What is Laboratory Accreditation?

 Laboratory accreditation is a formal recognition earned by organizations proving they are

qualified, competent, and comply with international standards.
 Lab accreditation is a process by which an authoritative body gives formal recognition that an
organization is competent to carry out specific tasks.

Why is Laboratory Accreditation Important?

 It shows that an organization and its personnel are qualified and competent.
 It also inspires confidence in test results and assures customers of a product or service’s quality,
strengthening an organization’s credibility.
 It allows organizations from all over the world to more easily sell their products and services in
other countries.

What are the Major Steps of Laboratory Accreditation Process?

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The laboratory accreditation process typically involves several major steps to ensure that a
laboratory meets specific standards of quality and competence. Here are the general steps:

Preparation and Application:

1. The laboratory decides to pursue accreditation and selects an accrediting body that
aligns with its needs and the industry standards it must meet.
2. Application forms are completed and submitted to the accrediting body, often
including detailed documentation about the laboratory's operations, quality
management system, and procedures.

Document Review:

1. The accrediting body conducts an initial review of the laboratory’s documentation,

including quality manuals, standard operating procedures (SOPs), and records of
previous testing and calibration.

On-site Assessment (Audit):

1. A team of auditors appointed by the accrediting body visits the laboratory to conduct a
thorough on-site assessment.
2. The audit typically includes interviews with personnel, observations of processes and
procedures, review of documentation and records, and assessment of the laboratory’s
facilities and equipment.

Audit Report:

1. The audit team compiles a detailed report documenting their findings during the on-
site assessment.
2. This report highlights areas of compliance, non-conformance (if any), and
opportunities for improvement.

Corrective Actions:

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 1. If any non-conformities are identified during the audit, the laboratory is required to
develop corrective action plans.
2. These plans detail how and when the issues will be resolved, ensuring that the
laboratory meets the required standards.

Decision and Accreditation:

1. Based on the audit findings and the effectiveness of corrective actions, the accrediting
body makes a decision regarding accreditation.
2. If the laboratory meets all the standards and requirements, accreditation is granted.
Otherwise, further actions or assessments may be required.

Continuous Improvement and Surveillance:

1. Accredited laboratories are typically subject to regular surveillance audits to ensure

ongoing compliance with standards.
2. Laboratories are also encouraged to continually improve their processes and quality
management systems to maintain accreditation.

Each accrediting body may have specific variations or additional steps in their process, but these are
the fundamental stages involved in the laboratory accreditation process.

Benefits of Laboratory Accreditation

Formal recognition of the competence of a laboratory by AERSSC in accordance with international

criteria has many advantages:

 A ready means for customers to identify and select reliable testing, measurement and calibration
services that can meet their needs.
 Increased confidence in Testing/ Calibration Reports issued by the testing, calibration and
medical testing laboratories which emphasize accuracy and reliable results.
 The results from accredited laboratories are used extensively by regulators for the public benefit
in the provision of services that promote an unpolluted environment, safe food, clean water,
energy, health and social care services.
 Better control of laboratory operations and feedback to laboratories as to whether they have
sound Quality Assurance systems and are technically competent.
 Helpful in participating in tenders that require independently verified laboratories.
 Potential increase in business due to enhanced customer confidence and satisfaction. Accredited
laboratories receive a form of international recognition, which allows their data and results to be
more readily accepted in overseas markets.
 Accreditation helps to reduce costs for manufacturers and exporters who have their products or
materials tested in accredited laboratories, by reducing or eliminating the need for retesting in
another country.
 Users of accredited laboratories enjoy greater access for their products, in both domestic and
international markets.
 Savings in terms of time and money due to reduction or elimination of the need for re-testing of
products.

ISO 17025 Certification in Nepal

ISO 17025 Certification in Nepal is a significant accreditation for laboratories, showcasing their
competence and adherence to international testing and calibration standards. It ensures the accuracy
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and reliability of test results and calibration data. For laboratories servicing a variety of industries,
including healthcare, industrial, and environmental testing, ISO 17025 Certification in Nepal is
essential to show their dedication to quality.

