INTERNATIONAL ACCREDITATION SERVICE (IAS) Conducting a Pre-Assessment By: Mohan Sabaratnam, IAS Quality Manager 4th Annual Manufactured Food Regulatory Program Alliance (MFRPA) Meeting & Governmental Food and Feed Laboratories Accreditation Meeting March 9-12, 2015 San Diego, California

Overview of Presentation Provision under ISO/IEC 17011 Limitations of an AB Selection of an AB Advantages of Pre-Assessments Preparing for Pre-Assessment or Initial Assessment Accreditation Route About IAS Q & A

Provision under Accreditation Body Standard ISO/IEC 17011: 2004 - General requirements for accreditation bodies accrediting conformity assessment bodies November 11, 2018 Copyright 2011

Provision under Accreditation Body Standard ISO/IEC 17011, Clause 7.5.1: Before the initial assessment, a preliminary visit may be conducted with the agreement of the CAB. Identification of system deficiencies and/or competencies in CAB; 2) AB to avoid consultancy. November 11, 2018 Copyright 2011

The ‘No-No’ of an AB ISO/IEC 17011, Clause 3.11: Definition of the term ‘consultancy’ Participation in any of the activities of a CAB subject to accreditation EXAMPLES: preparing or producing manuals or procedures; participating in the operation or management of the system; giving specific advice or specific training towards development and implementation of: management system and/or competence of a CAB; operational procedures of a CAB November 11, 2018 Copyright 2011

Selection of AB IAS—Signatory to the MRA/MLA IAS is a ILAC Mutual Recognition Arrangement (MRA) signatory for Testing, Calibration and Inspection. IAS is a IAF Multi-lateral Recognition Arrangement (MLA) signatory for Product Certification. PAC Re-Evaluation completed in December 2014 for Product PAC Evaluation completed in December 2014 for Management Systems

Laboratory Accreditation Standard Laboratory Accreditation Standard ISO/IEC 17025: 2005 - General requirements for the competence of testing and calibration laboratories November 11, 2018 Copyright 2011

Advantages of a Pre-Assessment Understand the AB Assessor(s) style and questioning approaches; Eliminate any potentially unpleasant surprises at the initial assessment; Pre-Assessment is a gap-analysis activity; Assist to clarify any questions regarding the interpretation of the standard and AB accreditation requirements; November 11, 2018 Copyright 2011

Advantages of a Pre-Assessment Identifying areas where competencies need to be improved; Able to limit or propose an appropriate scope of accreditation; Pre-applicant staff: comfortable asking questions. take time to think through their answers. acknowledge any weak points in the system. November 11, 2018 Copyright 2011

Preparing for a Pre-Assessment or Initial Assessment Participation in suitable proficiency testing program; Conducting an internal audit; Completion of management review; November 11, 2018 Copyright 2011

Preparing for a Pre-Assessment or Initial Assessment Establishing the procedure for estimating measurement uncertainty; Completing a measurement uncertainty budget for at least one test method; Providing an Awareness training to all personnel. November 11, 2018 Copyright 2011

IAS Accreditation Route Conduct Pre-Assessment (optional) Fix identified deficiencies Submit Application for Accreditation November 11, 2018 Copyright 2011

Fix identified Deficiencies or else “We didn’t allow for wind again….” … learning from your mistakes

IAS Accreditation Route Initial Assessment 12 months Surveillance Assessment (Mandatory) 24 months Re-Assessment (Mandatory) November 11, 2018 Copyright 2011

International Accreditation Service - History 1975 ICBO-ES (IAS established) Apr 1999-Oct 2000 APLAC and ILAC MRA signatory March 2002 IAS incorporated as a nonprofit, public benefit corporation Jan 2003 IAS transition into ICC as wholly owned subsidiary May 2011 IAS achieves IAF and PAC MRA recognition (567 accreditations) Summer 2013, Spring 2014, February 2015 Continued growth at domestic and international levels with wide regulatory acceptance (706 accreditations)

IAS Growth November 11, 2018 Copyright 2011

IAS Accreditation Infrastructure IAS BOARD OF DIRECTORS appoints all AC, TAC and staff members sitting on these committees AC is supported by TAC and IAS staff TAC is supported by IAS staff and management team IAS Staff/Assessors /Experts IAS BOARD Accreditation Committee (AC) 7 Technical Advisory Councils (TAC)

Q & A Thank you