WELCOME 2013 Communication Meeting September 2013.

WELCOME

2013 Communication MeetingSeptember 2013

CEO Report

2013 Communication MeetingSeptember 2013

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;

Focus 2010 to 2015

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

Testing

Medica

l

Veterinary

BBBEE

Verifica

tion

Calibra

tion

Inspecti

on

Pharmace

utical

BTS

Fore

nsics

GCP/GLP

CRM PTS

Certifica

tion0

50

100

150

200

250

300

350

302292

17

65

149

211

148

6

181

2 7 2 4

34

Total Number of Accredited Facilities: 1420 as at June 2013

Growth Statistics: March 2012 to March 2013

Total Number of Accredited Facilit-ies: June 2013

Calibra

tionCRM PTS

Cert

Medica

l

Legal M

etr

Inspecti

on

Testing

BTS

Veterinary GLP GCP

Fore

nsic

Pharmace

utical

BBBEE-10

-5

0

5

10

15

20

12

0 0 0

3

-7

18

20

0

31

0 10

-8

Growth increase by (58) 43 accredited facilities since 2012

Upcoming ExtensionsOwner Status Inspection/

VerificationTesting Calibration Certificatio

nOthe

r

Dept. of tourism Responsible tourism Launched

- - - X -

Dept. Of Labour Occupational Health and

SafetyPartially rolled out

X X X

Risk Based Inspection (RBI) Launched x x

Dept. of Energy & BUSA

Energy Management ISO/IEC 5003 - February 2014 Carbon tax incentives

Feb 2014 roll out

X

- OHSAS 1800 LaunchedX

BUSAGreenhouse Gas ISO/IEC 14065 Validation and Verification ,

Launchedx x

Dept. Environmental Affairs

Air Quality Monitoring newX x

Water & Environmental Affairs

Waste Water Management newX x

Industrial Policy Action Plan (IPAP) Priority Sector needs

Sector Testing Calibration Certification Inspection

Green Economy: Energy savings

Stack Emission Testing X X

Certification of Buildings X X

Nuclearx x X X

Information Security X

Road transport Management

Truck owner compliance

?? ??

Supporting the acceptance of Conformity Assessment Bodies (CAB’s) results in AfricaPan 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’ AlignmentArea Status June 2013 Target (2015)

Staff compliment62 75

• Improve service delivery & communication

ICT• Application process

partially automated;• Finance and

procurement updated

• Online registration and tracking of processes

Customer Experience measure

• 47.2 • 60

Finance (Under recovery on provision of services excluding government contribution)

- 6.78 0

• Invoicing;• Budgeting: Under

recovering for services rendered;

• Efficiency improvement

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

Target Sample: 170Sample realised: 236

Total Sample = 236(5.29% margin of error at a confidence level of 93%)

Available Contacts: 752

2011 2012 2013

Sample (n) = 171 Sample (n) = 144 Sample (n) = 236

NPS 20.6% 28.6% 35.1%

CSM

40.00 100

55.3%

Failure Delight

43.70 100

2.8% 60.4%

Failure Delight

47.20 100

1.7% 61.4%

Failure Delight

0.6%

Modelled Score – Annual Change20132011 2012

NPS = Net Promoters Score;CSM = Customer Satisfaction Measure

Slide 15

Modelled Index Score by Division by Year2011 2012 2013

Sample (n) = 171 Sample (n) = 144 Sample (n) = 236

Query

Assessment

Benefits

Certificates

66.5 70.0 73.00 100 0 100 0 100

77.1 80.3 82.50 100 0 100 0 100

69.4 71.9 73.70 100 0 100 0 100

67.7 71.3 74.70 100 0 100 0 100

20122011 2013

EventsEvent Date

Accreditation Day - Durban 9 June 2013

Annual Communication Meeting - Gauteng

16 September 2013

Annual Communication Meeting - Durban

18 September 2013

Annual Communication Meeting – Cape Town & PE

19 & 20 September 2013

AFRAC General Assembly (Kenya) 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: Inspection2013 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 Re-assessment 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 Re-assessment 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

[email protected]

REVISED / NEW SANAS ACCREDITATION REQUIREMENTS

Sept. 2013

Yolanda [email protected]

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

F 14

9 x SANAS Application Forms

Main Changes• Invoicing Information• Information on key personnel and deputies – specific to standard• Application for Approval of Personnel – replaces F18• 17025: Detailed information on Proficiency Testing• 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

