Tuesday, November 12, 2019

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.

Friday, May 3, 2019

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.

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Sunday, April 21, 2019

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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Friday, March 22, 2019

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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Thursday, February 21, 2019

ISO 17021 consultancy, ISO 17021 accreditation



Accreditationconsultancy.com provides ISO 17021:2015 accreditation and documentation consultancy for certifying bodies. ISO 17021:2015 Standard specifies requirements for certifying bodies which conduct audit and certification of management systems. It gives generic requirements for certifying bodies performing audit and certification in the field of quality, environmental and other types of management systems. ISO/IEC 17021:2015 Accreditation is intended for the benefit of certification bodies and accreditation bodies. Certification of management systems is a third-party conformity assessment activity and bodies performing this activity are therefore third-party conformity assessment bodies. ISO 17021: 2015 accreditation gives recognition to the competence of certifying bodies for carrying out their activities.ISO 17021 Accreditation allows a certifying body to demonstrate its integrity, reliability, and technical competence as well as compliance with internationally recognized good practices. ISO 17021: 2015 accreditation promotes confidence in the bodies performing certifying. ISO 17021 accreditation covers all the activities of certifying bodies and used for the determination of their conformity with requirements.
ISO 17021:2015 Accreditation Consultancy

We offer ISO 17021:2015 Accreditation consultancy for system implementation, documentation, internal auditing, auditors training, etc. We have rich experience of providing ISO 17021:2015 Accreditation consultancy to certifying bodies by helping them in system implementation, preparation of ISO 17021:2015 documents, including ISO 17021:2015 Manual and ISO 17021:2015, as well as conducting training programs on system awareness. Our team of ISO 17021:2015 accreditation consultants provides full support in the entire process of ISO 17021:2015 accreditation. Our services are helpful for certifying bodies to achieve ISO 17021:2015 accreditation in minimum time and cost.
ISO 17021:2015 Accreditation Documents - ISO 17021 Manual, Procedures, Audit Checklist

To achieve ISO 17021:2015 accreditation, well-written and organized ISO 17021:2015 documents are a must for the certifying body. ISO 17021:2015 accreditation documentation should essentially include ISO 17021:2015 manual, ISO 17021:2015 procedures, SOPs, formats for various activities, audit checklist, etc. The overall aim of our ISO 17021:2015 documents is to support certifying bodies in ISO 17021:2015 documentation and give confidence to their customers, regulating authorities, accreditation bodies that are associated with the certifying body, as well as ISO 17021 consultants that the certifying body meets all the documentation requirements as per the standard . Our ISO 17021:2015 documents cover all the requirements for ISO 17021:2015 accreditation. Our ISO 17021:2015 manual, policy, procedures and ISO 17021:2015 audit checklist 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 of certifying body.
What do ISO 17021:2015 accreditation documents include?


The ISO 17021:2015 documents for certifying body’s accreditation include the following:

1. ISO 17021:2015 Manual
2. ISO 17021:2015 Policies
3. Mandatory Procedures
4. SOPs for good work practices
5. Blank and Filled forms and templates
6. ISO 17021 Audit checklist
7. Sample Risk Template
8. Compliance matrix of documents

Features

• Written in easily understandable 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 17021:2015 consultants.

Benefits of ISO 17021:2015 accreditation documents

• Saves much time and cost in document preparation.
• Templates can be easily modified as per working system of the certifying body.
• Defines the baseline system that satisfies requirements for certifying bodies as well as covers ISO 17021:2015 principles.
• Helpful in improving quality system of the certifying body.
• Minimizes excessive paperwork
• Takes care of all the sections and sub-sections to get better confidence and improves the system for achieving ISO 17021:2015 accreditation.

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ISO 17065 accreditation, ISO 17043 accreditation, ISO 17034 accreditation