EGAC Requirements Changes

Mohamed Adel Rezk Quality & Develop Manager

EGAC Information Pack

http://www.egac.gov.eg/www/InfoCenterCategory.aspx?InfoCenterTypeID=1

Calibration Labs Testing Labs Certification Bodies (QMS,EMS,FSMS,) PT providers Contents of each: EGAC Application EGAC Accreditation Agreement Publications for the field Regulations for the field EGAC Accreditation Fee Structure Scope of EGAC the field

Medical Labs Inspection Bodies

EGAC

EGAC Publications
http://www.egac.gov.eg/www/InfoCenter.aspx?InfoCenterTypeID=2

List of Publications PB01L EGAC Accreditation Process For Laboratories PB02C EGAC Accreditation Process For Certification Bodies PB03I EGAC Accreditation Process For Inspection Bodies PB04G EGAC Policy On Traceability For Measurements PB05L EGAC Policy On Measurement Uncertainty For Testing Laboratories PB06L EGAC Policy On Measurement Uncertainty For Calibration Laboratories PB07L Guidelines Concerning The Validity Of Calibration Certificates PB12L EGAC Policy on implementation and use of Proficiency Testing PB13L Guidelines for Uncertainty of measurement in Quantitative Testing PB14G EGAC Policy on Cross Frontier PB15L Guidelines for Laboratories in Calibration Metrology

EGAC Publications
http://www.egac.gov.eg/www/InfoCenter.aspx?InfoCenterTypeID=2

Accreditation Process

PB01L - Accreditation Process Lab

Benefits of accreditation Who can seek accreditation? How does ISO 9000 fit with Lab Accreditation? The Accreditation Process / flowchart The process for Granting accreditation
o The Technical Advisory Committee (TAC) meeting o The Accreditation Committee (AC) meeting o Decision making and granting accreditation

Feedback, Complaints and Appeals

Accreditation Process

Measurement Traceability

PB04L EGAC Policy on Traceability of Measurements and Calibration

Accredited calibration labs, shall in all cases:

Calibrate critical equipment and calibrations relevant to the scope of accreditation, Derive the traceability from direct reference to Accredited Labs.
o o o or if not available, directly from NMI. or reference to SI unit, or Calibration Lab that can demonstrate competence, measurement capability and traceability with appropriate CMC.

Has to be confirmed with EGAC Accreditation Manger on a case by case basis. (ILAC P10)

Measurement Traceability

PB04L EGAC Policy on Traceability of Measurements and Calibration

Accredited Testing labs, shall ensure:

In-house calibration and accredited test/calibration results should be traceable to accredited Lab with suitable uncertainty. If not available, in sequence
- to a National Metrology Institute, - National Reference Laboratory, - a Certified Reference Material, - Mutual Consent Standard,

Has to be confirmed with EGAC Accreditation Manger on a case by case basis. (ILAC P10)

Measurement Uncertainty

PB05L EGAC Policy on Measurement Uncertainty for Testing Labs Testing Laboratories must report uncertainty estimates: When specified by the method, When required by the client When interpretation of results could be compromised. Lab Categories: I- Qualitative tests for which measurement uncertainty budgets will not be required II- Following Well-recognized test methods that specify major sources of uncertainty & their calculations III-Test methods that require uncertainty estimates calculated in accordance with the ISO GUM"

Measurement Uncertainty

PB05L EGAC Policy on Measurement Uncertainty for Testing Labs Objective evidence of compliance, reviewed before & verified during the assessment visit: Procedure for estimating measurement uncertainty, Resulting documented uncertainty estimates, Trained personnel on measurement uncertainty, and Supporting information, where relevant,

In any case Laboratories must know & be able to show the uncertainty associated with a measurement whether reported or not.

Measurement Uncertainty

PB06L EGAC Policy on Measurement Uncertainty for Calibration Labs Uncertainty Estimates are: Crucial part to ensure traceability. Calculations in accordance with the GUM. Expanded uncertainty, coverage factor, confidence level. Calibration certificates with statements of measurement results and uncertainty. Appropriate, defined, and documented methods to develop uncertainty estimates. Good statistical practice and methodology, If cannot, estimation of uncertainty is still required (see GUM).

