WELCOME
2013 Communication Meeting
September 2013
CEO Report
2013 Communication Meeting
September 2013
Focus 2010 to 2015
Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice
Act, 2006 (Act 19 of 2006)
Functions:
d) Promote the acceptance of its activities and those of all bodies accredited by SANAS or
its international counterparts;
e) Promote the recognition of accredited bodies by users of conformity assessment;
f) Liaise with regional and international standard bodies and with technical regulatory and
metrology organisations in respect of any matter related to accreditation;
Content
•
•
•
•
•
•
•
Growth in accreditation & analysis;
New areas and associate conformity assessment required;
Acceptance of Conformity Assessment results in Africa;
Support for Conformity Assessment Bodies;
Preparing SANAS
Feedback on Customer Experience measure;
Upcoming events
Accreditation Stats – June 2013
Total Number of Accredited Facilities: 1420 as at June 2013
350
302
300
292
250
211
181
200
149
148
150
100
50
0
65
34
17
6
2
7
2
4
Growth Statistics:
March 2012 to March 2013
Growth increase by (58) 43 accredited facilities since 2012
20
18
20
15
12
10
3
3
5
0
0
0
0
1
0
1
0
0
-5
-7
-10
-8
Upcoming Extensions
Owner
Dept. of
tourism
Dept. Of
Labour
Status
Responsible tourism
Launched
Occupational Health and
Safety
Partially
rolled out
Risk Based Inspection (RBI)
Launched
Energy Management ISO/IEC
5003 - February 2014 Carbon
tax incentives
Feb 2014
roll out
-
OHSAS 1800
Launched
BUSA
Greenhouse Gas ISO/IEC
14065 Validation and
Verification ,
Water &
Environment
Air Quality Monitoring
Waste Water Management
Testing
Calibration
Certificatio
n
Othe
r
-
-
-
X
-
X
X
X
x
x
X
Dept. of
Energy &
BUSA
Dept.
Environment
al Affairs
Inspection/
Verification
X
x
x
Launched
X
x
X
x
new
new
Industrial Policy Action Plan (IPAP) Priority
Sector needs
Sector
Green
Economy:
Energy savings
Stack Emission
Testing
Testing
Calibration
X
X
Certification Inspection
Certification of
Buildings
Nuclear
x
x
Information
Security
Road transport
Management
X
X
X
X
X
Truck owner
compliance
??
??
Supporting the acceptance of Conformity
Assessment Bodies (CAB’s) results in Africa
Pan African Accreditation Cooperation (AFRAC)
The aim is to ensure the acceptance of our goods and service in Africa based
on the acceptance of our testing, inspection and certification results.
–
South Africa through SANAS hold the Chair and Secretariat of AFRAC;
–
MoU signed between AFRAC, African Standards Organisation (ARSO), African Electro
technical Standards Commission (AFSEC) and the African Metrology Institute
(AFRIMETS);
–
The above cooperation known as the Pan African Quality Infrastructure (PAQI)
approved by the African Union (AU) Council of Ministers of Trade (CAMI) and will be
table at the upcoming Heads of AU States meeting early new year for endorsement
Support for Conformity Assessment
Bodies (CAB’s)
• MCEP : a Department of Trade and Industry
incentive, supporting CAB’s on a cost share basis:
– Development& Implementation of Management
system;
– Equipment;
– Extension of facilities;
– Further incentive for job creation;
– the dti website: www.thedti.gov.za
SANAS’ Alignment
Area
Staff compliment
ICT
Customer Experience
measure
Finance (Under
recovery on provision
of services excluding
government
contribution)
Status June 2013
Target (2015)
62
75
•
•
•
Application process
partially automated;
Finance and
procurement
updated
•
47.2
•
- 6.78
Online registration
and tracking of
processes
•
Improve service delivery
& communication
•
•
Invoicing;
Budgeting: Under
recovering for services
