Mr. N. Venkateswaran, Technical Operations Manager, National Accreditation Board for Testing and Calibration Laboratories, Gurgaon ISO/IEC 17025 :2005 1 “General Requirements for the Competence Of Testing and Calibration Laboratories”
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Mr. N. Venkateswaran,
Technical Operations Manager, National Accreditation Board for Testing and
Calibration Laboratories, Gurgaon
ISO/IEC 17025 :2005
1
“General Requirements for the Competence Of
Testing and Calibration Laboratories”
Scope
Normative References
Terms and Definitions
Management Requirements (15)
Technical Requirements (10)
2
Contents of ISO / IEC 17025 : 2005
4.1 Organization
4.2 Management System
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the Customer
4.8 Complaints
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
4.10 Improvement
4.11 Corrective actions
4.9 Control of non conforming testing and/or calibration work
3
Management Requirements
4.1.1- Legal Identity
4.1.2- Regulatory Authorities, Customer needs & AB requirements
4.1.3- Facilities (Permanent/ Site/Temporary/Mobile)
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4.1 Organization
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4.1.4 - Potential Conflict of Interest
4.1.5 (a)- Managerial and Technical personnel
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4.1.5(b)- Commercial and Financial Pressures
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4.1.5 (c)- Confidentiality
4.1.5 (d)- Impartiality and Integrity
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4.1.5(e)- Organization Structure
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4.1.5 (f)- Responsibility and
Authority
4.1.5 (g)- Adequate Supervision
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4.1.5(h)- Technical Management
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4.1.5(i)- Quality Manager
4.1.5 (j)- Deputies
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4.1.5(k)- Awareness of Lab activities
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4.1.6- Effective Communication Processes
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4.2 Management System
4.2.1 Documentation and Implementation
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4.2.2- Quality Policy and Objectives
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4.2.3- Top Management Commitment
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4.2.4- Communication by Top Management
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4.2.5- Quality Manual/Documentation Structure
Quality Manual
Quality System Procedures
SOP’s, Work Instructions
Blank Tags, Forms, Labels, Cards,
Worksheets
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4.2.6- Roles and Responsibilities
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4.2.7- Integrity of Management system
4.3.1- General (External & Internal)
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4.3 Document Control
4.3.2- Document Approval & Issue
4.3.2.1- Master List of Documents
4.3.2.3- Unique Identification
4.3.2.2- Availability of appropriate documents & Removal of obsolete documents
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4.3.3- Document Changes
4.3.3.1- Review and Approval
4.3.3.2- Identification of New Text
4.3.3.4- Changes in computerized system documents
4.3.3.3 - Amendment of Documents by Hand
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4.4.1 Contract Review
4.4.2- Records of review
4.3.3- Review of Subcontracted work
4.3.4- Information to customer when deviation in contract
4.3.5- Amendment in contract after commencement of work
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4.4 Review of Request, Tenders & Contracts
4.5.1 Competent Subcontractor
4.5.2 Approval from Customer
4.5.3 Responsibility for Subcontracting work
4.5.4 Record of Subcontractor
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4.5 Subcontracting of Test & Calibrations
4.6.1 Policy/ Procedure-Selection & Purchasing of Services/ Supplies
4.6.2 Records
4.6.3 Review & Approval of Purchasing Documents
4.6.4 Records of Supplier Evaluation
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4.6 Purchasing Services & Supplies
4.7.1 Co-operation with customers
4.7.2 Seek Feedback(Positive/Negative)
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4.7 Service to the Customer
Policy, procedure & Records for Resolution of Complaints from Customers
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4.8 Complaints
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4.9 Control of nonconforming testing and/ or
calibration work
4.9.1 Identification of Non-conforming work & Correction
4.9.2 Corrective action on Non- conforming work
Continual improvement towards effectiveness of management system
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4.10 Improvement
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4.11.1 General
4.11.2 Cause Analysis
