2 accreditation updates

7/29/2019 2 Accreditation Updates

1/29

Mahmoud Eltayeb

Accreditation UpdatesAccreditation Updates

Eng. Mahmoud Eltayeb

EGAC Executive Director


2/29

Mahmoud Eltayeb

Calibration & Testing Labs

Accreditation

Calibration & Testing Labs

Accreditation


3/29

Mahmoud Eltayeb

The standard will not be revised, as a result

of a systematic review of ISO/IEC 17025: 2005

The next systematic review will not occur

until year 2015 as expected.

Standard ISO/IEC 17025: 2005


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Mahmoud Eltayeb

ILAC- P9: 11/2010 ILAC Policy for

Participation in Proficiency Testing Activities"

Effective date: 11/2010

This policy sets the requirements for the

use of the PT in the accreditation process

Applied to testing , cal and medical labs

also to inspection bodies where relevant.

Proficiency Testing (PT)


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Mahmoud Eltayeb

ILAC- P9: 11/2010 ILAC Policy for

Participation in Proficiency Testing

Activities"

Minimum PT activities: satisfactory

participation prior to gaining accreditation.

Further and ongoing activity that is

appropriate to the scope of accreditation.

PT lans re ared b lab & reviewed b AB



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Mahmoud Eltayeb

PB12L EGAC Policy on implementation and

use of Proficiency testing.

EGAC web site includes updated list of

national & international PT providers that are

accredited or trusted.



7/29

Mahmoud Eltayeb

Growth of accredited Laboratories

by EGAC


8/29

Mahmoud Eltayeb

Medical Labs AccreditationMedical Labs Accreditation


9/29

Mahmoud Eltayeb

ISO 15189 is covered by the ILAC recognition

Arrangement for testing

(ILAC Resolution GA 13.25 Oct 2009)

ILAC ISO 15189: 2007 has been subjected to

early revision.

A draft of a new ISO 15189 has been

circulated for comments.

Medical Laboratories


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Mahmoud Eltayeb

There are currently more than 2200 medical

labs worldwide accredited to ISO 15189: 2007

Accredited medical labs : 3

in process: 4

Medical Laboratories


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Mahmoud Eltayeb

PT Providers AccreditationPT Providers Accreditation

ProbabilityDensity

-6.2 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.2

-6.06 -4.545 -3.03 -1.515 0.0 1.515 3.03 4.545 6.06

Vendor X(PPM)

0.00

0.10

0.20

0.30

0.40

-6.2 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.2

-4 -3 -2 -1 0.0 1 2 3 4

-6.06 -4.545 -3.03 -1.515 0.0 1.515 3.03 4.545 6.06

Vendor X(PPM)

Vendor Y

(PPM)

Standard Deviations (Coverage Factor)

0.00

-6.20 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.20

Vendor Z(PPM)

4.0-4.0

-6.2 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.2

-4 -3 -2 -1 0.0 1 2 3 4

-6.06 -4.545 -3.03 -1.515 0.0 1.515 3.03 4.545 6.06

Vendor X(PPM)

Vendor Y(PPM)


0.00

-6.20 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.20

Vendor Z(PPM)

4.0-4.0

-6.2 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.2

-4 -3 -2 -1 0.0 1 2 3 4

-6.06 -4.545 -3.03 -1.515 0.0 1.515 3.03 4.545 6.06

Vendor X(PPM)

Vendor Y(PPM)


0.00

-6.20 -4.65 -3.1 -1.55 0.0 1.55 3.1 4.65 6.20

Vendor Z

(PPM)

4.0-4.0


12/29

Mahmoud Eltayeb

ISO / IEC 17043: 2010 has been Published inFeb 2010

The new standard cancels and replaces both

parts of ISO/IEC Guide 43: 1997

withdraw of ILAC G13 within 2 years from thestandard publication date ( i.e. Feb 2013)

(ILAC Resolution GA 13.27 Oct 2009 )

PT Providers Accreditation


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Mahmoud Eltayeb

ILAC G25: 01/2012Accreditation of PT Providers to

ISO/IEC 17043:2010 - A Crosswalk to

ILAC G13:2007

ILAC- P13:10/2010

Application of ISO/IEC 17011 for the

Accreditation of Proficiency Testing Providers

EGAC is ready to receive first application

from PT providers since 1 June 2012

PT Providers Accreditation


14/29

Mahmoud Eltayeb

Inspection Bodies AccreditationInspection Bodies Accreditation


15/29

Mahmoud Eltayeb

The responsibility for the scope of inspection

has been transferred from a joint IAF/ILAC

activity to ILAC alone since Oct 2010.

(ILAC Resolution GA 14.12 Oct 2010)

(IAF Resolution 2010 - 24 Oct 2010)

Responsibility Transfer


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Mahmoud Eltayeb

The new standard ISO/ IEC 17020: 2012 wasreleased in March 2012 to replaceISO/ IEC 17020: 1998

It applies to inspection bodies type A, B,Candto any stage of inspection

IAF/ILAC A4: 2004 Guidance on theapplication of ISO/IEC 17020 is included inthe new standard.

Standard ISO/ IEC 17020


17/29

Mahmoud Eltayeb

No applications have been accepted by EGACOn the new standard since 1 June 2012

Action plan for implementation of the newstandard is required by IB

Standard ISO/ IEC 17020


18/29

Mahmoud Eltayeb

EGAC is in process of extending scope of its

MRA to include inspection activity.

Inspection bodies accredited by EGAC: 5

In process: 1

EGAC accredited inspection bodies


19/29

Mahmoud Eltayeb

Certification Bodies

Accreditation


Accreditation


20/29

Mahmoud Eltayeb

Management system certification bodies

Product certification bodies

Bodies certifying persons



21/29

Mahmoud Eltayeb

ISO/IEC 17021: 2011

The Standard ISO/ IEC 17021 was revised and

published on 1 Feb 2011

The standard ISO/IEC 1702: 12011 includes

the existing text of ISO/IEC 17021: 2006

virtually unchanged.

The standard contains additional

requirements for competence and the auditrocess .

Accreditation of management system

certification bodies


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Mahmoud Eltayeb

Normative references to ISO 19011 aredeleted.

References to ISO 19011 guidelines are

replaced by detailed audit processrequirements .

The standard is applicable to the certification

of all types of management systems.




23/29

Mahmoud Eltayeb

The transition period is 2 years from the dateof publication which will end on 1 Feb 2013 .

CB accredited by EGAC : 4

Suspended : 1

In process : 6




24/29

Mahmoud Eltayeb

New ISO/IEC 17065

Current revision : ISO/ IEC guide 65: 1996

ISO/ IEC 17065 is under development to

replace ISO/ IEC guide 65: 1996

Target date of publication: 31July 2012

Accreditation of product



25/29

Mahmoud Eltayeb

ISO/IEC 17024: 2003

A new revision of ISO/ IEC 17024 is under

development.

Near future implementation of MLA to include

accreditation of bodies certifying persons.

Accreditation of Personnel



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Mahmoud Eltayeb

CB for persons survey by IAF 17024 group - 2009

Answered question: 56 Total: 267536

Accreditation of Personnel



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Mahmoud Eltayeb

EGAC Accreditation

in

Food Sector

EGAC Accreditation

in

Food Sector


28/29

Mahmoud Eltayeb

Accredited In process

Testing labs 41 10

Inspection bodies 2 ---

Certification bodies 2 2

Accredited services

In Food Sector


29/29

Mahmoud Eltayeb

Thank YouThank YouThank You

2 accreditation updates

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