ISO 17025:2017 Documentation Requirements

What is ISO/IEC 17025?

The ISO 17025 standard specifies the general requirement for the ability to hold out tests and calibration as well as sampling. The check and calibration ways performed area unit categorized as standard, non-standard and laboratory developed. It covers 1st, second and third party laboratories wherever testing and calibration forms a part of scrutiny and products certification.

This international ISO 17025 standard is applicable to all or any laboratories in spite of the amount of personnel or the extend of the scope of testing and calibration activities. it's employed by laboratories to develop their management system for quality, body and technical operations.

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Changes in New Version of ISO 17025:2017 The International Organization for Standardizations (ISO) has released new version of its Testing and Calibration Laboratory accreditation standard ISO/IEC 17025 in November, 2017. The format of the new standard has been significantly changed to be more in line with new ISO formatting guidelines One of the most important aspects of ISO/OEC 17025:2017 is the emergence of the concept of risk. This implies a series of changes that directly and indirectly affect requirements that already existed in previous version: impartiality confidentiality, corrective actions, assurance of the validity of the results, etc.

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Aim of ISO/IEC 17025:2017  Provide a basis for use by accreditation bodies in assessing the competence of laboratories.  Establish general requirements for demonstrating lab compliance to perform specific tests or calibrations.  Assist in the development and implementation of a lab's quality system.

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Benefits of ISO/IEC 17025:2017  Increase in productivity  Rework and retesting reduction  Reduced instrument repairs and defect levels  Due to establishment of control chart and regular monitoring test and instrument capability is improved in turn benefited in Higher yield  Improvement in knowledge level and multi skirling

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ISO/IEC 17025:2017 Document Requirements When Laboratories going for accreditation, there are specific ISO/IEC 17025:2017 documentation requirements that need to be fulfill. used to designed and developing testing and calibration laboratory. List of such requirements for better understanding and defining quality system in laboratory as per ISO/IEC 17025:2017 are as below:  ISO 17025:2017 Manual  Procedures  Exhibits

 Work Instruction  Sample Forms and Templates  ISO 17025:2017 Audit Checklist www.globalmanagergroup.com

ISO 17025:2017 Manual ISO 17025:2017 Manual states the ISO 17025 policy and describes the ISO 17025 system of an organization. It may relate to an organization’s total activities or to a selected part of it, e.g. specified requirements depending upon the nature of products or services, processes, contractual requirements, governing regulations etc. It should include how ISO 17025:2017 system is implemented in the organization at macro level.

ISO 17025:2017 manual should normally contain, or refer to:  Introduction  Scope  Definitions and Terminology  Management Requirements  Technical Requirements www.globalmanagergroup.com

ISO/IEC 17025:2017 Procedures ISO 17025 procedures are also called operational procedure, as they are a snapshot of the actual activities taking place in a company at a particular point of time.

They are considered to be the core of the system documentation for ISO 17025:2017 achievement and assurance and confidential documents. They are intended for internal use and should be protected from misuse. These procedures are meant to instruct in broad terms, how the policies and objectives expressed in the ISO 17025 manual are to be addressed and achieved. They describe how the tasks and functions of the various departments should be performed to meet the requirements of the ISO 17025:2017 standard at micro level.

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Exhibits The ISO 17025 Exhibits are very helpful tool to teach all employees and staff about how to implements and improvements quality requirements for laboratories and get number of benefits. Following are list of Exhibits covering all the details of ISO 17025:2017 requirements.  skill requirements

 codification system  calibration periodicity  secrecy rules  communication Process  instrument receipt checklist  intermediate check frequency www.globalmanagergroup.com

Work Instruction The standard requires work instructions to be available, where the absence of such instruction would adversely affect ISO 17025. In the practical sense, work instruction may be written, drawings, photographs, computer menu options, machine care / operation, work production documentation etc. Work instructions deals with shop-floor level of activities. Their purpose is to clearly direct the operator as to what has to be done, and what standard of workmanship is required to control significant aspects.

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Sample Forms and Templates Sample forms, records etc. are supporting documents used by the company to record information for different procedures followed. They link the activities written in the procedure to the records kept in the department. This documentation serves to demonstrate that the ISO 17025 system is operating efficiently to produce the product in accordance with specified requirements of the ISO 17025:2017 system. They should be legible, easily retrievable and available when asked for by the auditor. On all the forms establish proper document control on them.

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ISO 17025:2017 Audit Checklist The ISO 17025:2017 Audit Checklist is a good tool or the internal to make audit questionnaire while auditing and make effectiveness in auditing. It covers sample audit questions based on all the ISO 17025:2017 requirements. It can be used as a very good tool for logically auditing during internal audit for laboratory accreditation for calibration. During internal audit verification of system to meet ISO/IEC 17025:2017 requirements helps for smooth accreditation audit.

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ISO 17025:2017 Documentation Kit Global Manager Group provides ISO/IEC 17025:2017 Documentation kit that having sample documents required for laboratory accreditation. It contains all documents that covers all such requirements of upgraded standard. The ISO 17025:2017 manual to ISO 17025:2017 audit checklist are provided in editable format that serves as the primary source of documentation.

Global Manager Group had ready ISO/IEC 17025:2017 documents for the types of laboratories listed below:      

Calibration Lab Testing Lab Petroleum Lab Oil Refinery Metal Testing Material Testing

For further details and free demo write us at sales@globalmanagergroup.com www.globalmanagergroup.com

Global Manager Group ď ś We provide industry specific documents based on ISO/IEC 17025:2017. ď ś The ready to use list of documents required as per ISO/IEC 17025:2017 is available on our website. Visit @ www.Globalmanagergroup.com

For further inquiry contact us : sales@Globalmanagergroup.com

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