Title: What is ISO/IEC 17025 Accreditation?
1ISO/IEC 17025 Accreditation
2What 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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3What is Accreditation?
Accreditation could be a formal, third party
recognition of competency to perform specific
tasks. It provides a method to spot a
established, competent authority so the choice of
a laboratory, review or certification body is
associate enlightened alternative. ISO 17025
accreditation suggests that the authority will
demonstrate to its client that it's been winning
at meeting the wants of international
accreditation standards. Usually the explanation
for obtaining one thing severally evaluated is to
verify it meets specific needs so as to scale
back risks. Obvious examples are product failure,
health risks, company name or to satisfy legal or
client needs. something or anyone is evaluated -
product, equipment, people, management systems or
organizations.
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4Aim of ISO/IEC 17025
- 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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5Steps of ISO 17025 Accreditation
- File Application
- Receive Quote
- Enter Contract
- Prepare for Accreditation
- Document Review
- Preliminary Assessment
- Opening Meeting
- Accreditation Assessment
- Closing Meeting
- Corrective Action
- Executive Committee's Decision
- Executive Committee's Decision
- Surveillance Assessments
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6Elements of ISO/IEC 17025
- Scope The area of the lab being evaluated that
will represent the lab as a whole (i.e.
mechanical equipment, environmental conditions) - Normative References Documents that give the
most recent information about every area of the
process and equipment standards. - Terms and Definitions The labeling of all
equipment, instruments, work stations, employees,
and defining instructions, protocol, procedure,
and safety measures. - Management Requirements document control,
service to clients, contract reviews,
preventative actions, internal audits, management
reviews, etc. - Technical Requirements Safe working conditions,
functional equipment, proper calibration of
devices, handling of tests and substances, result
reporting etc.
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7What is ISO/IEC 17025 Management Requirements
- Organization
- Management System
- Document control
- Review of requests, tenders and contracts
- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to Customer
- Complaints
- Control of non-conforming testing/ calibration
- Improvement
- Corrective actions
- Preventive actions
- Control of records
- Internal audits
- Management reviews
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8Benefits of ISO/IEC 17025
- 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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9What to Document for ISO/IEC 17025 Accreditation
ISO/IEC 17025 documents used to designed and
developing testing and calibration laboratory.
The laboratory management system needs standard
documents that cover all requirements of ISO/IEC
170252005 for quick accreditation. Following are
the key document provided by ISO 17025 consultant.
- Manual
- Procedures
- Standard Operating Procedures
- Exhibits
- Blank and Filled forms
- Audit checklist
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