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CAB Self-Assessment & Document Review Report for Forensic Service Provider Inspection Body

Based on ISO/IEC 17020:2012, ILAC-P15:2016 & ILAC-G19:08/2014

Organization NameInspection Body NameDivision / Dept.IB Rep. Name / PositionInspection Body Ref. No.Inspection Body Activities Type A Type B Type CAssessment Type Pre-Assessment Initial Assessment No. ( ) Re-Assessment ExtensionThis report covers Self-Assessment Document Review

Case numberFor/toAnd

IB has several locations: Yes No

Assessed locations:(Name)/Address:

(Name)/Address:

Assessed area (technical fields of EGAC, inspection fields, sector-specific requirements):

Details of the team member Team leader Assessor

Name / Institution / Telephone / Fax / E-Mail

General remarks/notes to the use of the checklist for inspection bodies from forensic Agency This checklist for Forensic Service Providers Performing Inspection is based on the standard text of ISO/IEC17020:2012, ILAC-P15:2016 and ILAC G19: 2014.The notes are not requirements.The first column refers to the ISO/IEC17020:2012 and the second column to the related standard textIn c o l u m n 3 , t h e a pp lica n t s h all fill it before quality system document review Then column 4 will be filled by the assessor indicating the compliance or Non-compliance of the requirement subjected with objective evidences.In column5, the applicant shall fill it as response to finding raised out from document review*Team Leader (TL) determine during the opening meeting which clauses to be covered by assessor and which to covered by TL ** Document review of TL(N/C & Cm), assessment team and Lab response will be written in this checklist specified columnREQUIREMENTS & COMMENTS Compliance = C, Non-compliance = NCComment below on adequacy of how requirements have been addressed, documented and/or implemented. References to ISO/IEC 17020:2012 &ILAC are in italics & indicated as Std. The order of assessment need not follow the order of the checklist. Assessment team are expected to know & have the standard, this worksheet is designed as guidance to prompt detailed recording of the process.REFER TO ISO/IEC 17020:2012, ILAC-P15:2016 and ILAC G19: 2014 FOR DETAIL AND FOR CLARIFICATION NOTES.

Clause Requirement CAB Self-Assessment CNC

Document review TL comments and/or assessor

4 General requirements4.1 Impartiality and independence4.1.1 Inspection activities shall be undertaken impartially4.1.2 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

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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.

ILAC-P15 (4.1.3a)

4.1.3a. Risks to the impartiality of the inspection body shall be considered whenever events occur which might have a bearing on the impartiality of the inspection body or its personnel.

ILAC-P15 (4.1.3b)

4.1.3.b.The inspection body should describe any relationships that could affect its impartiality to the extent relevant, using organizational diagrams or other means. Examples of relationships that could influence the impartiality include: - Relationship with a parent organization- Relationships with departments within the same organization- Relationships with related companies or organizations- Relationships with regulators - Relationships with clients - Relationships of personnel

- Relationships with the organizations designing, manufacturing, supplying, installing, purchasing, owning, using or maintaining the items inspected

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.

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

ILAC-P15 (4.1.5a)

4.1.5aThe inspection body should have a documented statement emphasizing its commitment to impartiality in carrying out its inspection activities, managing conflicts of interest and ensuring the objectivity of its inspection activities. Actions emanating from the top management should not contradict this statement.

ILAC-P15 (4.1.5b)

4.1.5bOne way for the top management to emphasize its commitment to impartiality is to make relevant statements and policies publicly available.

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:-

4.1.6. a An inspection body providing third party inspections shall meet the type A requirements of Clause A.1 (third party inspection body).

A.1 Requirements for inspection bodies (Type A) a) The inspection body shall be independent of the

parties involved. b) The inspection body and its personnel shall not

engage in any activities that may conflict with their independence of judgment and integrity in relation to their inspection activities. In particular, they shall not be engaged in the design, manufacture, supply, installation, purchase, ownership, use or maintenance of the

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items inspected. NOTE 1 This does not preclude exchanging

technical information between the client and the inspection body (e.g. explanation of findings or clarifying requirements or training).

NOTE 2 This does not preclude the purchase, ownership or use of inspected items that are necessary for the operations of the inspection body, or the purchase, ownership or use of the items for personal purposes by the personnel.

c) An inspection body shall not be a part of a legal entity that is engaged in design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected. NOTE 1 This does not preclude exchanging

technical information between the client and any other part of the same legal entity of which the inspection body is a part (e.g. explanation of findings or clarifying requirements or training).

NOTE 2 This does not preclude the purchase, ownership, maintenance or use of inspected items that are necessary for the operations of another part of the same legal entity, or for personal purposes by the personnel.

d) The inspection body shall not be linked to a separate legal entity engaged in the design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected by the following: 1) common ownership, except where the

owners have no ability to influence the outcome of an inspection;

EXAMPLE 1 A cooperative type of structure where there are large numbers of stakeholders, but they (individually or as a group) have no ability to influence the outcome of an inspection.

EXAMPLE 2 A holding company consisting of several separate legal entities (sister companies) under a common mother company, where neither the sister companies nor the mother company can influence the outcome of an inspection.