rendered;
Efficiency improvement
60
0
•
Customer Experience Measure
2012/13
Methodology & Sample Realisation
• All interviews were done telephonically (CATI system)
• Interviews were conducted 4 March to 4 April 2013
• Average duration of interviews: 11min 30secs
Total Sample = 236
(5.29% margin of error at a confidence level of 93%)
Target Sample: 170
Sample realised: 236
Available Contacts: 752
Modelled Score – Annual Change
2011
2011
2012
2012
Sample (n) = 171
Sample (n) = 144
Failure
Delight
Failure
2013
2013
Sample (n) = 236
Delight
Failure
Delight
CSM
0
0.6%
NPS
100
40.0
0
55.3%
20.6%
NPS = Net Promoters Score;
CSM = Customer Satisfaction Measure
2.8%
100
43.7
28.6%
0
60.4%
1.7%
100
47.2
35.1%
61.4%
Modelled Index Score by Division by Year
2011
2011
2012
2012
Sample (n) = 171
Sample (n) = 144
2013
2013
Sample (n) = 236
Query
0
100
0
66.5
100
0
70.0
100
73.0
Assessment
0
100
0
77.1
100
0
80.3
100
82.5
Benefits
0
100
0
69.4
100
0
71.9
100
73.7
Certificates
0
100
67.7
Slide 15
0
100
71.3
0
100
74.7
Events
Event
Date
Accreditation Day - Durban
9 June 2013
Annual Communication Meeting Gauteng
Annual Communication Meeting Durban
Annual Communication Meeting –
Cape Town & PE
AFRAC General Assembly (Kenya)
16 September 2013
18 September 2013
19 & 20 September 2013
24 to 27 September 2013
ILAC and IAF General Assembly (Korea) 16 to 25 October 2013
Thank You
RE-ASSESSMENT AND ASSOCIATED
DOCUMENTATION REVIEWS
Linda Grundlingh
Field Manager: Inspection
2013 Communication Meetings
RE-ASSESSMENTS
ISO/IEC 17011 clause 7.11.1:
• Re-assessment is similar to an Initial
assessment as described in clauses 7.5 to
7.9, except that experience gained during
previous assessments shall be taken into
account.
• During the August 2011 peer evaluation, it
was brought to our attention that we did
not comply with clauses 7.5.10, 7.6 &
7.11.1 in that we did not conduct
document reviews prior to Re-assessment.
SANAS CORRECTIVE ACTION
•
Re-assessments are conducted at least 3-months
(6-months in regulatory fields) prior to the start
of each new accreditation cycle.
•
Re-assessment
visits
will
involve
a
comprehensive re-examination of the facility’s
accredited activities at the beginning of each
new cycle, and will be similar to the Initial
assessment.
•
This includes a full documentation review.
RECENT CHANGES
•
The Re-assessment process has been revised to
include a re-application process which is
mandatory, followed by the review of facility
documents prior to the Re-assessment.
•
This means that as of 01 April 2013, each facility
is required to re-apply for accreditation at least
6-months prior to, and in the case of Inspection
Bodies 9-months prior to the expiry of their
Certificate and Schedule of Accreditation.
WHAT HAS CHANGED?
1. On re-application, each facility will need to
complete the relevant revised F14
application form and submit it to SANAS
with the relevant documentation as
prescribed in each application form.
2. This will include the facilities Management
System Documentation (Quality manual),
along with specific information or
documents as specified in each application
(Checklists etc.)
WHAT HAS CHANGED?
3. On receipt of the application, SANAS will
conduct a review of the information
submitted.
4. SANAS will arrange for a Re-assessment
approximately 3-months prior to, and in the
case of Inspection Bodies 6-months prior to
the expiry of the Certificate and Schedule of
Accreditation.
WHAT IF A FACILITY DOES
NOT RE-APPY?
1. Where SANAS has not received the
application for Re-assessment, the Reassessment will not be scheduled.