4.11 Corrective Action
4.11.3 Selection and implementation of Corrective Actions
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4.11.4 Monitoring of Corrective actions
4.11.5 Additional Audits
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4.12.1 Identification of Preventive actions
4.12.2 Implementation & Effectiveness
4.12 Preventive Action
4.13.1 General
4.13.1.1- Procedures for Identification, collection, indexing, access, filing, storage, maintenance & disposal
4.13.1.2- Retention & Retrievability
4.13.1.3- Security
4.13.1.4- Protection of records stored electronically
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4.13 Control of Records
4.13.2 Technical Records
4.13.2.1 Records of Original observations
4.13.2.2 Recording of observations, data & calculations
4.13.2.3 Alteration in Records
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4.13 Control of Records
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4.14.1 Audit Plan, Schedule and Procedure
Trained, Qualified & Independent internal auditor
4.14.2 Audit Findings/ Doubt on effectiveness of operations- Corrective actions/ Notify customers
4.14 Internal Audit
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4.14.3 Records
4.14.4 Effectiveness of Corrective actions
4.15.1 Conduct of Management Review
4.15.2 Findings, Decisions taken, Responsibility & Time frame for taking actions
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4.15 Management reviews
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5.1 General
5.2 Personnel
5.3 Accommodation and Environmental conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
4.6 Purchasing services and supplies
4.7 Service to the Customer
4.8 Complaints
5.10 Reporting the results
5.7 Sampling
5.8 Handling of Test and Calibration Items
5.6 Measurement Traceability
5.9 Assuring the Quality of Test and Calibration results
Technical Requirements
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5.2 Personnel
5.2.1 -Competency
5.2.2 Identification of training needs
5.2.3 Contractual personnel
5.2.4 Job Descriptions
5.2.5 Authorization & Records
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5.3 Accommodation and Environmental
Conditions
5.3.1 -Accommodation
5.3.2 Monitor, Control & Records of Environmental Conditions
5.3.3 Incompatible Activities/Cross-contamination
5.3.4 Access Control
5.3.5 House Keeping
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5.4 Test and calibration methods and
Method validation
5.4.1 General
5.4.2 Selection of Methods
5.4.3 Laboratory Developed Methods
5.4.4 Non-Standard Methods
5.4.5 Validation of Methods
5.4.6 Estimation of Measurement
Uncertainty
5.4.7 Control of Data
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5.5 Equipments
5.5.1 Availability/ Capability
5.5.2 Calibration
5.5.3 Authorization & Operating instructions
5.5.4 Identification
5.5.5 Records
5.5.6 Safe Handling, Transportation & Storage
5.5.7 Overloading
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5.5 Equipments
5.5.8 -Labelling
5.5.9 Outside the permanent Control
5.5.10 Intermediate Checks
5.5.11 Correction Factors
5.5.12 Safeguard
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5.6 Measurement Traceability
5.6.1 General
5.6.2.1 Calibration
5.6.2.1.1 Traceability to SI Units
5.6.2.1.2 Traceability by other means
5.6.2 Specific Requirements
5.6.2.2 Testing
5.6.2.2.1 If test results affected-
Traceability to SI Units as per 5.6.2.1.1
5.6.2.2 .2 Traceability by other means
as per 5.6.2.1.2
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5.6.3.1 Reference Standards
5.6.3.2 Reference Materials
5.6.3.3 Intermediate Checks
5.6.3.4 Transport & Storage
5.6.3 Reference Standards & Reference Materials
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5.7 Sampling
5.7.1 Sampling Plan & Procedure
5.7.2 Deviation from documented sampling procedure
5.7.3 Records of Relevant data & operations
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5.8 Handling of Test & Calibration Items
5.8.1 Procedures for handling, receipt, disposal etc.
5.8.2 Identification of Test/ Calibration items
5.8.3 Abnormalities in received test / calibration items
5.8.4 Storage & Security
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5.9 Assuring the quality of test and
Calibration results
5.9.1 Statistical Techniques for Quality control checks
5.9.2 Analysis of Quality control data
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5.10 Reporting the results
5.10.1 General
5.10.3 Test Reports
5.10.2 Test Reports & Calibration Certificates
5.10.4 Calibration Certificates
5.10.5 Opinions and Interpretation
5.10.6 Subcontracted results
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5.10.7 Electronic Transmission of results
5.10.9 Amendments to test reports/ calibration certificates
5.10.8 Formats of reports & certificates
5.10 Reporting the results
Thanks for your attention !!!
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