PWA ISO 17020:2012 Internal Audit Checklist

• Started on

  Date

• Completed on

  Date

• Prepared by

• Location
  Address

• Note of advice:
  
  Inspection results are based upon interviews with staff, observation of staff, and/or the presence of objective evidence. Examples of objective evidence are manuals, forms/worksheets/templates, signed affidavits/statements/agreements/etc., technical records, administrative records, quality assurance records, logs, correspondence, legal documents, etc.
  
  For standards where objective evidence may not be reasonable or possible to obtain, such as knowledge and understanding of impartiality, interviews with staff and/or observations of work performed can be utilized. In such instances, it is advisable that notes be taken of staff member interviews/observations to maintain sufficient records for evaluation.

4 General Requirements

4.1 Impartiality and Independence

• 4.1.1 Inspection activities shall be undertaken impartially

  Yes

  No

  N/A

• 4.1.2 The inspection body shall be responsible for the impartiality of its inspection activities and shall not allow commercial, financial or other pressures to compromise impartiality

  Yes

  No

  N/A

• 4.1.2.1 The management system shall:<br>a) have a code of ethics as part of the management’s commitment to good professional practice;<br>b) ensure annual review of the document by all personnel and maintain a record of the review; and<br>c) ensure appropriate actions are taken when necessary.

  Yes

  No

  N/A

• 4.1.3 The inspection body shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present an inspection body with a risk to impartiality

  Yes

  No

  N/A

• NOTE A relationship that threatens the impartiality of the inspection body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new clients, etc

• 4.1.3.1 Risks of the inspection body shall be considered when it becomes aware of events which might have a bearing on the impartiality of the inspection body or its personnel

  Yes

  No

  N/A

• 4.1.4 If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates or minimizes such risk

  Yes

  No

  N/A

• 4.1.5 The inspection body shall have top management commitment to impartiality

  Yes

  No

  N/A

• 4.1.6 The inspection body shall be independent to the extent that is required with regard to the conditions under which it performs its services. Depending on these conditions, it shall meet the minimum requirements stipulated in Annex A, as outlined below<br>a) An inspection body providing third party inspections shall meet the type A requirements of Clause A.1 (third party inspection body). <br>b) An inspection body providing first party inspections, second party inspections, or both, which forms a separate and identifiable part of an organization involved in the design, manufacture, supply, installation, use or maintenance of the items it inspects and which supplies inspection services only to its parent organization (in-house inspection body) shall meet the type B requirements of Clause A.2. <br>c) An inspection body providing first party inspections, second party inspections, or both, which forms an identifiable but not necessarily a separate part of an organization involved in the design, manufacture, supply, installation, use or maintenance of the items it inspects and which supplies inspection services to its parent organization or to other parties, or to both, shall meet the type C requirements of Clause A.3.

  Yes

  No

  N/A

4.2 Confidentiality

• 4.2.1 The inspection body shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of inspection activities. The inspection body shall inform the client, in advance, of the information it intends to place in the public domain. Except for information that the client makes publicly available, or when agreed between the inspection body and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential

  Yes

  No

  N/A

• NOTE Legally enforceable commitments can be, for example, contractual agreements

• 4.2.2 When the inspection body is required by law or authorized by contractual commitments to release confidential information, the client or individual concerned shall, unless prohibited by law, be notified of the information provided

  Yes

  No

  N/A

• 4.2.3 Information about the client obtained from sources other than the client (e.g. complainant, regulators) shall be treated as confidential

  Yes

  No

  N/A

5 Structural Requirements

5.1 Administrative requirements

• 5.1.1 The inspection body shall be a legal entity, or a defined part of a legal entity, such that it can be held legally responsible for all its inspection activities

  Yes

  No

  N/A

• NOTE A governmental inspection body is deemed to be a legal entity on the basis of its governmental status

• 5.1.2 An inspection body that is part of a legal entity involved in activities other than inspection shall be identifiable within that entity

  Yes

  No

  N/A

• 5.1.3 The inspection body shall have documentation which describes the activities for which it is competent

  Yes

  No

  N/A

• 5.1.4 The inspection body shall have adequate provision (e.g. insurance or reserves) to cover liabilities arising from its operations

  Yes

  No

  N/A

• NOTE The liability can be assumed by the State in accordance with national laws, or by the organization of which the inspection body forms a part

• 5.1.5 The inspection body shall have documentation describing the contractual conditions under which it provides the inspection, except when it provides inspection services to the legal entity of which it is a part

  Yes

  No

  N/A

• NOTE A statute, regulation or other legal requirement is an example of documentation describing contractual conditions under which the inspection body provides services

• 5.1.6 The inspection body shall conform to requirements in PR 1018 ANAB Policy on Use of ANAB Accreditation Symbols and Claims of Accreditation Status

  Yes

  No

  N/A

5.2 Organization and management

• 5.2.1 The inspection body shall be structured and managed so as to safeguard impartiality

  Yes

  No

  N/A

• 5.2.2 The inspection body shall be organized and managed so as to enable it to maintain the capability to perform its inspection activities

  Yes

  No

  N/A

• NOTE Inspection schemes can require that the inspection body participates in the exchange of technical experience with other inspection bodies in order to maintain this capability

• 5.2.2.1 The inspection body shall have an organization that enables it to maintain the capability and competence to perform its technical functions satisfactorily and take steps to keep it appropriately informed about applicable technical and/or legislative developments concerning its activities. This includes inspection activities performed infrequently (defined as intervals longer than one year)

  Yes

  No

  N/A

• 5.2.3 The inspection body shall define and document the responsibilities and reporting structure of the organization

  Yes

  No

  N/A

• 5.2.3.1 The inspection body shall maintain an up-to-date organization chart clearly showing the lines of authority for staff

  Yes

  No

  N/A

• 5.2.4 Where the inspection body forms a part of a legal entity performing other activities, the relationship between these other activities and inspection activities shall be defined

  Yes

  No

  N/A

• 5.2.5 The inspection body shall have available one or more person(s) as technical manager(s) who have overall responsibility to ensure that the inspection activities are carried out in accordance with this International Standard

  Yes

  No

  N/A

• NOTE This person fulfilling this function does not always have the title of technical manager