2. The facility’s accreditation will expire on the
expiry of the Certificate and Schedule of
accreditation.
HOW CAN THIS BE
PREVENTED?
• To prevent any periods of non-accreditation,
or to prevent losing your accreditation status,
facilities must re-apply within the timelines
stipulated by SANAS. These are:
• At least 6-months prior to, and in the case of
Inspection Bodies 9-months prior to the
expiry date of their Certificate and Schedule
of Accreditation).
IMPLEMENTATION TIME
LINE
Facilities should have submitted their
applications already for Certificates expiring in
October and November 2013, however, if this
has not yet been done, SANAS will allow a grace
period and still accept the applications for Reassessment at this stage.
WHAT ELSE HAS CHANGED?
• Whilst reviewing the re-application process,
SANAS also took the opportunity to review
the current Accreditation Agreement.
• Decrease the administrative burden of
obtaining a signed accreditation agreement
from each and every applicant.
• Also decrease the risk of not having a
contractual arrangement with our accredited
facilities.
WHAT ARE THE
IMPLICATIONS
• Once an applicant signs an application form,
they will automatically accept the Terms and
Conditions of Accreditation.
• Very soon SANAS will implement an on-line
system to accept the Terms and Conditions
and submit the application.
• F 147 - SANAS Terms and Conditions for
Accreditation
• F 199 - SANAS Terms and Conditions for
GLP/GCP Compliance.
DOCUMENTATION REVIEW FINDINGS
• In the case of an Initial assessment, a
maximum period of 6-months is allowed
for applicant facilities to address the
document review findings, after which the
application will cease.
• For Re-assessments, SANAS will not
require evidence of corrective actions
prior to the re-assessment, as these will
be verified during the re-assessment.
BRANCH FACILITIES
• If branch facilities operate under the same
management system as the Head Office:
• The checklists submitted by the Head
Office as well as the Lead Assessor’s
document review report will be sent to any
other Lead Assessor(s) appointed to
conduct
assessment(s)
at
branch
facilities.
PAYMENT CONDITIONS
Thank you
lindag@sanas.co.za
REVISED / NEW SANAS ACCREDITATION REQUIREMENTS
Sept. 2013
Yolanda Vinnicombe
yolandav@sanas.co.za
Terms and Conditions of Accreditation &
GLP/GCP Compliance
Stakeholder input
• Terms and Conditions together with an example of the revised application form
(ISO/IEC 17025) were published on the SANAS website for a period of 60 days.
• 125 comments were received from 13 stakeholders
• Each comment was reviewed, considered and where viable the Terms were amended
• Published on 30 May ‘13:
• F 147-01 Terms and Conditions of Accreditation
• F 199-01 Terms and Conditions of GLP/GCP Compliance
Terms and Conditions of Accreditation or
GLP/GCP Compliance
Replaces the following documents:
• F57 Accreditation Agreement
• R01 “Transfer of Accreditation / GLP Compliance and Franchising”
• R05 “The Requirements, Obligations and Duties of an Accredited / GLP Compliant
Facility
Main Changes
• List of definitions
• The TOR becomes binding on signing the application form and remains in force for
the period of validity of the Certificate of Accreditation
• Conditions for objections to assessors
• Full payment required before accreditation services conducted
• Conditions for acceptance of an application
• Specifies the validity period for applications
Terms and Conditions of Accreditation or
GLP/GCP Compliance
Main Changes
• Extraordinary assessments and the development of short-term methods of
assessment
• The period for which the CAB is required to maintain records for accreditation
purposes
• Conditions under which an assessment can be terminated
• Conditions for the use of the combined mark
• Conditions for renewal of accreditation
• Information SANAS requires from a Certification Body on termination of accreditation
• Publishing the accreditation status of CAB’s.