Merits of ISO 17025 Certification In Nepal

Among the best benchmark for Continuous improvement and self-correction is ISO/IEC 17025
standard and the labs that are involved with testing and calibration experiencing 17025 requirements
has many benefits now let’s see few of these:

 It improves the reliability of the test results and reports that are generated by the lab
 It provides an effective and efficient management system for all the processes and ensures
adequate documentation
 An effective work management system could be ensured by conserving valuable money and
time and this is done by getting the needs of 17025 standard
 The lapse, which is well maintained, will make certain the appropriate and valid testing and
calibration of their equipment.
 There could be confidence and awareness of quality in the test and calibrated results and reports
 By providing precise results the labs can gain a powerful competitive advantage and can reduce
the customer requirements
 It aids the labs to define policies, actions, and goals to have a strategic target for a company.
The standard creates a proactive risk-based quality and Company culture
 By using the newest Documentation, technologies analyzing, and calibration methods must be
Reviewed and audited and ISO/IEC 17025 that guarantees the credibility of this Laboratories
can do this.

Why is ISO 17025 Certification in Nepal Laboratory Management System important for you?

Becoming certified against ISO 17025 Services in Nepal demonstrates your commitment to
implement the requirements of this standard. As a certified professional, you will enable your
company to become technically proficient and produce accurate test and calibration data. In
addition, you will be able to increase your job opportunities because there are many large laboratory
companies which will value your comprehensive knowledge as a professional in this field. ISO
17025 in Nepal As a matter of fact, many organizations have started to offer contracts only to
certified professionals and laboratories, as the majority of customers prefer to receive services from
certified labs, consequently, enabling you to maximize your earning potential

Who needs ISO 17025 certification in Nepal?

ISO 17025:2017 is useful for any company that performs testing, sampling or calibration and wants
reliable results. This consists of all sorts of laboratories, whether they be owned and operated with
the aid of government, industry or, in fact, any different company. ISO 17025 in Nepal standard is
also effective to universities, research centers, governments, regulators, inspection bodies, product
certification companies and other conformity assessment bodies with the need to do testing,
sampling or calibration.

Benefits of ISO 17025:2017 Certification in Nepal

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International Reputation

When you grow to be authorized for your laboratory will be capable of winning an exquisite
recognition and showing that it has excessive standards, inserting it above competitors.
Furthermore, when you have a good reputation amongst auditors and regulatory departments, this
will help enhance the lab’s recognition now not only locally, but nationally and internationally.

Cost Reduction

ISO 17025 Cost in Nepal has strict hints and requires labs to carefully monitor results. Getting
correct and particular results helps minimize the lab’s operational costs. When retesting is reduced,
money will be saved. Overall, the popular creates parameters to manipulate over lab operations and
therefore drives the operational costs down.

Systematic Approach

ISO 17025 in Nepal requires labs to have taken a systematic method to their activities. As a result,
this helps control lab protocols in place.

Improved Lab Testing Environment

Validity and appropriateness of test methods under prescribed lab surroundings results in more
accurate outcomes. This ISO 17025 ensures quality to customers, and also for your lab. When lab
testing is enhanced it will save you time and number of tests and in return save your money. The
ISO 17025 Implementation in Nepal standard also has exacting guidelines for instruments and
equipment, which in return results in reduced repairs and defect levels.

Documentation

ISO 17025 Certification in Nepal requires appropriate documentation of all processes, changes
made blunders or discrepancies and helps mitigate problems, all in all imparting steadiness and
better consequences for the lab. When the suitable documentation is followed, the staff will become
more accountable.

