Considerations ISO 17020 accreditation 21 22

Considerations – ISO 17020 accreditation 21 – 22 January 2013 Jimmy van der Merwe

Presentation overview Introduction Resources Planning Implementation Maintenance January 2013 2

Introduction INTENT OF ISO 17020 Competence Independence Reliability Trust January 2013 3

Resources Manager Adjustments to time Technical Expert Time per week Technical Expert Administration

Planning Statement of Work CONSULT TR_83 and TR_84 Understanding of the standard Scopes of technical and system documents Formatting – documents, manuals, forms Development of documentation Risk assessment and implementation of controls Collection of data for validation (standard and new methods) Internal Audit Review Application Accreditation Audit MONTH 1 2 3 4 5 6

Planning – increase know-how Onbewustelik onbedrewe (unconsciously incompetent) onbewustelik bedrewe (unconsciously competent) bewustelik onbedrewe (incompetent consciously) Bewustelik bedrewe (consciously competent)

Implementation Satisfaction GOAL 1 Momentum through Change 3 “Outer control limits” 4 Risk phase 2 “Warning limits” Need Client Scope creep Interventions AIA Professional processes Completion

Objectives and targets Wheel of Continuous Improvement Waste Standardise!

Process validation Mens Machine Material EFFECT Method Measure Environment EXAMPLE PROCEDURE FOR PROCESS VALIDATION. DOC UNCERTAINTY IN MEASUREMENT. pdf

Objectives and targets S-M-A-R-T What to Start, Increase, Introduce, Maximise What to Stop, Reduce, Eliminate, Minimise

Implementation List documents and their records Documents and their attributes Records and their attributes Data, software See Content List as an example

Implementation 00 MANAGEMENT SYSTEM System Contents 0101 ISO 17020 Contents - Reference to system items. doc

Implementation Caution – ISO 170202 “shall” - requirements “should” - recommendation “may” - permission “can” – possibility or capability

Implementation Pitfalls in shortcuts Re-invention of the wheel Price Speed of implementation Resources Copied text from the standard Systems on sale does not guarantee implementation

Typical pitfalls during implementation Too little ownership from owner – controlled by consultant or facilitator. Too little time. Too little knowledge of the standard. Too little technical knowledge. Too little legal knowledge. Access to knowledge (legal, technical) SANAS inexperience. Continuous improvement – difficult to prove

Painkillers for implementation Fees – compare with others before you buy. SANAS – Do not underestimate the pre-assessment on offer. Work together with colleagues and others. Go first – last audits are well informed. Take part in SAIOH initiatives.

Thank you for listening Jimmy van der Merwe iso 9000@iburst. co. za 0824906104 70 Franshoek Drive DURBANVILLE