R 01-07
TRANSFER OF ACCREDITATION
/ GLP COMPLIANCE AND FRANCHISING
Approved By:
Revised By:
Date of Approval:
Date of Implementation:
Acting Chief Executive Officer:
Executive Committee
Accreditation Managers
Quality Manager:
2020-11-12
2020-11-12
SANAS
Mpho Phaloane
Yolanda Vinnicombe
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R 01-07
CONTENTS
1.
Purpose and Scope ................................................................................................................ 3
2.
References and Definitions ..................................................................................................... 3
3.
Regulations ............................................................................................................................. 3
4.
Franchising of Accredited CABs.............................................................................................. 4
ADDENDUM 1: Amendment Record ............................................................................................. 6
SANAS
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1.
Purpose and Scope
The purpose of this document is to define the requirements regarding changes affecting the South
African National Accreditation System (SANAS) accreditation/compliance status of a Conformity
Assessment Body (CAB) and to define the relationship between franchising and accreditation / GLP
Compliance. This document is applicable to all divisions of SANAS and all accredited Conformity
Assessment Bodies (CABs) / Compliant Facilities.
2.
References and Definitions
PM
A 01
F 147
F 199
R 03
SANAS Policy Manual
References, Acronyms and Definitions
Terms and Conditions of Accreditation
Terms and Conditions of GLP and GCP Compliance
Nominated Representative and Signatories: Responsibilities, Qualifications and
Approval
Suspensions, Reductions, Withdrawals and Re-instatement of Accredited or
GLP/GCP Compliant Organisations
R 51
ISO/IEC 17011 Conformity assessment – Requirements for accreditation bodies accrediting
conformity assessment bodies
3.
Regulations
3.1
SANAS retains the sole responsibility for the granting, maintaining, extending, reducing,
suspending, withdrawing of accreditation / compliance status, and shall not delegate this
responsibility to a third party.
The assessment may be subcontracted to a third party but the evaluation of the
assessment and all subsequent decisions, i.e. granting of accreditation, etc., remains with
SANAS.
3.2
Accreditation or Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) compliance
status, or part thereof, shall not be transferred from one entity to another, whether to a
different legal entity, whether to a different branch, site or location of the same legal entity,
or whether to an unincorporated joint venture. Any change in company registration number
will be seen as a different legal entity.
3.3
SANAS shall decline all applications for changes to accreditation where the CAB sells,
relinquishes or otherwise disposes of a material portion of its undertaking, or a majority
shareholding of the legal entity or changes its asset structure, and where such changes
would in the reasonable opinion of SANAS result in:
i)
ii)
the CABs inability to perform or observe all of its obligations in terms of the Terms
and Conditions (F147 or F199); and/or
the CAB no longer complying with the Accreditation or GLP/GCP Compliance
requirements.
Changes of a CABs asset structure in the normal course of its business is exempted from
this requirement.
3.4
In accordance with the Terms and Conditions of Accreditation (F147), the Terms and
Conditions of GLP and GCP Compliance (F199), and R03 “Nominated Representative and
Signatories: Responsibilities, Qualifications and Approval” a CAB shall inform SANAS in
writing of any changes which may affect the CABs compliance with the Terms and
Conditions and all relevant Accreditation or GLP/GCP Compliance requirements, or which
affects or may potentially affect the CABs capability or scope of Accreditation, including but
not limited to changes to:
©SANAS
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i)
ii)
iii)
Location;
legal, commercial, ownership or organisational status;
organisation, top management and key personnel, including but not limited to NRs,
authorised signatories, quality assurance personnel, study directors, all in respect of
SANAS;
iv) The scope of Accreditation or GLP/GCP Compliance status;
v) resources, including equipment, facilities, working environment or financial position;
vi) capability to adequately service its scope of Accreditation or GLP/GCP Compliance,
due to, for example, acts of nature, industrial action;
vii) material portion of its undertaking;
viii) asset structure;
ix) any matters that can affect the ability to comply with the Accreditation / Compliance
requirements; or
x) major changes to policies or procedures that may affect the Accreditation /
Compliance status.
3.5
Failure to notify SANAS of any such changes may result in the suspension of the accredited
CAB or GLP/GCP Compliant facility.
3.6
SANAS may perform additional unscheduled accreditation assessments or compliance
inspections if there are any changes as specified in clause 3.4 to confirm the extent of the
changes and the effect it may have on the accreditation. SANAS reserves the right to
decide on the extent of the assessment / inspection as a result of any such changes.
3.7
Where a change in legal, commercial, ownership or organisational status is requested, a
formal application must be submitted by the CAB / Compliant facility through the SANAS
online portal. The Accreditation Manager will review the application to ascertain the extent
of further actions required and ensure the following:
i)
ii)
iii)
iv)
3.8
4.
A document review of the Management System is conducted;
At the discretion of the AM, an additional assessment comprising of at least a Team
Leader is conducted. Technical assessors can be included in the assessment team
as deemed necessary;
Upon confirmation that the CAB has met all accreditation requirements a new
accreditation number shall be granted, and a new accreditation cycle will apply; and
SANAS will confirm the withdrawal of previous accreditation in writing once the new
accreditation is granted.
Where only a name change is requested, and without any changes to the company
registration number, a formal application and a declaration submitted by the Nominated
Representative confirming that there are no changes to the management system
documentation will be sufficient. A new certificate bearing the new name shall then be
issued.
Franchising of Accredited CABs
4.1
General
Franchising is the business practice whereby a franchisor allows a franchisee to use a
certain trademark or trading name, and typically supplies support and training in exchange
for a recurring royalty fee. The trademark is typically the name under which the business
operates. The franchisee is a separate legal entity to that of the franchisor, although this is
not necessarily apparent to the customer who assumes that the legal entity is the holder of
the trademark or name under which the organisation operates.
As the franchisee does not own the trademark or name under which they operate, the
franchisee is not explicitly identified as the entity that is legally responsible.
4.2
CABs / GLP/GCP compliant facilities shall under no circumstances franchise their
accreditation / compliance activities to other CABs or organizations.
SANAS
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4.3
Each CAB / GLP/GCP compliant facility shall be assessed / inspected as a separate entity
and shall be held legally responsible with regard to their accreditation activities. This shall
be clearly defined and documented.
4.4
The accreditation / compliance status of a CAB found to be franchising their accreditation /
compliance activities to other CABs or organizations, will be withdrawn in accordance with
SANAS R51 “Suspensions, Reductions, Withdrawals and Re-instatement of Accredited or
GLP/GCP Compliant Organisations”.
©SANAS
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ADDENDUM 1: AMENDMENT RECORD
Proposed By:
QM / AM
Section
Change
1
“regarding changes affecting the” replaced “concerning the transfer of”
Added of a “Conformity Assessment Body (CAB)”
Added reference to R51
Changed from “Accreditation or GLP/GCP compliance status shall
not be transferred from one entity to another”
1st line: Added “changes to”
2nd line: “relinquishes” replaced “transfers”
Added “or a majority shareholding of the legal entity”
Added “additional unscheduled”……….” to confirm the extent of the changes
and the effect it may have on the accreditation.”
Added “legal, commercial or organisational status”….” through the SANAS
online portal” ….. “ and ensure the following:
Points i) to iv) added
Clause added
Clause added
2
3.2
3.3
3.6
QM / AM
3.7
3.8
4.4
SANAS
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