INTRODUCTION TO AERSSC

Accreditation Education Research & Scientific Service Center (AERSSC), Nepal an independent
Accreditation Body, engaged in the accreditation of Conformity Assessment Bodies (CABs) is a
part of Accreditation Education Research and Scientific Service Center (AERSSC) Pvt. Ltd.
Accreditation Education Research & Scientific Service Center (AERSSC), Nepal operates an
Accreditation System with impartiality, fairness, efficiency, and transparency to achieve
international recognition.
ILAC (International Laboratory Accreditation Cooperation) is the international organization
for accreditation bodies operating in accordance with ISO/IEC 17011 and involved in the
accreditation of conformity assessment bodies including calibration laboratories (using ISO/IEC
17025), testing laboratories (using ISO/IEC 17025), medical testing laboratories (using ISO 15189),
inspection bodies (using ISO/IEC 17020), proficiency testing providers (using ISO/IEC 17043) and
reference material producers (using ISO 17034).
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International Accreditation Forum (IAF) is a worldwide association of accreditation bodies and
other bodies interested in conformity assessment in the fields of management systems (using
ISO/IEC 17021), products, processes, services (using ISO/IEC 17065), personnel (using ISO/IEC
17024), validation and verification (using ISO/IEC 17029) and other similar programmes of
conformity assessment.

Asia Pacific Accreditation Cooperation (APAC)‘s primary role is to manage and expand a mutual
recognition arrangement (MRA) among accreditation bodies in the Asia Pacific region.

What’s the ISO 17025 certification mean?

ISO 17025 standard Prove the competent calibration lab to have a global structure. The practices
that take place within the laboratory must have a clarified structure which must be known by a
proper person. The laboratory must consist of a manual which must define the roles and
responsibility of each team. As resourceful as the standard ISO 17025 the execution must include
individual resources with a successful mindset. Laboratory experts must understand the specific
requirements are the times to run tests. The samples that are offered by the customers must be
assessed well and quality checks are done frequently. By proving the quality checks and other
regular basis performances the calibration could be gotten as a valued result. Producing a valid
result is the most important factor for a laboratory with or without certification. ISO 17025 standard
accredited organization is going to have a technical session that states and demonstrates precision is
the most significant element

Step-by-Step Guide to Laboratory Accreditation:

1. Assess Accreditation Requirements:

Begin by researching and understanding the accreditation requirements applicable to your

laboratory's scope of testing or calibration activities. Identify the relevant accreditation bodies,
standards, and guidelines applicable to your geographical location and specialty area.

2. Establish Quality Management System (QMS):

Develop and implement a robust Quality Management System (QMS) tailored to your laboratory's
specific needs and objectives. A comprehensive QMS should encompass policies, procedures,
documentation, training programs, and quality control measures to ensure compliance with
accreditation standards.

3. Conduct Gap Analysis:

Perform a thorough gap analysis to identify areas where your laboratory's current practices and
processes deviate from accreditation requirements. Address any deficiencies by implementing
corrective and preventive actions (CAPAs) to bring your laboratory into compliance.

4. Document Policies and Procedures:

Document all policies, procedures, and protocols related to testing, calibration, quality control,
equipment maintenance, personnel training, and other aspects of laboratory operations. Ensure that
documentation is comprehensive, up-to-date, and accessible to laboratory staff.
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5. Implement Quality Control Measures:

Establish robust quality control measures to monitor the accuracy, precision, and reliability of
testing and calibration processes. Implement internal quality control procedures, proficiency testing,
and external quality assurance programs to ensure the validity of laboratory results.

6. Train Personnel:

Provide comprehensive training and education programs for laboratory personnel involved in
testing, calibration, sample handling, data analysis, and quality assurance activities. Ensure that the
staff members are adequately trained and competent to perform their respective roles and
responsibilities.

7. Prepare Documentation:

Compile all necessary documentation and evidence required for the accreditation process, including
policies, procedures, quality records, proficiency testing results, training records, equipment
maintenance logs, and other relevant documentation.

8. Select an Accreditation Body:

Choose an accredited accreditation body or regulatory agency that aligns with your laboratory's
scope of testing or calibration activities and geographical location. Research the accreditation
criteria, application process, fees, and timeline for accreditation.

