What is Certified Reference Material? – Advantages & Uses

CRM is different from reference material because it is certified, it has metrology tracking, and each property value has an uncertain value given to it. The ISO 17034 defines reference equipment as “sufficient and stable” in relation to one or more specified areas, established for its intended use in the measurement process.

To become a CRM manufacturer, the manufacturer's methods must meet the requirements of ISO 17034:2016 General Competitive Requirements for Manufacturers of Products. To obtain ISO 17034 Accreditation, the manufacturer must demonstrate that they are able to provide CRM. For implementing all types of reference material producers in the field of Chemical Composition, Biological and Clinical Properties, Physical Properties, Engineering Properties as per the ILAC RM category, Contact Punyam.com – A leading ISO 17034 Consultancy Company in India which develops the system for customers in the following manners for ISO 17034 Accreditation:

• Micro–level survey for each and every department of the RM Producer and submission of detailed Gap Analysis report,
• Preparation of applicable documents required by ISO 17034:2016 based on detail study of all activities of the RM Producer,
• ISO 17034:2016 training to all levels of employees of RM Producer,
• Helps in effective implementation of system by periodic visit till ISO 17034 accreditation,
• Conduct internal audit to check readiness for the ISO 17034 accreditation.
• Preparation of all related documents,
• Formats to establish the objective evidence of implementation and to ensure control over all the activities.
• ISO 17034 training to all levels of employees within the organization;
• Help in effective implementation of system by periodic visit till certification;
• Conduct internal audit to check readiness for the certification.
• Conduct management review meeting in presence of Top Management to guide the RM Producer for effective implementation on all the issues related to RM Production.
• Witnessing the whole process of reference materials production,
• Pre–assessment and final assessment by Accreditation body.

CRMs provide metrological tracking and known uncertainty of item prices. CRMs can ensure reliable user ratings. Traceability is provided by an ISO 17034 Certificate that records property values, uncertainty, and an authorized Certifying body. The Values for certified consumer goods from reference material manufacturers compliant with ISO 17034 provide metrology compliance.” CRM users are responsible for determining whether CRM is suitable for its intended use. The user must follow all the label instructions given by the CRM Manufacturer.

General Uses of CRM:

• Verification of Method: A laboratory or industry may need to verify the methods or equipment used to measure or obtain an object. CRM can be used to verify the measurement method or the ability to find something.
• How to verify: The laboratory may need to monitor the process at any time to ensure that the process continues to be measured and detected as previously confirmed.
• Evaluation: CRM is a pure object that can be used to measure equipment, intended to detect or measure that object, or CRM can be used as an independent measurement check.
• How to monitor or control the process: CRMs can be used continuously to provide evidence that processes are stable and continue to measure and detect as needed.
• Training: The laboratory can use CRMs to train and/or test operators using something with a well-known property and product prices.

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Preparation for ISO 15189 Documents for Accreditation in Medical Laboratories

The ISO 15189 Accreditation is the recognition of a competent medical laboratory, testing body or certification body to perform specific functions that are clearly defined and evaluated throughout the ISO 15189 accreditation study. This knowledge of skills is intended to assure clients of accredited bodies, that the delivery of these accredited organizations, under their accreditation, is reliable.

Emphasizes the implementation of a quality plan that incorporates key or minor approaches that can lead to compliance with international quality standards, such as ISO 15189. The ISO 15189 Document and its recommendations related to implementation strategy can be easily used as it stands, or after adaptation to meet ISO 15189 requirements. The Guidance should be read as development recommendations as well implementation of quality standards that can be done by all types of health and health laboratories.

The ISO 15189 - Quality manual should describe the quality management system and its document structure. The quality manual should include or refer to supporting ISO 15189 procedures; including technical processes. It should highlight the textual structure of the quality management system.

ISO 15189 Documentation Requirements

The 15189 Documentation should include:

• quality policy statement;
• quality manual;
• the procedures and records required for the relevant procedures;
• documents and records, determined by the laboratory to ensure good order, the operation and control of its processes; and
• copies of relevant local and international regulations, laws and standards ordinary texts.

The laboratory must regulate the documentation required by the quality management system and ensure that the unintentional use of any outdated ISO 15189 document is prohibited.