• The person(s) fulfilling this function shall be technically competent and experienced in the operation of the inspection body. Where the inspection body has more than one technical manager, the specific responsibilities of each manager shall be defined and documented

  Yes

  No

  N/A

• NOTE Technical competence includes an understanding of all significant issues involved in the performance of inspection activities

• 5.2.5.1 The person(s) serving as technical manager(s) shall be employed by or under contract to the inspection body

  Yes

  No

  N/A

• 5.2.6 The inspection body shall have one or more named person(s) who will deputize in the absence of any technical manager responsible for ongoing inspection activities

  Yes

  No

  N/A

• 5.2.7 The inspection body shall have a job description or other documentation for each position category within its organization involved in inspection activities

  Yes

  No

  N/A

• 5.2.7.1 The job description or other documentation shall detail the duties, responsibilities, and authorities for each position category

  Yes

  No

  N/A

6 Resource Requirements

6.1 Personnel

• 6.1.1 The inspection body shall define and document the competence requirements for all personnel involved in inspection activities, including requirements for education, training, technical knowledge, skills and experience

  Yes

  No

  N/A

• NOTE The competence requirements can be part of the job description or other documentation mentioned in 5.2.7

• 6.1.1.1 When an inspection body needs to determine conformity to specific inspection requirements, the professional judgement needed to do so shall be considered when defining competence requirements for personnel involved in the inspection activity

  Yes

  No

  N/A

• NOTE Currency manufacturing regulations are an example of specific inspection requirements that may be used for an inspection of currency authentication

• 6.1.2 The inspection body shall employ, or have contracts with, a sufficient number of persons with the required competencies, including, where needed, the ability to make professional judgements, to perform the type, range and volume of its inspection activities

  Yes

  No

  N/A

• 6.1.3 The personnel responsible for inspection shall have appropriate qualifications, training, experience and a satisfactory knowledge of the requirements of the inspections to be carried out. They shall also have relevant knowledge of the following:<br> the technology used for the manufacture of the products inspected, the operation of processes and the delivery of services; <br> the way in which products are used, processes are operated and services are delivered; <br> any defects which may occur during the use of the product, any failures in the operation of the process and any deficiencies in the delivery of services.

  Yes

  No

  N/A

• They shall understand the significance of deviations found with regard to the normal use of the products, the operation of the processes and the delivery of services

  Yes

  No

  N/A

• 6.1.3.1 All personnel who perform inspection shall be competency tested. The competency test shall include practical examination(s) that cover the spectrum of anticipated tasks related to the inspection. The competency test intended results shall be achieved prior to performing the tasks during an inspection

  Yes

  No

  N/A

• NOTE Competency testing can be conducted for an individual task or a group of tasks covered by a module of a training program

• 6.1.3.2 Personnel who perform technical review of results or testimony, shall meet the competency requirements as specified in 6.1.3.1 for the inspection tasks being reviewed

  Yes

  No

  N/A

• 6.1.4 The inspection body shall make clear to each person their duties, responsibilities and authorities

  Yes

  No

  N/A

• 6.1.5 The inspection body shall have documented procedures for selecting, training, formally authorizing, and monitoring inspectors and other personnel involved in inspection activities

  Yes

  No

  N/A

• 6.1.5.1 The procedure for monitoring performance of the inspection body shall at a minimum:<br>a) ensure successful completion of at least one proficiency test for each discipline prior to accreditation being granted in that discipline; and <br>b) ensure each location on the scope of accreditation successfully completes, per calendar year, at least one proficiency test for each discipline in which accredited services are provided, with authorized release of the test results to ANAB from the test provider.

  Yes

  No

  N/A

• NOTE For proficiency tests taken at the end of one calendar year, evaluation of successful completion can occur in the subsequent calendar year

• 6.1.5.2 The performance of personnel shall be monitored. This monitoring shall ensure that all personnel who perform inspection shall successfully complete at least one intralaboratory comparison, interlaboratory comparison or proficiency test per calendar year in each discipline on the scope of accreditation in which the individual conducts work. In the event that the preceeding options are not available or appropriate, observation-based performance monitoring is acceptable

  Yes

  No

  N/A

• NOTE 1 The monitoring should be varied over time to cover all aspects of assigned job functions, but does not have to include all aspects of the work performed each time

• NOTE 2 Solely performing verifications (7.3.1.6) is considered to be inspection and is subject to these requirements

• NOTE 3 For performance monitoring conducted at the end of one calendar year, evaluation of successful completion can occur in the subsequent calendar year

• 6.1.5.3 The process for monitoring of performance by intralaboratory comparison, interlaboratory comparison, proficiency testing or observation-based testing shall at a minimum:<br>a) ensure that results are not known or readily available to the participant being monitored; <br>b) ensure use of approved methods; <br>c) establish criteria for determining successful completion prior to the monitoring activity; and <br>d) require a mechanism to ensure the quality of intralaboratory comparisons, interlaboratory comparisons and observation-based monitoring prior to the monitoring activity.

  Yes

  No

  N/A

• 6.1.5.4 There shall be a plan that will:<br>a) demonstrate conformance with the requirements stated in clause 6.1.5.1.b) and 6.1.5.2; and <br>b) ensure inclusion of a representative sample of the components/parameters, and equipment/technologies within each discipline listed on the scope of accreditation.

  Yes

  No

  N/A

• 6.1.5.5 To satisfy the proficiency test requirements in clauses 6.1.5.1.a) and b), the forensic service provider shall:<br>a) where available and appropriate for the work conducted, use a proficiency test provider that is accredited to ISO/IEC 17043 by an accreditation body that is a signatory to either the ILAC Mutual Recognition Arrangement, the APAC MRA or the IAAC MLA and has the applicable proficiency test(s) on its scope of accreditation; or <br>b) where not available or not appropriate for the work conducted, gain approval from ANAB for alternative means by which the inspection body’s performance can be assessed (FM 3041 Alternative Proficiency Test Request Form); and<br>c) submit results to the proficiency test provider, if applicable, on or before the agreed upon due date.

