R 03-07 (DRAFT)
NOMINATED REPRESENTATIVE AND SIGNATORIES:
RESPONSIBILITIES, QUALIFICATIONS AND APPROVAL
Approved By:
Reviewed By:
Date of Approval:
Date of Implementation:
Chief Executive Officer:
Ron Josias
Executive Committee
Quality Manager:
Yolanda Vinnicombe
SANAS
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CONTENTS
1.
2.
3.
4.
5.
Purpose and Scope ...................................................................................................... 3
Definitions and References .......................................................................................... 3
General ........................................................................................................................ 3
Nominated Representative (NR) / (Management Representative) ................................ 3
Signatories ................................................................................................................... 4
5.1
5.2
5.3
6.
Technical Signatory (TS) ................................................................................ 4
Laboratories Contracted Technical Signatory (CTS) ....................................... 5
Management Signatory (MS) .......................................................................... 6
Application and Approval Procedure ............................................................................. 6
ADDENDUM 1: Amendment Record ...................................................................................... 8
SANAS
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1.
Purpose and Scope
This document covers the responsibilities and qualifications of Nominated Representatives of
accredited / compliant organisations, Technical Signatories and the procedure for approval of these
persons.
Nominated Representatives and Signatories to certificates and reports shall comply with the
requirements as laid down in this document.
2.
Definitions and References
SANAS PM
SANAS A01
3.
General
3.1
The staff of SANAS accredited facilities must have the appropriate qualifications, training
and / or experience in order to competently perform the tasks for which the facility is
accredited. They must be able to demonstrate their competence to a SANAS assessor for
the fields for which the facility is accredited. Accredited facilities shall ensure that all
signatories to certificates are approved by SANAS.
3.2
The lack of suitable and competent staff shall result in a facility failing to initially obtain or
losing existing accreditation.
3.3
For the application of approval of a person as Nominated Representative (NR) and/or
Technical Signatory (TS) and/or Contracted Technical Signatory (CTS), an organisation
should be aware of the criteria for approval.
3.4
These criteria are based on the desire of SANAS to:
a)
b)
c)
4.
SANAS Policy Manual
References, Acronyms and Definitions
provide the NR with the necessary authority within the organisation to ensure that
accreditation standards are upheld;
define desirable capabilities and aptitudes, which the NR should have to actively
promote SANAS and its declared objectives;
define requirements to aid an accredited organisation in selecting/ appointing a TS
and CTS based on technical competence.
Nominated Representative (NR) / (Management Representative)
4.1
All SANAS Accredited Organisations and Compliant Facilities shall appoint a NR (in some
cases referred to as the Management Representative or Contact Person) to act as the single
contact person responsible for all SANAS matters relating to the accreditation / compliance of
the organisation at all times.
4.2
The Nominated Representative / Management Representative / Contact Person shall:
a)
b)
c)
be familiar with and fully understand the requirements of the relevant standard, guide or
principles applicable to the organisation’s field of accreditation / compliance;
know what accreditation / compliance is and have a positive attitude toward
accreditation / compliance and its processes;
irrespective of other duties and responsibilities, have a defined responsibility and
authority for ensuring that the quality system / principles are implemented and followed
at all times to support their current accreditation / compliance schedule (in the case of
accredited organisations, this includes ensuring results released are authorized by the
SANAS approved Technical Signatory (TS) / Contracted Technical Signatory (CTS));
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d)
e)
f)
5.
must have direct access to the highest level of management at which decisions are
made on the accredited facility’s policy or resources;
must have an in-depth knowledge of all SANAS accreditation / compliance
requirements applicable to the organisation’s field of accreditation / compliance
(particularly as defined in the SANAS Requirement documents); and
is responsible to timeously inform SANAS of changes within the organisation which
may affect the accreditation / compliance status of the organisation (this includes
changes in key personnel such as the NR, TS or CTS). Failure to notify SANAS of any
such changes prior to them taking effect may result in the laboratory having its
accreditation / GLP Compliant status suspended or withdrawn.
Signatories
Not applicable to Medical laboratories (refer to clause 5.1.5), OECD GLP and GCPV Compliant
facilities, and Certification Bodies.
