Embed Size (px)
DESCRIPTION
This publication is about ISO 17025 Certification for Laboratory Accreditation. ISO/IEC 17025 accreditation provides the assurance that calibration and testing laboratories are delivering good services, and consistent data.
Citation preview
ISO 17025 CertificationFor
Laboratory Accreditation
ISO 17025 Certification
ISO/IEC 17025 is the global quality standard for testingand calibration laboratories. It is the basis foraccreditation from an accreditation body. The currentrelease was published in 2005.
There are two main clauses in ISO 17025 – ManagementRequirements and Technical Requirements. Managementrequirements are related to the operation andeffectiveness of the quality management system withinthe laboratory, and this clause has similar requirementsto ISO 9001. Technical requirements address thecompetence of staff; testing methodology; equipmentand quality; and reporting of test and calibration results.
Certificationconsultancy.com
Why should one achieve ISO 17025 Accreditation
Accreditation is an objective way to assure yourcustomers that you have demonstrated technicalcompetence to provide reliable and accurate test orcalibration results. Accreditation is objective because anindependent, third party accreditation body performsannual assessments to verify whether your system ismeeting all of the requirements of ISO/IEC 17025. Thisindependent evaluation is important to the customer,because it is an unbiased guarantee that your laboratoryis performing at its highest level.
Certificationconsultancy.com
ISO 17025 for Laboratory Quality System
Quality has become an important issue to people all overthe world. ISO/IEC 17025 accreditation provides theassurance that calibration and testing laboratories aredelivering good services, and consistent data.
The accreditation body is responsible for assessing thequality system and technical aspects of your system todetermine your compliance to the requirements ofISO/IEC 17025. It is the accreditation body that ultimatelydecides whether or not a laboratory is complying withthe standard.
Certificationconsultancy.com
ISO 17025 Certification Process
As with other ISO certifications, companies can decide tocomplete the steps in-house or hire a consultant tomanage the certification process. A brief understandingof the ISO 17025 standard is the first step. The companyshould then conduct a gap analysis to determine thelaboratory’s current stage of compliance with the ISO17025 Standard requirements. While most laboratorieshave to meet stringent technical requirements, they maybe lacking in the management quality systemcomponents such as documentation and documentcontrol.
Certificationconsultancy.com
The results of the gap analysis are the basis for thequality plan and implementation strategy. Once thestandard requirements are satisfied, an internal audit willdetermine if there are still gaps in the qualitysystem. Once these are satisfied, it is time to contact anISO 17025 registrar who will conduct and independentcertification audit.
Certificationconsultancy.com
Key steps For ISO 17025 Accreditation
There are eight key steps towards laboratoryaccreditation:
• Management defines a project owner.• The project owner studies details of the standard,supporting literature, and other relevant information.• The project owner defines the preliminary scope ofaccreditation and works with laboratory professionals toprepare a list with requirements.• The project owner and laboratory professionalsperform a gap analysis to determine the differencebetween the requirements and what is currentlyimplemented in the laboratory.
Certificationconsultancy.com
• Based on the outcome of the gap analysis, the projectowner, laboratory professionals, financing anddocumentation professionals, and external consultantsestimate the costs for accreditation.• Estimated costs are presented to management, alongwith incremental opportunities.• Management decides to proceed with accreditation.• The project owner leads implementation steps.
Certificationconsultancy.com
How does ISO 17025 Accreditation Cost?
When you enter the market for an accreditation body,you'll find there is a wide range of prices for accreditationservices, depending on different factors. Each laboratoryhas its own unique characteristics, and these come intoplay in estimating costs. There are three key elementsthat make up the cost of accreditation:
• Daily rate• Overhead expenses• Travel and accommodations
Certificationconsultancy.com
What to include in ISO/IEC 17025 Documentation?
When organization, either testing or calibration laboratoriesgoing for ISO 17025 accreditation, there are specificdocumentation requirements that need to be fulfill. List of suchrequirements for better understanding and defining qualitysystem in laboratory as per ISO/IEC 17025:2005 are as bellow.
• ISO 17025 Manual• Mandatory procedures• Quality policy, SOP, Work Instruction• Forms for record keeping• Audit Checklists to verify implementedQMS system.
Certificationconsultancy.com
Download SampleISO 17025 Documents List
Time require achieving ISO 17025 Accreditation
Typically, it takes a laboratory six months to one year toprepare for the accreditation assessment. Theassessment itself, from the day of closure of anyapplicable non conformances to the issuance of acertificate, takes approximately 8 weeks to complete. Thisincludes Executive Committee review and administrativetime required for paperwork and approval.
Certificationconsultancy.com
Benefits of achieving ISO 17025 Accreditation
• Recognition in the testing and calibration laboratoryindustry as an ISO 17025 certified facility.• A competitive edge over competitors who are notcertified in a globally-accepted quality system.• Clearly document processes and procedures within aquality management system.• A system to continuously improve both themanagement and technical aspects of the business• Improved customer service and higher customersatisfaction with laboratory testing and calibrationservices.• An internal audit process to identify non-conformanceto standards and a process for corrective action andupdating the quality system to the new quality standards
Certificationconsultancy.com
Global Certification Consultancy
Global Certification Consultancy is the leading company that
introduces Online Consultancy by offering International System
Certification Documentation and Auditor Training Packages.
Contact Us...
Web Site: www.Certificationconsultancy.com
E-mail ID: [email protected]
Follow Us...