2013/05/30

F14M-2012Application for Medical Laboratory Accreditation to ISO 15189:2012

New Document, to the new IOS 15189 standard2013/05/30

F 14TC-01

Application for Testing and Calibration Laboratory Accreditation to ISO/IEC 17025

New, Combined all the ISO/IEC Application Forms, i.e. Testing, Calibration, Forensic, Pharmaceutical, Veterinary, Blood Transfusion

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

A 01-09References, Acronyms and Definitions

Refer to amendment form – aligns to TOR 2013/06/13

P14-23

SANAS Fees

Applied 5.5% increase to fees as per National Treasury Requirements, Corrected amount for Certification Bodies: Additional assessor units per day.

2013-07-31

P 32-03Transition to New Standards

Minor changes regarding SANAS internal processes2013/02/27

Revised: Generic Procedures and Requirements

Doc Title Date

R 03-07Nominated Representative and Signatories: Responsibilities, Qualifications and Approval.

Refer to amendment form – aligns to TOR2013/06/13

R 51-07Suspension and Re-instatement of Accredited / Compliant Organisations

Entire document re-written to clarify requirements and align with TOR 2013/06/06

Calibration, Testing, Medical: Revised Requirements

Doc Title Date

R 50-03

Estimation of the Uncertainty of Measurement by Calibration Laboratories and Specification of Calibration and Measurement Capability on Schedules of Accreditation

Revised to align with ILAC P14 “ILAC Policy for Uncertainty in Calibration”2013-08-14

R 79-03Requirements for the Issue of SANAS Calibration Certificates

Minor amendments 2013-07-31

TG 07-01

Technical Guidelines for validation of methods used by chemical laboratories in the food, water and related industries

New document2012/10/10

TR 87-01

Calibration of Installation and Appliance Testers

New document 2013/02/13

Inspection: Revised Technical Requirements (TR) & Forms (F)

Doc Title Date

TR 78-03

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

Minor amendment – 1 clause added2013/02/13

TR 89-01

SANAS Technical Requirements on the Application of SANS/ISO/IEC 17020:2012

New document2013/03/14

Transition to ISO/IEC 17020:2012 ends 1 March 2015

Certification: NEW Requirements

Doc Title Date

TR 88-01Technical Requirements for Bodies providing Greenhouse Gas Validation and Verification

New document

2013/03/14

Documents made Obsolete

Doc. Title Date Obsolete Reason

CL 14 x SANAS Manual contents for the individual programmes 2013/06/06

The SANAS Website “Publications and Manuals” search function replaces the

need for programme specific contents lists

F 14B Application for Accreditation of Blood Transfusion Service Laboratories 2013/05/30

Replaced by F14TC “Application for Testing and

Calibration Laboratory Accreditation to ISO/IEC

17025”

F 14C Application for Accreditation of Calibration Laboratories 2013/05/30F 14F Application for Accreditation of Forensic Laboratories 2013/05/30

F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30

F 14T Application for Accreditation of Testing Laboratories 2013/05/30

F 14TP Application for Accreditation of Mechanical & Physical Testing Laboratories 2013/05/30

F 14V Application for Accreditation of Veterinary Laboratories 2013/05/30

F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30

F 171 Organs of State Accreditation Agreement 2013/05/30 Replaced by F 147 “Terms and Conditions of

Accreditation” and F 199 “Terms and Conditions of

GLP/GCP Compliance”

F 57 Accreditation Agreement 2013/05/30

F 114 Accreditation Agreement - International Facilities 2013/05/30

F 18 Application for the Approval of Personnel 2013/05/30Included a section for

approval of personnel in each F14 application form

International Laboratory Accreditation Co-operation

(ILAC) documents revised

Doc Title Date

ILAC P14-01/ 2013

ILAC Policy for Uncertainty in Calibration

Date of implementation: January 2014. 2013/02

ILAC P10-01/2013

ILAC Policy on the Traceability of Measurement Results

Date of implementation: January 2014. 2013/02

Thank You

COMMUNICATION MEETING

AAC PROCESS

Christinah Leballo

Senior Manager: Testing, Certification and BBBEE

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 PROCESS

◙ 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 MEMBERS

AAC PROCESSInformation 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;

◙ Unconditional accreditation

◙ Deferral of decision(Initial)

◙ Rejection of accreditation

◙ Conditional accreditation

◙ Suspension of accreditation

◙ Withdrawal of accreditation

TYPES OF DECISIONS

Questions

Thank You