The laboratory must ensure that:

• All documents, including computer-generated, are issued as part of the quality management system is periodically updated and approved by authorized personnel prior to dismissal;
• only current, authorized types of active documents available locally for use;
• altering changes in the text;
• texts are readable;
• documents are periodically updated and updated periodically that they are always ready for the purpose; any changes to the document need to be permanent re-authorization;
• Be careful. The duration of the document review should be defined by the lab according to its requirements,
• The records are kept for a specified period in the laboratory
• storage policy and compliance with privacy requirements.
• obsolete documents dated and marked as obsolete;
• archiving and tracking records; and
• The authorization to obtain documents is clearly defined and in writing.

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How ISO 17034 – Reference Materials Helps to Meet Regulatory Requirements for Laboratories?

Laboratories are required to provide proof that the materials used for method validation and process controls are objective, uniform and stable. Certified Reference Materials (CRMs) are designed to meet these strict standards. As regulatory standards of ISO 17034 continue to increase, additional burden is placed on laboratories to ensure the quality and safety of finished products. Now more than ever, tracking is a major problem.

ISO 17034 defines reference equipment as “sufficient and stable” in relation to one or more specified areas, designed to be suitable for its intended use in the measurement process. Features can be quantitative or qualitative. Certified Reference Materials is different from reference information because it is more compliant with ISO 17034 certification, has more metrology, and each property value has a certain amount of uncertainty. When goods are assigned to CRM, prices are "stored" by CRM and transferred when the CRM itself is moved from one location to another.

To become a Certified Reference Materials manufacturer, the manufacturer's methods must meet the requirements of ISO 17034:2016 General Competitive Requirements for Manufacturers of Products. To obtain ISO 17034 Accreditation, the manufacturer must demonstrate that they are able to provide CRM.

Here are some advantages we consider:

• As technology advances over time, the ability and need to measure more and more accurately increases.
• This drives the requirement for better identification tools that can be used in testing and evaluation.
• CRMs provide metrological tracking and known uncertainty of item prices.
• CRMs can ensure reliable user ratings. Tracking is provided by a certificate that records the prices of the goods, the uncertainty, and the authorized Certifying body.
• CRM users are responsible for determining whether CRM is suitable for its intended use.
• The user must follow all the label instructions given by the CRM manufacturer.

Following are the General Use of CRM:

• Validation of Method: A laboratory may need to verify the methods or equipment used to measure or obtain an object. CRM can be used to verify the measurement method or the ability to find something.
• Method Verification: The laboratory may need to test the process at any time to ensure that the process continues to measure and detect as confirmed earlier. For example, CRM can be used to monitor the process and determine whether inconsistencies have occurred and problem solving is needed.
• Calibration: CRM is a pure object that can be used to measure equipment, intended to detect or measure that object, or CRM can be used as an independent measurement check.
• How to monitor or control the Method: CRMs can be used continuously to provide proof that processes are stable and continue to measure and detect as needed.
• Training: The laboratory can use CRMs to train and/or test operators using an object with a known proportion of ownership and assets.

There is ISO 17034 Documents are essential for RMPs to achieve ISO 17034 accreditation that demonstrates the competence of reference material producers by formal compliance with a set of internationally-recognized criteria. The ISO 17034 covers the production of all reference materials, including certified reference materials and is intended to be used as part of the general quality assurance procedures of the reference material producer.

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Overview and Training Requirements for ISO 15189

ISO 15189 Accreditation is a guarantee that the laboratory has been tested by internationally recognized standards aimed at proving the availability of the program, the technical capacity, and that the staff actually has the ability to produce appropriate technical results and specific details for the purposes for which each test is used.

In order to comply with the requirements of ISO 15189, strong involvement of laboratory staff is required to understand the best process for satisfying the requirements according to the latest technology and methodology, scientific documents, but also time and cost. A growing number of voluntary medical are taking the path to approval, so ensure practice and technical competence in accordance with the Laboratories Best Practice policy, as well as boost confidence in laboratory tests by all participants, thus including patients and physicians.

The ISO 15189 Standard requires, in part, a document, to agree on the purpose for which each test is intended. For example, it instructs laboratory staff to evaluate the validity of the performance indicators of the test procedures and whether the limitations can be controlled by the lab, so that the adverse impact on patients' outcomes can be avoided.

Another important factor related to choosing the size of ISO 15189 is accreditation. Each test, independently of the environment or technology, can vary widely the patient's health and safety outcome. Therefore, accreditation of clinical laboratories should include the largest number of laboratory tests performed.

