Document ID LA/GD01

Philippine Accreditation Bureau Issue Number 01

Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 1 of 10

Accreditation Process
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 2 of 10

Part 1

INTRODUCTION

Accreditation is defined as a procedure by which an authoritative body gives formal recognition

that a body or person is competent to carry specific tests, calibrations or inspections. Accreditation
is available to any type of testing laboratory (including medical), calibration laboratory and
inspection body.

The general requirements for accreditation are the following international standards:

 PNS ISO/IEC 17025:2005 General Requirements for the Competence of Testing and
Calibration Laboratories

 PNS ISO/IEC 17020:2012 Conformity Assessment- Requirements for the operation of

various types of bodies performing inspection

 PNS ISO 15189:2012 Medical Laboratories – Requirements for quality and competence

Additional requirements for specific fields (e.g. calibration, chemical testing, etc.) or specific
programs, which are necessary to meet particular user needs, complement these general
requirements.

The PAB accreditation covers the following field:

Chemical Testing Medical/Clinical Testing

Biological Testing Calibration
Electrical Testing
Mechanical Testing

Users of accredited laboratories and inspection bodies are advised to obtain the Scope(s) of
Accreditation from the accredited laboratory and inspection body or from PAB. The Scope(s) of
Accreditation identifies the specific tests or types of tests or calibration capability for which the
laboratory or inspection body is accredited.

Part 2

CONDITIONS FOR ACCREDITATION

In order to attain and maintain accreditation, laboratories and inspection bodies must comply with
the PAB Conditions for Accreditation.

The applicant laboratory’s inspection body’s Authorized Representative must agree to the
conditions for accreditation and must attest that all statements made on the application are correct
to the best of his/her knowledge and belief. He/she must accomplish Acceptance of Accreditation
Conditions (LA/SF27) and submit to PAB together with the other application requirements.

An accredited laboratory’s Authorized Representative is responsible for ensuring that all of the
relevant conditions for accreditation are met. During the on-site assessment, the assessor will
determine that the Authorized Representative and a deputy are knowledgeable about the
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 3 of 10

accreditation requirements and require that the Authorized Representative and a deputy sign a
statement that the Conditions for Accreditation will be upheld.

Part 3

ACCREDITATION PROCESS

3.1 The First Step

When considering to seek PAB accreditation, laboratory or inspection body management should
examine this document LA/GD01 – Accreditation Process, the international standards mentioned
in Part 1 of this document, Supplementary Requirements and other Guidance Documents (GDs)
issued by PAB in the relevant field of testing, calibration and inspection.

Laboratory or inspection body management is encouraged to hold discussion (personal, thru e-

mail or phone call) with the PAB technical staff before lodging an application for accreditation. If a
pre-assessment is desired at this stage, an informal review of the major elements of the
laboratory’s resources, procedures and documentation is undertaken. A completed assessors’
briefing (LA/SF06) and application form (LA/SF03) should be submitted for review together with
the laboratory’s Quality and Procedures manuals.

3.2 Application for Accreditation

Applications for accreditation may be made only by legally identifiable organizations. A laboratory
or inspection body applying for accreditation shall submit the necessary forms and documents:
 Application for Accreditation/Reaccreditation
 Quality Manual and Procedures Manual
 Test Method/Calibration Method/Inspection Method (for In-House Methods)
 Application for Signatory Approval with updated CVs and summary of trainings
 Assessors’ Briefing and associated document required
 Acceptance of Accreditation Conditions

Only complete application will be schedule for assessment. For PAB schedule of fees refer to
LA/GD20.

3.3 Authorized Representative

The applicant or accredited laboratory/inspection body should nominate the authorized

representative who should represent the organization in all matters relating to the accreditation.
This person is the official contact of the laboratory/inspection body.