  Yes

  No

  N/A

• 6.1.5.6 The following records shall be maintained for all intralaboratory comparisons, interlaboratory comparisons, proficiency tests and observation-based monitoring:<br>a) discipline(s) monitored; <br>b) design of the monitoring activity; <br>c) expected results; <br>d) location, when more than one location is associated with a single accreditation certificate; <br>e) records submitted to a proficiency test provider, when applicable; <br>f) appropriate inspection records; <br>g) evaluation of results and action taken for unexpected results; and <br>h) feedback on individual performance provided to the participant.

  Yes

  No

  N/A

• 6.1.6 The documented procedures for training (see 6.1.5) shall address the following stages:<br>a) an induction period; <br>b) a mentored working period with experienced inspectors; <br>c) continuing training to keep pace with developing technology and inspection methods.

  Yes

  No

  N/A

• 6.1.6.1 The training procedures, to the extent necessary based on job function, shall include:<br>a) the knowledge, skills, and abilities needed to perform work; <br>b) general knowledge of forensic science; <br>c) the application of ethical practices in forensic science; <br>d) criminal law, civil law, and testimony; <br>e) provisions for retraining; <br>f) provisions for maintenance of skills and expertise; and <br>g) criteria for acceptable performance.

  Yes

  No

  N/A

• 6.1.7 The training required shall depend upon the ability, qualifications and experience of each inspector and other personnel involved in inspection activities, and upon the results of monitoring (see 6.1.8)

  Yes

  No

  N/A

• NOTE Past work experience and training may be substituted for portions of the training program to the extent that it has been demonstrated to be relevant and sufficient

• 6.1.8 Personnel familiar with the inspection methods and procedures shall monitor all inspectors and other personnel involved in inspection activities for satisfactory performance. Results of monitoring shall be used as a means of identifying training needs (see 6.1.7)

  Yes

  No

  N/A

• NOTE Monitoring can include a combination of techniques, such as on-site observations, report reviews, interviews, simulated inspections and other techniques to assess performance, and will depend on the nature of inspection activities

• 6.1.9 Each inspector shall be observed on-site, unless there is sufficient supporting evidence that the inspector is continuing to perform competently

  Yes

  No

  N/A

• NOTE It is expected that on-site observations are performed in a way that minimizes the disturbance of the inspections, especially from the client's viewpoint

• 6.1.9.1 In inspection areas where the inspection body has only one technically competent person, arrangements shall be in place for external resources to perform any necessary on-site observations

  Yes

  No

  N/A

• 6.1.10 The inspection body shall maintain records of monitoring, education, training, technical knowledge, skills, experience and authorization of each member of its personnel involved in inspection activities

  Yes

  No

  N/A

• 6.1.11 The personnel involved in inspection activities shall not be remunerated in a way that influences the results of inspections

  Yes

  No

  N/A

• 6.1.12 All personnel of the inspection body, either internal or external, that could influence the inspection activities shall act impartially

  Yes

  No

  N/A

• 6.1.13 All personnel of the inspection body, including sub-contractors, personnel of external bodies, and individuals acting on the inspection body's behalf, shall keep confidential all information obtained or created during the performance of the inspection activities, except as required by law

  Yes

  No

  N/A

6.2 Facilities and equipment

• 6.2.1 The inspection body shall have available, suitable and adequate facilities and equipment to permit all activities associated with the inspection activities to be carried out in a competent and safe manner

  Yes

  No

  N/A

• NOTE The inspection body need not be the owner of the facilities or equipment that it uses. Facilities and equipment can be borrowed, rented, hired, leased or provided by another party (e.g. the manufacturer or installer of the equipment). However, the responsibility for the suitability and the calibration status of the equipment used in inspection, whether owned by the inspection body or not, lies solely with the inspection body

• NOTE 2 “equipment” includes, but may not be limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus

• 6.2.2 The inspection body shall have rules for the access to, and the use of, specified facilities and equipment used to perform inspections

  Yes

  No

  N/A

• NOTE Topics to consider may include, but are not limited to, access to building, access by personnel, access by visitors, security during operational hours and non-operational hours, and devices that grant access

• 6.2.3 The inspection body shall ensure the continued suitability of the facilities and the equipment mentioned in 6.2.1 for their intended use

  Yes

  No

  N/A

• 6.2.3.1 If controlled environmental conditions are needed, e.g. for the correct performance of the inspection, the inspection body shall monitor these and record the results. If conditions were outside acceptable limits for the inspection to be performed, the inspection body shall record what action was taken

  Yes

  No

  N/A

• 6.2.4 All equipment having a significant influence on the results of the inspection shall be defined and, where appropriate, uniquely identified

  Yes

  No

  N/A

• 6.2.4.1 Reagents prepared shall be labeled with, at a minimum, the identity of the reagent and the date of preparation or lot number. Records shall be maintained identifying who made the reagent and the components used in preparation

  Yes

  No

  N/A

• 6.2.5 All equipment (see 6.2.4) shall be maintained in accordance with documented procedures and instructions

  Yes

  No

  N/A

• 6.2.6 Where appropriate, measurement equipment having a significant influence on the results of the inspection shall be calibrated before being put into service, and thereafter calibrated according to an established programme

  Yes

  No

  N/A

• 6.2.6.1 The required measurement accuracy and range for measuring equipment having a significant influence on the results of the inspection shall be defined

  Yes

  No

  N/A

• 6.2.6.2 The program for the calibration of measuring equipment shall include:<br>a) a list of the equipment requiring calibration; <br>b) specifications for the calibration laboratory; <br>c) specified requirements for the calibration; and <br>d) the interval of calibration.