9. Submit Application:

Ensure all required documentation and evidence are included when submitting the accreditation
application to the chosen body. Follow the accreditation body's instructions and guidelines for
applying.

10. Undergo On-Site Assessment:

Prepare for and undergo an on-site assessment or audit conducted by the accreditation body's
assessors. The assessors will evaluate your laboratory's compliance with accreditation standards,
review documentation, observe testing processes, and interview laboratory staff.

11. Address Findings and Recommendations:

Address any findings or recommendations identified during the on-site assessment by

implementing corrective actions and improvements as necessary. Work closely with the
accreditation body to resolve any issues and ensure compliance with accreditation standards.

12. Receive Accreditation:

After completing the accreditation process and meeting all requirements, your laboratory will be
accredited for a certain period, and re-accreditation may be necessary.

प्रयोगशाला मान्यताको लागि चरण-दर-चरण गाइड:

1. मान्यता आवश्यकताहरू मूल्याङ्कन गर्नुहोस्:

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तपाईंको प्रयोगशालाको परीक्षण वा क्यालिब्रेसन गतिविधिहरूको दायरामा लागू हुने मान्यता आवश्यकताहरू
अनुसन्धान र बुझेर सुरु गर्नुहोस्। तपाईंको भौगोलिक स्थान र विशेषता क्षेत्रमा लागू हुने सान्दर्भिक मान्यता
निकायहरू, मापदण्डहरू र दिशानिर्देशहरू पहिचान गर्नुहोस्।

2. गुणस्तर व्यवस्थापन प्रणाली (QMS) स्थापना गर्नुहोस्:

तपाईंको प्रयोगशालाको विशेष आवश्यकता र उद्देश्यहरू अनुरूप एक बलियो गुणस्तर व्यवस्थापन प्रणाली (QMS)
विकास र कार्यान्वयन गर्नुहोस्। एक व्यापक QMS ले मान्यता मापदण्डहरूको अनुपालन सुनिश्चित गर्न नीतिहरू,
प्रक्रियाहरू, कागजातहरू, प्रशिक्षण कार्यक्रमहरू, र गुणस्तर नियन्त्रण उपायहरू समावेश गर्नुपर्छ ।

3. अन्तर विश्लेषण सञ्चालन गर्नुहोस्:

तपाईंको प्रयोगशालाको हालको अभ्यास र प्रक्रियाहरू मान्यता आवश्यकताहरूबाट विचलित हुने क्षेत्रहरू पहिचान
गर्नको लागि विस्तृत अन्तर विश्लेषण गर्नुहोस्। तपाईंको प्रयोगशालालाई अनुपालनमा ल्याउन सुधारात्मक र
निवारक कार्यहरू (CAPAs) लागू गरेर कु नै पनि कमीहरूलाई सम्बोधन गर्नुहोस्।

4. कागजात नीति र प्रक्रियाहरू:

परीक्षण, क्यालिब्रेसन, गुणस्तर नियन्त्रण, उपकरण मर्मत, कर्मचारी प्रशिक्षण, र प्रयोगशाला सञ्चालनका अन्य
पक्षहरूसँग सम्बन्धित सबै नीतिहरू, प्रक्रियाहरू, र प्रोटोकलहरू कागजात गर्नुहोस्। सुनिश्चित गर्नुहोस् कि
कागजातहरू व्यापक, अप-टु -डेट, र प्रयोगशाला कर्मचारीहरूको लागि पहुँचयोग्य छ।

5. गुणस्तर नियन्त्रण उपायहरू लागू गर्नुहोस्:

परीक्षण र क्यालिब्रेसन प्रक्रियाहरूको शुद्धता, परिशुद्धता र विश्वसनीयता निगरानी गर्न बलियो गुणस्तर नियन्त्रण
उपायहरू स्थापना गर्नुहोस्। प्रयोगशाला परिणामहरूको वैधता सुनिश्चित गर्न आन्तरिक गुणस्तर नियन्त्रण
प्रक्रियाहरू, प्रवीणता परीक्षण, र बाह्य गुणस्तर आश्वासन कार्यक्रमहरू लागू गर्नुहोस्।