1) common ownership appointees on the boards or equivalent of the organizations, except where these have functions that have no influence on the outcome of an inspection;

EXAMPLE A bank financing a company insists on an appointee to the board who will overview how the company is managed but will not be involved in

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any decision-making. 2) directly reporting to the same higher level of

management, except where this cannot influence the outcome of an inspection;

NOTE Reporting to the same higher level of management is permitted on matters other than design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected.

3) contractual commitments, or other means that may have an ability to influence the outcome of an inspection.

4.1.6 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.

A.2 Requirements for inspection bodies (Type B)

a) Inspection services shall only be supplied to the organization of which the inspection body forms a part.

b) A clear separation of the responsibilities of the inspection personnel from those of the personnel employed in the other functions shall be established by organizational identification and the reporting methods of the inspection body within the parent organization.

c) The inspection body and its personnel shall not engage in any activities that may conflict with their independence of judgment and integrity in relation to their inspection activities. In particular, they shall not be engaged in the design, manufacture, supply, installation, use or maintenance of the items inspected. NOTE 1 This does not preclude exchanging

technical information between the inspection body and the other parts of the organization of which the inspection body forms a part, e.g. explanation of findings or clarifying requirements or training.

NOTE 2 This does not preclude the purchase, ownership or use of inspected items that are necessary for the operations of the inspection body, or the purchase, ownership or use of the items for personal purposes by the personnel.

4.1.6 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

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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.

A.3 Requirements for inspection bodies (Type C) a) The inspection body shall provide safeguards

within the organization to ensure adequate segregation of responsibilities and accountabilities between inspection and other activities.

b) The design/manufacture/supply/installation/servicing/maintenance and the inspection of the same item carried out by a Type C inspection body shall not be undertaken by the same person. An exception to this is where a regulatory requirement explicitly allows an individual person from a Type C inspection body to undertake both the design/manufacture/supply/installation/servicing/maintenance and the inspection of the same item, as long as this exception does not compromise the inspection results.

NOTE Inspections carried out by Type C inspection bodies cannot be classified as third party inspections for the same inspection activities because they do not meet the requirements of independence of operations for Type A inspection bodies.

4.2 Confidentiality4.2.1 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.

ILAC G19 (4.9)

The output given to the customer shall not in any way be misleading.The type and amount of information required in the report may depend on the legal system. However, in all cases, there shall be a clear indication of which parts are background information, which are facts and which are interpretations or opinions. The forensic unit may give an oral report, if required by the customer and permitted by laboratory policy and, where applicable, by legislation. An oral report should only be given by suitably competent staff and should always be recorded and followed by a written report.

4.2.2 When the inspection body is required by law or authorized by contractual commitments to release confidential information, the client or individual

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concerned shall, unless prohibited by law, be notified of the information provided.

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

5 Structural requirements5.1 Administrative requirements ILAC G19 (4.3.2)

Once assessment of the scene of crime has been performed, which includes any discussions with the law enforcement investigator or first responder, it is acceptable that the forensic unit may determine a different scope of investigation than what was initially defined (see 4.4.1 in G19 document). In that case, this shall be clearly recorded, clarified and, where appropriate, authorized by the customer. At this stage a search pattern may need to be decided.

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.

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.

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

ILAC –P15 (5.1.3)

a . T he inspection body should describe its activities by defining the general field and range of inspection (e.g. categories/sub-categories of products, processes, services or installations) and the stage of inspection, (see note to clause 1 of the standard) and, where applicable, the regulations, standards or specifications containing the requirements against which the inspection will be performed.

ILAC G19 (4.4.1)

Scene of crime investigation procedures:-The forensic unit shall conduct scene of crime investigations in accordance with the processes and procedures stipulated in their management system.

In certain circumstances, the customers provide additional or background information, which should be considered or explicitly examined at the time of the scene of crime investigation. If such additional or background information is used, the information shall be recorded.

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

ILAC-P15 (5.1.4)

a. .The level of provisions should be commensurate with the level and nature of liabilities that may arise from the inspection body’s operations.

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.

ILAC G19

It is the responsibility of the forensic unit to make sure that any work it undertakes is within its scope of

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(4.1.1) competence.

The forensic unit should have a system that ensures that upcoming assignments are reviewed promptly and either managed appropriately or, where necessary, rejected according to defined policies and procedures.

5.2 Organization and management5.2.1 The inspection body shall be structured and managed

so as to safeguard impartiality.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.

ILAC-P15 (5.2.2a)

(5.2.2a) . The size, structure, composition and management of an inspection body, taken together, shall be suitable for the competent performance of the activities within the scope for which the inspection body is accredited.

ILAC-P15 (5.2.2 b)

(5.2.2b) . “To maintain the capability to perform the inspection activities” implies that the inspection body shall take steps to keep it appropriately informed about applicable technical and/or legislative developments concerning its activities.

ILAC-P15 (5.2.2c)

(5.2.2c) . Inspection bodies shall maintain their capability and competence to carry out inspection activities performed infrequently (normally with intervals longer than one year). An inspection body may demonstrate its capability and competence for inspection activities performed infrequently through ‘dummy inspections’ and/or through inspection activities conducted on similar products.

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

ILAC-P15 (5.2.3)

(5.2.3a). The inspection body shall maintain an up-to-date organizational chart or documents clearly indicating the functions and lines of authority for staff within the inspection body. The position of the technical manager(s) and the member of management referenced in clause 8.2.3 should be clearly shown in the chart or documents.

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.