3.4 Scope of Accreditation

An application should clearly define the scope and in the form of a series of classes of test or parts
thereof. Each field of testing has been divided into a series of classes of test. The classes of test
are listed in relevant reference material. For tests, the scope of accreditation is normally identified
in terms of standard test methods prepared by national, international, and professional standards
writing bodies. For calibrations, the scope of accreditation is described typically in terms of
measurement parameter, range of measurement and best attainable uncertainties (calibration
measurements capabilities).
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 4 of 10

3.5 Assessment

The Team Leader/Lead Assessor in coordination with the Program Manager/Accreditation Officer
shall organize an assessment team. The Director/Officer-in-Charge appoints the assessment
team. The assessment team reviews the quality manual and related documentation before
assessment can begin.

Compliance of an applicant laboratory/inspection body with the accreditation requirements is

determined primarily by an assessment of its resources, procedures and documentation. The
basic objective of the assessment is to establish whether a laboratory or inspection body can
competently perform the tests for which accreditation is sought.

Assessment is carried out by a team, which begins with an opening meeting, led by a Team
Leader/Lead Assessor who may be a PAB Accreditation Assessor or a qualified external assessor.
The team includes technical assessor/expert (s), selected for the relevance of expertise and
freedom from conflict of interest.

Assessments are conducted in a day and may extend to more and include detailed discussions
with laboratory/inspection body management and personnel, inspection of equipment and
premises, and examination of documentation and records. Assessors normally witness some or all
of the tests/calibration/inspection activity covered by the accreditation or applied for accreditation.

A closing meeting is held at the completion of the assessment. The authorized representative is
provided with a written report on the on-site assessment findings, including details related to any
corrective action required before accreditation can be granted.

3.6 Deficiencies

During assessment, assessors may observe deficiencies. A deficiency is any nonconformity to

accreditation requirements. Refer to LA/GD 06: Guidelines on Grading of Non-conformities.

3.6.1 During the presentation of the report to the laboratory/inspection body, all non-conformities
and any observations shall be fully discussed, including the time scales agreed to or set by
the Team Leader/Lead Assessor for implementation of the corrective actions on the non-
conformities.

3.6.2 The laboratory/inspection body is informed that corrective actions to assessment findings
shall be submitted two (2) months from the date of the on-site assessment. Subsequent
corrective actions if required by the assessors shall be completed by the
laboratory/inspection body, evaluated and cleared by the assessors within four (4) months
from the date of initial assessment. Entire accreditation process must be completed within
five (5) months.

3.6.3 The laboratory/inspection body is given opportunity to clarify the findings and to offer
alternative suggestions. At the close of the meeting, mutually acceptable date for
completion of corrective actions is agreed, sufficient to bring the laboratory’s/inspection
body’s technical and/or management systems into compliance with the criteria for
accreditation.
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 5 of 10

3.7 Accreditation Decisions

The Officer-in-Charge/Director approves the accreditation upon the recommendation by the

Laboratory Accreditation Committee (LAC). This is based on the laboratory’s or inspection body’s
complete assessment documentations and assessment report endorsed by the assessment team
through the Division Manager/Program Manager.

3.8 Proficiency Testing

Proficiency testing is a process for checking actual laboratory testing performance, usually by
means of inter-laboratory test data comparisons or measurement audit for calibration. For many
tests and calibrations, results from proficiency testing are very good indicators of competence.
Proficiency testing programs may take many forms and standards for satisfactory performance can
vary depending on the field and is used to compliment on-site assessment in evaluating laboratory
performance. Satisfactory performance is a condition for granting accreditation. For details on the
requirements for proficiency testing refer to LA/SR09: Supplementary Requirements on Proficiency
Testing.

3.9 After Accreditation

An accredited laboratory must continue to comply with the requirements in the documents listed in
Section 1, including their revisions.

The authorized representative is required to notify the PAB immediately of:

 Any changes in name or ownership of the laboratory;
 Changes on duties, resignations of staff; or
 Significant changes to accommodation or equipment,
 Relocation of laboratory/inspection body facilities

Accredited laboratories/inspection bodies are subject to two (2) surveillance visits. The first
surveillance visit is done within twelve (12) months from the date of initial assessment. The second
surveillance visit is conducted not later than the 22nd month after the first surveillance visit.

