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How to get ISO 17025 certification in Hyderabad

ISO 17025
ISO 17025 – Lab management system

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ISO 17025 general requirements for the competence of testing and calibration laboratories, every lab in Hyderabad must blend the standard requirements with the internal process to deliver the test results with accuracy and with impartiality. By acquiring this international standard, lab can strongly brand as technically competent. In many cases, suppliers and regulatory bodies will not entertain test or calibration results from a lab that is not accredited through accredited registrar. With kwalitycert your ISO 17025 accreditation is guaranteed.
This standard was framed and published by international organization for standardization in the year 1999.laboratories use ISO 17025 to implement a quality system driven to improve their ability to consistently produce accurate results with impartiality. The standard has undergone changes thrice and released in 1999, 2005 and latest version is ISO 17025:2017.

ISO 17025
Key ItemsDescription
ISO 17025Lab Management System
Year Published2017
Objective
  1. Frame up a strong system ( Document what you do and take action)
  2. Keep the process impartial
  3. Keep the data confidential
  4. Keep the customer happy

Structure of ISO 17025

ClausesWhat
Clause 1Scope
Clause 2Normative Reference
Clause 3Terms & Definitions
Clause 4General Requirements
Clause 5Structural Requirements
Clause 6Resource Requirements
Clause 7Process Requirements
Clause 8Management Requirements
Clause 4
WhatGeneral Requirements
ObjectiveManage – Impartiality & confidentiality
WhoManagement + All staffs + External parties(if any)
Key NotesImpartiality :
  1. Identify potential risk associated to impartiality (Test Results).
  2. Include the risks arising from the LAB associated personnel, external party (customer – bribe or any material), Management.
  3. Have a mitigation plan for the same.
  4. Have an agreement signed (Unbiased Agreement).
  5. Have a unbiased team ( independent from the lab process).
Confidentiality :
  1. Customer should be informed in writing, if taking any information (Test Result or could be any data) to the public.
  2. All the associated personnel should sign a confidentiality declaration.
To Do List (Only Example)Documents :
Risk Assessment procedure

Records :
Risk register
Impartiality declaration
Confidentiality declaration
Risk Mitigation plan
Clause 5
Key Items Description
WhatStructural Requirements
ObjectiveLAB structure – Define and document all want
WhoManagement
Key Notes
  1. Identify right leader to carry forward the standard
  2. List all the legal and statutory requirements
  3. Have the organization chart framed
  4. Frame up the communication hierarchy (internal and External)
  5. Have the LAB policy framed
  6. List all the LAB activities ( include if any subcontracted)
To Do List (Only Example)Documents :
Job description of leader – ISO
Procedure for in identifying the legal & Statutory requirements

Records :
Org chart
Communication hierarchy chart
Legal and statutory register
Activity List -LAB
Clause 6
Key Items Description
WhatResource Requirements
ObjectiveHave a strong and competent resource
WhoPurchase + HR + Training
Key Notes
  1. Appoint the LAB supervisor (or LAB manager if) to monitor the personnel
  2. Identify training need for the personnel
  3. Have clean sophisticated environment to carry out the testing process
  4. Frame up the communication hierarchy (internal and External)
  5. Have the right calibrated equipment to carry out the tests
  6. Have unique part/ serial number track back the insatiable results
  7. Have solid control over the purchasing of equipment & subcontracting the service
To Do List (Only Example)Documents :
Training Procedure
Procedure to track up the uncertain of test results
Job description of all personnel

Records :
Org chart
Training Plan
Training feedback form
Purchase order
Clause 7
Key Items Description
WhatProcess Requirements
ObjectiveHave a strong sampling, test method(s) , validation , verification , reporting and information management system.
WhoLAB Manager
Key Notes
  1. Define a contract / tendering procedure
  2. Identify training need for the personnel
  3. Identify the right sampling, testing and calibration methods and document the same
  4. Frame up the right reporting plan and also managing the technical record
  5. Frame up a customer complaint handling procedure
  6. Frame up a procedure to handle nonconformity of test work
  7. Implement information security polices to protect the data
To Do List (Only Example)Documents :
Contract/Tender Procedure
Procedure for sampling, Test and Validation
Customer complaint handling procedure
Information security policies

Records :
Contract review
Results report
Customer complaint form
Clause 8
Key Items Description
WhatManagement System Requirements
ObjectiveHave a procedure to control documents, records, internal audit and corrective action
WhoManagement + LAB Manager + All staffs
Key Notes
  1. Frame up procedure to handle documents and records
  2. Perform internal Audit
  3. Perform Management Review Meeting
  4. Take corrective action
  5. Risk management ( blend with clause 4 – impartiality )
To Do List (Only Example)Documents :
Control of document procedure
Control of records procedure
Procedure to perform internal audit
Information security policies

Records :
Internal audit calendar
Risk register
Minutes of meeting
Auditable Clauses
ClausesWhat
Clause 4General Requirements​
Clause 5Structural Requirements​
Clause 6Resource Requirements​
Clause 7Process Requirements
Clause 8Management Requirements

Why ISO 17025 ?

ISO 17025 is the unique and most sought after ISO standard for calibration and testing laboratories across the globe.ISO 17025 accredited laboratory’s have demonstrated that they are technically competent and able to produce the accurate test results and calibration data.

Laboratory that are accredited with ISO 17025 are able to shape up few key factors along with the accurate test result and calibration data

  1. Technical competence of staff
  2. Traceability
  3. Maintenance of test equipment
  4. Quality assurance of test and calibration data
  5. Validity and appropriateness of test methods
  6. Quality of testing environment and sampling

How to get ISO 17025 certification ?

Our masters have more than 10 plus years of global experience, with hands-on experience in the field of ISO certification in Hyderabad, assessment and training.

With KwalityCert your Business and process excellence is guaranteed.

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