ILAC-P15 (5.2.4)

(5.2.4a). It may be relevant to provide information concerning personnel which carry out work tasks for both the inspection body and for other units and departments.

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.The person(s) fulfilling this function shall be technically competent and experienced in the operation of the inspection body. Where the

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inspection body has more than one technical manager, the specific responsibilities of each manager shall be defined and documented.

ILAC-P15 (5.2.5 a)

(5.2.5 a) In order to be considered as “available”, the person shall be either employed or otherwise contracted.

ILAC-P15 (5.2.5 b)

(5.2.5 b) In order to ensure that the inspection activities are carried out in accordance with ISO/IEC 17020, the technical manager(s) and any deputy(ies), shall have the technical competence necessary to understand all significant issues involved in the performance of inspection activities.

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.

ILAC-P15 (5.2.6)

(5.2.6). In an organization where the absence of a key person causes the cessation of work, the requirement for having deputies is not applicable.

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.

ILAC-P15 (5.2.7 a)

(5.2.7a)The position categories involved in inspection activities are inspectors and other positions which could have an effect on the management, performance, recording or reporting of inspections.

ILAC-P15 (5.2.7 b)

(5.2.7 b) The job description or other documentation shall detail the duties, responsibilities and authorities for each position category referred to in 5.2.7a.

6 Resource requirements

6.1 Personnel

ILAC G19 (3.7)

The evaluation and assessment of the implementation of the forensic unit’s procedures shall include direct observation of the examinations and testing undertaken on-site or in the laboratory.

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.

ILAC G19 (3.3)

The forensic unit shall have a policy that ensures all staff working in the forensic unit are competent to perform the work required.The management system shall define each role in the forensic unit and its limitations and specify requirements for qualifications, training, experience and knowledge for the tasks assigned to each role. Having qualifications, training and experience neither guarantees practical competence nor sound judgment. Therefore, management or responsible persons shall be able to demonstrate with objective evidence that all personnel are competent, by carrying out assessments of their knowledge and skills against defined criteria.

ILAC In assessing the competence of an individual the F4WI12FP

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G19 (3.3)

forensic unit shall ensure that where appropriate staff has relevant understanding of the technology behind the crime e.g. firearms, and the technology used to investigate the crime e.g. fingerprints, DNA profiling, blood pattern analysis. They shall also have sufficient competence and experience to recognize the significance of anything unusual, for example, a staged burglary or altered exhibits. Training shall follow an up-to-date, defined training program and the assessment of competence shall take place at every level of professional development for the person involved. Where test or technique specific training is given, acceptance criteria shall be assigned to demonstrate the effectiveness of the training e.g. observation of the relevant examinations/tests or analyses by an experienced officer, satisfactory performance in the analysis of quality control/quality assurance samples, correlation of results with those obtained by other trained staff. Where necessary, training programs should also include training in the presentation of evidence in court.

ILAC P15 (6.1.1)

a. Where appropriate, inspection bodies shall define and document competence requirements for each inspection activity, as described in 5.1.3a.b. For “personnel involved in inspection activities”, see 5.2.7a.c. Competence requirements should include knowledge of the inspection body’s management system and ability to implement administrative as well as technical procedures applicable to the activities performed.d. When professional judgment is needed to determine conformity, this shall be considered when defining competence requirements.

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 judgments, to perform the type, range and volume of its inspection activities.

ILAC P15 (6.1.2a)

(6.1.2.a)All requirements of ISO/IEC 17020 apply equally for both employed and contracted persons.

ILAC G19 (3.3)

The forensic unit shall ensure that temporary staff are competent and work in accordance with the unit’s management system.

Notes: A subcontractor is a legal entity that is not part of the forensic unit and that is contracted to do work for the forensic unit within the subcontractor’s own legal entity and under the subcontractor’s own management system.

6.1.3 The personnel responsible for inspection shall have appropriate qualifications, training, experience and a satisfactory knowledge of the requirements of the

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inspections to be carried out. They shall also have relevant knowledge of the following:

The technology used for the manufacture of the products inspected, the operation of processes and thedelivery of services;

the way in which products are used, processes are operated and services are delivered;

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.

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.

ILAC G19 (4.1.4)

The forensic unit shall have a clear policy and procedure for appointing and assigning personnel with the responsibility for the scene of crime investigation. An appropriate competent person, however named, shall be assigned as responsible for the case depending on: legislation/policy, type of crime: volume crime versus major crime, the character of the case, the complexity or other conditions at the scene.

ILAC G19 (3.3)

Each forensic unit shall maintain an up-to-date record of the training that each member of staff has received. These records shall include academic and professional qualifications, external or internal courses attended and relevant training (and retraining, where necessary) received whilst working in the forensic unit. Records shall be sufficiently detailed to provide evidence that each member of staff has been properly trained and that their competence to perform a task or test has been formally assessed. These records should be retained for an appropriate defined period according to the expectations of the customer and / or the legal system.

ILAC G19 (3.3)

A procedure shall be in place for introducing employees into the forensic unit, and should define the training and the supervision required. This procedure or process may vary depending on the ability, qualifications and experience of those being trained. An individual’s training programme shall be based around their expertise, specialist knowledge and their experience.The forensic unit shall also have procedures for the on-going training and maintenance of competence, skills and expertise.