  Yes

  No

  N/A

• 6.2.7 The overall programme of calibration of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the inspection body are traceable to national or international standards of measurement, where available. Where traceability to national or international standards of measurement is not applicable, the inspection body shall maintain evidence of correlation or accuracy of inspection results

  Yes

  No

  N/A

• 6.2.7.1 The inspection body shall establish and maintain metrological traceability of its measurement results by utilizing products and services from suppliers of external calibration services for measuring equipment and/or reference standards, and certified reference materials (see also ISO/IEC 17020:2012, 6.2.10) that are:<br>a) a National Metrology Institute that is a signatory to the BIPM1 - CIPM Mutual Recognition Arrangement with the calibration of measuring equipment and/or reference standard to be purchased or the certified reference material listed to be purchased in Appendix C of the BIPM key comparison database (KCDB)2 ; or <br>b) a service supplier accredited to ISO/IEC 17025 by an accrediting body that is a signatory to the ILAC Mutual Recognition Arrangement, with the calibration of measuring equipment and/or reference standard to be purchased listed in a scope of accreditation; or <br>c) an accredited reference material producer that is accredited to ISO 170343,4 by an accrediting body that is a signatory to a mutual or multilateral recognition arrangement in an ILAC recognized regional accreditation cooperation or the ILAC Mutual Recognition Arrangement, with a scope of accreditation covering the certified reference material to be purchased.

  Yes

  No

  N/A

• 6.2.7.2 In situations where a supplier that meets 6.2.7.1 is not available, the competence, capability, and metrological traceability for the supplier and the external product or service being purchased shall be confirmed. Objective evidence of the confirmation shall be available for review

  Yes

  No

  N/A

• 6.2.7.3 For the purpose of establishing traceability of a measurement, an accredited inspection body may calibrate its own equipment that supports an accredited parameter on the scope if the related requirements in ISO/IEC 17020 and this document are met:<br>a) the calibration and any check of the calibration status shall be carried out by appropriately trained, competency tested, and authorized personnel; <br>b) the calibration method shall be validated or verified prior to use; <br>c) certified reference materials or measuring instruments used in the calibration method shall be traceable with appropriate measurement uncertainties; <br>d) the calibration shall be carried out in an appropriate environment; <br>e) records of the calibration shall be established and maintained; <br>f) the inspection body shall have and apply a procedure for calculating the measurement uncertainty for each equipment calibration it conducts; and <br>g) a technical review of the calibration records including any data transfers and calculations shall be completed by an individual other than the person(s) who performed the work.

  Yes

  No

  N/A

• 6.2.8 Reference standards of measurement held by the inspection body shall be used for calibration only and for no other purpose. Reference standards of measurement shall be calibrated providing traceability to a national or international standard of measurement

  Yes

  No

  N/A

• 6.2.9 Where relevant, equipment shall be subjected to in-service checks between regular recalibrations

  Yes

  No

  N/A

• NOTE When evaluating the need for in-service (intermediate) checks, topics to consider include, but are not limited to, the calibration interval, the use of the equipment, the stability of the equipment, the method specifications, and risk associated with a failed check

• 6.2.10 Reference materials shall, where possible, be traceable to national or international reference materials, where they exist

  Yes

  No

  N/A

• NOTE See 6.2.7.1

• 6.2.11 Where relevant for the outcome of inspection activities, the inspection body shall have procedures for the following:<br>a) selection and approval of suppliers; <br>b) verification of incoming goods and services; <br>c) ensuring appropriate storage facilities.

  Yes

  No

  N/A

• 6.2.12 Where applicable, the condition of stored items shall be assessed at appropriate intervals to detect deterioration

  Yes

  No

  N/A

• 6.2.13 If the inspection body uses computers or automated equipment in connection with inspections, it shall ensure that:<br>a) computer software is adequate for use; <br>NOTE This can be done by the following: <br> validation of calculations before use; <br> periodic revalidation of related hardware and software; <br> revalidation whenever changes are made to related hardware or software; <br> software updates implemented as required. <br>b) procedures are established and implemented for protecting the integrity and security of data; <br>c) computer and automated equipment is maintained in order to ensure proper functioning.

  Yes

  No

  N/A

• 6.2.14 The inspection body shall have documented procedures for dealing with defective equipment. Defective equipment shall be removed from service by segregation, prominent labeling or marking. The inspection body shall examine the effect of defects on previous inspections and, when necessary, take appropriate corrective action

  Yes

  No

  N/A

• 6.2.15 Relevant information on the equipment, including software, shall be recorded. This shall include identification and, where appropriate, information on calibration and maintenance

  Yes

  No

  N/A

• 6.2.15.1 Reference collections shall have each entry in the collection documented, uniquely identified and handled properly to protect the characteristic(s) of interest

  Yes

  No

  N/A

6.3 Subcontracting

• 6.3.1 The inspection body shall itself normally perform the inspections that it contracts to undertake. Where an inspection body subcontracts any part of the inspection, it shall ensure and be able to demonstrate that the subcontractor is competent to perform the activities in question and, where applicable, complies with the relevant requirements stipulated in this International Standard or in other relevant conformity assessment standards

  Yes

  No

  N/A

• NOTE 1 Reasons to subcontract can include the following:
   an unforeseen or abnormal overload;
   key inspection staff members being incapacitated;
   key facilities or items of equipment being temporarily unfit for use;
   part of the contract from the client involving inspection not covered by the inspection body's scope or being beyond the capability or resources of the inspection body.

• NOTE 2 The terms “subcontracting” and “outsourcing” are considered to be synonyms

• NOTE 3 Where the inspection body engages individuals or employees of other organizations to provide additional resources or expertise, these individuals are not considered to be subcontractors provided they are formally contracted to operate under the inspection body's management system (see 6.1.2)

• 6.3.2 The inspection body shall inform the client of its intention to subcontract any part of the inspection

  Yes

  No

  N/A

• 6.3.3 Whenever subcontractors carry out work that forms part of an inspection, the responsibility for any determination of conformity of the inspected item with the requirements shall remain with the inspection body

  Yes

  No

  N/A

• 6.3.4 The inspection body shall record and retain details of its investigation of the competence of its subcontractors and of their conformity with the applicable requirements of this International Standard or in other relevant conformity assessment standards. The inspection body shall maintain a register of all subcontractors

  Yes

  No

  N/A

• 6.3.4.1 If the evaluation of the competence of the subcontractor is based partly or in full on its accreditation, the inspection body shall ensure that the scope of the subcontractor’s accreditation covers the activities to be sub-contracted

  Yes

  No

  N/A

7 Process requirements

7.1 Inspection Methods and Procedures

• 7.1.1 The inspection body shall use the methods and procedures for inspection which are defined in the requirements against which inspection is to be performed. Where these are not defined, the inspection body shall develop specific methods and procedures to be used (see 7.1.3). The inspection body shall inform the client if the inspection method proposed by the client is considered to be inappropriate