Revised: Generic Procedures and Requirements
9 x SANAS Application Forms
Main Changes
F 14
•
•
•
•
•
•
Invoicing Information
Information on key personnel and deputies – specific to standard
Application for Approval of Personnel – replaces F18
17025: Detailed information on Proficiency Testing
2013/05/30
Standard specific checklist – indicates an overview of
implementation of requirements. Specifies the minimum policies
and procedures required.
Signing of the application form binds the applicant to the Terms and
Conditions
Application for Medical Laboratory Accreditation to ISO 15189:2012
F14M-2012
New Document, to the new IOS 15189 standard
Application for Testing and Calibration Laboratory Accreditation to ISO/IEC
17025
F 14TC-01
New, Combined all the ISO/IEC Application Forms, i.e. Testing, Calibration,
Forensic, Pharmaceutical, Veterinary, Blood Transfusion
2013/05/30
2013/05/30
Stakeholder input
Documents published for a comment period:
• Draft R51-07 “Suspensions, Withdrawals and Re-Instatement of Accredited
Organisations” – 30 day by 6 Sept’12
• Draft R03-07 “Nominated Representative and Signatories: Responsibilities,
Qualifications and Approval”– 30 day by 15 Nov ’12
• Draft SANAS application form (F14:17025) – 60 day by 14 Sept
Revised: Generic Procedures and Requirements
Doc
Title
Date
References, Acronyms and Definitions
A 01-09
Refer to amendment form – aligns to TOR
2013/06/13
SANAS Fees
P14-23
Applied 5.5% increase to fees as per National Treasury Requirements,
Corrected amount for Certification Bodies: Additional assessor units per
day.
2013-07-31
Transition to New Standards
2013/02/27
P 32-03
Minor changes regarding SANAS internal processes
Revised: Generic Procedures and Requirements
Doc
R 03-07
Title
Nominated Representative and Signatories: Responsibilities,
Qualifications and Approval.
Date
2013/06/13
Refer to amendment form – aligns to TOR
Suspension and Re-instatement of Accredited / Compliant Organisations
R 51-07
Entire document re-written to clarify requirements and align with TOR
2013/06/06
Calibration, Testing, Medical: Revised Requirements
Doc
R 50-03
Title
Estimation of the Uncertainty of Measurement by Calibration Laboratories and
Specification of Calibration and Measurement Capability on Schedules of
Accreditation
Date
2013-08-14
Revised to align with ILAC P14 “ILAC Policy for Uncertainty in Calibration”
Requirements for the Issue of SANAS Calibration Certificates
R 79-03
2013-07-31
Minor amendments
Technical Guidelines for validation of methods used by chemical laboratories
in the food, water and related industries
TG 07-01
2012/10/10
New document
Calibration of Installation and Appliance Testers
TR 87-01
New document
2013/02/13
Inspection: Revised Technical Requirements (TR) &
Forms (F)
 Transition to ISO/IEC 17020:2012 ends 1 March 2015
Doc
TR 78-03
Title
Department of Health (DoH) and SANAS Technical Requirements for the
application of SANS/ISO/IEC 17020: 2012 for testing of Diagnostic X-Ray
Imaging Systems by Inspection Bodies
Date
2013/02/13
Minor amendment – 1 clause added
SANAS Technical Requirements on the Application of SANS/ISO/IEC
17020:2012
TR 89-01
2013/03/14
New document
Certification: NEW Requirements
Doc
Title
Technical Requirements for Bodies providing Greenhouse Gas
TR 88-01 Validation and Verification
New document
Date
2013/03/14
Documents made Obsolete
Doc.