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When employing staff from another organization (including a forensic unit) their competence shall be verified by the forensic unit.

ILAC G19 (3.8)

The forensic unit should have a witnessing program to ensure that the persons working in the organization have the competence required of them.The person who performs the witnessing shall have the appropriate competence. Witnessing should not only cover the procedural part of the work but also go into the depth of the technical competence of the staff and their ability to take relevant decisions at the scene of crime.

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

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.

ILAC P15 (6.1.5a)

(6.1.5.a)The procedure for formally authorizing inspectors should specify that the relevant details are documented, e.g. the authorized inspection activity, the beginning of the authorization, the identity of the person who performed the authorization and, where appropriate, the termination date of the authorization

6.1.6 The documented procedures for training (see 6.1.5) shall address the following stages:

a) an induction period; b) a mentored working period with experienced

inspectors; c) Continuing training to keep pace with

developing technology and inspection methods. ILAC P15 (6.1.6.a)

(6.1.6.a)The “mentored working period” mentioned in item b normally includes activities where inspections are performed.

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).

ILAC P15 (6.1.7.a)

(6.1.7.a)Identification of training needs for each person should take place at regular intervals. The interval should be selected to ensure fulfillment of clause 6.1.6 item c. The results of the review of training, e.g. plans for further training or a statement that no further training is required, should be documented.

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).

ILAC P15 (6.1.8.)

a. A major aim of the monitoring requirement is to provide the inspection body with a tool to ensure the consistency and reliability of inspection

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outcomes, including any professional judgments against general criteria. Monitoring may result in the identification of needs for individual training or needs for review of the inspection body’s management system.

b. For “other personnel involved in inspection activities”, see 5.2.7a.

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

ILAC G19 (4.3.3)

When sampling at scenes of crime, emphasis is placed on the competence of the staff. Therefore the training and competence of staff in these activities is of prime importance. All aspects of sampling at scenes of crime shall be covered during training, and competence assessed initially and on an on-going basis.

ILAC P15 (6.1.9.a)

(6.1.9.a)To be considered sufficient, the evidence that the inspector is continuing to perform competently should be substantiated by a combination of information such as; - Satisfactory performance of examinations and

determinations, - Positive outcome of report reviews, interviews,

simulated inspections and other performance assessments (see note to clause 6.1.8),

- Positive outcome of separate evaluations to confirm the outcome of the inspections (this may be possible and appropriate in the case of e.g. the inspection of construction documentation),

- Positive outcome of mentoring and training, - Absence of legitimate appeals or complaints, and- Satisfactory results of witnessing by a competent

body, e.g. a certification body for persons.ILAC P15 (6.1.9.b)

(6.1.9.b)An effective program for the on-site observation of inspectors may contribute to fulfill the requirements in clauses 5.2.2 and 6.1.3. The program should be designed considering; - The risks and complexities of the inspections, - Results of previous monitoring activities, and - Technical, procedural or legislative developments

relevant to the inspections. The frequency of on-site observations depends on the issues listed above, but should be at least once during the accreditation re-assessment cycle, however see application note 6.1.9a. If the levels of risks or complexities, or the results from previous observations, so indicate, or if technical, procedural or legislative changes have occurred, then a higher frequency should be considered. Depending on the fields, types and ranges of inspection covered by the inspector’s authorizations, there may be more than one observation per inspector necessary to adequately cover the whole range of required competencies. Also, more frequent on-site observations may be necessary if there is lack of evidence of continuing satisfactory performance.

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ILAC P15 (6.1.9 c)

(6.1.9.c)In inspection areas where the inspection body has only one technically competent person the internal observation on-site cannot take place. In such cases the inspection body shall have arrangements in place for external observations on-site, unless other sufficient supporting evidence that the inspector is continuing to perform competently is available (see 6.1.9a).

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.

ILAC P15 (6.1.10a)

(6.1.10.a)Records of authorization should specify the basis on which authorization was granted (e.g. the on-site observation of inspections).

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

ILAC-P15 (6.1.11a)

(6.1.11a)Remuneration methods that provide incentives to perform inspections quickly have the potential to negatively affect the quality and outcome of inspection work.

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

ILAC-P15 (6.1.12a)

(6.1.12a)Policies and procedures should assist inspection body personnel in identifying and addressing commercial, financial or other threats or inducements which could affect their impartiality, whether they originate inside or outside the inspection body. Such procedures should address how any conflicts of interests identified by personnel of the inspection body are reported and recorded. Note, however, that while expectations for inspector integrity can be communicated by policies and procedures, the existence of such documents may not signal the presence of integrity and impartiality required by this clause.

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.

6.2 Facilities and equipmentILAC G19 (3.12)

The forensic unit shall operate a program for the maintenance and calibration of critical equipment used; this shall allow for the demonstration of measurement traceability, where appropriate. Equipment which influences the quality of the examination and testing shall be labelled or in other ways identified. Equipment may be owned by the laboratory, borrowed, rented, hired, leased or provided by another source. The responsibility for the calibration status and overall suitability of the equipment used lies solely with the forensic unit.

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ILAC G19 (3.12)

Some pieces of equipment used at the scene of crime have self-checks, some are not subject to effects of transportation and require only verification and others may require use of a reference material that validates the calibration and function status as shown to be satisfactory. Verification of equipment performance shall be conducted by staff with the recognized competence to operate and verify the 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.