  Yes

  No

  N/A

• NOTE The requirements against which the inspection is performed are normally specified in regulations, standards or specifications, inspection schemes or contracts. Specifications can include client or in-house requirements

• 7.1.2 The inspection body shall have and shall use adequate documented instructions on inspection planning and on sampling and inspection techniques, where the absence of such instructions could jeopardize the effectiveness of the inspection process. Where applicable, the inspection body shall have sufficient knowledge of statistical techniques to ensure statistically sound sampling procedures and the correct processing and interpretation of results

  Yes

  No

  N/A

• 7.1.2.1 Statistical sampling at a stated level of confidence shall be used if an inference will be made to report on the whole population

  Yes

  No

  N/A

• 7.1.3 When the inspection body has to use inspection methods or procedures which are non-standard, such methods and procedures shall be appropriate and fully documented

  Yes

  No

  N/A

• NOTE A standard inspection method is one that has been published, for example, in international, regional or national standards, or by reputable technical organizations or by co-operation of several inspection bodies or in relevant scientific text or journals. This means that methods developed by any other means, including by the inspection body itself or by the client, are considered to be non-standard methods

• 7.1.3.1 The inspection body shall verify that it can properly perform standard methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the standard method is revised by the issuing body, verification shall be repeated to the extent necessary

  Yes

  No

  N/A

• 7.1.3.2 The inspection body shall validate non-standard methods, inspection body developed methods and standard methods used outside their intended scope or otherwise modified

  Yes

  No

  N/A

• 7.1.3.2.1 The inspection body procedure for method validation shall:<br>a) include the associated data analysis and interpretation; <br>b) establish the observations or data required to report a result; <br>c) identify limitations of the method and reported results.

  Yes

  No

  N/A

• 7.1.3.3 When changes are made to a validated method, the influence of such changes shall be determined and where they are found to affect the original validation, a new method validation shall be performed

  Yes

  No

  N/A

• NOTE Changes to associated data analysis and interpretation are considered changes to a validated method

• 7.1.3.4 The inspection body shall retain records of each method validation performed

  Yes

  No

  N/A

• 7.1.3.5 All inspection methods that involve the comparison of an unknown to a known shall require the evaluation of the unknown item(s) to identify characteristics suitable for comparison prior to comparison to one or more known items

  Yes

  No

  N/A

• NOTE Characteristics include, but are not limited to, friction ridge detail in a latent print or striation detail on a bullet

• 7.1.3.6 Measurement uncertainty shall be evaluated, or estimated when applicable, for all reported quantitative results

  Yes

  No

  N/A

• NOTE An item descriptor that includes a number is not considered a result. This difference should be clear to the reader of the report

• 7.1.3.6.1 The method of analysis for evaluation of measurement uncertainty shall:<br>a) require the specific measuring device or equipment used for a reported result to have been included in or evaluated against the estimation of measurement uncertainty for that method; <br>b) include the process of rounding the expanded uncertainty; <br>c) require the coverage probability of the expanded uncertainty to be a minimum of 95.45% (often referred to as approximately 95%); and <br>d) specify the schedule to review and/or recalculate the measurement uncertainty.

  Yes

  No

  N/A

• 7.1.3.6.2 The following records shall be maintained for each evaluation and estimation of measurement uncertainty:<br>a) statement defining the measurand; <br>b) statement of how traceability is established for the measurement; <br>c) the equipment (e.g., measuring device[s]) used;<br>d) all uncertainty components considered; <br>e) all uncertainty components of significance and how they were evaluated; <br>f) data used to estimate repeatability, intermediate precision, and/or reproducibility; <br>g) all calculations performed; and <br>h) the combined standard uncertainty, the coverage factor, the coverage probability, and the resulting expanded uncertainty.

  Yes

  No

  N/A

• 7.1.4 All instructions, standards or written procedures, worksheets, check lists and reference data relevant to the work of the inspection body shall be maintained up-to-date and be readily available to the personnel

  Yes

  No

  N/A

• 7.1.5 The inspection body shall have a contract or work order control system which ensures that:<br>a) work to be undertaken is within its expertise and that the organization has adequate resources to meet the requirements; <br>NOTE Resources can include, but are not limited to, facilities, equipment, reference documentation, procedures or human resources. <br>b) the requirements of those seeking the inspection body's services are adequately defined and that special conditions are understood, so that unambiguous instructions can be issued to personnel performing the duties to be required; <br>c) work being undertaken is controlled by regular review and corrective action; <br>d) the requirements of the contract or work order have been met.

  Yes

  No

  N/A

• 7.1.5.1 In situations where verbal work orders are acceptable, the inspection body shall keep a record of all requests and instructions received verbally

  Yes

  No

  N/A

• 7.1.5.2 The extent of database (e.g., friction ridge and ballistics) searches shall be communicated to customers and updated as needed

  Yes

  No

  N/A

• NOTE 1 “extent” will be specific to the database but may include aspects of the scope or range of the search (e.g., local, state, national, international), the frequency of the search or if the customer is required to make a request to elevate the scope of the search or to have a search performed

• NOTE 2 This may be communicated on a case-by-case basis, in the report, or in a general customer communication

• 7.1.6 When the inspection body uses information supplied by any other party as part of the inspection process, it shall verify the integrity of such information

  Yes

  No

  N/A

• 7.1.7 Observations or data obtained in the course of inspections shall be recorded in a timely manner so as to prevent loss of relevant information

  Yes

  No

  N/A

• 7.1.7.1 In the absence of exigent circumstances that may exist in field inspection, observations or data obtained in the course of inspections shall be recorded at the time they are made

  Yes

  No

  N/A

• 7.1.8 Calculations and data transfers shall be subject to appropriate checks

  Yes

  No

  N/A

• NOTE Data can include textual material, digital data and anything else that is transferred from one location to another where errors could be introduced

• NOTE 2 This requirement does not apply if the calculation or data transfer is secure and not subject to human error

• 7.1.8.1 The inspection record shall indicate the check was performed and who performed the check. When possible, this check shall not be conducted by the person who performed the calculation(s) or the data transfers