5.1
Technical Signatory (TS)
5.1.1
The TS is a person deemed as competent by SANAS, whose signature confers
validity on the organisation’s certificates, reports and/or results issued under its
SANAS accreditation. Technical signatories include those individuals authorised by
regulations to sign certificates/reports (i.e. IPE Inspectors, Competent Persons,
Verification Officers etc.) however they must also must be deemed as competent by
SANAS to sign results issued under SANAS accreditation.
The Technical Signatory shall:
a)
b)
c)
d)
e)
f)
accept responsibility for the contents (i.e. results and/or measurements) of the
Certificate/Report which he/she is signing or authorising;
have sufficient current knowledge of the method used, as well as the objectives
of the test/calibration/inspection;
be able to assess and interpret the data;
be confident when authorising results or measurements, that all the necessary
checks had been completed as required by the quality system to ensure the
quality of the results;
have comprehension of the Technical Requirements of the relevant
International or National standard or guide covering the accredited
organisation’s scope of accreditation and any SANAS requirements specific to
the responsibilities of signatories and the technical field of operation of the
organisation; and
be conversant with the quality management system implemented within the
organisation.
5.1.2
All technical signatories must be fulltime employees fulfilling the requirements as
defined in section 51 of the Labour Relations Amendment Act 12 of 2002:
5.1.3
In the case of Accredited Calibration Laboratories, technical signatories shall be
certified and registered as metrologists by the National Laboratory Association (NLA)
as part of the “MetCert” certification program. The “Metcert” replaces the SANAS
“Certificate of Competence”.
The following requirements are applicable:
(i)
(ii)
All new and existing technical signatory applicants shall ensure that they
meet the pre-requisites for certification, and must hold the applicable
certification;
Technical Signatories who fail to complete the certification process will have
their technical signatory status revoked.
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5.1.4
In the case of Inspection Bodies and Verification Laboratories, operating under a
regulation, the technical signatories must possess the qualification as required by the
relevant regulation or national standard. However this does not absolve these
signatories from also complying with all the requirements listed in clause 5.1.1 a) to f).
Note: For Verification Laboratories, NRCS Legal Metrology trains and qualifies
verification officers (VO’s) in terms of the Trade Metrology Act. Qualified
VO’s become signatories to Verification Certificates, and are required to
forward a copy of their VO certificate and F 18 to the FM prior to inclusion
on the Schedule of Accreditation.
5.2
5.1.5
Signatories in Medical Laboratories are those persons appropriately qualified and
competent in a specific discipline, to issue results and sign reports in that discipline,
as defined in the scope issued by the Health Professions Council of South Africa
(HPCSA). As they are approved by the HPCSA for a specific discipline, they do not
require further approval by SANAS. Medical Laboratories shall have a procedure that
identifies and controls the process of signing of reports. This will be verified during
the assessment process.
5.1.6
All Technical Signatories (including CTS) should be evaluated by SANAS at least
once within the accreditation cycle.
Laboratories Contracted Technical Signatory (CTS)
Not applicable to Verification Laboratories or BBBEE Verification agencies
Note: In terms of the specification as defined in SANS 10378, clause 5.2.1.3, technical
signatories may not appear on more than 1 schedule of accreditation at a time.
5.2.1
The use of CTS is an interim arrangement to aid an accredited organisation finding
itself unexpectedly without a SANAS Approved Technical Signatory on its own staff.
The period of using a CTS may not exceed 1 year.
5.2.2
In addition to the CTS complying with all requirements as defined in 5.1 above, the
Accredited Organisation intending to make use of a CTS shall:
a)
b)
c)
d)
e)
f)
g)
h)
i)
inform SANAS of its intent to obtain approval for a CTS;
have a formal agreement covering the arrangements, including confidentiality
and conflict of interest between the accredited organization and the
contracted person/ external body;
take full responsibility for authorisations made by the CTS on its behalf;
ensure that the CTS meets all the requirements as defined in 5.1 above;
have records of the proof of competence of the CTS permanently available at
its premises;
ensure that the CTS has sufficient presence within the accredited organisation
to be able to demonstrate satisfactory control of his/her function;
ensure that the CTS repeats or reconstructs a specified number of
tests/calibrations for which he/she is signatory where all these are not
performed by the CTS;
ensure that where all work is not performed by the CTS ( not applicable to
Pressure Equipment Regulation Inspection Bodies), the CTS is required to
review the competence of those performing work in his/her absence prior to
implementation of the contract and then on a regular basis thereafter.
