#ISO 17043 standard
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Implement the ISO/IEC 17043:2023 Proficiency Testing Standard Changes as Per the Revised Standard
The general requirements for the creation, management, and expertise of proficiency testing scheme providers are outlined in ISO/IEC 17043. These specifications can serve as the basis for more detailed technical specifications for particular domains and are meant to be general for all types of proficiency testing schemes. It is commonly acknowledged that proficiency testing (PT) is a crucial instrument for proving the expertise of conformity assessment bodies. PT can demonstrate expertise and act as a warning sign for hidden or developing issues.
#iso17043#iso17043proficiencytesting#iso17043accreditation#iso 17043:2023 standard#iso 17043:2023 documents
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Punyam Academy – A globally recognized training provider and a leading name in E-learning, training, documentation and certification for various international management systems – has launched the latest and updated ISO 17043:2023 certified auditor training online course and completely editable ISO/IEC 17043:2023 documentation kit, which are based on the 2nd edition (current version) of ISO/IEC 17043 standard published in year 2023. Now any proficiency testing providers, ISO 17043 consultants, ISO/IEC 17043 auditors who want to update their knowledge of new standard, job seekers who want to make a career as a certified ISO/IEC 17043 assessor and any desirous individuals, can enrol in this globally certified ISO/IEC 17043:2023 online auditor course.
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What is Proficiency Testing & Why is it important?
With inter-laboratory comparisons, Proficiency testing (PT) is the evaluation of participant performance against pre-established criteria according to ISO/IEC 17043:2010 standard. Or we can say, a proficiency test is a method that used to demonstrate competency and validate a laboratory’s measurement process by comparing results to the results of a participant laboratories and other reference laboratories.
A coordinating body sends a test item or in other words reminder to a reference laboratory for testing. Each participant laboratory will test the item independently, submit their results to the coordinating body, and forward the item to the next participating laboratory. The item is returned to the coordinating body after each participating laboratory has completed testing. To each participating laboratory, the coordinating body will evaluate the all the test results and issue a performance report.
Importance of Proficiency Testing
For Several reasons Proficiency Testing is important. Basically, it enables your laboratory to demonstrate competency for a particular measurement discipline which can be used to validate;
A measurement method;
Technical training of personnel;
Traceability of standards, and
Estimates of measurement uncertainty.
Imagine that A new measurement or testing capability to your scope of accreditation is added that your laboratory. Even with all of that hard work, times, and money invested into your new process. Your laboratory can externally validate your new measurement or testing process with participating in proficiency testing. Hence, the reason accreditation body requires you to successfully complete a proficiency test before they will add it to your scope of accreditation.
One of the proficiency test providers - ISO 17043:2010 Accreditation Consultancy is assisting with system implementation, preparation of ISO 17043 documents, including ISO 17043 manual, as well as conducting training programs on system awareness and training of auditors; The team of experienced ISO 17043 accreditation consultants offers guidance on ISO 17043 accreditation and documentation.
Behind the goal of editable ISO 17043 Documents is to support proficiency test provider in ISO 17043:2010 documentation and give confidence to their customers, regulating authorities and accreditation bodies, As well as ISO 17043 consultants that meet all documentation requirements. Accreditationconsultancy.com provides services which are helpful for proficiency test provider to achieve ISO 17043:2010 accreditation in minimum time and cost.
You could possibly require (both mandatory and optional) every document template for ISO 17043, as well as additional work instructions, project tools and documentation structure guidance, the really is the most comprehensive option - ISO 17043 Documentation Toolkit on the market for completing your documentation.
Advantages of ISO 17043 documents for proficiency test provider’s accreditation
Easily modifiable templates according to your requirements.
For establishing good ISO 17043 system, Helps in fine-tuning the processes.
To prepare any document that saves much time and cost.
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To determine the baseline system of ISO 17043 that satisfies requirements for personnel certification body as well as covers its principles.