There will only be two surveillance assessments within 5 years but during the 2nd and 4th year of
the accreditation, the accredited laboratory/inspection body shall be required to submit their
internal audit report, management review report, proficiency testing (PT) participation and their
results and (PT) proficiency testing plan one (1) month after the conduct of laboratory’s/inspection
body’s management review.

The PAB may conduct additional visit when the following scenarios occur:
 Request from the laboratory or inspection body
 Unsatisfactory result in proficiency testing participation
 No action plans formulated during the management review

3.10 Reassessment and Renewal of Accreditation

Accredited laboratories/inspection bodies are subject to reassessment every five (5) years.
Accredited laboratory/inspection body that intends to renew its accreditation shall file application
for renewal six (6) months before the validity expires. Application documents are specified in 3.2 of
this document.
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 6 of 10

A reassessment of a laboratory/inspection body resembles an initial assessment in all aspects

except on the review of previous assessment findings; in that, it is a full assessment of the
laboratory’s/inspection body’s operations and procedures.

3.11 Extension or Variation to the Scope of Accreditation and Additional Signatory

An accredited laboratory/inspection body may request for increase of its scope of accreditation or
add approved signatory at any time and shall officially notify PAB of its intention including the
following documents:

For additional scope or subscope, an accredited laboratory/inspection body shall submit the
following:
 Application for Special Assessment
 Assessors’ Briefing
 Application for Signatory Approval with updated CV and summary of training
 Test Method/Calibration Method/Inspection for In-House Methods
 Application for Signatory Approval with updated CV and summary of training

For additional signatory, an accredited laboratory/inspection body shall submit the following:
 Application for Special Assessment
 Application for Signatory Approval with updated CV and summary of training

PAB makes the necessary adjustments and changes in the Directory of Accredited
Laboratories/Inspection Bodies based on amendments in scope of accreditation or list of approved
signatories.

3.12 Laboratory Reference to PAB Accredited Status

The requirements pertaining to the use of the PAB symbol and to any other reference to PAB
accreditation are outlined in the LA/SR11 (PAB Requirements for the Use of PAB Laboratory
Accreditation and Inspection Body Accreditation Symbols). Failure to comply with these
requirements may result in suspension or revocation of a laboratory’s accreditation.

3.13 Suspension of Accreditation

3.13.1 The following are the grounds for suspension of accreditation:

a) When an accredited laboratory/inspection body signifies that it is temporarily unable to
comply with the accreditation requirements.
b) When an assessment reveals that an accredited laboratory/inspection body has failed
to comply with the requirements for accreditation and corrective action cannot be taken/
submitted within the specified time to achieve full compliance. (Note: Submission of
corrective actions is one (1) month for surveillance visit and special assessment; two
(2) months for initial and renewal assessment)
c) When the accredited laboratory/inspection body fails to submit its annual reports (i.e.
Internal Audit Report, Management Review, annual PT plan and participation results).
d) When the accredited laboratory/inspection body have two (2) consecutive
unsatisfactory PT results due to ineffective corrective actions on the affected scope.
e) Inappropriate use of PAB accreditation symbol (Refer to LA/SR11 PAB Requirements
for the Use of PAB Laboratory Accreditation and Inspection Body Accreditation
Symbols).
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 7 of 10

f) When the laboratory or inspection body fails to pay its Billing Statements two (2)
months from its due date, this includes Assessment Fees, Annual Fees, and
Accreditation Fees.

3.13.2 A accredited laboratory or inspection body whose accreditation is suspended is still

required annual accreditation fees and any special assessment fees associated with the
reactivation of accreditation.

3.13.3 A accredited laboratory or inspection body whose accreditation is suspended shall be

directed to remove from public view Certificates of Accreditation, Scope of Accreditation,
and cease issuing endorsed reports. The laboratory or inspection body shall also be
directed to cease referring to itself as a PAB Accredited laboratory or inspection body in
any documents, brochures, catalogues, correspondence, etc, that it issues within the
period of suspension. Refer to LA/SR11 PAB Requirements for the Use of PAB Laboratory
Accreditation and Inspection Body Accreditation Symbols.