Proper training of laboratory staff is the first step in introducing accreditation. This clearly includes acknowledging the importance of laboratory medicine in health care and ensuring that the right results are given to doctors. However, continuous monitoring and monitoring of the entire process is needed to ensure consistency of the methods and procedures that should ensure the effective contribution of the test results to patient care.

The ISO 15189 Auditor Training, in which can understand the requirements for Quality and Competence in Medical Laboratories and to learn everything that an ISO 15189 certified auditor needs to aware about auditing a laboratory. First, all the ISO 15189 requirements are discussed in order to understand and accept the basis under approval. Treated as a workplace training exercise, is where all employees are involved in a professional forum by saying the following:

1. Read and interpret all requirements and concurrent negotiations of procedures, ensure compliance of requirements and in accordance with revised and approved guidelines;
2. Collection of proposals for improving the level of compliance and assessment accordingly and feasible;
3. Exploring new approaches and / or processes, and introducing alternatives.

The Accreditation Body plays an important role in teaching and training the auditors correctly. Training needs to focus on the processes and procedures of the audit but, first of all, how to emphasize the quality of the lab, not only in terms of requirements, but also in relation to improvement programs and projects, which should be clearly recognized as an additional value. For getting ISO 15189 Accreditation Consultancy services please visit: http://www.accreditationconsultancy.com/iso-15189-accreditation-consultancy.htm

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Introduced ISO 17020:2012 Document Template Online at Accreditationconsultancy.com

Accreditationconsultancy.com, website that aims to share information and knowledge regarding all ISO/IEC accreditation standards has introduced Ready to use ISO 17020:2012 Documentation Template online. The ISO 17020 document kit will be useful as key guide and readymade solution for conformity assessment inspection body certification documentation process.

After help of experienced team of consultants and auditor in preparation of ISO 17020:2012 documentation, this product has been ready and introduced to global market on website to comply with ISO 17020:2012 Standard. ISO/IEC 17020 documents templates will guide user to easily create fast and effective conformity assessment for inspection body. The ISO 17020 documents product offered online has covered all the requirements as per ISO 17020:2012 standard, which includes ISO 17020:2012 manual, procedures, exhibits, SOP, ISO 17020:2012 audit checklists etc.

Organization has short of time and do not want to spend their entire time in documenting task. Accreditationconsultancy.com has introduced ISO 17020 Documents to help such people by delivering accurate information and reference documents required for ISO 17020:2012 that minimize Clients' time and results quick certification.

The ready to use ISO 17020:2012 Documents priced at 450 USD, which covers sample templates that are written in simple English and easily editable format. The user can update total documentation templates as per organization working system and create own documents for their company in quick time.

For getting this ISO 17020 Documents visit at http://www.accreditationconsultancy.com/documents-manual-procedures-checklists.htm or kindly inquire us at sales@globalmanagergroup.com

About www.Accreditationconsultancy.com

Accreditationconsultancy.com is provider of ISO/IEC accreditation solutions online, which is owned by Global Manager Group. The company delivers benefits to laboratories or organization by providing information about all ISO Accreditation Standards. Company has team of expert consultants having rich experience of implementing various international system certification and / or documentation that works with their customers to reduce cost and save time in implementing the system. The website offers a wide range of certification solutions for ISO 17020, ISO 17021, ISO 17024, ISO 17025, ISO 17034, ISO 17043, ISO 17065, ISO 15189 and more. To know more about the documentation and company's online consultancy services visit website at www.accreditationconsultancy.com

Things that you should know about the ISO 17025:2017 Documentation for Various Laboratories

One such rule for ISO/IEC 17025 for that includes a list of ISO 17025:2017 requirements for testing laboratories. Testing laboratories need to be accredited to ISO/IEC 17025 to demonstrate their technical expertise and to ensure the accuracy of test results.

As we all know, ISO/IEC 17025 is one of the most important standards for all types of workplaces, universities and research institutes that perform experiments and calculations. ISO/IEC 17025 incorporates management and technical requirements that enable the testing or calibration laboratory to claim its technical competence. To have ISO 17025 accreditation by regulatory bodies proves that results are consistent and accurate and are produced using industry-standard standards.