#ISO/IEC 17043:2010 standard#Proficiency Testing#ISO 17043:2010 Accreditation Consultancy#ISO 17043 documents#ISO 17043 manual#ISO 17043 accreditation consultants#ISO 17043 accreditation#ISO 17043 consultants#ISO 17043:2010 documentation#ISO 17043:2010 accreditation#ISO 17043 Documentation Toolkit
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Why ISO 9001 Certification in Kuwait
Why ISO 9001 Certification in Kuwait?
ISO 9001 Certification in Kuwait sets out customize the factors for a high-quality management system and is that the sole standard within the family which will be certified to (although this is often not a requirement). It will be utilized by any organization, giant or tiny, notwithstanding its field of activity. In fact, their square measure over one thousand to thousand firms and organizations in over a hundred and seventy countries certified to ISO 9001.
This customary is predicated on a variety of quality management principles as well as a robust client focus, the motivation and implication of prime management, the method approach, and continual improvement. These principles square measure explained in additional detail in ISO’s Quality management principles. exploitation ISO 9001 helps make sure that customers get consistent, good-quality merchandise and services, that successively brings several business edges.
How to get a certification of iso 9001
For obtaining certification of ISO 9001 Certification in Kuwait, foremost selected the certification body
When selecting a certification body, you should,
Evaluate many certification bodies.
Check if the certification body uses the relevant CASCO customary
Check if it's authorized. certification isn't mandatory, and non-accreditation doesn't essentially mean it's not respected, however it will offer freelance confirmation of competency. to search out associate authorized certification body, contact the national certification body in your country or visit the International certification Forum.
INTERNATIONAL ORGANIZATIONS IN COOPERATION WITH ISO FOR certification
The International certification Forum (IAF) is that the world association of Conformity Assessment Certification Bodies and alternative bodies fascinated by conformity assessment within the fields of management systems, products, services, personnel, and alternative similar programs of conformity assessment.
In this ISO 9001 Consultant in Kuwait ILAC is that the alliance for certification bodies operative in accordance with ISO/IEC 17011and concerned within the certification of conformity assessment bodies as well as standardization laboratories (using ISO/IEC 17025), testing laboratories (using ISO/IEC 17025), medical testing laboratories (using ISO 15189), scrutiny bodies (using ISO/IEC 17020) and proficiency testing suppliers (using ISO/IEC 17043).
WHERE am I able to resolve a lot concerning AUDITING ISO 9001?
Support on auditing quality management systems will be found on the website of the ISO 9001 Auditing Practices cluster. this is often an off-the-cuff cluster of quality management system specialists, auditors, and practitioners from ISO/TC 176 and therefore the International certification Forum.
DOES MY ORGANIZATION want CERTIFICATION TO ISO 9001?
Checking that the system works may be an important part of ISO 9001. it's counseled that a company performs internal audits to envision however its quality management system is functioning. a company could attempt to invite an associate freelance certification body to verify that it's in conformity to the quality, however, there's no demand for this. as an alternative, it would invite its shoppers to audit the standard system for themselves.
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R304 – General Requirements: ISO 17034 Reference Material Producer Accreditation Program R307 - General Requirements - Accreditation of ISO-IEC 17065 Product Certification Bodies R311 - Specific Requirements - Federal Risk and Authorization Management Program. ISO/IEC 17025 for Testing/Calibration Laboratories ISO 15189 and CLIA for Clinical Testing Laboratories. ISO/IEC 17020 for Inspection Bodies ISO/IEC 17043 for Proficiency Testing Providers. A2LA is governed by a Board of Directors. International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA.
The latest iteration of ISO 17025:2017 was revised for harmonization with ISO 9001:2015. Whenever changes are applied to standards, the first questions that come to mind are: “Which documents are required?” and “How many documents are required?” For currently accredited systems, your questions may be something like: “What changes are required to our current documents?” or “What new documents do we need to generate to ensure compliance?” The ISO 17025:2017 standard actually requires fewer documents than the 2005 revision. In this article, you’ll find a snapshot of what documents you need to have to be compliant with the 2017 revision of ISO 17025.
