment
Facilities & Safety

Contract

Supplier Issues

Production

Process Control

Quality Control

Assessments

Complaints Procedure &

Product Recall

Incidents, Errors,
Accidents

Self-Inspection

Process Improvement

Resource Management

Product Realization

Measurement, Analysis
& Improvement

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Quality Management System

QUALITY MANAGEMENT SYSTEM
Processes and Products/Services defined
PERSONNEL
LEADERSHIP

POLICIES
STRATEGIES

PROCESSES
&
SERVICES
MANAGE
MENT

RESOURCES

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Documentation Corrective Loop

Write what you do
Do what is written
Record what you did

Corrective loop

Revise what you will do

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Layers of Documentation
ISO 9001: 2008
Level 1 ~
Quality Manual
(policies)

Level 2 ~
Quality processes
Level 3 SOPs, EOPs, JDs
Level 4 ~ Records, forms, labels

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Continuous Improvement
Deming Cycle
Plan Do Check - Act

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Why Go For Accreditation ?

International Recognition
Benchmarking ; A defined and systematic quality system in placed

Building Trust
Assure public, patients, hospitals and the Ministry of Health of the
standard of quality of blood supply and service

Quality Culture & Processes

Reduced wastage, Increased productivity & efficiency
Safe environment for donors and staff
Competent staff & Improve morale of staff and pride in their work
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Accreditation Process

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What Just
Next ?do it!
Get familiarized with the accreditation process
Initiate application process
Share plans and objectives with blood centre staff
Acquire knowledge and information about
accreditation requirements
Conduct Gap Analysis current processes
against requirements
Initiate documentation (SOPs, records, checklists)
Develop schedule and timelines
Guidance from consultants
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External Consultation and Audit

Provide training in quality system essentials
and principles
Conduct audit and baseline assessments
Identify gaps & advise on improvements and
timelines
Help stimulate quality consciousness

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The Most Important Factors

Top management support

Buy-in of all staff
Staff knowledgeable and aware of quality concepts,
principles and practice
Reduce the fear factor
Be patient it always takes longer than you expect
Quality is a journey, not a destination aim for
accreditation for the right reasons
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2006
~ 1st AABB
Accreditation
Assessment

The

Q journey begins for BSG

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Staff Buy-In

2008 ~ 2nd AABB Re-Assessment

Staff Buy-In
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 Staff Buy-In
2010 ~ 3rd AABB Re-assessment
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Thank You !

Extracts from ISO in Brief

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