Due to the use of unmaintained and uncalibrated instruments, Environment/Chemical Testing Laboratory factors, and to the skill level of the laboratory technician performing the tests are these variations. One reason for this variation is the production of potency reports to increase sales. This is usually done through the process of converting samples and test results.

The main purpose of any laboratory involved in analyzing the evaluation to obtain reliable results as possible, in a very short time. This means that regardless of the lab type, high quality and reliable analytical results. There is a need to efficiently manage resources such as personnel, test equipment and equipment, chemicals and reagents, laboratory environment and any other person involved in the production of results and data.

When you choose to provide laboratory testing or calibration, customer there may be a need to ensure that the supplier may issue relevant results. There are many aspects such as personnel competence, equipment reliability, validation and validation of testing methods, sample measurement procedures and calibration tracking at national and international standards that participate in laboratory technology.

So, For ISO/IEC 17025:2017 accreditation consultancy; Global Manager Group which has NABL 17025 Accredited Calibration lab provides facility Ready-to-Use ISO 17025 Documents to accreditation procedures in the calibration laboratory, Environment/Chemical Testing Laboratory as well as Civil Testing Laboratory across the globe. Also over 30 calibration laboratories globally are already accredited under guidance of GMG.

Based on good quality laboratory practices, Global Manager Group provides complete set of lab accreditation documentation kit with sample ISO 17025:2017 Manual, Quality Procedures, Exhibits, Work Instructions, and Sample Formats as well as ISO 17025:2017 Audit checklist for quick accreditation application for various such as Civil Material Testing Lab, Calibration Lab, Environmental Testing Lab, Chemical Testing Lab, Petroleum Testing Lab and Metal Testing Lab.

A global standard - ISO/IEC 17025 is for continuous improvement and maintenance. The laboratory complies with ISO/IEC 17025 benefits in the following ways:

• Improves the reliability of laboratory test results
• May develop technical capacity in case of consideration and/or legal issues
• The efficiency of lab increases , laboratory gains strong competitive advantage, and spending is reduced, customer complaints are reduced
• The Regulation facilitates tracking of ratings and calculations of good performance, sets the technical capacity of staff, maintains inspection equipment records, verifies the accuracy of test results, the accuracy and accuracy of test and calibration methods, the handling and flow of test materials, and the quality of the testing environment.

To get ISO 17025:2017 Consultancy for Accreditation for laboratories you can directly visit here - https://www.globalmanagergroup.com/Services/iso-17025-2017-consultancy-accreditation

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How should you choose best ISO/IEC 17020 Consultancy for Accreditation?

Thorough evaluation of a product (design and quality), service, process or plant is called "Inspection", which is also used to determine the conformity of an item in accordance with the requirements provided. ISO/IEC 17020:2012 is used to improve the quality and accuracy of Inspection Bodies.

Inspection Bodies Accreditation monitors the technical capabilities of the quality management system and provides guidelines for obtaining consistent and accurate inspection procedures.

Experts doing the test work are called inspectors and the general name "Inspection Bodies". The Inspection Bodies accreditation scheme provides formal recognition of the reliability and reliability of the testing body services. Proper implementation of ISO 17020 is critical to the complete maintenance of equipment, plant, tools, infrastructure, processes and the system itself.

The operations of various types of bodies performing inspection have been developed in order to build confidence in the inspection bodies are the requirements of ISO/IEC 17020 conformity assessment. The last version of ISO/IEC 17020 was published in year 1998. Since then, the 2012 version of ISO 17020 is in the implementation.

Mainly there are three major categories in which ISO 17020:2012 standard has categorized:

• Type-A: Inspection body, means an independent assessment body, which performs assessment tasks only,
• Type-B: Inspection body, means that its Inspection services will be provided only to the organization for which the test body is a component, and
• Type-C: Inspection body means that the Inspection body will provide security within the organization to ensure adequate separation of responsibilities and reporting between inspections and other activities.

Taking services of ISO 17020 consultancy for the implementation and ISO/IEC 17020:2012 certification for all types of inspection bodies, either on a temporary or long-term basis is very helpful in documentation, system implementation and getting accreditation or re-accreditation, as well as maintenance of the management system. But it is a very crucial to get a right consultancy such as any business partnership.