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Mandatory documents for ISO 17025:2017
The documents listed below are must-haves according to ISO 17025:2017. Keep in mind that if you exclude some of the clauses from the scope of your implementation, then documents for those clauses will not be required for your lab.
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Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
Quality Policy (Clauses 8.2.1 & 8.2.2)
Competence, Training and Awareness Procedure (Clause 6.2.5)
Externally Provided Products and Services Procedure (Clause 6.6.2)
Facilities and Environment Procedure (Clause 6.3)
Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
Customer Service Procedure (Clauses 7.1.1 & 8.6)
Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)
Mandatory records for ISO 17025:2017
Records are generated to demonstrate compliance with the standard and related internal procedures and serve as evidence during audits. Here are all the required records according to ISO 17025:2017:
List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
List of Types of Records (Clause 8.4)
Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
Quality Objectives (Clauses 8.2.1 & 8.2.2)
Training Program (Clause 6.2.3)
Training Record and Performance Monitoring (Clause 6.2.2)
Record of Attendance (Clause 6.2.2)
Competence Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
Supplier Evaluation and Approval Record (Clause 6.6.2a)
List of Approved Suppliers of Products and Services (Clause 6.6.2a)
Record of Laboratory Environmental Controls (Clause 6.3.3)
List of Laboratory Equipment (Clause 6.4.13a)
Calibrated Equipment Record (Clause 6.4.13a)
Calibration Record (Clause 6.4.13e)
Equipment Maintenance Record (Clause 6.4.13g)
Customer Order Review (Clause 7.1.1a)
Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
Sampling Plan (Clause 7.3.1) (as applicable)
Sampling Report (Clause 7.3.3) (as applicable)
Corrective Action Report (Clause 8.7.3)
Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
Measurement Uncertainty Record (Clause 7.6.3)
Audit Nonconformity Report (Clause 8.8.2d)
Internal Audit Report (Clause 8.8.2e)
Management Review Record (Clause 8.9.2)
Commonly used non-mandatory ISO 17025 documents and records
You should also maintain any other documents and records that you have identified as necessary to ensure your management system can be maintained efficiently and improve over time, such as:
Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
Report of Customer Satisfaction (Clause 8.6.2)
Internal Audit Procedure (Clause 8.8.2)
Management Review Procedure (Clause 8.9)
Think of the enormous benefit to you and your laboratory
You might be overwhelmed with all the documents and records listed here, but try to think in a positive way – such documents will help you organize your laboratory in a better way, and help you not to forget something that might prove to be very important.
Hurricane chris 51 50 ratchet download zip. For more help with managing the documents and all other aspects of the implementation project, download this free, easy-to-use Project Plan for ISO/IEC 17025 implementation.
About the author:
Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and the FBI’s QAS.
The latest iteration of ISO 17025:2017 was revised for harmonization with ISO 9001:2015. Whenever changes are applied to standards, the first questions that come to mind are: “Which documents are required?” and “How many documents are required?” For currently accredited systems, your questions may be something like: “What changes are required to our current documents?” or “What new documents do we need to generate to ensure compliance?” The ISO 17025:2017 standard actually requires fewer documents than the 2005 revision. In this article, you’ll find a snapshot of what documents you need to have to be compliant with the 2017 revision of ISO 17025.
Mandatory documents for ISO 17025:2017
The documents listed below are must-haves according to ISO 17025:2017. Keep in mind that if you exclude some of the clauses from the scope of your implementation, then documents for those clauses will not be required for your lab.
Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
Quality Policy (Clauses 8.2.1 & 8.2.2)
Competence, Training and Awareness Procedure (Clause 6.2.5)
Externally Provided Products and Services Procedure (Clause 6.6.2)
Facilities and Environment Procedure (Clause 6.3)
Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
Customer Service Procedure (Clauses 7.1.1 & 8.6)
Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)
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Mandatory records for ISO 17025:2017
Records are generated to demonstrate compliance with the standard and related internal procedures and serve as evidence during audits. Here are all the required records according to ISO 17025:2017:
List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
List of Types of Records (Clause 8.4)
Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
Quality Objectives (Clauses 8.2.1 & 8.2.2)
Training Program (Clause 6.2.3)
Training Record and Performance Monitoring (Clause 6.2.2)
Record of Attendance (Clause 6.2.2)
Competence Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
Supplier Evaluation and Approval Record (Clause 6.6.2a)
List of Approved Suppliers of Products and Services (Clause 6.6.2a)
Record of Laboratory Environmental Controls (Clause 6.3.3)
List of Laboratory Equipment (Clause 6.4.13a)
Calibrated Equipment Record (Clause 6.4.13a)
Calibration Record (Clause 6.4.13e)
Equipment Maintenance Record (Clause 6.4.13g)
Customer Order Review (Clause 7.1.1a)
Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
Sampling Plan (Clause 7.3.1) (as applicable)
Sampling Report (Clause 7.3.3) (as applicable)
Corrective Action Report (Clause 8.7.3)
Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
Measurement Uncertainty Record (Clause 7.6.3)
Audit Nonconformity Report (Clause 8.8.2d)
Internal Audit Report (Clause 8.8.2e)
Management Review Record (Clause 8.9.2)
Commonly used non-mandatory ISO 17025 documents and records
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You should also maintain any other documents and records that you have identified as necessary to ensure your management system can be maintained efficiently and improve over time, such as:
Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
Report of Customer Satisfaction (Clause 8.6.2)
Internal Audit Procedure (Clause 8.8.2)
Management Review Procedure (Clause 8.9)
Think of the enormous benefit to you and your laboratory
You might be overwhelmed with all the documents and records listed here, but try to think in a positive way – such documents will help you organize your laboratory in a better way, and help you not to forget something that might prove to be very important.
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For more help with managing the documents and all other aspects of the implementation project, download this free, easy-to-use Project Plan for ISO/IEC 17025 implementation.
About the author:
Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and the FBI’s QAS.
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NABL accredited laboratory in Chennai
NABL National Accreditation Board for Testing & Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories). NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC 17025, ISO 15189, ISO/IEC 17043 & ISO 17034:2016 Standards. It has Mutual Recognition Arrangement (MRA) with Asia Pacific Laboratory Accreditation Cooperation (APLAC), International Laboratory Accreditation Cooperation (ILAC). NABL is a constituent board of Quality Council of India which is an autonomous body setup under Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India NABL provides accreditation in all major fields of Science and Engineering such as Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological, Thermal & Forensics disciplines under testing facilities and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical & Radiological disciplines under Calibration facilities. In the field of Medical Testing laboratories accreditation is granted in Clinical Biochemistry, Clinical Pathology, Haematology & Immunohaematology, Microbiology & Serology, Histopathology, Cytopathology, Genetics, Nuclear Medicine (In-vitro tests only) disciplines. In addition, NABL offers accreditation for Proficiency testing providers & Reference Material producers for which it has APLAC MRA. Benefits of accreditation NABL is a Full member (ILAC MRA signatory) to ILAC as well as APLAC Mutual Recognition Arrangements (MRA), based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent. Read More
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NDDB Recruitment 2020 – Food Technology & Food Science Scientist Job
New Post has been published on https://biotechtimes.org/2020/11/19/nddb-recruitment-2020-food-technology-food-science-scientist-job/
NDDB Recruitment 2020 – Food Technology & Food Science Scientist Job
NDDB Recruitment 2020
NDDB Recruitment 2020 – Food Technology & Food Science Scientist Job. National Dairy Development Board (NDDB) is hiring Food Technology & Food Science Scientist. NDDB Recruitment 2020. Candidates having a background in Food Science and Food Technology are requested to go through the details given below:
Food Technology & Food Science Scientist Job
Job Details
Job Name: Scientist-I (CALF)-Reserved for EWS (Economically Weaker Section)
Job Location: Anand
Job Category: Centre for Analysis and Learning in Livestock and Food (CALF)
Description:
NDDB offers an excellent learning environment with considerable freedom for creative and innovative activities. We are looking for a young and energetic Scientist for the Centre for Analysis and Learning in the Livestock and Food (CALF) laboratory.
