#ISO 15189 Certification services in Malaysia

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How does ISO 15189 Certification help firms in Malaysia increase their consumer trustworthiness?

ISO 15189 Certification in Malaysia

A prestigious accreditation for medical laboratories and testing facilities in Malaysia is the ISO 15189 certification. It guarantees that these institutions adhere to the highest levels of quality and proficiency in performing medical tests and analysis. Acquiring ISO 15189 certification in Malaysia shows a dedication to providing accurate and trustworthy results, which is essential for patient safety and excellence in healthcare. To sustain the highest standards in healthcare services, this certification process includes stringent examinations, paperwork compliance, and ongoing improvement initiatives. Obtaining ISO 15189 accreditation in Malaysia improves a medical laboratory's credibility and reputation, inspiring trust in patients, healthcare providers, and regulatory bodies.  

The ISO 15189 accreditation provides comfort. It minimises the possibility of inaccurate or inconsistent results by assuring clients that the laboratory they entrust with their samples adheres to international standards. Healthcare workers may depend on the accuracy of diagnostic data from laboratories with ISO 15189 certification to make wise decisions about patient treatment, which is another benefit. 

Benefits of ISO 15189 Certification in Malaysia?

More Accurate and trustworthy Test findings: ISO 15189 assures that laboratories uphold strict quality control procedures, resulting in more accurate and trustworthy test findings. This directly affects patient care and diagnostic precision.

Improved Patient Confidence: Patients can have more faith in healthcare services knowing that results from laboratories that have earned ISO 15189 certification in malaysia will be accurate and reliable, lowering the possibility of a misdiagnosis or ineffective course of treatment.

International Standards Compliance: ISO 15189 accreditation brings Malaysian laboratories into compliance with international standards, facilitating collaboration with organisations around the world and assuring compatibility with best practises from around the world.

Global Recognition: The ISO 15189 certification is acknowledged on a global scale, facilitating international partnerships and collaborations that can enhance medical research and knowledge-sharing.

Process of ISO 15189 Certification in Malaysia

Getting Ready and Gap Analysis : Determine the exact laboratory services and procedures that will be covered by ISO 15189 certification to determine the certification's scope.

Make a management representative appointment: A responsible person or group should be chosen to manage the certification process.

To identify areas that require improvement, conduct a gap analysis by comparing your laboratory's present procedures and documentation to the criteria of ISO 15189.

Quality Management System (QMS) and documentation

Make a quality management system or update one: Establish a QMS with policies, processes, and work instructions that adhere to ISO 15189 criteria.

Create thorough documentation of all laboratory procedures and processes, including staff qualifications, equipment calibration, and quality control standards.

Acceptance of Certification:

The certification organisation evaluates audit results and makes a conclusion regarding ISO 15189 certification.

How to get ISO 15189 Certification in Malaysia?

In order to be ready, determine the certification's scope, name a representative, and carry out a gap analysis.Establish a Quality Management System that adheres to ISO 15189.Employers should educate themselves on ISO 15189 regulations and their respective duties.Conduct routine internal audits to find and correct non-conformities.The QMS should be reviewed on a regular basis by top management.Select a certified certification body.Await the certification body's conclusion before proceeding.Regular surveillance is necessary to maintain compliance.Improve procedures constantly.Recertify to ISO 15189 as necessary.

The top ISO 15189 Certification in Malaysia is offered by the company Certvalue, which charges reasonable prices for its services. According to the ISO 15189 Standard,If you are looking for ISO 15189 certification in  Malaysia then feel free to send your requirements contact@certvalue.com or visit certvalue.com and get more details or reach out to our experts.

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ISO 15189 CERTIFICATION

Achieving ISO 15189 Certification assists medical laboratories in developing their quality management system and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by regulating authorities, laboratory customers, and accreditation bodies. Overall, ISO 15189 certification demonstrates a laboratory’s commitment to providing accurate and reliable results. ISO 15189 in Malaysia is becoming increasingly popular as more medical laboratories are striving to become certified.

IAS provides a very simple yet efficient ISO 15189 certification process to help your organization achieve ISO 15189 certification in a timely manner!