3.13.4 When accreditation is suspended or withdrawn, all reference to the accredited laboratory or
inspection body shall be deleted from any subsequent directories of accredited laboratories
or inspection bodies issued by PAB.

3.13.5 Suspended accreditation can be reactivated only after the laboratory/inspection body has
submitted to PAB proof that it is able to comply with the accreditation criteria, or after PAB
has verified compliance.

3.14 Withdrawal of Accreditation

Accreditation shall be withdrawn if the laboratory/inspection body fails to achieve full compliance,
declines to take appropriate corrective action within six (6) months from the date of the
suspension; does not intend to renew its accreditation at the end of the accreditation period; and
voluntarily declares non-interest in accreditation within the accreditation period.

An accredited laboratory/inspection body whose accreditation is withdrawn shall return to PAB the
Original Certificate of Accreditation, List of Approved Signatories and Scope of Accreditation.

The laboratory/inspection body shall be directed to immediately cease referring to itself as a PAB
accredited laboratory/inspection body in any documents, brochures, catalogues, correspondence,
etc. that it issues after the date of withdrawal of accreditation.

The laboratory/inspection body shall also be directed to notify all customers and all other persons
who may have been previously notified of its accreditation that its accreditation has been
withdrawn.

Reactivation of accreditation shall be done only after a full assessment is conducted and the
laboratory is found to comply with the accreditation criteria. The laboratory/inspection body shall
reapply and pay all the required fees and other costs that may be entailed during the assessment.

A laboratory/inspection body whose accreditation is suspended or withdrawn may appeal this

decision.
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 8 of 10

3.15 Confidentiality Policy

All information provided by the laboratory in connection with a preliminary inquiry or an application
for accreditation and all information obtained in connection with an assessment or proficiency test
is confidential. PAB Accreditation Officers/staff, assessors and experts who examine such
information are made aware of its confidentiality and are required to sign a confidentiality
agreement with the PAB.

Documents necessary to convey information about accredited laboratories and their scopes of
accreditation are not confidential.

3.16 Conflict of Interest Policy

Consistent with principles set forth in ISO/IEC 17011:2004 - General requirements for
accreditation bodies accrediting conformity assessment bodies, it is vital that PAB accreditation
services be impartial and objective, uninfluenced by the private interests of individuals acting for
PAB. Accordingly, any person directly involved in actions relating to the PAB accreditation process
shall avoid direct participation in PAB actions that may involve an actual or apparent conflict of
interest.

Part 4

APPROVED SIGNATORY

An Approved Signatory is any laboratory/inspection body personnel who have satisfied the criteria
listed in LA/GD07 Guidelines for Laboratory Personnel and Approved Signatories and have been
granted signatory approval by the PAB.

PAB-endorsed documents shall be signed by a PAB approved signatory. The validity and
completeness of endorsed documents are the responsibility of the Approved Signatory.
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 9 of 10

Part 5

ACCREDITATION PROCESS

START

Customer inquiries on accreditation requirements &

application documents

Customer submits complete application documents with

quality/procedures manuals & other required documents

PAB constitutes Assessment Team

Assessment Team reviews submitted documents

NO
Compliant? Customer to comply

YES

Assessment Team conducts on-site assessment and

document assessment findings

PAB evaluates adequacy of

customer’s corrective actions

Compliant? NO Customer corrects

nonconformities

YES

Final review and recommendation of Laboratory

Accreditation Committee (LAC)

Grant of Accreditation

END
 Document ID LA/GD01
Philippine Accreditation Bureau Issue Number 01
Guidance Document Revision Number 0
Accreditation Process Effectivity Date January 2015
Page Page 10 of 10

ISSUE AND AMENDMENT RECORD

Title Issue Date Amendments

Accreditation Process 01 January 2015 Initial Issue