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What is ISO/IEC 17025 accreditation and why should you procure the services of an accredited laboratory?
ISO/IEC 17025 accreditation is an important standard for calibration and testing laboratories worldwide. The accreditation proves that a laboratory is technically competent and able to produce accurate test and calibration data. One significant requirement of ISO/IEC 17025 is metrological traceability. International Vocabulary of Metrology explains metrological traceability as “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty”. Every laboratory equipment with measuring function affects the uncertainty of a test result and as such must be calibrated. Without measurement traceability and verification by an independent body, a laboratory is free to make fraudulent claims in a test report. (H5)
The voluntary, third-party-review process also includes regular quality management system evaluation to ensure continued technical competence and compliance with ISO/IEC 17025.
To maintain the integrity of accreditations, laboratory accreditation can only be granted by an accreditation body (AB). In Malaysia, laboratory accreditation is within the purview of the Department of Standards Malaysia under the Ministry of Science, Technology and Innovation and it is administered through Skim Akreditasi Makmal Malaysia (SAMM). According to Standards Malaysia, “the primary objective of SAMM is to provide a credible accreditation service to testing and calibration laboratories including medical testing laboratories such that ultimately SAMM endorsed test reports and calibration certificates are accepted internationally.” Mutual acceptance of test results endorsed by ABs between different governmental and regulatory organisations is guaranteed throughout the world through International Laboratory Accreditation Cooperation (ILAC) arrangement.
As a customer or manufacturer who procures the services of a laboratory, ISO/IEC 17025 accreditation helps you distinguish between laboratories with proven technical competency and a sturdy quality management system and those without. The benefits of an accredited laboratory to manufacturers can be summarised as follows:
- You avoid risking your investment by sending samples to laboratories with dubious track record.
- You save time when tests are conducted with tried and tested methods endorsed by an independent third party.
- You avoid wasting money on botched tests and expensive re-testing with an accredited laboratory.
We at Viroxy laboratories are aware how time is of the essence when it comes to launching a new medical device. This is one of the reasons we combine affordability with quality and punctuality. Give us a call today to find out how we can help you.
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What is ISO/IEC 17025 accreditation and why should you procure the services of an accredited laboratory?
ISO/IEC 17025 accreditation is an important standard for calibration and testing laboratories worldwide. The accreditation proves that a laboratory is technically competent and able to produce accurate test and calibration data. One significant requirement of ISO/IEC 17025 is metrological traceability. International Vocabulary of Metrology explains metrological traceability as “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty”. Every laboratory equipment with measuring function affects the uncertainty of a test result and as such must be calibrated. Without measurement traceability and verification by an independent body, a laboratory is free to make fraudulent claims in a test report. (H5)
The voluntary, third-party-review process also includes regular quality management system evaluation to ensure continued technical competence and compliance with ISO/IEC 17025.
To maintain the integrity of accreditations, laboratory accreditation can only be granted by an accreditation body (AB). In Malaysia, laboratory accreditation is within the purview of the Department of Standards Malaysia under the Ministry of Science, Technology and Innovation and it is administered through Skim Akreditasi Makmal Malaysia (SAMM). According to Standards Malaysia, “the primary objective of SAMM is to provide a credible accreditation service to testing and calibration laboratories including medical testing laboratories such that ultimately SAMM endorsed test reports and calibration certificates are accepted internationally.” Mutual acceptance of test results endorsed by ABs between different governmental and regulatory organisations is guaranteed throughout the world through International Laboratory Accreditation Cooperation (ILAC) arrangement.
As a customer or manufacturer who procures the services of a laboratory, ISO/IEC 17025 accreditation helps you distinguish between laboratories with proven technical competency and a sturdy quality management system and those without. The benefits of an accredited laboratory to manufacturers can be summarised as follows:
- You avoid risking your investment by sending samples to laboratories with dubious track record.
- You save time when tests are conducted with tried and tested methods endorsed by an independent third party.
- You avoid wasting money on botched tests and expensive re-testing with an accredited laboratory.