In addition to a) to h) above, Inspection Bodies and Gas Test Station CTS shall
have a formal agreement covering the arrangements for the period that the
inspection body requires them, including confidentiality and conflict of interest
between the accredited organization and the contracted person/ external
body.
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5.3
6.
5.2.3
It is the responsibility of the accredited organisation wishing to use a CTS to have
documented procedures covering the abovementioned requirements as well as
maintaining records to demonstrate full implementation thereof.
5.2.4
Technical Signatories who are employed on a regular but not full time basis (i.e. 2
days per week) are not considered as contracted technical signatories, but may be
considered as employees provided they meet the applicable requirements (refer to
5.1.2), and therefore may be registered as Technical Signatories.
Management Signatory (MS)
5.3.1
In the case where Laboratories and Inspection Bodies want to impart official
company status on a SANAS Certificate/Report, some organisations require that a
senior representative from management also sign the Certificate/Report. SANAS
recognizes this requirement as a token of the status and significance of SANAS
Certificates/Reports within an organisation. This signature alone, however, does
not confer validity on a Certificate/Report or results generated under SANAS
accreditation.
5.3.2
Certification Bodies certify compliance to a specific standard.
Since their
processes also require the involvement of a decision making committee, there is no
need for a TS. Senior management responsible for running the certification
scheme are required to have knowledge of certification and this is sufficient to allow
the Management Signatory’s signature to confer validity on the certificate. The
signatory to a SANAS endorsed certificate needs to be “approved” by SANAS.
Application and Approval Procedure
6.1
Applications for approval of MS, MR, TS, CTS and NR (or contact person) must be made on
SANAS form F 18 “Application for the Approval of Personnel”.
6.2
Where the personnel evaluation is required to take place during the initial or surveillance
assessment visit, the completed application must be forwarded to the SANAS Office at least 6
weeks prior to the planned visit.
6.3
For an application for a NR (or Contact Person) of an already accredited organisation/GLP
compliant facility, or a MS of an already accredited Certification Body, the relevant SANAS
Field Manager would, based on the information supplied, either arrange to assess the
applicant by interview or approve the application, deferring the interview to the next planned
visit to the organisation. For a new application this interview will take place at the initial
assessment.
6.4
For an application for a MS of a Laboratory or Inspection Body no evaluation and approval by
SANAS is required as these signatories do not have any bearing on the accreditation / GLP
compliance status of the organisation.
6.5
Based on the information supplied for an application for a TS or a CTS, the relevant SANAS
Field Manager would normally appoint an Assessor(s) to assess the applicant. This may be
done by interview, witnessing, evaluation of relevant competency records generated by the
applicant, or a combination of these. This will be for the organisation’s account.
6.6
The appropriate Approval Advisory Committee shall review the credentials of signatories for
approval. An Approval Committee may decide to approve a signatory based on the
information contained in their completion of form F 18 “Application for Approval of
Personnel”. Where the Approval Committee is not satisfied with the competence of the
applicant signatory, it may require a technical assessor to re-confirm the technical
competence of the applicant signatory. This confirmation is usually done on-site and all
costs associated with the confirmation are borne by the applicant. Signatories for new
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laboratories and inspection authorities are assessed during the initial assessment. New
applications for signatory in an existing accredited facility are usually assessed during the
surveillance where practical or by an additional visit to the facility. Facilities will be charged
additionally for these types of visits.
6.7
The applicant MS, MR, TS, CTS, NR / Contact Person is required to sign acceptance of the
conditions for the type of approval sought, on SANAS Form F18 “Application for Approval of
Personnel”.
Note 1:
It is advisable that the accredited organisation forwards applications for approval of Contracted
Technical Signatories to SANAS prior to entering into a contract with the CTS.
SANAS
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ADDENDUM 1: Amendment Record
Proposed By:
Section
Change
SANAS
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