Benefits of ISO 15189 Certification

Implementing ISO 15189 in Malaysia can improve medical laboratory processes and increase customer satisfaction. With ISO 15189 certification, medical laboratories can:

Enhance the quality of patient care by providing accurate results on tests Develop a systematic approach to management which helps in achieving efficiency Strengthen the institution’s reputation as one that provides high quality services Increase credibility and trust among customers Enhance customer confidence in the institution Benefit from better cost control and improved profits

Overall, ISO 15189 certification ensures that medical laboratories meet international standards for quality and accuracy. It also enables them to provide accurate results on tests, thereby enhancing patient care. By achieving ISO 15189 Certification, medical laboratories can be recognized for their commitment to providing quality services.

How to Achieve ISO 15189 Certification Through IAS?

Contact IAS by sending the Application Form and call us for a discussion to guide you in getting ISO 15189 certification.

Prepare your organization for ISO 15189 certification by implementing and practicing the standard, monitoring, and continually improving. You can even register for ISO 15189 Internal Auditor Training to train your employees on how to conduct effect internal audits of the medical laboratory quality management system. Majorly, the process of ISO 15189 certification includes 2 audit stages: Stage 1 Audit: Readiness Audit Stage 2 Audit: Verifying the Effectiveness of the System The organization applying for ISO 15189 certification will be audited based on an extensive sample of its sites, services, process, products & functions.

If there is any deviation observed during the audit, a deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS. After the effective closure of Nonconformity, ISO 15189 certification is issued with the scope that was audited.

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ISO 15189 CERTIFICATION

IMPORTANCE OF ISO 15189 CERTIFICATION

Achieving ISO 15189 Certification assists medical laboratories in developing their quality management system and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by regulating authorities, laboratory customers, and accreditation bodies. Overall, ISO 15189 certification demonstrates a laboratory’s commitment to providing accurate and reliable results. ISO 15189 in Malaysia is becoming increasingly popular as more medical laboratories are striving to become certified.

IAS provides a very simple yet efficient ISO 15189 certification process to help your organization achieve ISO 15189 certification in a timely manner!

Benefits of ISO 15189 Certification

Implementing ISO 15189 in Malaysia can improve medical laboratory processes and increase customer satisfaction. With ISO 15189 certification, medical laboratories can:

Enhance the quality of patient care by providing accurate results on tests

Develop a systematic approach to management which helps in achieving efficiency

Strengthen the institution’s reputation as one that provides high quality services

Increase credibility and trust among customers

Enhance customer confidence in the institution

Benefit from better cost control and improved profits

Overall, ISO 15189 certification ensures that medical laboratories meet international standards for quality and accuracy. It also enables them to provide accurate results on tests, thereby enhancing patient care. By achieving ISO 15189 Certification, medical laboratories can be recognized for their commitment to providing quality services.

How to Achieve ISO 15189 Certification Through IAS?

Contact IAS by sending the Application Form and call us for a discussion to guide you in getting ISO 15189 certification.

Prepare your organization for ISO 15189 certification by implementing and practicing the standard, monitoring, and continually improving. You can even register for ISO 15189 Internal Auditor Training to train your employees on how to conduct effect internal audits of the medical laboratory quality management system.

Majorly, the process of ISO 15189 certification includes 2 audit stages:

Stage 1 Audit: Readiness Audit

Stage 2 Audit: Verifying the Effectiveness of the System

The organization applying for ISO 15189 certification will be audited based on an extensive sample of its sites, services, process, products & functions.

If there is any deviation observed during the audit, a deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS. After the effective closure of Nonconformity, ISO 15189 certification is issued with the scope that was audited.

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INTEGRATED ASSESSMENT SERVICES SDN. BHD is a registered organisation in Malaysia and group company of M/s. Integrated Assessment Services Pvt. Ltd. (IAS-INDIA). IAS has its direct presence in 6 countries and its associates in 14 more countries to deliver ISO certification, ISO training activities to its customers.

From the Initial inception of 2007, it has grown in many ways in the certification business. Its directors have strong conviction in delivering quality services to its customers in transparent and efficient manner.

Iso Certification Philippines SDN. BHD will be managing its operations in Malaysia under the monitoring and guidance of IAS-INDIA. We audit and issue certification against the following popular standards such as ISO 9001, ISO 14001, ISO 22000, ISO 45001, ISO 50001, ISO 27001, ISO 20000-1, ISO 13485, TS 16949, ISO 15189 etc., and other ISO standards as per the customer’s requirements.