Profile Summary
Responsible for routine testing of samples; method development, standardizations, validation & verifications; compliance to ISO 17025 & regulatory agencies guidelines; assisting in activities of National Reference Laboratory (NRL) & Proficiency Testing (PT) programs; and conducting sponsored/internal analytical research trails & training.
Key roles and Responsibility
1)Analysis of milk and milk products, feed, water, fats and oils samples as per defined protocols and adhering to the ISO 17025 practice.
2)Carrying out various activities as per ISO 17043 and ISO 17034. Plan experiment for homogeneity & stability studies for Proficiency Testing in different product.
3)The candidate shall be well versed with the statistical analysis, use of excel and computer programmes for preparation of technical and scientific reports. Statistical analysis of data for PT evaluation and report preparation.
4)Review of literature, writing and carrying out research projects, preparation of reports, research publications and writing of SOPs/ MSPs/ OIs.
5)Maintaining documentation of National Reference Laboratory (NRL) for routine technical operations.
6)Handling of routine and state-of-art equipment like LC-MSMS/GC-MSMS/ICP-MS/LC-IRMS/EA-IRMS/NMR/ICP etc. for analytical work.
7)Method development, standardization, validation, method harmonization.
8)Organizing internal/external training programs.
9)Supervision of the analytical work of Trainee /Scientist/ Technician in Laboratory.
10)Following Good Laboratory practices and safety guidelines.
11)Proper handling, maintenance of sophisticated equipment.
12)Usage & proper storage of CRM/SRM.
13)Ensure good housekeeping and maintain required environmental conditions as per test method.
14)It may be required at many times to work in night shifts.
15)Any other relevant work assigned by the supervisor.
Qualification & Experience
1.The incumbent should have a Master’s degree in Chemistry (any discipline)/ Dairy / Food Technology /Food Science with 2-5 years of experience in the testing/analytical R&D of Food/ Dairy products using routine and state-of-art equipment like HPLC/ GC/ LC-MSMS/ GC-MSMS/ ICP-MS etc.
or
PhD in any of the above disciplines with a minimum of 1-year experience in the testing/ analytical R&D of Food products using routine and state-of-art equipment like HPLC/ GC/ LC-MS/ GC-MS/ ICP-MS etc.
2.Candidates with prior work experience in an accredited laboratory as per ISO-17025 will have an added advantage.
Other Essential attributes and skills
Technical:
1.Incumbent shall have basic knowledge on composition, micronutrients and safety hazards of dairy/ food products.
2.Understanding of Regulatory limits as per FSSAI/ BIS/ Codex/ EU etc.
3.Hands on experience in various advanced analytical equipment.
4.Understanding of ISO 17025 &17043
5.Understanding Statistical analysis /tools /packages for routine quality control evaluation.
Managerial:
1. Working as per timelines and handle work pressure
2.Research & innovation oriented and creative & strategic thinking.
3.Being adaptable, effective in building relationships and work in team.
4.Capable of persuading, resolving conflicts and other problems.
5.Good communication and presentation skills and proficiency in English.
The last date of receiving the updated online applications is 04 December 2020.
(Candidates above 30 years of age as on 01 December 2020 need not apply)
The position is on fixed-term employment for a period of 5 years which is renewable.
This position is reserved for candidates belonging to the Economically Weaker Section (EWS).
Location: Anand, Gujarat and the candidates should be ready to work anywhere in India.
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ISO 17020, 17021, 17024, 17025, 17043, 17065 Standards Quality Full Sytems, suitable according to Accreditation Rules.
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There’s a growing demand among cannabis consumers for high potency marijuana products backed by accurate test results. This recent article from the Anchorage Daily News discusses Alaskans’ obsession with high potency: https://bit.ly/2N1ba9h
However, the lack of “clear and enforceable standardization requirements” means that different cannabis testing labs may declare vastly different results for potency. The article goes on to describe a notable example of this problem occurring in Alaska.