CL
Title
14 x SANAS Manual contents for the individual programmes
Date Obsolete
Reason
2013/06/06
The SANAS Website
“Publications and Manuals”
search function replaces the
need for programme specific
contents lists
F 14C
F 14F
Application for Accreditation of Blood Transfusion Service
Laboratories
Application for Accreditation of Calibration Laboratories
Application for Accreditation of Forensic Laboratories
F 14PH
Application for Accreditation of Pharmaceutical Laboratories
2013/05/30
F 14T
2013/05/30
F 14V
Application for Accreditation of Testing Laboratories
Application for Accreditation of Mechanical & Physical Testing
Laboratories
Application for Accreditation of Veterinary Laboratories
F 14PH
Application for Accreditation of Pharmaceutical Laboratories
2013/05/30
F 171
F 57
Organs of State Accreditation Agreement
Accreditation Agreement
2013/05/30
2013/05/30
F 114
Accreditation Agreement - International Facilities
2013/05/30
F 18
Application for the Approval of Personnel
2013/05/30
F 14B
F 14TP
2013/05/30
2013/05/30
2013/05/30
2013/05/30
Replaced by F14TC
“Application for Testing and
Calibration Laboratory
Accreditation to ISO/IEC
17025”
2013/05/30
Replaced by F 147 “Terms
and Conditions of
Accreditation” and F 199
“Terms and Conditions of
GLP/GCP Compliance”
Included a section for
approval of personnel in
each F14 application form
International Laboratory Accreditation Co-operation
(ILAC) documents revised
Doc
Title
Date
ILAC Policy for Uncertainty in Calibration
ILAC P1401/ 2013
Date of implementation: January 2014.
2013/02
ILAC Policy on the Traceability of Measurement Results
ILAC P1001/2013
Date of implementation: January 2014.
2013/02
Thank You
COMMUNICATION MEETING
AAC PROCESS
Christinah Leballo
Senior Manager: Testing, Certification and BBBEE
AAC PROCESS
WHAT IS AAC PROCESS
• It is a decision making process on the granting,
denying, extending, suspending or withdrawal of
accreditation
• It is a requirement of ISO/IEC 17011.
Clause 7.9. 2 states that the accreditation body shall,
without undue delay, make the decision on whether to
grant or extend accreditation on the basis of an
evaluation of all information received (see 7.8.6) and
any other relevant information.
AAC PROCESS
ISO/IEC 17011 also requires that the AB describes its accreditation
decision-making process including effective separation of the
assessment team and the decision makers
SANAS DECISION-MAKING PROCESS METHODS (SANAS P20)
◙ For high risk decision making emanating from initial,
re-assessments and extension of new scopes of
accreditation, recommendations are made by an
Approval Advisory Committee.
◙ For surveillance assessments, extension of existing
scopes of accreditation and additional signatories of
existing accredited facilities, decisions are made by
SANAS Field Managers.
AAC MEMBERS
◙ The AAC shall consist of not less than 2 members of
which 1 shall be a permanent SANAS staff member.
SELECTION CRITERIA
Members are selected based on:
◙ their knowledge of the accreditation process;
◙ a general knowledge of the area of assessment to be
evaluated;
◙ knowledge of SANAS requirements; and
◙ where applicable, regulatory requirements
AAC MEMBERS
TRAINING
◙ Induction
◙ Mentoring during at least one formal AAC proceeding;
◙ Monitoring:
The competence of a “new” AAC member will be
confirmed by an approved AAC member re-evaluating a
pack reviewed by that member
ON GOING MONITORING: IS AT LEAST ONCE IN EVERY
3 YEARS
AAC PROCESS
Information to be supplied to the AAC
◙ Assessment documentation, corrective actions and relevant
supporting evidence
Proceedings
◙ a review of the completeness of the documentation;
◙ evaluating whether the information submitted is adequate
◙ evaluation of the corrective actions and supporting evidence
◙ the coverage of the scope assessed;
◙ evidence that validation, verification of results and
proficiency testing data had been assessed
◙ A review of the evidence submitted in support of
granting signatory status
◙ Review of proposed schedule of accreditation
recommended;
TYPES OF DECISIONS
◙ Unconditional accreditation
◙ Deferral of decision(Initial)
◙ Rejection of accreditation
◙ Conditional accreditation
◙ Suspension of accreditation
◙ Withdrawal of accreditation
Questions
Thank You