  Yes

  No

  N/A

• NOTE This check may be part of a technical review

• 7.1.9 The inspection body shall have documented instructions for carrying out inspection in a safe manner

  Yes

  No

  N/A

7.2 Handling Inspection Items and Samples

• 7.2.1 The inspection body shall ensure items and samples to be inspected are uniquely identified in order to avoid confusion regarding the identity of such items and samples

  Yes

  No

  N/A

• 7.2.1.1 The system used to identify items shall cover all items received

  Yes

  No

  N/A

• 7.2.2 The inspection body shall establish whether the item to be inspected has been prepared

  Yes

  No

  N/A

• 7.2.3 Any apparent abnormalities notified to, or noticed by, the inspector shall be recorded. Where there is any doubt as to the item's suitability for the inspection to be carried out, or where the item does not conform to the description provided, the inspection body shall contact the client before proceeding

  Yes

  No

  N/A

• 7.2.4 The inspection body shall have documented procedures and appropriate facilities to avoid deterioration or damage to inspection items while under its responsibility

  Yes

  No

  N/A

• 7.2.4.1 For all inspection items received except known origin individual characteristic database samples, the procedures shall:<br>a) address requirements for storage, packaging, and sealing of items to: <br>1. protect the integrity of all items; and <br>2. require items to be re-sealed as soon as practicable; <br>b) address measures to be taken to secure unattended items; <br>c) require chain-of-custody for: <br>1. all items received; and <br>2. items that are collected or created and preserved for future testing (e.g., ESDA lifts, test-fired ammunition, latent print lifts, trace evidence);<br>d) require chain-of-custody to securely and accurately identify: <br>1. the individual(s) or location(s) receiving or transferring the item(s); and <br>2. the item(s) being transferred; and <br>3. the chronological order of all transfers, minimally including the date; <br>e) require communication to the customer regarding the disposition of all items received; and <br>f) address communication to the customer regarding items collected or created and preserved for future inspection.

  Yes

  No

  N/A

• NOTE 1 c) An item being tracked could contain multiple components and be tracked as one item

• NOTE 2 d)1) Documentation of internal transfers does not need to include use of personal storage locations

7.3 Inspection Records

• 7.3.1 The inspection body shall maintain a record system (see 8.4) to demonstrate the effective fulfilment of the inspection procedures and to enable an evaluation of the inspection

  Yes

  No

  N/A

• 7.3.1.1 Where abbreviations or symbols specific to the forensic service provider are used, the meaning of the abbreviations or symbols shall be defined

  Yes

  No

  N/A

• 7.3.1.2 Inspection records to support a reported result shall be such that, another reviewer possessing the relevant knowledge, skills, and abilities could evaluate the inspection

  Yes

  No

  N/A

• 7.3.1.3 Records shall be created or maintained in a permanent manner

  Yes

  No

  N/A

• NOTE For example, inspection records originally captured in pencil (e.g., a rough sketch) can be maintained in a permanent manner by photocopying, scanning, or taking a photo

• 7.3.1.4 If an observation, data, or calculation is rejected, the reason, the identity of the individual(s) taking the action and the date shall be recorded in the inspection record

  Yes

  No

  N/A

• 7.3.1.5 The inspection body shall ensure that amendments to inspection records can be tracked to previous versions or to original observations. Both the original and amended data and files shall be retained, including the date of alteration, an indication of the altered aspects and the personnel responsible for the alterations

  Yes

  No

  N/A

• NOTE Contemporaneous revisions are not considered amendments

• 7.3.1.6 When a verification of a result is carried out:<br>a) it shall be conducted by an individual who is currently authorized to perform the inspection; <br>b) a record of the verification shall be made and the record shall identify who performed the verification, when it was performed, and the result of the verification; and <br>c) the resolution of any discrepancy shall be recorded.

  Yes

  No

  N/A

• NOTE b) Verification may be recorded for each result verified or as a summary for all results verified

• 7.3.1.7 There shall be a procedure for the technical review of inspection records, including reports, and testimony. The procedure shall:<br>a) require the individual performing the technical review to have been competency tested to perform the inspection work that is being reviewed; <br>b) preclude an individual from technically reviewing their own work; <br>c) define the method to be used to ensure a representative sample of inspection records and reports in each discipline are subjected to technical review; <br>d) define the method to be used to ensure testimony in each discipline is reviewed; <br>e) define the mechanism to be used to conduct and record the review; <br>f) ensure that the results are accurate, properly qualified and supported by the inspection record; <br>g) ensure conformance with methods and applicable management system documents; and <br>h) describe a course of action to be taken if a discrepancy is found.

  Yes

  No

  N/A

• NOTE 1 An individual conducting the technical review need not be an employee of the inspection body, currently proficiency tested or currently performing the work

• NOTE 2 An individual who performs a verification can also perform a technical review

• NOTE 3 The frequency may vary for different disciplines

• 7.3.2 The inspection report or certificate shall be internally traceable to the inspector(s) who performed the inspection

  Yes

  No

  N/A

7.4 Inspection Reports and Inspection Certificates

• 7.4.1 The work carried out by the inspection body shall be covered by a retrievable inspection report or inspection certificate

  Yes

  No

  N/A

• 7.4.1.1 The inspection report shall be provided in a written report or through electronic access

  Yes

  No

  N/A

• NOTE The reporting of results does not include inspection of known origin samples for the purpose of constructing an individual characteristic database or maintaining the quality and/or effectiveness of information in such a database

• 7.4.2 Any inspection report/certificate shall include all of the following:<br>a) identification of the issuing body; <br>b) unique identification and date of issue; <br>c) date(s) of inspection; <br>d) identification of the item(s) inspected; <br>e) signature or other indication of approval, by authorized personnel; <br>f) a statement of conformity where applicable; <br>g) the inspection results, except where detailed in accordance with 7.4.3.