We at Viroxy laboratories are aware how time is of the essence when it comes to launching a new medical device. This is one of the reasons we combine affordability with quality and punctuality. Give us a call today to find out how we can help you.
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The first time I saw the inside of a laboratory was during a school trip to a veterinary laboratory. I was 10 years old and as excited as any kid who had just discovered there is a whole range of cooler toys for grown-ups. I was unusually quiet that day, absorbing every word of our facilitator and observing everything in sight. At the end of that trip, I knew what I wanted to be when I grew up.
It has been 8 years since I wore my first lab coat as a microbiologist and I have worked in a variety of laboratories since, including quality control laboratory, commercial testing laboratory and academic laboratory. Even after all this time, my passion has not waned. In fact, it has strengthened and peaked especially after witnessing (and being a part of) some of the most heart-warming success stories of our clients.
But life as a microbiologist is not always rosy and well. Disappointments are natural accompaniments, especially when factors not within our control limit the breadth and depth of our service. I am well aware of the challenges that clients (often manufacturers) typically face when dealing with a testing or research laboratory. The industry from which most of our clients come is heavily regulated and in order to run a legitimate business, there is a price to be paid. It isn’t cheap and it’s as inevitable as death and taxes.
It comes as a no surprise then, that the price of microbiological testing services remains at the top of their grievances. After being in this business for years, nurturing and praying for the success of our clients, it is painful to see them struggling amidst rising cost of raw materials and numerous other expenses related to meeting regulatory requirements. Especially small players with big, honest hearts.
Another bane for manufacturers is the turnaround time (TAT). Testing laboratories usually have a queue of clients. Without a streamlined process, the wait can be anywhere between a few weeks to several months. A lot can change in in that time and business plans can get disrupted. This is still manageable if the test result comes out as expected but what if it doesn’t? Adjustments have to be made and the product sent for re-testing. And then, another round of waiting. A year can fly by this way if multiple rounds of tests are required. We can all agree that in this era where everyone’s time is equivalent to money, manufacturers can’t afford to squander it by waiting around for test results.
These two issues touched me on a personal level and set me on a journey to offer credible testing services at affordable rates in a timely manner. I admit, the services we offer are highly specialised, time consuming and involve a high degree of precision. It is no easy feat to actualise my mission but I have been fortunate to have gathered a team of well qualified microbiologists who share the same values and work tirelessly.
Although disinfectant efficacy testing formed the core of our service at the beginning, the 6200-sf facility is now fully equipped to support sterility testing, bioburden testing, environmental monitoring service and product registration & consultation. Within 10 months of incorporating Viroxy on 30 June 2016 in Kuala Lumpur, we acquired ISO/IEC 17025 accreditation, bearing testament to our diligence, capability and resolution in establishing ourselves as a formidable player in the field as a newcomer”.
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The first time I saw the inside of a laboratory was during a school trip to a veterinary laboratory. I was 10 years old and as excited as any kid who had just discovered there is a whole range of cooler toys for grown-ups. I was unusually quiet that day, absorbing every word of our facilitator and observing everything in sight. At the end of that trip, I knew what I wanted to be when I grew up.
It has been 8 years since I wore my first lab coat as a microbiologist and I have worked in a variety of laboratories since, including quality control laboratory, commercial testing laboratory and academic laboratory. Even after all this time, my passion has not waned. In fact, it has strengthened and peaked especially after witnessing (and being a part of) some of the most heart-warming success stories of our clients.
But life as a microbiologist is not always rosy and well. Disappointments are natural accompaniments, especially when factors not within our control limit the breadth and depth of our service. I am well aware of the challenges that clients (often manufacturers) typically face when dealing with a testing or research laboratory. The industry from which most of our clients come is heavily regulated and in order to run a legitimate business, there is a price to be paid. It isn’t cheap and it’s as inevitable as death and taxes.
It comes as a no surprise then, that the price of microbiological testing services remains at the top of their grievances. After being in this business for years, nurturing and praying for the success of our clients, it is painful to see them struggling amidst rising cost of raw materials and numerous other expenses related to meeting regulatory requirements. Especially small players with big, honest hearts.