ILAC-P15 (6.2.1)

(6.2.1a)Equipment required to carry out inspection in a safe manner may include e.g. personal protective equipment and scaffolding.

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.

ILAC G19 (4.2.3)

A record should be retained of all persons entering and leaving the scene of crime. All personnel entering the scene shall wear personal protective equipment that ensures that they do not contaminate the scene. The forensic unit shall dispose of relevant items used or worn at the scene of crime in a timely manner, to ensure that exhibits recovered from other scenes of crime are not compromised.

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.

ILAC-P15 (6.2.3a)

(6.2.3a)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. See also clause 8.7.4.

ILAC-P15 (6.2.3b)

(6.2.3b)Continued suitability may be established by visual inspection, functional checks and/or re-calibration. This requirement is particularly relevant for equipment that has left the direct control of the inspection body.

ILAC G19 (3.11)

The environmental conditions within laboratory premises, or any location where examinations and testing are performed, shall be defined if the conditions are critical for the outcome of the results. The specified conditions shall be monitored and recorded. Appropriate personal protective equipment shall be worn to ensure exhibits and personnel are protected. Access to laboratory facilities with special requirements concerning contamination issues shall be restricted and controlled. Environmental monitoring could be necessary for equipment, work areas, clothing and consumables.

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

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appropriate, uniquely identified.ILAC-P15 (6.2.4a)

(6.2.4a). In order to enable tracking when items are replaced, the unique identification of an item of equipment may be appropriate even when there is only one item available.

ILAC-P15 (6.2.4b)

(6.2.4b). When controlled environmental conditions are needed, the equipment used to monitor such conditions should be considered as equipment that significantly influences the result of inspections.

ILAC-P15 (6.2.4c)

(6.2.4c)When appropriate (normally for the equipment covered by clause 6.2.6) the definition shall include the required accuracy and measurement range.

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

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.

ILAC P15 (6.2.6a)

(6.2.6a) The justification for not calibrating equipment that has a significant influence on the outcome of inspection (see clause 6.2.4) should be recorded.

ILAC P15 (6.2.6b)

(6.2.6b)Guidelines on how to determine calibration intervals can be found in ILAC G24.

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.

ILAC P15 (6.2.7)& R2G

(6.2.7a) According to ILAC P10 it is possible to perform in-house calibration of equipment used for measurements. It is a requirement for accreditation bodies to have a policy to ensure that such in-house calibration services are performed in accordance with the relevant criteria for metrological traceability in ISO/IEC 17025.

ILAC P15 (6.2.7b)& R2G

(6.2.7b) According to ILAC P10 the preferred routes for conformity assessment bodies who seek external services for calibration of their equipment are defined in sub- sections 1) and 2) of section 2 in ILAC P10. If however, it is not possible to comply with these two routes for any justifiable reason, then it is acceptable to use the routes 3a) or 3b) of section 2 of ILAC P10. It is a requirement for accreditation bodies to have a policy to ensure that such external calibration services meet the relevant criteria for metrological traceability in ISO/IEC 17025.

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ILAC P15 (6.2.7c)& R2G

(6.2.7c)Where traceability to national or international standards of measurement is not applicable, the participation in relevant comparison programs or proficiency tests is an example of how to obtain evidence of correlation or accuracy of inspection results.

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.

ILAC P15 (6.2.8a)

(6.2.8a)When inspection bodies use reference standards of measurement to calibrate working instruments the reference standards of measurement should have a higher degree of accuracy than that required of the working instruments they are used to calibrate.

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

ILAC P15 (6.2.9a)

(6.2.9a)Where equipment is subjected to in-service checks between regular recalibrations, the nature of such checks, the frequency and acceptance criteria should be defined.

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

ILAC P15 (6.2.10a)

(6.2.10a)The information provided in 6.2.7a, 6.2.7b and 6.2.7c for programs of calibration of equipment is valid also for programs of calibration of reference materials.

6.2.11 Where relevant for the outcome of inspection activities, the inspection body shall have procedures for the following:a selection and approval of suppliers; b Verification of incoming goods and services;

ensuring appropriate storage facilities.ILAC-P15 (6.2.11a)

(6.2.11a) When the inspection body engages suppliers to perform activities which do not include the performance of part of the inspection, but which are relevant for the outcome of inspection activities, e.g. order registration, archiving, delivery of auxiliary services during an inspection, the editing of inspection reports or calibration services, such activities are covered bythe term “services” used in this clause.

ILAC-P15 (6.2.11b)

(6.2.11b)The verification procedure should ensure that incoming goods and services are not used until conformance with specification has been verified.

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

6.2.13 If the inspection body uses computers or automated equipment in connection with inspections, it shall

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ensure that:a) Computer software is adequate for use; b) Procedures are established and implemented for

protecting the integrity and security of data; c) Computer and automated equipment is

maintained in order to ensure proper functioning.

ILAC-P15 (6.2.13a)

(6.2.13a)Factors that should be considered in protecting the integrity and security of data include;

- Backup practices and frequencies, - Effectiveness in restoring data from backup, - Virus protection, and - Password protection.

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.

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.

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.

ILAC G19 (4.1.3)

In all cases where contracted or other technical support personnel are engaged the forensic unit shall provide evidence of their competence for their assigned tasks.