Calibration Guidance

PB07L Guideline on Validity of Calibration

Certificates Validity Expiry date (reference to ILAC GD 24:2007) Repaired Tampering & Abuse Excessive Shock

Assuring Quality of Test Results

EGAC Policy & Procedure for PT

Ibf/in
2

Pressure (5000 Ibf/in2) deviation values

15.000 10.000 5.000 0.000 -5.000 -10.000 -15.000 -20.000 -25.000

PB12L EGAC Policy on implementation and use of Proficiency Testing

Asigned Value

P18L Assessment of the Laboratorys Participation and Performance in Proficiency Testing

2 02 B

4 02 B

Reported Value

3 02 B

Asigned Unc

5 02 B

6 02 B

-Asigned Unc

7 02 B

8 02 B
2 SD

9 02 B

-2 SD

0 03 B

Assuring Quality of Test Results

PB12L - EGAC Policy on PT

PT should cover at least one activity in the scope of accreditation of the accredited laboratory Frequency of participation in PT once/4 years/ major sub discipline of the scope. The Lab should have a plan for the whole scope of accreditation. It will be required to follow it. Disciplines/Sub-disciplines on EGAC website PT providers have to be accredited or at least trusted by EGAC Med Labs have special PT rules.

Assuring Quality of Test Results

PB12L - EGAC Policy on PT

Results documented seen by accreditation process Take necessary corrective/preventive action Records of PT results accumulated & analyzed to show the competence & stability of accredited lab Acceptable types of PT in accreditation are: Bilateral proficiency testing Proficiency testing schemes ILC designed for other purposes

Assuring Quality of Test Results

PB12L - EGAC Policy on PT

Additional PT may be required when:
External quality measures are not sufficient, e.g.: * Number of PT performed in specific scopes * Extension of the scope of accreditation * Insufficiently validated in-house methods Changes of personnel in the accredited scope * Procedural steps deviating from test standard Results of PT are unsatisfactory CAs not carried out, documented, or sufficient To detect systematic errors in the lab To provide evidence on quality/competence

Assuring Quality of Test Results

PB12L - EGAC Policy on PT

CARs may be Internal/External Quality Measures:
Calibration of measuring devices. Use of quality control charts. Multiple measurements & statistical methods. Use of standard methods for calibration/ testing. For testing: - use of CRM/calibration/control material. - blind test materials (e.g. by Q Manager). For calibration: - use of Cross Checks & Higher Level calibrations. PTs carried out on the laboratory's own initiative.

Assuring Quality of Test Results

PB12L - EGAC Policy on PT

Internal/External Addition Quality Measures: To repeat the PT. To check internal quality assurance measures. To get detailed report on corrective actions. To make an on-site surveillance

Procedures for Lab Accreditation

P18L Assessment of Proficiency Testing

Preface Role of EGAC Acc manager Assessment process Document review & preliminary assessment Acceptability Criteria Assessment of results Corrective actions and additional measures

Assuring Quality of Test Results

Documentreview& Preliminaryassessment

Documents available& sufficient?

No

Yes
Planisplace andcovering thewhole scope?

Yes

criteria adequate?

Yes No

No
SetCriteria

CheckResults

Assuring Quality of Test Results 2

End

Yes

Satisfactory?

No Yes Yes
Explanation& correctiveactions available?

End

Acceptable?

No
Additionalmeasures

Yes
End

Measures arepositive?

No
Restrictionofthescopeofaccreditation, eventuallysuspensionorwithdrawalofaccreditation.

Measurement Uncertainty

PB13L Guidelines on Calculation of Measurement Uncertainty for Testing Labs Factors contributing to Uncertainty
Definition of the measurand Sampling Handling of Samples

Preparation of samples Personnel

Variations in the test procedure

Environmental and measurement conditions Calibration Standards or Reference Materials Software / Methods of measurement Correction due to systematic effects Measuring Instruments

Measurement Uncertainty

PB13L Guidelines on Calculation of Measurement Uncertainty for Testing Labs

Guidance on implementation

Fundamental Points:
A. The statement of uncertainty contain sufficient information for comparisons; B. Use GUM and sector specific interpretations; C. Only uncertainty of measurement in quantitative testing for now. Qualitative testing is developing; D. An estimation of overall uncertainty, or identification of major components with estimate of size of combined uncertainty; E. Use existing knowledge / Experimental data (quality control charts, validation, round robin tests, PT, CRM, handbooks etc.);

