Punyam Management Services Pvt. Ltd.

Punyam

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Punyam

MESSAGE
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style
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 MESSAGE IN 5 LINES FOR LABORATORIES
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• –Click
Say what
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you do Master text styles
level
 Do what you say
• Second
• Third
Record
level
level
what you do
• Third
Check – level
theFourth level
difference
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Act on the level
difference

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 MESSAGE levelIN 1 LINE
 Do right thing, first time, every time to Achieve Consistent
Quality
 MESSAGE IN 1 LINE
 Continual improvement is the way of life

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ISO/IEC 17025: 2017 Requirements Punyam

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4. General 5. Structural 6. Resource 7. Process 8. Management System

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Requirements Requirements Requirements Requirements Requirements

4.1• Click to edit Master text styles 7.1 Review of 7.2 Selection, 8.1 Options
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Impartiality General requests, tenders
and contracts
verification
and validation
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level
of methods 8.2 Management
system
8.3 Control of
management
system documents
4.2 6.2 Personnel 7.4 Handling of documentation

• Third–level
Confidentiality Fourth level 7.3 Sampling test or calibration
items
(Option A) (Option A)

6.3 Facilities and 8.5 Actions to

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environmental 7.6 Evaluation of 8.4 Control of address risks and
7.5 Technical records (Option A) opportunities
conditions measurement
records (Option A)
uncertainty
• Fifth level6.4 Equipment 8.6 Improvement 8.7 Corrective
7.7 Assuring the 7.8 Reporting of (Option A) action (Option A)
validity of results results
6.5 Metrological
traceability 8.8 Internal audits 8.9 Management
7.9 Complaints 7.10 Non (Option A) reviews (Option A)
conforming work
6.6 Externally
provided products 7.11 Control of
and services data –
Information
management

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Punyam Management Services Pvt. Ltd.
4 TIER DOCUMENTATION STRUCTURE FOR Punyam

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LABORATORY Master title
ISO/IEC style
17025:2017
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Quality
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Manual

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Fourth level Procedures
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• Fourth level
• Fifth level standards/Test
Work Instruction/SOP/ test
Methods/other
documents

Forms/Records

Sample receipt Record Personnel & Trg.

Purchasing Sampling Testing preparation Dispatch

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Risk and Opportunity Punyam

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The objective ofedit Master
this presentation
an QMS is established in terms of:
title
are to appreciate style
and understand how

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Risk
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level Master text styles
Risk Analysis Risk Evaluation
• Second
 •Intended
level
Third level
user Identification  Risk acceptability decisions
• Third level
 Area–wise
Fourth
risk level
identification
 Risk estimation
» Fifth level
• Fourth level
• Fifth level
Risk monitoring and control Post test operation information
 Post-production experience
 OPTION analysis  Review of Risk management
 Implementation of measures experience- customer use
 RESIDUAL RISK evaluation  Take appropriate actions in
 Overall RISK acceptance MRM

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 Application for Accreditation (by
Laboratory)

Accreditation Procedure
Acknowledgement & Scrutiny of Application
(by accreditation body Secretariat)
Feedback
to
Adequacy of Quality Manual (by Laboratory
Lead Assessor)

Stage 1 audit of Laboratory (Optional) and

Final Assessment of Laboratory (by Necessary

Assessment Team)
Corrective
Action
Scrutiny of Assessment Report (by by
accreditation body Secretariat)
Laboratory

Recommendations for Accreditation (by

Accreditation Committee)

Approval for Accreditation (by

Chairman, accreditation body)

Issue of Accreditation Certificate (by

accreditation body Secretariat)

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Audit Steps Punyam

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1. Audit Plan
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• Click to
2. Develop Checklists
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• Second 3. Opening
level Meeting
• Third level
• Third–level
Fourth level
4. Gather
» Fifth level Evidence
• Fourth level
• Fifth level 5. Record Results

6. Closing Meeting

7. Audit report
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 ISO/IEC 17025 Accreditation Steps For accredited laboratories
 Steps to update existing ISO/IEC 17025:2005 system to revised ISO/IEC 17025:2017
laboratory management system (Existing accredited laboratories)
► Conduct awareness program for revision to ISO/IEC 17025:2017
► Review all documents to meet revised ISO/IEC 17025:2017 requirements and Identify changes.
► Promote the use of risk based thinking and determine risk and opportunities
► Review quality policy and establish quality objectives as well as prepare risk sheet
► Revise Quality Manual and prepare documents as per revised ISO/IEC 17025:2017.
► Train internal auditors for requirements of revised ISO/IEC 17025:2017 standard
► Assess the system through internal audit as per revised ISO/IEC 17025:2017 standard.
► Take corrective actions on identified non-conformities.
► Apply to revised existing certificate to ISO/IEC 17025:2017 standard to your existing accreditation
body.
► Final audit (Either in surveillance audit or special audit by accreditation body on ISO/IEC
17025:2017
Note: Also all accredited laboratories needs to update the system within 3 year of release of
standard.
The ISO/IEC 17025:2017 is released in November 2017, the accredited laboratories may
go for Upgradation to ISO/IEC 17025:2017 before November 2020

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