In all cases of subcontracting, the forensic unit shall provide appropriate evidence of the subcontracted body’s competence, such as accreditation certificate or records of evaluation performed by qualified personnel according to appropriate procedures.

ILAC G19 (4.2.2)

The forensic unit may not always have the specific competence or the capacity to perform all of the necessary examinations / tests. In that case it may need to use other resources than its own. These may, for example, be other forensic units or experts from other forensic units. In these cases there may be need for coordination of all resources involved in the scene of crime investigation. In that case the following should be considered:

Coordination of sequence of activities to maximize exhibit protection prevention of contamination or cross-contamination of exhibits clarification of roles

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and responsibilities.ILAC-P15 (6.3.1a)

(6.3.1a)Inspection activities can overlap with testing and certification activities where these activities have common characteristics (See Introduction of ISO/IEC 17020). For example, examination of a product and testing of the same product can both be the basis for the determination of conformity in an inspection process. It should be noted that ISO/IEC 17020 specifies requirements for bodies performing inspection, whereas the relevant standard to apply for bodies performing testing is ISO/IEC 17025 or ISO 15189.

ILAC-P15 (6.3.1b)

(6.3.1b)By definition (ISO/IEC 17011, clause 3.1), accreditation is limited to conformity assessment tasks which the inspection body has demonstrated competence to perform itself. Thus,accreditation cannot be granted for activities referred to in the fourth bullet point under note 1, if the inspection body does not have the required competence and/or resources. However, the task of assessing and interpreting the results of such activities for the purpose of determining conformity may be included in the scope of accreditation, provided adequate competence for this has been demonstrated.

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

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.

ILAC-P15 (6.3.3 a)

(6.3.3 a)In note 2 to the definition of “inspection” in clause 3.1 it is indicated that in some cases inspection may be examination only, without a subsequent determination of conformity. In such cases clause 6.3.3 does not apply since there is no determination of conformity.

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.

ILAC-P15 (6.3.4a)

(6.3.4 a) 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.

7 Process requirements7.1 Inspection methods and procedures 7.1.1 The inspection body shall use the methods and

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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.

ILAC G19 (3.5)

Records of observations shall be made at the time of the examination or as soon as practicable thereafter, and these shall include, where relevant, who carried out the scene of crime investigation, date, location, sampling, examination/testing results, quality checks and conditions of examination/testing. Where instrumental analysis is conducted, operating parameters should be recorded. It shall be clear from the case record who has performed each stage of the process, when e.g. relevant date(s) and what was examined. Manual calculations and data transfers that do not form part of a validated electronic process should be checked by a second person. The case record should include an indication that such checks have been carried out, by whom and when.

ILAC G19 (4.1.1)

For any specific scene the following aspects shall be considered:

- jurisdiction - integrity of the scene of crime - environmental conditions- need for any special equipment or special

competencies - health and safety issues - size and complexity of the scene(s) of crime

and need for additional resources- assignment of responsibility for one scene of

crime and coordination responsibility for several

ILAC G19 (3.10)

All methods shall be fully documented including procedures for quality control, and, where appropriate, the use of reference materials. Irrespective of whether the forensic unit implements ISO/IEC 17025 or ISO/IEC 17020, methods of examination/testing shall be fit for purpose. In demonstrating this, the forensic unit will need to refer to appropriate validation / verification data.

ILAC G19 (4.4.1)

The forensic unit shall conduct scene of crime investigations in accordance with the processes and procedures stipulated in their management system. In certain circumstances, the customers provide additional or background information, which should be considered or explicitly examined at the time of the scene of crime investigation. If such additional or

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background information is used, the information shall be recorded.

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.

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.

ILAC G19 (3.10)

Validation studies are required for all methods including comparative methods. Validation studies can be conducted by the scientific community (as in the case of standard or published methods) or by the forensic unit itself (as in the case of methods developed in-house or where significant modifications are made to previously validated methods). When developing their processes, forensic units shall show with objective evidence that they have assessed the factors that can influence the results and have recorded these.

ILAC G19 (3.10)

When a method has been validated in another organization the forensic unit shall review validation records to ensure that the validation performed was fit for purpose. It is then possible for the forensic unit to only undertake verification for the method to demonstrate that the unit is competent to perform the test/examination. Any validation/verification procedure conducted in-house shall be documentedand validation/verification records shall be kept.

ILAC G19 (3.10)

Where practicable, technical procedures used by a forensic unit shall be validated or verified before being used on casework or applied at a scene of crime. An instance of when this would not be practicable would be when a new substance is found, for example, a new drug. In any circumstance the technical procedures used shall be validated or verified before any results are reported. In validating test methods, the following issues (among others) may need to be determined, as appropriate, for example, if the method is quantitative or qualitative:

- Scope of the method- Intended purpose and limitations- Sampling, sampling strategy

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- Sample preparation, sample homogeneity- Testingaccuracy, precision, measurement

uncertainty, matrix effects, interference, limit of detection, limit of quantification, linearity range, stability of measured compounds, specificity and selectivity, repeatability, reproducibility, robustness, Interpretation, Performance characteristics,

- Hypothesis and/or scenarios, - Databases, Statistical Evaluation,

Limitations of conclusions7.1.4 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.