  Yes

  No

  N/A

• NOTE Optional elements that can be included in inspection reports or certificates are listed in Annex B

• NOTE 2 c) Date(s) may be reflected as a range of dates or the date of each activity

• 7.4.2.1 There shall be a procedure for reporting of results that:<br>a) identifies what will be reported for all items received, including items on which no work was performed, items collected or created and preserved for future inspection, and for partial work performed; <br>b) requires qualifying the significance of associations in the report whether by a statistic or a qualitative statement; <br>c) requires communicating the reason(s) in the report when the reported results are inconclusive; <br>d) requires reporting of the initial database entry (e.g., friction ridge and ballistics); and<br>e) requires reporting the confidence level and corresponding inference regarding the population if statistical sampling is used.

  Yes

  No

  N/A

• NOTE b) Associations for multiple results may be qualified by a single statistic or qualitative statement if the statistics are identical or, where applicable, meet or exceed a defined minimum threshold

• 7.4.2.2 The measurement uncertainty shall:<br>a) be included in the report or an annex to the report when it impacts the evaluation of a specification limit stated by a regulatory body, a statute, case law, or other legal requirement; <br>b) include the measured quantity value, y, along with the associated expanded uncertainty, U, and the coverage probability; <br>c) be in the same unit as the reported result and in the format of y ± U; <br>d) be limited to at most two significant digits, unless there is a documented rationale for reporting additional significant digits; and <br>e) be reported to the same level of significance (i.e., same number of decimal places or digits) as the measurement result.

  Yes

  No

  N/A

• NOTE 1 a) A legal requirement is created, imposed, and enforced by a third-party external to the laboratory agency

• NOTE 2 c) For asymmetrical uncertainties, it may be inappropriate to quote a single result for the uncertainty and presentations other than y ± U may be needed

• NOTE 3 e) Reducing or simplifying a fraction is not a change in level of significance

• 7.4.3 An inspection body shall issue an inspection certificate that does not include the inspection results [see 7.4.2 g)] only when the inspection body can also produce an inspection report containing the inspection results, and when both the inspection certificate and inspection report are traceable to each other

  Yes

  No

  N/A

• 7.4.4 All information listed in 7.4.2 shall be reported correctly, accurately, and clearly. Where the inspection report or inspection certificate contains results supplied by subcontractors, these results shall be clearly identified

  Yes

  No

  N/A

• 7.4.5 Corrections or additions to an inspection report or inspection certificate after issue shall be recorded in accordance with the relevant requirements of this subclause (7.4). An amended report or certificate shall identify the report or certificate replaced

  Yes

  No

  N/A

7.5 Complaints and Appeals

• 7.5.1 The inspection body shall have a documented process to receive, evaluate and make decisions on complaints and appeals

  Yes

  No

  N/A

• 7.5.2 A description of the handling process for complaints and appeals shall be available to any interested party upon request

  Yes

  No

  N/A

• 7.5.3 Upon receipt of a complaint, the inspection body shall confirm whether the complaint relates to inspection activities for which it is responsible and, if so, shall deal with it

  Yes

  No

  N/A

• 7.5.4 The inspection body shall be responsible for all decisions at all levels of the handling process for complaints and appeals

  Yes

  No

  N/A

• 7.5.5 Investigation and decision on appeals shall not result in any discriminatory actions

  Yes

  No

  N/A

7.6 Complaints and Appeals Process

• 7.6.1 The handling process for complaints and appeals shall include at least the following elements and methods:<br>a) a description of the process for receiving, validating, investigating the complaint or appeal, and deciding what actions are to be taken in response to it; <br>b) tracking and recording complaints and appeals, including actions undertaken to resolve them; <br>c) ensuring that any appropriate action is taken.

  Yes

  No

  N/A

• 7.6.2 The inspection body receiving the complaint or appeal shall be responsible for gathering and verifying all necessary information to validate the complaint or appeal

  Yes

  No

  N/A

• 7.6.3 Whenever possible, the inspection body shall acknowledge receipt of the complaint or appeal, and shall provide the complainant or appellant with progress reports and the outcome

  Yes

  No

  N/A

• 7.6.4 The decision to be communicated to the complainant or appellant shall be made by, or reviewed and approved by, individual(s) not involved in the original inspection activities in question

  Yes

  No

  N/A

• 7.6.5 Whenever possible, the inspection body shall give formal notice of the end of the complaint and appeals handling process to the complainant or appellant

  Yes

  No

  N/A

8 Management System Requirements

8.1 Options

8.1.1 General

• The inspection body shall establish and maintain a management system that is capable of achieving the consistent fulfilment of the requirements of this International Standard in accordance with either Option A or Option B

• 8.1.1.1 In order for Option B to be available to a forensic service provider, the provider must maintain an accredited ISO 9001 certification. The certification body, which certified the provider to ISO 9001, must be accredited for ISO 9001 by an IAF MLA signatory accreditation body for management systems. Any forensic service provider that does not meet this criteria must choose Option A

• 8.1.1.2 The Option A requirements under 8.2 through 8.8 in this document are also applicable to forensic service providers who choose Option B

8.1.2 Option A

• The management system of the inspection body shall address the following:<br> management system documentation (e.g. manual, policies, definition of responsibilities, see 8.2); <br> control of documents (see 8.3); <br> control of records (see 8.4); <br> management review (see 8.5); <br> internal audit (see 8.6); <br> corrective actions (see 8.7); <br> preventive actions (see 8.8); <br> complaints and appeals (see 7.5 and 7.6).

  Yes

  No

  N/A

8.1.3 Option B

• An inspection body that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requiremnts of this International Standard, fulfils the management system clause requirements (see 8.2 to 8.8)

  Yes

  No

  N/A

8.2 Management System Documentation (Option A)

• 8.2.1 The inspection body's top management shall establish, document, and maintain policies and objectives for fulfilment of this International Standard and shall ensure the policies and objectives are acknowledged and implemented at all levels of the inspection body's organization

  Yes

  No

  N/A

• 8.2.1.1 The following words (to include forms of the same word) used in ISO/IEC 17020:2012 or in this document require addressing the requirement in writing: agreed, appoint, authorize, define, instructions, method, plan (noun only), procedure, program, record, rules, schedule, specify

• 8.2.2 The top management shall provide evidence of its commitment to the development and implementation of the management system and its effectiveness in achieving consistent fulfilment of this International Standard

  Yes

  No

  N/A

• 8.2.3 The inspection body's top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that include the following:<br>a) ensuring that processes and procedures needed for the management system are established, implemented and maintained; and <br>b) reporting to top management on the performance of the management system and any need for improvement.