Such ISO 17020 consultancy provides following points can help you make the right selection:

• For each and every inspection parameter of the inspection bodies and preparation of detail Gap Analysis report and do Micro–level survey,
• Based on detailed study of all activities of the inspection bodies Preparation of applicable documents required by ISO/IEC 17020:2012, such as;
  1. ISO 17020 Quality Manual,
  2. Quality Procedures for ISO/IEC 17020:2012
  3. Standard Operating Procedures (SOPs) for inspection
  4. Formats to establish the objective evidence
• For maintaining and assuring quality of inspection services provided to its customer, Preparation of Quality Assurance Plan,
• Within the inspection bodies provide ISO 17020 training to all levels of employees,
• By periodic visit till accreditation, Help in effective implementation of system.
• To check readiness for the accreditation, Conduct internal audit for ISO 17020 system.
• In presence of Top Management, Conduct management review meeting to guide the inspection bodies for effective implementation of all the issues related to inspection,
• To build confidence among the employees, etc demonstrates the activities of inspection.

The ISO 17020 accreditation of inspection bodies need to have well-maintained ready-to-use ISO 17020 documents, which must contain ISO 17020:2012 Manual, iso 17020 procedures, formats, SOPs, audit checklist. So don’t waste time, choose a consultancy soon to conveniently achieve ISO 17020 Accreditation Certification in short time.

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ISO 17021 – What Mandatory Documents are required for ISO 17021 Accreditation for Certifying Body?

ISO/IEC 17021 is a standard developed for the evaluation of certification bodies to ensure they are qualified and compatible with all forms of management systems. A standards series of ISO 17021 is that set out requirements for organizations which provide certificates of conformity to all types of management systems. Accreditation bodies uses the ISO 17021 standards to evaluate the procedures that certification bodies have in place to make sure that they are impartial and the results of their assessments are consistent.

In actual, the original ISO/IEC 17021 was published in 2006. In the year 2015, a new version of ISO/ IEC 17021 is released. The norm helps guarantee certification bodies will be unbiased and compliant with their audit findings. According to this first release, two years from the first date of publication, approved IAF MLA management system certification bodies have been granted compliance with the standard.  In 2011, there was a revision that was focused on competence, and all certification bodies were given two years to conform to the new ISO 17021 standard.

For getting other international certifications, the ISO/IEC 17021 accreditation for certifying body requires standard documentation. And this Kind of standard documentation must conform to the Requirements of Conformity Assessment of certifying bodies as per ISO/IEC 17021:2015. The ISO 17021:2015 documents are globally used by certifying bodies and ISO 17021 consultants.  Such documents covers ISO/IEC 17021:2015 clause-wise requirements for quick ISO 17021 accreditation.

Following are the Mandatory ISO 17021 Documents which conforming to the conformity assessment requirements of Certifying Bodies as per ISO 17021:2015 is listed below:

• Sample ISO 17021 manual
• Quality Policy
• Procedures
• Standard Operating Procedures
• ISO 17021 Audit Checklist
• Sample Risk Templates
• Compliance Matrix

Accreditationconsultancy.com provides this kind of ISO 17021:2015 Documentation Kit for Certifying Body. One of the most significant features of this documentation kit is its user compatibility. An ISO 17021:2015 compliance matrix are requirements wise reference documents which also provided in the kit. So this kind of features makes easy for ISO 17021 consultants or any certifying body to establish linkage of standard requirements.

For worldwide recognition and credibility, An ISO 17021 accredited certification body has a definite edge over competitors. Here are the advantages of ISO/IEC 17021 accreditation include:

• Improvement of efficiency, productivity and effectiveness in the overall operation of certification
• Improvement in level of motivation, co-operation, and quality awareness including competence
• With the accreditation, Greater control of processes and activities throughout certification bodies
• The accreditation helps in analysis of data as well as perfect record-keeping
• It provides guidelines and better control for maintenance of records, etc.
• It establishes confidence of management and customers in the certificate  
• It increases customer trust as well as market shares
• The accreditation is helpful to make a better image as a quality certification body in global market

All details are of this sample ISO 17021:2015 documentation is in simple English, so there will be no difficulty in understanding the contents of this ISO 17021:2015 documentation kit. The certifying bodies or their ISO 17021 consultants can update sample document templates as per their working system and create own ISO 17021 documents for their company in only few days.

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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.
• Minimizes excessive paperwork.
• To determine the baseline system of ISO 17043 that satisfies requirements for personnel certification body as well as covers its principles.