“Lab owners and the state both say a big part of the challenge is that cannabis testing lacks the standardized procedures found in other fields, like soil or water testing. For example: When a testing facility is given marijuana bud, each lab does its own sample preparation. In that process, the bud is mixed with reagents — things like solvent — and put into the testing instrument. That part of the process is most likely to give you varying results because each lab conducts this process in their own way. There are no standards.”
In a rapidly growing cannabis industry lacking federal standards, cannabis testing labs are increasingly leveraging the Emerald Test to help produce reliable, accurate results. The Emerald Test utilizes a well-established standard for testing found in the environmental, food, pharmaceutical, water, and petrochemical testing industries.
Through the participation of labs around the world, the Emerald Test establishes an industry benchmark for cannabis testing. State regulatory agencies use proficiency testing (PT) programs for laboratory licensure and compliance to promote accurate testing for cannabis quality and safety. Accreditation bodies, including ANAB, A2LA and PJLA recognize well organized ILC/PT programs that follow ISO/IEC 17043 to address the requirement to participate in external proficiency testing.
Enrollment for the fall Emerald Test opens tomorrow! Learn more: http://emeraldtest.com/
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Preserving quality and uniformity throughout testing facilities crucial in the complicated industries and regulations of today. Throughout this process, ISO 17043, ‘Conformity assessment- General requirements for proficiency testing, is crucial. To guarantee that testing facilities across the globe can produce consistence and dependable finding, an international standard establishes the rules for proficiency testing (PT) providers. This article shows the relevance, advantages, and value that ISO 17043 provides to laboratories, industries and regulations to explain why it is significant.
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Introduction to ISO 17043 Accreditation requirements
To consider conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. ISO 17043 standard was developed by ISO committee on conformity assessment.
The ISO/IEC 17043:2010 accreditation specifies requirements of conformity assessment for proficiency testing. ISO 17043 Accreditation for proficiency test providers makes sure those customers of compliance with international standards and good practices. With ISO 17043 Accreditation, proficiency test providers gain increased confidence that the programs that depends on are being operated competently in accordance with the specified technical and management system requirements.
Proficiency testing is the one of mechanisms through which the performance of an organization can be checked to confirm its ability to stick to the organization’s procedures. Proficiency testing (PT) is a current requirement of accreditation programs offered by International Laboratory Accreditation Cooperation Mutual Recognition Arrangement signatory accreditation bodies and is a common requirement of regulatory and oversight programs. Proficiency testing is a quality control tool that can be utilized prior to achieving accreditation.
ISO 17043:2010 Accreditation demands technical competence assurance and good quality management practices, but also includes verification of the proficiency test management of the provider. ISO/IEC 17043:2010 recognizes proficiency testing as a participant performance as well as evaluation against pre-established criteria which is meaning of interlaboratory comparisons for the determination of laboratory performance.
Following are ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing,
Personnel
Design of proficiency testing schemes
Preparation of proficiency testing items
Assigned values
Data analysis and proficiency testing evaluation scheme results
Data analysis and their records
Reports
ISO/IEC 17043 states purpose of Proficiency testing,
Performance of laboratories evaluation for specific tests or measurements and monitoring laboratories’ continuing performance;
Problems in laboratories of identification and initiation of actions for improvement,
Establishment of the effectiveness of test and compare to them ;
Inter-laboratory differences identification;
Education of participating laboratories based on the outcomes of such comparisons;
Validation of uncertainty claims.
Proficiency testing programs exist in different formats. As well as in the most comprehensive form, proficiency testing involves three distinct entities: the participant of proficiency provider, the proficiency test provider, and the bodies that accredit the proficiency test providers. Anyways, the roles of each entity may overlap.
The accreditation programs require that the proficiency test user’s results are reported within the participant’s quality assurance system.
Different forms of Proficiency tests:
Accrediting bodies may facilitate a proficiency test.
Users may create and administrate a proficiency test to internal and external users
Users may evaluate proficiency through alternatives such as observation or case presentation
Proficiency tests may be purchased and results reported externally.
Proficiency tests may be created or purchased externally.
Proficiency tests results may be reported internally.
