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.

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,

1. Performance of laboratories evaluation for specific tests or measurements and monitoring laboratories' continuing performance;
2. Problems in laboratories of identification and initiation of actions for improvement, 
3. Establishment of the effectiveness of test and compare to them ;  
4. Inter-laboratory differences identification;  
5. Education of participating laboratories based on the outcomes of such comparisons;
6. 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.

ISO 15189 Check List and Requirement

ISO 15189 pens down the requirements for quality and competence in medical laboratories. This international standard is used by medical laboratories in developing their quality management systems and assessing their own competence.

This standard is essential for the company’s goodwill as it is used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and other accreditation bodies.

ISO 15189 Check List:

Based on ISO 17025 and ISO 9001 few additional requirements are laid down in ISO 15189. Such as-

•    Providing advice on the type of sample and testing that are required.

•    Having an interaction with clinical staff responsible for the quality of service to clinicians.

•    Providing opinions on the results of testing.

•    Collecting samples or suggesting information on collection procedures, sample containers, and sample volumes.

•    To check whether they are working as per ethics.

ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors.

Qualified auditors conduct a thorough evaluation of all factors affecting the production of test data. To ensures the quality regular checkups are conducted.

Accreditation consultancy is one of the premier documents selling companies and is serving national and international markets with full dedication since ages.

We are engaged in providing consultancy services and training on ISO 15189 Certification. Known for serving customers with all the best efforts, we assure you on every step about your ISO 15189 certification.

ISO 15189 accreditation, ISO 15189 consultancy

ISO 17020 consultancy, ISO 17020 accreditation

ISO 17020 Consultancy and Check List:

ISO 17020 is an international standard that specifies requirements for the competence of bodies engaged in performing inspection and for the impartiality and consistency of their inspection activities. It has been developed to build confidence in the inspection bodies and through this procedure, an authoritative body gives formal recognition of technical competence for specific inspection, based on third-party assessment based on ISO 17020 standards.

ISO 17020 accreditation is managed by IAF MRA (International Accreditation Forum Multilateral Recognition Arrangement) and the certificate is issued for a period of 2 years after successful completion of pre-assessment and registration or final assessment. Surveillance audits are conducted by the Accreditation body annually. It is unlike other ISO standards as ISO 17020 is accreditation, not certification.

Requirements:

Few technical requirements are mandatorily practised to avail for ISO 17020 accreditation. The following technical requirements are inspected by authorities before accreditation:

•    Nominate one person as Management Representative for monitoring the effective implementation of the management system's requirements

•    Nominate one person as Technical Manager for establishing and monitoring of the effective implementation of the technical requirements,

•    Detailed inspection parameters such as location and process.

•    Check the level of competence against other ISO 17020accredited inspection body, based on statistical analysis.

Accreditation consultancy:

Accreditation consultancy is one of the premier companies that provide documentation, training and consultancy on ISO 17020. But our manual checklist can be used by businesses to perform self-assessments and identify the hindrances that are faced while applying for ISO 17020.

Our checklist is a great help for the organization and officers as it eases half the job of accreditation.

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ISO 17043 accreditation

Accreditationconsultancy.com provides ISO 17043:2010 accreditation and documentation consultancy for Proficiency Test (PT) providers. ISO 17043 Accreditation gives recognition to the competence of proficiency testing schemes providers, who wish to demonstrate their competence through formal compliance with a set of internationally-recognised requirements for the planning and implementation of proficiency testing programs. ISO 17043 Accreditation for proficiency test providers ensures customers of compliance with international standards and good practices. With ISO 17043 Accreditation, proficiency test providers gain increased confidence that the programs they rely on are being operated competently in accordance with the specified technical and management system requirements. ISO 17043:2010 Accreditation involves assurance of technical competence and good quality management practices, but also adds verification of the proficiency test management of the provider.

ISO 17043 Accreditation Consultancy

We offer ISO 17043:2010 Accreditation consultancy for system implementation, documentation, internal auditing, auditors training, etc. We have rich experience of providing ISO 17043 Accreditation consultancy to a number of proficiency test provider by helping them in system implementation, preparation of ISO 17043 documents, including ISO 17043 manual, as well as conducting training programs on system awareness and auditors training. Our team of ISO 17043 accreditation consultants has rich experience of ISO 17043 accreditation and documentation consultancy. Our services are helpful for proficiency test provider to achieve ISO 17043:2010 accreditation in minimum time and cost.

ISO 17043 Accreditation Documents– ISO 17043 Manual, Procedures, Audit Checklist

To achieve ISO 17043 Accreditation, well-written and organized ISO 17043 documents are a must forthe proficiency test provider. ISO 17043 accreditation documentation should essentially include ISO 17043manual, ISO 17043 procedures, SOPs, formats for various activities, audit checklist, etc. The overall aim of our 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 that are associated with the proficiency test providers, as well as ISO 17043 consultants that all the documentation requirements are met. Our ISO 17043 documents cover all the requirements for ISO 17043 Accreditation. All documents are provided in editable format. They are also useful for auditors and consultants as the primary source of documentation to carry out the process of assessment.

What do ISO 17043 accreditation documents include?

The ISO 17043 documents for proficiency test provider’s accreditation include the following :

1. ISO 17043 Manual

2. ISO 17043 Procedures

3. Set of blank formats

4. Standard Operating Procedures.

5. Exhibits

6. Proficiency Testing Design Plan

Features

• Written in plain English.

• Editable soft copy of documents is provided

• Easy to learn, user-friendly and complies with all accreditation requirements.

• Developed by a team of experienced ISO 17043 consultants.

Benefits of ISO 17043 accreditation documents

• Easily modifiable templates according to your requirements.

• Helps in fine-tuning the processes and establishinga good ISO 17024:2012system.

• Saves much time and cost in document preparation.

• Minimizes excessive paperwork.

• Defines the baseline system that satisfies requirements for personnel certification body as well as covers ISO 17043:2010 principles.

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ISO 17065 accreditation, ISO 17043 accreditation, ISO 17034 accreditation