Another bane for manufacturers is the turnaround time (TAT). Testing laboratories usually have a queue of clients. Without a streamlined process, the wait can be anywhere between a few weeks to several months. A lot can change in in that time and business plans can get disrupted. This is still manageable if the test result comes out as expected but what if it doesn’t? Adjustments have to be made and the product sent for re-testing. And then, another round of waiting. A year can fly by this way if multiple rounds of tests are required. We can all agree that in this era where everyone’s time is equivalent to money, manufacturers can’t afford to squander it by waiting around for test results.
These two issues touched me on a personal level and set me on a journey to offer credible testing services at affordable rates in a timely manner. I admit, the services we offer are highly specialised, time consuming and involve a high degree of precision. It is no easy feat to actualise my mission but I have been fortunate to have gathered a team of well qualified microbiologists who share the same values and work tirelessly.
Although disinfectant efficacy testing formed the core of our service at the beginning, the 6200-sf facility is now fully equipped to support sterility testing, bioburden testing, environmental monitoring service and product registration & consultation. Within 10 months of incorporating Viroxy on 30 June 2016 in Kuala Lumpur, we acquired ISO/IEC 17025 accreditation, bearing testament to our diligence, capability and resolution in establishing ourselves as a formidable player in the field as a newcomer”.
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Text with Image Subtitle
Image 1 Caption
The first time I saw the inside of a laboratory was during a school trip to a veterinary laboratory. I was 10 years old and as excited as any kid who had just discovered there is a whole range of cooler toys for grown-ups. I was unusually quiet that day, absorbing every word of our facilitator and observing everything in sight. At the end of that trip, I knew what I wanted to be when I grew up.
It has been 8 years since I wore my first lab coat as a microbiologist and I have worked in a variety of laboratories since, including quality control laboratory, commercial testing laboratory and academic laboratory. Even after all this time, my passion has not waned. In fact, it has strengthened and peaked especially after witnessing (and being a part of) some of the most heart-warming success stories of our clients.
But life as a microbiologist is not always rosy and well. Disappointments are natural accompaniments, especially when factors not within our control limit the breadth and depth of our service. I am well aware of the challenges that clients (often manufacturers) typically face when dealing with a testing or research laboratory. The industry from which most of our clients come is heavily regulated and in order to run a legitimate business, there is a price to be paid. It isn’t cheap and it’s as inevitable as death and taxes.
It comes as a no surprise then, that the price of microbiological testing services remains at the top of their grievances. After being in this business for years, nurturing and praying for the success of our clients, it is painful to see them struggling amidst rising cost of raw materials and numerous other expenses related to meeting regulatory requirements. Especially small players with big, honest hearts.
Another bane for manufacturers is the turnaround time (TAT). Testing laboratories usually have a queue of clients. Without a streamlined process, the wait can be anywhere between a few weeks to several months. A lot can change in in that time and business plans can get disrupted. This is still manageable if the test result comes out as expected but what if it doesn’t? Adjustments have to be made and the product sent for re-testing. And then, another round of waiting. A year can fly by this way if multiple rounds of tests are required. We can all agree that in this era where everyone’s time is equivalent to money, manufacturers can’t afford to squander it by waiting around for test results.
These two issues touched me on a personal level and set me on a journey to offer credible testing services at affordable rates in a timely manner. I admit, the services we offer are highly specialised, time consuming and involve a high degree of precision. It is no easy feat to actualise my mission but I have been fortunate to have gathered a team of well qualified microbiologists who share the same values and work tirelessly.
Although disinfectant efficacy testing formed the core of our service at the beginning, the 6200-sf facility is now fully equipped to support sterility testing, bioburden testing, environmental monitoring service and product registration & consultation. Within 10 months of incorporating Viroxy on 30 June 2016 in Kuala Lumpur, we acquired ISO/IEC 17025 accreditation, bearing testament to our diligence, capability and resolution in establishing ourselves as a formidable player in the field as a newcomer”.
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