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National Accreditation Board for Testing and Calibration Laboratories
National Accreditation Board for Testing & Calibration Laboratories (NABL) is an autonomous society providing Accreditation (Recognition) of Technical competence of a testing, calibration, medical laboratory & Proficiency testing provider (PTP) & Reference Material Producer (RMP) for a specific scope following IEC/ISO17025:2005, ISO 15189:2012, IEC/ISO 17043:2010 & IEC/ISO 17034:2016 Standards.
NABL provides accreditation in all major fields of Science and Engineering such as Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological, Thermal & Forensics under testing facilities and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical & Radiological under Calibration facilities. NABL also provides accreditation for medical testing laboratories. In addition, NABL also offers accreditation for Proficiency testing providers & Reference Material producers and is now signatory to APLAC MRA for both.
Founded in the year 2004, “Prism Calibration Center” NABL Approved Instruments Calibration Lab have earned tremendous fame in offering Calibration, Validation, Instant Supply and Work Optimization. We have also gained appreciation in trading Measuring Instruments, Work Optimization Tools and Infrared Guns.
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California Releases Draft Lab Testing Regulations: Last Friday, the Bureau of Marijuana Control, the regulatory body overseeing California's cannabis industry, released a set of proposed regulations for the lab testing market. The regulations are somewhat comprehensive, covering sampling, licensing, pesticide testing, microbiological contaminants, residual solvents, water activity and much more. Formerly named the Bureau of Medical Cannabis Regulation under the state's Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation and enforcement of the regulations for the state's cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon's already implemented testing regulations. The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids. The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations. The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA's Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC's Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology. Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency-test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab's license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program. The post California Releases Draft Lab Testing Regulations appeared first on Cannabis Industry Journal. http://bit.ly/2q6xRMB @CannabisEditor #Cannabis
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Adherence to quality standards is critical in the field of proficiency testing schemes. ISO 17043 lays the framework for proficiency testing providers to assure accuracy, dependability, and consistency in their testing operations. Two important components are at the heart of maintaining these standards: nonconformity and corrective actions. Laboratory mistakes are estimated to occur in 0.012-0.6% of all test findings. This is why proficiency testing (PT), which is a formal sort of interlaboratory comparison, is such an important part of the laboratory accreditation process. By following to the ISO/IEC 17043 PT requirements, PT suppliers may adequately monitor the quality of a laboratory's performance, assuring accurate and safe product performance.
#ISO 17043#ISO 17043 accreditation#ISO 17043 documents#ISO 17043 documentation#ISO 17043 documentation templates#accreditationconsultancycom
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Harmonization with ISO/IEC 17025:2017 and ISO 13528:2022, as well as the addition of the requirement that testing and calibration activities and proficiency testing item production conform to pertinent requirements of appropriate ISO conformity assessment standards, are the main changes to the 2023 edition of ISO/IEC 17043. New standards regarding impartiality, risk, and information management were added to the standard in addition to updating and harmonizing the existing requirements.
#ISO 17043#ISO 17043 Accreditation#ISO 17043 Documents#ISO 17043 training#ISO 17043 auditor training#online ISO 17043 auditor training
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Recognize How the ISO 17043 Documentation Kit from Accreditationconsultancy.com Would be Beneficial
It's challenging to pass a laboratory inspection. Documentation is essential while preparing for a laboratory inspection. The foundation of a successful quality assurance (QA) plan is frequently good documentation practices. The proficiency testing (PT) procedure for the laboratory should also be documented with the same level of specificity. According to ISO 17043 proficiency testing standard is an assessment of a participant's performance against established requirements utilizing inter-laboratory assessments. Results of proficiency tests are frequently forgotten to be documented. To know more, visit here: https://www.evernote.com/shard/s681/sh/0a784e33-a5de-93e5-1559-2621b6abfc40/PNSQs582MyLOECEM4n-25VgF2UTDSnAa8Zslc_sob3We9WOYaqVj4ysHqQ
#iso17043standard#iso17043documents#iso17043accreditation#iso17043consultant#iso17043auditortraining
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