Having strong presence in Certification has complemented IAS in delivering training programmes on ISO Lead Auditor, Internal Auditor trainings and Awareness Training etc.

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Integrated Assessment Services is an accredited certification body for providing process certification and product certification in South Africa.

We provide ISO 15189 Certification services in South Africa and also in various countries across the globe including African countries such as Nigeria, Morocco, Kenya, Ghana, Ethiopia, etc. Also, we offer certification services in major cities of the following countries India, Malaysia, Singapore, Italy, UK, Netherlands, Germany, France, Thailand, Bangladesh, Turkey, Egypt, Oman, Qatar, Kuwait, Brazil, Mexico, etc.

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How Does ISO 17025 Help in Testing and calibration laboratories?

ISO 17025 Certification in Malaysia is a globally perceived standard it determines general prerequisites for the capability of testing and alignment research centers. The standard was created and distributed with the joint effort with the International Organization for Standardization ISO and International Electro specialized Commission IEC. ISO 17025 standard can be executed by any lab no matter what its size which completes testing and alignment rehearses. The ISO 17025 Certification is valuable for any association that requires perceiving item bundling testing strategies for their items. It incorporates a wide range of research centers, regardless of whether possessed and worked by the public authority, industry, or some other organization. Certvalue is well versed in giving ISO 17025 Certification and Consultation. We give the best ISO Consultant Services in India, Australia, Malaysia, Sri Lanka, Dubai, Qatar, and other significant Countries with the assistance of interview, execution, documentation, preparing, evaluating, and enrollment. We do give All ISO Standard help all over the planet at a reasonable expense.

The extension currently covers all the lab exercises including adjustment, testing, and inspecting related to resulting alignment and testing. The overhauled standard places the significance on the consequences of a cycle, rather than the definite depiction of its assignments and steps, term re-appropriating is supplanted by outside arrangement, accreditation body has been supplanted by the lab, a new standard has the utilization of PC frameworks, electronic records and the creation of electronic outcomes and reports which have modernized the archive. Another design has been embraced to adjust this norm to the next existing ISO IEC congruity evaluation principles like the ISO IEC 17000 series on similarity appraisal.

OUR STEPS TOWARDS ISO 17025 CERTIFICATION

·         ISO 17025 Consultant in Qatar, Micro-level overview for every single test/alignment boundary of the research center and arrangement of definite Gap Analysis report,

·         Readiness of appropriate archives expected by ISO/IEC 17025:2017 in light of detailed investigation of movements of every sort of the research center,

·         Estimation of vulnerability and giving programming to something very similar.

·         Helps in a successful execution of research facility framework by occasional visit till ISO 17025

·         Direct inner review to take a look at preparation for the ISO 17025 license.

·         Direct administration audit meeting in presence of Top Management to direct the Laboratory for powerful execution on every one of the issues connected with testing/adjustment.

·         Seeing/show of test boundary/alignment to construct certainty among the representatives and so forth

·         Pre-review and last review by certification body inspectors and help research centers in shutting the NCR given by them

Why ISO 17025 standard was modified?

The prior form of ISO IEC 17025 was the second release which was distributed in 2005 after that economic situations have changed the common angles among ISO global principles has led to the requirement for additional association among other worldwide records which are current which added to the improvement of the third version of the norm. It has been grown mutually by ISO and IEC and the advisory group on congruity appraisal (CASCO). The interaction approach of the report presently matches that of various guidelines, for example, ISO 9001, ISO 15189, and ISO IEC 17021-1. Key changes in 17025 different terms have been refreshed. Model:

·         Definition for research center has been incorporated

·         Rules for cycles and systems

·         Reported data and authoritative obligations have greater adaptability now

Another part has been added on hazard-based reasoning which leads to decrease of the norms severe rules and has been supplanted by execution based rules in test report date of issue of a report is required, the interaction approach currently matches that of various guidelines, for example, ISO 9001 Quality Management System, ISO 15189 Quality of Medical Laboratories and ISO IEC 17021-1 prerequisites for affirmation bodies.

Advantages of being certified ISO 17025 in Dubai:

·         Increase lab validity

·         National and International acknowledgment

·         Public and Industry acknowledgment

·         Provide worldwide identicalness

·         Decision producers can depend on test results

·         Engagement of representatives and staff inspiration

·         Saves cash by getting it right the first time.

