1. The Role of SANAS in Support South African Government Objectives
Shadrack Phophi
South African National Accreditation System 1

2. PRESENTATION LAYOUT Background to SANAS
Relationship between SANAS & Regulators
Benefits for regulators 2

3. SANAS The South African National Accreditation System
SANAS is currently the one of the largest, internationally recognized, national accreditation body in the world. It was inaugurated in (as a section 21 company)
The Accreditation Act, Act 19 of 2006, was passed and SANAS became a public entity (agency of the dti) on 16 March 2007
(Full Title: The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act)
Accreditation is increasingly being used by SA Regulators, as part of managing local regulatory risk, to ensure both the competence and consistency of outcomes of service providers used in the local regulatory domain 3

4. SANAS
SANAS is recognized as the only national body responsible for carrying out accreditation in respect of conformity assessment, which includes:
Calibration, Testing and Verification Laboratories
Certification Bodies
Inspection Bodies
Rating Agencies and
Monitoring of GLP compliance with OECD principles 4

5. SA TECHNICAL INFRASTRUCTURE
Government Acts & Regulations
NRCS; DoL, DEAT, DME, DoH
etc.
SABS Standard
Div.
SANAS
Accreditation
Standards/Specifications
Technical
Infrastructure
Traceability
Conformity Inspections
NMISA
NRCS

6. SA TECHNICAL INFRASTRUCTURE6

7. Roles of Government Bodies and Regulators
Protecting the health and welfare of consumers and the public.
Protecting the environment
Developing new regulations and requirements
Measuring compliance with regulatory and legal requirements
Allocating resources, both technical and financial 7

8. Roles of Government Bodies and Regulators
In order to make informed decisions, they must have confidence in the data generated by laboratories carrying out testing, measurement or calibration in these fields
Using an accredited laboratory can help establish and assure this confidence 8

9. Government using Accreditation
Many countries now rely on Accreditation as a means of determining technical competence.
Accreditation has become “mandatory” in many regulated areas as more and more regulators appreciate the benefits that accreditation brings in assisting governments to meet their obligations and responsibilities to safeguard the public and the environment 9

10. Cont…
Minister Davies in 2006 noted that the change to a public entity was, amongst other things,
‘required to;
facilitate the use of accreditation by government departments, especially in support of the use of conformity assessment in regulation,

11. Areas were accreditation is mandatory
Inspection field
Major Hazard Installation
Legal metrology
Gas Test station
Food Inspection
Explosive facilities, equipment and processes
Diagnostic X-Ray Imaging System.
b) Verification field
Mass
Volume 11

12. Areas were accreditation is mandatory
Several other areas in process of development:
Electrical Inspections
Organically Produced Products
Health & Safety
Lift Inspection 12

13. Regulators using Accreditation
Department of Labour
Department of Minerals
NRCS – Legal Metrology
Department of Health 13

14. Benefits of using accredited laboratories by Government
Increasing confidence in data that is used to establish baselines for key analyses and decisions
Reducing uncertainties associated with decisions that affect the protection of human health and environment
Increasing public confidence, because accreditation is a recognisable mark of approval
Eliminate redundant reviews and improving the efficiency of the assessment process (which may reduce costs) 14

15. Accreditation Bodies Market Conformity assessment service
Demands for facilitating trade
Accreditation Bodies
Certification
Body
Inspection
Test
Lab
Cal
Product/
service
Suppliers
Purchasers
Regulators
Trade
Organizations
and Authorities
Conformity assessment bodies
Conforming product/service
Requirements
Demands for competent conformity assessment
Accreditation service

16. SANAS and Accreditation
Peer
Evaluation
ISO 17011
SANAS
Accreditation
Government
Recognition
Testing Laboratory or Medical Laboratories
E.g. SAPS, DoH, DAFF, Private Labs
ISO or ISO 15189
Customers
E.g. Police Forces, Courts, Farmers, patients
Customer Requirements 16

17. How can one tell that the Lab is technically competent?
Technical competence of staff
Validity and appropriateness of tests methods
Traceability of measurements and calibrations to national standards
Suitability, calibration and maintenance of test equipment
Test environment
Sampling, handling and transportation of test items
Quality assurance of test and calibration data 17

18. ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories
Scope of ISO/IEC 17025:
“…demonstrate that they (laboratories) operate a quality system, are technically competent, and are able to generate technically valid results”
“specifies the general requirements for the competence to carry out tests and/or calibrations including sampling” 18