Measurement Uncertainty

PB13L Guidelines on Calculation of Measurement Uncertainty for Testing Labs

Guidance on implementation

Fundamental Points:
F. When using a Std Test Method there are three cases: - If it has guidance to uncertainty evaluation, follow; - If it gives typical uncertainty, comply & quote it; - If it implicitly includes uncertainty, just quote it;. G. Factors to be taken into account: - Common sense; - Influence of uncertainty of measurement on result; - Degree of rigor in determination of uncertainty. H. In certain cases it can be sufficient to report only reproducibility; I. When estimation of uncertainty is limited it should be made clear;

Measurement Uncertainty

PB13L Guidelines on Calculation of Measurement Uncertainty for Testing Labs

Procedures for the evaluation of the result uncertainty Quantitative test result
Based on quantitative attribute values

Qualitative test result

Based on qualitative attribute values

PB13L (References)

Measurement Uncertainty

A. ISO International Vocabulary of Basic and General Terms in Metrology (VIM) 2nd ed. 1993, ISBN 92-67-10175-1 B. ISO Guide to the Expression of Uncertainty in Measurement (GUM): 1993 (revised 1995), ISBN 92-67-10188-9 C. ISO 5725 (Part 1 6):1994 Accuracy (trueness and precision) of measurement methods and results (n.b. Part 5 is 1998) D. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories E. ILAC G17: 2002: Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025. F. CITAC / Eurochem Guide to Quality in Analytical Chemistry: 2002. (see www.eurachem.org) G. EA-4/16: 2003 Guidelines on the expression of Uncertainty in Quantitative Testing. (see www.european-accreditation.org) H. APLAC TC 005:2004 Interpretation and guidance on the estimation of uncertainty of measurement in testing; Asian Pacific Lab. Acc. Cooperation. (see www.aplac.org) I. UKAS LAB 34: 2003: The Expression of Uncertainty in EMC Testing; United Kingdom Accreditation Service. (see www.ukas.org)

Cross Frontier

PB14G EGAC Policy on Cross Frontier

In general EGAC complies with the Guidance documents on cross frontier from : IAF (GD3:2003). ILAC (G21:2002). in the following situations: When EGAC performs accreditation for a CAB located outside Egypt. When an MRA/MLA signatory international Accreditation Body performs accreditation for a CAB located inside Egypt.

Calibration Guidance

PB15L Guidelines for Laboratories in Calibration Metrology Dimension, Temperature, Force, Electrical

EGAC Regulations

EGAC Regulations

EGACs Regulations

R01L Regulations for Conformity Assessment bodies

Accreditation Criteria Conditions for Conformity Assessment Bodies: o General o For Certification Bodies o For Inspection Bodies o For Calibration / Testing Laboratories Significance of Accreditation Notification of change Suspension & withdrawal Appeals Complaints

EGACs Regulations

R02G Measurement & Calibration Systems

Planing & Selection of Equip./Ref. Materials (ILACG9:2005) Uncertainty of measurement (ILAC-G17:2002) Calibration procedures Records Calibration Intervals (ILAC G24:2007) Sealing of Calibrated Equipment Labeling of Calibrated Equip./Ref. Material

EGACs Regulations

R03G Accreditation Fee Structure

Application fees Document review fees Assessment visits:
o pre-assessment o initial assessment o follow-up

Surveillance / extension of scope Administration fees: administrative, and subsistence expenses

EGACs Regulations

R04G Use of EGAC Symbol

General Format & Display Use of Symbol by Laboratories Use on Calibration Certificates & Labels Use on Test Reports & Certificates Use on QMS Certificates Use on EMS Certificates Use on Publicity Materials Other Restrictions & Sanction

Accredited bodys

mark

Corrective Actions - Withdrawal of certificates, Publication of transgression - Suspension / withdrawal of accreditation and / or legal action

Testing CAB#206024

Appendices: 1: Symbol display 2: Symbol Design examples

3: Calibration Label design, use and control

EGACs Regulations

R05G - Accreditation Process Time Limitations and

Response Actions to the Nonconformities of the CABs
Grading of nonconformities in EGAC Very serious credibility of the accreditation program is seriously threatened Quite significant validity or integrity of EGAC is threatened Minor / isolated does not affect the core activities of the CAB Actions taken by EGAC according to nonconformity grade Actions of EGAC according to NC grade
According to seriousness: Very serious rejection in initial assessment or immediate
suspension in surveillance/reassessment Quite significant CA must be completed within the specified time interval as in table Minor / isolated non-conformity noted in the assessment notes

EGACs Regulations R05G - Accreditation Process Time Limitations

Who Accredit Accrediting Bodies?