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What ISO 17025 certification brings to the Organization?

ISO 17025 Certification in Malaysia is the QMS head standard used by different testing and change labs. This International Standard calls attention to the overall necessities that are expected to finish the tests or adjustments with samplings. It indicates the exercises that should be remembered for research facility tasks. It assists with getting the capacity to deliver legitimate and reliably dependable testing, alignment, and inspecting results. ISO 17025 is one of the administrations presented by Certvalue, the worldwide counseling and accreditation arrangements supplier. The labs and testing focuses could get the ISO 17025 accreditation to further develop norms and increment effectiveness. We convey ISO 17025 certificate administrations across the world. By getting ISO 17025 Certification there is a chance for expanded business openings in both existing and developing business sectors. There is additionally an overall improvement like the help/item given to the customer.

Our Steps towards ISO 17025

·         ISO 17025, Micro–level outline for every test/change limit of the exploration place and availability of unequivocal Gap Analysis report,

·         Arrangement of suitable documents required by ISO/IEC 17025:2017 ward on nitty-gritty examination of all activities of the exploration community,

·         ISO/IEC 17025:2017 getting ready to all levels of delegates inside the lab,

·         Computation of assessment of weakness and giving programming to something practically the same.

·         Helps in incredible execution of lab structure by intermittent visit till ISO 17025 Certification Consultants in India

·         Direct an internal audit to take a look at the situation with the ISO 17025 accreditation

·         Lead the board review meeting in presence of Top Management to coordinate the Laboratory for fruitful execution on all of the issues related to testing/change.

·         Seeing/appearing of test limit/acclimation to manufacture conviction among the delegates, etc.

·         Pre-audit and last survey by accreditation body reviewers and assist with exploring offices in closing the NCR given by them

Why ISO 17025 By Certvalue?

Certvalue is an ISO 17025 Consultant in Sri Lanka, we are offering support beginning around 2017, Our Expertise will assist you with getting the ISO affirmation. The ISO 17025 overall standard for labs can be embraced by all labs performing testing, change, or inspecting. Assuming the lab has presumed that they need to offer of real value capable, capable testing organizations, accreditation is a strong affirmation to customers that it offers critical organizations and makes a commitment of trust for those organizations. ISO 17025 offers labs the opportunity to unendingly stay aware of the muddled course of testing and to achieve a more critical degree of significant worth in their organization structure.

Advantages of being ISO 17025 certified:

·         Increase lab believability

·         National and International acknowledgment

·         Public and Industry acknowledgment

·         Provide worldwide proportionality

·         Decision producers can depend on test results

·         Engagement of workers and staff inspiration

·         Saves cash by getting it right the first time.

Why ISO 17025 standard was amended?

Prior rendition of ISO 17025 Services in Qatar was the second version which was distributed in 2005 later that economic situations have changed the common viewpoints among ISO global norms has to lead the requirement for additional association among other worldwide reports which are current which added to the advancement of the third release of the norm. It has been grown mutually by ISO and IEC and the panel on similarity evaluation (CASCO). The interaction approach of the report currently matches that of various forms, for example, ISO 9001, ISO 15189, and ISO IEC 17021-1. Key changes in 17025 different terms have been refreshed. Model:

·         Definition for research facility has been incorporated

·         Rules for cycles and methodology

·         Reported data and authoritative obligations have greater adaptability now

Another part has been added on hazard-based reasoning which leads to decrease of the norms severe rules and has been supplanted by execution based rules in test report date of issue of a report is required, the interaction approach presently matches that of various guidelines, for example, ISO 9001 Quality Management System, ISO 15189 Quality of Medical Laboratories and ISO IEC 17021-1 prerequisites for certification bodies.

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ISO Certifying Bodies in Philippines

INTEGRATED ASSESSMENT SERVICES SDN. BHD will be managing its operations in Malaysia under the monitoring and guidance of IAS-INDIA. We audit and issue certification against the following popular standards such as ISO 9001, ISO 14001, ISO 22000, ISO 45001, ISO 50001, ISO 27001, ISO 20000-1, ISO 13485, TS 16949, ISO 15189 etc., and other ISO standards as per the customer’s requirements.