19. ISO/IEC 17025:2005 vs. ISO 9001 Scope of ISO/IEC 17025:
“…demonstrate that they (laboratories) operate a quality system, are technically competent, and are able to generate technically valid results”
Scope of ISO/IEC 9001
“aims at confirming the compliance of the management system to this standard, but does not specifically evaluate the technical competence of a laboratory” 19

20. ISO/IEC 17025:2005
SANAS assess and accredit directly against ISO/IEC 17025
Two main sections – Management Requirements and Technical requirements
Used in relation to a variety of types of testing and calibration (flexible in its application) 20

21. Evaluating Competency for Accredited Laboratories21

22. Why competency so important? How do we assess competence?
What is competence?
Why competency so important?
How do we assess competence?
What SANAS accreditation is not 22

23. What is competence?
Competence is the demonstrated ability to apply knowledge and skills and where relevant, demonstrated personal attributes to achieve intended results. 23

24. What is competence? Competence: Skills Knowledge Experience
Qualifications
Ability 24

25. Conformity Assessment Body
What is competence?
Accreditation Body
Accreditation (Skills assessment)
Conformity Assessment Body
Certification (conformity)
Laboratory/Client 25

26. Technical competence of a Lab
Technical competence of a lab depends on a number of factors, namely:
Qualifications, training and experience of the staff
Correct equipment – proper calibrated and maintained
Adequate quality assurance procedures
Proper sampling practices
Appropriate and valid testing procedures and methods
Traceability of measurements to national standards
Accurate recording and reporting procedures
Suitable testing
By being accredited, the laboratory is demonstrating that these requirements, amongst others, have been and continue to be met 26

27. How we assess competence
Witnessing Assessment
Personnel member has competence for the activity performed
Personnel member’s competence are consistent with the records
Personnel member has been supplied with all necessary documented calibration/test methods and procedures
Procedures are up-to-date
Procedures are implemented in full and correctly (no shot cuts)
Promptly record of all observations
Facilities and equipment are fit for accreditation purpose 27

28. How we assess competence
Advantages of witnessing
Valid evidence
Direct evidence
Authentic evidence
Sufficient evidence 28

29. CASE STUDY 6 29

30. VERTICAL ASSESSMENT 30

31. Assuring the Quality of results
How we assess competence
b) Vertical Assessment
Equipment
Personnel
Environment
Test Methods
Assuring the Quality of results 31

32. CASE STUDY 4 32

33. What SANAS Accreditation is not
It is not merely a means of registering or listing someone or something
It is not a management system review dressed up with some scientific and technical elements
It is not the recognition of future capabilities
It is not the recognition of an individual’s qualifications
It is not a broad approval of everything a laboratory might do 33

34. Take home messages
Accreditation assessment of a laboratory is an independent assessment (by experts) on the competence of a laboratory to perform tests against a schedule of accreditation”
Accreditation confirms technical competence 34

35. Current Challenges
Reviewing of validation documentations before onsite assessment
Completion of recommendation form
Under utilization of F23 (pink form)
Under utilization of the Technical Requirements form (F49)
Annotation of Schedule of Accreditation
PT plan according to SANAS R80 35

36. CASE STUDY 5 36

37. RECOMMENDATION FORM (F04)37

38. What should be on the F04? Assessment’s team recommendation
A conclusion with respect to the effectiveness of the organisation’s system: - and +
Comments on ILC / proficiency testing activities
Report shall not be used to express gratitude or ant other sentiment relevant to the assessment 38

39. Initial Assessment Unconditional accreditation status to be granted
Accreditation status to be deferred until non-conformances have been cleared
Accreditation not recommended 39

40. CASE STUDY 2 40

41. Subsequent Assessments
Unconditional maintenance of accreditation status
Conditional maintenance of accreditation subject to satisfactory clearance of the non-conformances within stipulated timeframe of 25 working days
Conditional maintenance of accreditation subject to an on-site clearance of NC’s within a period of 3 months
Suspension of accreditation status 41

42. CASE STUDY 2 42

43. Clearance of Findings (P 40)43

44. Conditions for recommending an On-site Clearance of Findings Visit
Clearance of Findings is only applicable to:
A surveillance assessment
A 6 months follow-up visit
Extension of scope visit, where the extension is within an existing accredited scope 44

45. Conditions for recommending an On-site Clearance of Findings Visit
Clearance of Findings is not applicable to:
Initial Assessment
Re-Assessments
Extension of scope visit, where the extension is for a new scope 45

46. Conducting the On-site Clearance of Findings Visit
The purpose of the on-site clearance of findings is to verify implementation and effectiveness of corrective actions taken by the facility 46

47. Conducting the On-site Clearance of Findings Visit
All evidence and supporting documentation must be submitted to SANAS for perusal and acceptance prior to the on-site COF 47