NOT accredit but recognize

International Group
ILAC
International Laboratory Accreditation Cooperation

Regional Groups
EA
European Cooperation for Accreditation

APLAC
Asia Pacific Laboratory Accreditation Conference

IAAC
Inter American Accreditation Cooperation

ILAC / IAF Joint Documents

IAF-ILAC Joint Publication (A Series)

http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A3:05/2007 IAF/ILAC MRAs: Key Performance Indicators - A Tool for the Evaluation Process IAF/ILAC A5:03/2011 IAF/ILAC MLA/MRA: Application of ISO/IEC 17011:2004

IAF-ILAC Joint Publication (A Series)

http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A3:07/2011 Narrative Framework for Reporting on the Performance of an Accreditation Body A Tool for the Evaluation Process (1) to allow an evaluated accreditation body (AB) to present information about how it addresses ISO 17011 requirements; (2) to focus the evaluation agenda on important topics;

IAF-ILAC Joint Publication (A Series)

http://www.ilac.org/ilaciafjoint.html

IAF/ILAC A5:03/2011 IAF/ILAC MLA/MRA: Application of ISO/IEC 17011:2004

The purpose of this document is to enable accreditation bodies to better harmonize their application of the standards against which they assess conformity assessment bodies (CABs).

ILAC Documents

ILAC Procedural Series (P Series)

http://www.ilac.org/procseries.html

ILAC P9:2005

ILAC Policy for Participation in National and International Proficiency Testing Activities ILAC P10:2002 ILAC Policy on Traceability of Measurement Results ILAC P13:2010 Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers ILAC P14:12/2010 ILAC Policy for Uncertainty in Calibration (calculating & expressing CMC)

ILAC Procedures

ILAC P10
ILAC Policy on Traceability of Measurement Results

Calibration/Traceability of critical equipment & use of CRM Traceability to NMI or accredited Laboratory with suitable Uncertainty

ILAC Procedures

ILAC P9
ILAC Policy for participation in National & International Proficiency Testing Activities

One activity prior to accreditation A plan for the participation in the PT schemes for the whole scope

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G9:2005 Guidelines for the Selection and Use of Certified Reference Materials ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers ILAC-G13:2007 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025 ILAC-G20:2002 Guidelines on Grading of Non-Conformities ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing ILAC-G24:2007 Guidelines for the determination of calibration intervals of measuring instruments ILAC-G25:2012 Accreditation of Proficiency Testing Providers to ISO/IEC 17043:2010 - A Crosswalk to ILAC G13:2007

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G9:2005 Guidelines for the Selection and Use of Certified Reference Materials

These guidelines aim at establishing the framework by which laboratories seeking accreditation, and technical assessors, will be able to propose and evaluate the CRMs relevant to their specific needs.

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers

These Guidelines have been developed for evaluation of the competence of reference materials producers with a view to the eventual establishment of internationally accepted criteria. This document is intended as a guide to ISO Guide 34.

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G13:08/2007 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

This document is for providers of proficiency testing schemes who wish to demonstrate their competence by formal compliance with a set of internationally-acceptable requirements for the planning and implementation of proficiency testing schemes. There is an ISO document under development ISO 170

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025

This document describes how the concept of uncertainty of measurement should be introduced taking into account present state of the art understanding. It is realized that during the course of the implementation of ISO/IEC 17025, suitable sector-specific guidance will be needed.

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G20:2002 Guidelines on Grading of Non-Conformities

This document outlines one approach to grading nonconformities, from more to less serious, through linking the seriousness of the nonconformity with the actions that the accreditation body may need to take. Some examples of the various grading are listed.

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing

The objective of this document is to ensure a consistent good practice for Accreditation Bodies and laboratories in the cost-effective use of proficiency testing in accreditation.

ILAC Guidance Documents (G Series)

http://www.ilac.org/guidanceseries.html

ILAC-G24:2007 Guidelines for the determination of calibration intervals of measuring instruments

The purpose of this document is to give laboratories, particularly while setting up their calibration system, guidance on how to determine calibration intervals. This document identifies and describes the methods that are available and known for the evaluation of calibration intervals.

Thank you