६. ट्रेन कर्मचारी:

परीक्षण, क्यालिब्रेसन, नमूना ह्यान्डलिंग, डाटा विश्लेषण, र गुणस्तर आश्वासन गतिविधिहरूमा संलग्न प्रयोगशाला
कर्मचारीहरूको लागि व्यापक प्रशिक्षण र शिक्षा कार्यक्रमहरू प्रदान गर्नुहोस्। कर्मचारी सदस्यहरू आ-आफ्नो भूमिका र
जिम्मेवारीहरू पूरा गर्न पर्याप्त रूपमा प्रशिक्षित र सक्षम छन् भनी सुनिश्चित गर्नुहोस्।

7. कागजात तयार गर्नुहोस्:

नीतिहरू, प्रक्रियाहरू, गुणस्तर अभिलेखहरू, प्रवीणता परीक्षण परिणामहरू, प्रशिक्षण रेकर्डहरू, उपकरण मर्मत
लगहरू, र अन्य सान्दर्भिक कागजातहरू सहित मान्यता प्रक्रियाको लागि आवश्यक सबै आवश्यक कागजातहरू र
प्रमाणहरू कम्पाइल गर्नुहोस्।

8. एक मान्यता निकाय चयन गर्नुहोस्:

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तपाईंको प्रयोगशालाको परीक्षण वा क्यालिब्रेसन गतिविधि र भौगोलिक स्थानको दायरासँग मिल्ने मान्यता प्राप्त
मान्यता प्राप्त निकाय वा नियामक निकाय छान्नुहोस्। मान्यता मापदण्ड, आवेदन प्रक्रिया, शुल्क, र मान्यता को
लागी समयरेखा अनुसन्धान गर्नुहोस्।

9. आवेदन पेश गर्नुहोस्:

छनोट गरिएको निकायमा मान्यता आवेदन पेश गर्दा सबै आवश्यक कागजातहरू र प्रमाणहरू समावेश छन् भनी
सुनिश्चित गर्नुहोस्। आवेदनको लागि मान्यता निकायको निर्देशन र दिशानिर्देशहरू पालना गर्नुहोस्।

10. साइटमा मूल्याङ्कन गर्नुहोस्:

मान्यता निकायका मूल्याङ्कनकर्ताहरूद्वारा गरिएको साइट मूल्याङ्कन वा लेखा परीक्षणको लागि तयारी गर्नुहोस् र
पास गर्नुहोस्। मूल्याङ्कनकर्ताहरूले तपाइँको प्रयोगशालाको मान्यता मापदण्डहरूको अनुपालनको मूल्याङ्कन
गर्नेछन्, कागजातहरूको समीक्षा गर्नेछन्, परीक्षण प्रक्रियाहरू अवलोकन गर्नेछन्, र प्रयोगशाला कर्मचारीहरूको
अन्तर्वार्ता लिनेछन्।

11. ठे गाना खोज र सिफारिसहरू:

साइट मूल्याङ्कनका क्रममा पहिचान गरिएका कु नै पनि निष्कर्ष वा सिफारिसहरूलाई आवश्यक अनुसार सुधारात्मक
कार्यहरू र सुधारहरू लागू गरेर सम्बोधन गर्नुहोस्। कु नै पनि समस्या समाधान गर्न र मान्यता मापदण्डहरूको
अनुपालन सुनिश्चित गर्न मान्यता निकायसँग नजिकबाट काम गर्नुहोस्।

12. मान्यता प्राप्त गर्नुहोस्:

मान्यता प्रक्रिया पूरा गरेपछि र सबै आवश्यकताहरू पूरा गरेपछि, तपाईंको प्रयोगशाला निश्चित अवधिको लागि
मान्यता प्राप्त हुनेछ, र पुन: मान्यता आवश्यक हुन सक्छ।