48. Conducting the On-site Clearance of Findings Visit
Assessment team shall only clear NC’s if evidence supports that proper root cause analysis was undertaken, the CA’s had been effectively implemented and the necessary preventative actions have been put in place
Should the team come across additional observations that are not related to the original NC’s, the assessor shall record the issues on the back of the F04. 48

49. Recommendation/Statement resulting from the Outcome of the CoF Visit
If all CA’s are effective and have been satisfactorily implemented, the statement should indicate that “All corrective actions have been implemented” .
If any or all of the CA’s have not been cleared, the statement should indicate that “Corrective actions have not been implemented / effectively implemented”. 49

50. CASE STUDY 3 50

51. Re-Assessment Unconditional re-accreditation status to be granted
Re-Accreditation status to be deferred until non-conformances have been cleared
Re-Accreditation not recommended 51

52. CASE STUDY 1 52

53. Re-instatement assessment
Re-instatement of accreditation status recommended
Re-instatement of accreditation subject to satisfactory clearance of the NC’s within the stipulated timeframe of 25 working days
Re-instatement of accreditation status not recommended 53

54. SANAS ADMINISTRATION PROCESSES54

55. PROGRAM FINISHES THE ASSESSMENT PLAN ASSESSOR CONFIRMATIONS COMPLETED
31 SEPTEMBER
PROGRAM FINISHES THE ASSESSMENT PLAN
24 DECEMBER
ASSESSOR CONFIRMATIONS COMPLETED 55

56. FACILITIES CONFIRMATIONS SECURED
31 MARCH
FACILITIES CONFIRMATIONS SECURED 56

57. 4 WEEKS BEFORE THE ASSESSMENT
ADMINISTRATOR COMMENCES WITH TRAVEL ARRANGEMENTS 57

58. 3 WEEKS BEFORE THE ASSESSMENT
ADMINISTRATOR SENT TRAVEL DOCUMENTATIONS TO RELEVANT ASSESSORS 58

59. 1 WEEKS BEFORE THE ASSESSMENT
ADMINISTRATOR CONFIRMS THAT ALL TRAVEL ARRANGEMENTS HAVE BEEN RECEIVED BY THE ASSESSORS 59

60. 4 WEEKS BEFORE THE ASSESSMENT
ADMINISTRATOR COMMENCES WITH ASSESSMENT PACK COLLATION 60

61. 2 WEEKS BEFORE THE ASSESSMENT
ADMINISTRATOR DISPATCHES THE ASSESSMENT PACKS 61

62. 2 DAYS AFTER DISPATCHING PACKS
ADMINISTRATOR CONFIRMS RECEIPT OF PACKS WITH THE ASSESSORS 62

63. WITHIN 5 WORKING DAYS AFTER THE ASSESSMENT
LA / ASSESSOR TO RETURN ASSESSMENT PACKS 63

64. 25 DAYS AFTER THE ASSESSMENT
FACILITY SUBMITS COMPLETED CORRECTIVE ACTIONS 64

65. 50 DAYS AFTER THE ASSESSMENT ASSESSMENT PACK CLOSED65

66. ASSESSOR CLAIMS 66

67. ASSESSOR SUBMITS CLAIM FM REVIEWS, SIGNS AND SUBMITS TO FINANCE67

68. FINANCE SENT THE CLAIMS TO SM
CFO SIGNS AND INSTRUCT THE BANK TO MAKE PAYMENTS 68

69. Questions
Thank You

70. Use of Standards in Forensic Science
ISO Laboratory based activities
ISO Scene of Crime activities 70

71. Guidance Documents
ISO17025 – ILAC G19 Guidelines for Forensic Science Laboratories
ISO17020 – EA 5/03 Guidance for the implementation of ISO/IEC in the field of crime scene investigation 71

72. Forensic Testing Definition of an objective test from ILAC G19
‘A test which having been documented and validated is under control so that it can be demonstrated that all appropriately trained staff will obtain the same results within defined limits. These defined limits relate to expressions of degrees of probability as well as numerical values.’ 72

73. Forensic Testing Objective tests will be controlled by:
Documentation of the test
Validation of the test
Training and authorization of staff
Maintenance of equipment
And where appropriate
Calibration of equipment, use of appropriate reference materials, provision of guidance for interpretation, checking of results, testing of staff proficiency, recording of equipment / test performance 73

74. Forensic Laboratory The term laboratory is often used to mean:- or
The organisation being assessed or
The facilities where relevant activities are being carried out e.g. garage / workshop / office/ firing range/photographic studio 74

75. Areas currently accredited include:-
Drugs
Body Fluids 75

76. Questions
Thank You