ILAC G19 (4.1.2)

In some circumstances, it may be appropriate for the forensic unit to give some instruction to the customer on how best to preserve the scene of crime. However, the amount of knowledge concerning the scene of crime at hand may be very limited and therefore it may be difficult to give exact instructions.

7.1.5 The inspection body shall have a contract or work order control system which ensures that:a) work to be undertaken is within its expertise and

that the organization has adequate resources to meet the requirements;

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;

c) work being undertaken is controlled by regular review and corrective action;

d) the requirements of the contract or work order have been met.

ILAC-P15 (7.1.5 a)

(7.1.5a) Where appropriate the contract or work order control system should also ensure that; - contract conditions are agreed - personnel competence is adequate - any statutory requirements are identified - safety requirements are identified - the extent of any subcontracting arrangements

required is identified For routine or repeat work requests the review may be limited to considerations of time and human resources. An acceptable record in such cases would be an acceptance of the contract signed by an appropriately authorized person.

ILAC-P15 (7.1.5 b)

(7.1.5b)In situations where verbal work orders are acceptable, the inspection body shall keep a record of all requests and instructions received verbally. Where appropriate, the relevant dates and the identity of the

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client’s representative should be recorded.ILAC-P15 (7.1.5 c)

(7.1.5c)The contract or work order control system should ensure that there is a clear and demonstrable understanding between the inspection body and its client of the scope of the inspection work to be undertaken by the inspection body.

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.

ILAC G19 (4.3.5)

A forensic unit with primary responsibility for a scene of crime may find it necessary, in some circumstances, to solicit the support of other forensic units or subcontractors to adequately process a scene of crime. Coordination among forensic units and/or subcontractors is absolutely essential to ensure the integrity of the scene and the value of all exhibits from the scene.The integrity of the scene of crime, the chain of custody of exhibits gathered from the scene of crime, and the unintentional destruction of available exhibits are all important considerations in coordinating the efforts of multiple forensic units or subcontractors.

ILAC-P15 (7.1.6a)

(7.1.6a)The information referred to in this clause is not information provided by a sub-contractor, but information received from other parties, e.g. a regulating authority or the client of the inspection body. The information may include background data for the inspection activity, but not results of the inspection activity.

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.

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

ILAC G19 (3.5)

Any changes made to records should be retained so the original information can be reviewed whether this is in hard copy form or electronic. When a test or examination result is rejected, the reason(s) shall be recorded, along with the date and an identification of who has rejected the result. The forensic unit’s retention policy shall consider the legal requirements and customer expectations of the applicable economy or region. Manual calculations and data transfers that do not form part of a validated electronic process should be checked by a second person. The case record should include an indication that such checks have been carried out, by whom and when.

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

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ILAC G19 (3.6)

The forensic unit should provide all personnel with a safe environment, including the adoption and use of a documented health and safety program. The health and safety program should consider and cover work carried out in the forensic unit’s permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.

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.

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

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.

ILAC G19 (3.11)

Special care is needed in forensic units involved in the determination of trace levels of materials, for example DNA and gunshot residue analysis. Physical separation of high level and low-level work, for example, bulk and trace drugs, is required as is a high awareness of contamination issues by all the personnel in the forensic unit. Appropriate personal protective equipment shall be worn to ensure exhibits and personnel are protected. Access to laboratory facilities with special requirements concerning contamination issues shall be restricted and controlled.Where possible the forensic unit should be able to identify potential contamination and its sources. This may require collecting background information which can be searched against if unusual results are obtained (e.g. DNA/Fingerprint/Footwear database of staff/visitors).

The access to the scene of crime should be controlled. The effects of the environmental conditions shall be considered to avoid loss or deterioration of exhibits. When significant environmental conditions are not possible to control, e.g. weather conditions at a scene of crime, the actual conditions shall be recorded.

ILAC G19 (4.3.3)

In order to identify the samples that need to be taken, and the sequence of performing different sampling and/or examinations/tests, a sampling strategy, sampling plan and sampling procedures are required. In determining the sampling strategy, sampling plans and sampling procedures to be used the following

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factors should be considered: - The background information available - Prioritizing the question(s) that need to be

answered - The generation of relevant hypotheses and their

refinement throughout the scene of crime investigation

- The type of forensic examination/testing that is relevant

- The need to employ statistical sampling - Any special considerations to be taken into

account such as weather, health and safety considerations, location of exhibit, possibility of contamination, possibility of exhibit being tampered with, interference with other exhibits, lack of homogeneity of the sample etc.

- The necessity to sequence the sampling that is to take place, for example, if you have a fingerprint in blood is it necessary for the fingerprint examiner to examine the print first prior to removing the blood for DNA profiling

- The necessity to consult all relevant experts/ personnel

- The necessity to establish an interagency strategy to ensure appropriate samples are taken

- Legal requirements - Policies of the organization

ILAC G19 (3.5)

Records of observations shall be made at the time of the examination or as soon as practicable thereafter, and these shall include, where relevant, who carried out the scene of crime investigation, date, location, sampling, examination/testing results, quality checks and conditions of examination/testing. Where instrumental analysis is conducted, operating parameters should be recorded. It shall be clear from the case record who has performed each stage of the process, when e.g. relevant date(s) and what was examined.

ILAC G19 (3.5)

Any changes made to records should be retained so the original information can be reviewed whether this is in hard copy form or electronic. When a test or examination result is rejected, the reason(s) shall be recorded, along with the date and an identification of who has rejected the result.

