ISO/IEC 17025: 2005 WORKING DOCUMENT WITH AOAC, …

1 ISO/IEC 17025 : 2005 WORKING DOCUMENT . with aoac , AAFCO, AND APLAC T007 GUIDANCE. NOTES: 1. This WORKING DOCUMENT is intended as a checklist for the assessor when conducting Testing and Calibration Laboratory Accreditation Assessments according to ISO/IEC 17025 : 2005 , aoac Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals An Aid to the Interpretation of ISO/IEC 17025 : 2005 (2015)" (ALACC Guidelines), and (AAFCO)-- Quality Assurance/Quality Control Guidelines For Feed Laboratories supplement to ISO/IEC . 17025 : 2005 General Requirements for the Competence of Testing and Calibration Laboratories including AAFCO Accreditation Requirements 2014.

2 This standard incorporates all elements of ISO 9001 relevant to testing and calibration laboratories. 2. Please note in the Comments column any deficiencies in the laboratory's management system identified during the assessment (see item #3). These observations may be useful when preparing the assessment report and indicate to the reviewer that a thorough assessment was conducted. It is also imperative to note evidence of compliance, making reference to procedures/work instructions, dates, and other specific observations. Note: At least 1 comment per section is required 3. Do not recommend specific solutions to deficiencies, as this would constitute a conflict of interest.

3 4. Assess the system only to the relevant standard and to the requested scope of accreditation. Do not be concerned with system requirements stemming from: Company- or facility-imposed policies Regulatory bodies Subcontractors Other sources 5. If additional questions arise during the assessment, indicate them (and the appropriate responses) either in the blank WORKING DOCUMENT pages at the end of this DOCUMENT or in the empty rows included in some of the sections. 6. Green Highlighted items indicate TC007 requirements, Red Highlighted items indicate AAFCO requirements, and Blue Highlighted items indicate aoac requirements.

4 All other items are ISO/IEC 17025 requirements 7. Please read the questions carefully, as the preferred answer in some cases may be no or not applicable.. 8. If, at any time, the assessment team requires assistance in the interpretation of the standard requirements, the PJLA office should be contacted immediately. Assessment Number: _____ Date:_____. Client: _____. Address: _____. _____. Contract/Management Rep: _____. Lead Assessor: _____. Assessment Team Member(s):_____. _____. Form # Issued: 9/14 Rev. LF-56-2k5 aoac and AAFCO Revised: 3/16 Page 1 of 94. ISO Characteristic Yes No Comments regarding Req.

5 Deficiencies/effectiveness (if applicable). MANAGEMENT REQUIREMENTS. Organization Is the laboratory or the organization of which it is part an entity that can be held legally responsible? Does the laboratory uphold its responsibility to carry out its testing and calibration activities in such a way as to meet the requirements of this standard? Does the laboratory carry out its testing and calibration activities in such a way as to meet the requirements of the customer, the regulatory authorities or organizations providing recognition? Does the management system cover work carried out in the laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities?

6 If the laboratory is part of an organization performing activities other than testing and/or calibration, are the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities defined in order to identify potential conflicts of interest? Does the laboratory (a-j): a) have managerial and technical personnel with the authority and resources needed to: - perform their duties? - identify departures from the management system or from the procedures for performing tests and/or calibrations? - initiate actions to prevent or minimize such departures?

7 _____. Form # Issued: 9/14 Rev. LF-56-2k5 aoac and AAFCO Revised: 3/16 Page 2 of 94. ISO Characteristic Yes No Comments regarding Req. deficiencies/effectiveness (if applicable). - implement, maintain and improve the management system irrespective of other responsibilities? b) have arrangements to ensure that its management & personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of their work? aoac Have conflict of interest International agreements been established along Guidelines with appropriate training programs for entry personnel?

8 aoac Do all affected staff members International annually attest that they understand Guidelines the conflict of interest agreement and adhere to the requirements? c) have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results? d) have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity? e) define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services?

9 aoac Is there an organizational International description that could include _____. Form # Issued: 9/14 Rev. LF-56-2k5 aoac and AAFCO Revised: 3/16 Page 3 of 94. ISO Characteristic Yes No Comments regarding Req. deficiencies/effectiveness (if applicable). Guidelines organizational chart or charts indicating all reporting relationships and responsibilities readily available to staff members? aoac Does the organizational chart International include the most responsible Guidelines position for the unit and all positions in that hierarchy? f) specify the responsibility, authority, and interrelation of all personnel who manage, perform or verify work affecting the quality of tests and/or calibrations?

10 G) provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, the purpose of each test and/or calibration and the assessment of the results? h) have technical management with overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory operations? i) appoint a member of staff as quality manager (however named)? - does this quality manager have defined responsibility and authority for ensuring that the management system is implemented and followed at all times?