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ISO/IEC 17025:2017 Documentation Requirements

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Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation. – PowerPoint PPT presentation

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Title: ISO/IEC 17025:2017 Documentation Requirements


1
ISO/IEC 170252017 Documentation Requirements
By Global Manager Group
2
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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3
Changes in New Version of ISO 170252017
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 170252017 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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4
Aim of ISO/IEC 170252017
  • 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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5
Benefits of ISO/IEC 170252017
  • 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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6
ISO/IEC 170252017 Document Requirements
When Laboratories going for accreditation, there
are specific ISO/IEC 170252017 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 170252017 are as below
  • ISO 170252017 Manual
  • Procedures
  • Exhibits
  • Work Instruction
  • Sample Forms and Templates
  • ISO 170252017 Audit Checklist

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7
ISO 170252017 Manual
ISO 170252017 Manual states the ISO 17025 policy
and describes the ISO 17025 system of an
organization. It may relate to an organizations
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 170252017 system
is implemented in the organization at macro
level. ISO 170252017 manual should normally
contain, or refer to
  • Introduction
  • Scope
  • Definitions and Terminology
  • Management Requirements
  • Technical Requirements

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8
ISO/IEC 170252017 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
170252017 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
170252017 standard at micro level.
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9
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 170252017 requirements.
  • skill requirements
  • codification system
  • calibration periodicity
  • secrecy rules
  • communication Process
  • instrument receipt checklist
  • intermediate check frequency

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10
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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11
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 170252017 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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12
ISO 170252017 Audit Checklist
The ISO 170252017 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 170252017 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 170252017 requirements
helps for smooth accreditation audit.
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13
ISO 170252017 Documentation Kit
Global Manager Group provides ISO/IEC 170252017
Documentation kit that having sample documents
required for laboratory accreditation. It
contains all documents that covers all such
requirements of upgraded standard. The ISO
170252017 manual to ISO 170252017 audit
checklist are provided in editable format that
serves as the primary source of
documentation. Global Manager Group had ready
ISO/IEC 170252017 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_at_globalmanagergroup.com
www.globalmanagergroup.com
14
Global Manager Group
  • We provide industry specific documents based on
    ISO/IEC 170252017.
  • The ready to use list of documents required as
    per ISO/IEC 170252017 is available on our
    website. Visit _at_ www.Globalmanagergroup.com

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sales_at_Globalmanagergroup.com
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