  Yes

  No

  N/A

• 8.2.4 All documentation, processes, systems, records, etc. related to the fulfilment of the requirements of this International Standard shall be included, referenced, or linked to documentation of the management system

  Yes

  No

  N/A

• 8.2.5 All personnel involved in inspection activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities

  Yes

  No

  N/A

8.3 Control of documents (Option A)

• 8.3.1 The inspection body shall establish procedures to control the documents (internal and external) that relate to the fulfilment of this International Standard

  Yes

  No

  N/A

• 8.3.2 The procedures shall define the controls needed to:<br>a) approve documents for adequacy prior to issue; <br>b) review and update (as necessary) and re-approve documents; <br>c) ensure that changes and the current revision status of documents are identified; <br>d) ensure that relevant versions of applicable documents are available at points of use; <br>e) ensure that documents remain legible and readily identifiable; <br>f) ensure that documents of external origin are identified and their distribution controlled; <br>g) prevent the unintended use of obsolete documents, and apply suitable identification to them if they are retained for any purpose. <br>

  Yes

  No

  N/A

• NOTE Documentation can be in any form or type of medium, and includes proprietary and in-house developed software

8.4 Control of Records (Option A)

• 8.4.1 The inspection body shall establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of its records related to the fulfilment of this International Standard

  Yes

  No

  N/A

• 8.4.2 The inspection body shall establish procedures for retaining records for a period consistent with its contractual and legal obligations. Access to these records shall be consistent with the confidentiality arrangements

  Yes

  No

  N/A

• NOTE Contractual obligations for records retention include legal requirements and customer expectations

8.5 Management Review (Option A)

8.5.1 General

• 8.5.1.1 The inspection body's top management shall establish procedures to review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfilment of this International Standard

  Yes

  No

  N/A

• 8.5.1.2 These reviews shall be conducted at least once a year. Alternatively, a complete review broken up into segments (a rolling review) shall be completed within a 12-month time frame

  Yes

  No

  N/A

• 8.5.1.3 Records of reviews shall be maintained

  Yes

  No

  N/A

8.5.2 Review inputs

• The input to the management review shall include information related to the following:<br>a) results of internal and external audits; <br>b) feedback from clients and interested parties related to the fulfilment of this International Standard; <br>c) the status of preventive and corrective actions; <br>d) follow-up actions from previous management reviews; <br>e) the fulfilment of objectives; <br>f) changes that could affect the management system; <br>g) appeals and complaints.

  Yes

  No

  N/A

8.5.3 Review outputs

• The outputs from the management review shall include decisions and actions related to:<br>a) improvement of the effectiveness of the management system and its processes; <br>b) improvement of the inspection body related to the fulfilment of this International Standard; <br>c) resource needs.

  Yes

  No

  N/A

8.6 Internal audits (Option A)

• 8.6.1 The inspection body shall establish procedures for internal audits to verify that it fulfils the requirements of this International Standard and that the management system is effectively implemented and maintained

  Yes

  No

  N/A

• NOTE ISO 19011 provides guidelines for conducting internal audits

• 8.6.2 An audit programme shall be planned, taking into consideration the importance of the processes and areas to be audited, as well as the results of previous audits

  Yes

  No

  N/A

• 8.6.3 The inspection body shall conduct periodic internal audits covering all procedures in a planned and systematic manner, in order to verify that the management system is implemented and is effective

  Yes

  No

  N/A

• 8.6.4 Internal audits shall be performed at least once every 12 months. The frequency of internal audits may be adjusted depending on the demonstrable effectiveness of the management system and its proven stability

  Yes

  No

  N/A

• 8.6.4.1 Internal audits provide information on whether the management system:<br>a) conforms to: <br>1) the inspection body’s own requirements for its management system; <br>2) the requirement of ISO/IEC 17020; and <br>3) the requirements of this document; and <br>b) is effectively implemented and maintained.

  Yes

  No

  N/A

• 8.6.5 The inspection body shall ensure that:<br>a) internal audits are conducted by qualified personnel knowledgeable in inspection, auditing and the requirements of this International Standard; <br>b) auditors do not audit their own work; <br>c) personnel responsible for the area audited are informed of the outcome of the audit; <br>d) any actions resulting from internal audits are taken in a timely and appropriate manner; <br>e) any opportunities for improvement are identified; <br>f) the results of the audit are documented.

  Yes

  No

  N/A

8.7 Corrective actions (Option A)

• 8.7.1 The inspection body shall establish procedures for identification and management of nonconformities in its operations

  Yes

  No

  N/A

• 8.7.2 The inspection body shall also, where necessary, take actions to eliminate the causes of nonconformities in order to prevent recurrence

  Yes

  No

  N/A

• 8.7.3 Corrective actions shall be appropriate to the impact of the problems encountered

  Yes

  No

  N/A

• 8.7.4 The procedures shall define requirements for the following:<br>a) identifying nonconformities; <br>b) determining the causes of nonconformity; <br>c) correcting nonconformities; <br>d) evaluating the need for actions to ensure that nonconformities do not recur; <br>e) determining the actions needed and implementing them in a timely manner; <br>f) recording the results of actions taken; <br>g) reviewing the effectiveness of corrective actions. <br>

  Yes

  No

  N/A

8.8 Preventive actions (Option A)

• 8.8.1 The inspection body shall establish procedures for taking preventive actions to eliminate the causes of potential nonconformities

  Yes

  No

  N/A

• 8.8.2 Preventive actions taken shall be appropriate to the probable impact of the potential problems

  Yes

  No

  N/A

• 8.8.3 The procedures for preventive actions shall define requirements for the following:<br>a) identifying potential nonconformities and their causes; <br>b) evaluating the need for action to prevent the occurrence of nonconformities; <br>c) determining and implementing the action needed; <br>d) recording the results of actions taken; <br>e) reviewing the effectiveness of the preventive actions taken.

  Yes

  No

  N/A

• NOTE The procedures for corrective and preventive actions do not necessarily have to be separate

• Internal Auditors

  Sign