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.

ILAC G19 (4.4.3)

All conducted activities, observations, findings and conclusions reached during the scene examination shall be recorded. The records shall be sufficient so that another competent person could understand and evaluate the scene of crime examination.

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The forensic unit should perform a search pattern according to a structured procedure, at least in the area of major crime. Records of this should be maintained. The collection of exhibits shall be conducted in accordance with the processes and procedures in the management system. The collected exhibits shall be clearly and uniquely identified to enable systematic evaluation. Exhibits collected and the locations at which they were found shall be documented or characterized using suitable procedures e.g. measurements, plans, diagrams, photography, photogrammetry, so that the exhibits can be identified at all times and the locations at which they were found can be determined. The identity for exhibits shall correlate with the report.The forensic unit shall take appropriate precautions to ensure that the identified exhibits taken for further examination are recovered, stored and transported without loss or contamination (from the environment, weather, people etc.). Normally, it would be expected that forensic personnel will continually review the plan and strategy for the scene of crime investigation. Any revisions shall be recorded.

ILAC G19 (4.5.1)

Abnormalities or irregularities at the scene of crime which are shown to or identified by the investigation team, shall be recorded and should be clarified before the scene of crime investigation itself commences.

ILAC G19 (4.5.3)

The forensic unit shall ensure that the identified exhibits taken for further examination/test are recovered, stored and transported without contamination (from the environment, weather, people etc.), deterioration and with due regard to the integrity and the chain of custody of the exhibits. Where perishable items are handled any deterioration of the items shall be minimized.

ILAC G19 (4.7.3)

Storage areas for exhibits shall be secure to prevent theft or interference and have their access limited and controlled. The storage conditions shall be such as to prevent loss, deterioration and contamination and to maintain the integrity and identity of the exhibit. This applies both before and after examinations have been performed. Where perishable items are handled any deterioration of the items shall be minimized.

ILAC G19 (4.7.6)

Selection, recovery, prioritization and sampling of materials from submitted test items are important parts of the forensic science process. Laboratories shall ensure that there are documented procedures and training programs to cover this aspect of their work and that detailed competency/training records are kept for

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all staff involved. See also 4.3.3 of this ILAC G19. ILAC G19 (4.7.7.1)

For legal purposes, forensic units shall be able to demonstrate that the items/samples examined and reported on were those submitted. A ‘chain of custody’ record shall be maintained from the receipt of items/samples which details each person who takes possession of an item or alternatively the location of that item (e.g. if in storage).There shall be documented procedures which describe the measures taken to secure exhibits in the process of being examined which are left unattended.

ILAC G19 (4.7.7.2)

Assuring the quality of examination and test results Analytical performance shall be monitored by operating quality control schemes that are appropriate to the type and frequency of examination/testing undertaken by a forensic unit.

7.3 Inspection records

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

ILAC G19 (4.3.2)

Once assessment of the scene of crime has been performed, which includes any discussions with the law enforcement investigator or first responder, it is acceptable that the forensic unit may determine a different scope of investigation than what was initially defined (see 4.4.1 in this document). In that case, this shall be clearly recorded, clarified and, where appropriate, authorised by the customer.

ILAC-P15 (7.3.1a)

(7.3.1a) The records should indicate which particular item of equipment, having a significant influence on the result of the inspection, has been used for each inspection activity.

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

ILAC G19 (4.1.4)

The forensic unit shall have a clear policy and procedure for appointing and assigning personnel with the responsibility for the scene of crime investigation. An appropriate competent person, however named, shall be assigned as responsible for the case depending on: - legislation/policy, - type of crime: volume crime versus major crime, - the character of the case, the complexity or other

conditions at the scene. The principal responsibility for each scene of crime investigation rests with the investigator assigned to be in charge of the case, which shall be documented in the case file. At all stages responsibilities shall be clearly identified, in particular if personnel from different organizational units are involved.

ILAC G19 (3.5)

The forensic unit shall have documented procedures to create and maintain records relating to each case under investigation. The information that is to be included in

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case records shall be documented appropriately and may include, but not be limited to, records of any communication with the customers (verbal or written), contract review, examination and testing requested and agreements with customer, exhibit receipts, descriptions of exhibits including packaging and seals, subpoenas, records of observations and test/examination results, reference to procedures used, diagrams, printouts, photographs, videos.

ILAC G19 (3.5)

The records required to support conclusions shall be such that in the absence of the original member of staff, another competent member of staff could evaluate what had been performed, interpret the data and if necessary repeat the activity. The records shall be sufficient to provide an auditable trail.

ILAC G19 (3.5)

The recording method chosen will depend on the aspect of the forensic science process being carried out at the time. Records can be obtained by e.g. drawing or writing, photocopies, computer, sound recording, voice recording, photographs, video, 3D laser scanning.

ILAC G19 (3.5)

It is not always possible to preserve potential evidence, for example, if it is necessary to remove part of a blood pattern for DNA analysis. In such a situation, the potential evidence shall be documented and/or measured using suitable recording techniques prior to its removal.

ILAC G19 (4.1.1)

In situations where verbal agreements are acceptable, the organization shall keep a record of all requests and instructions received verbally, dates and the identity of the customers’ representative.

ILACG19 (3.11)

The environmental conditions within laboratory premises, or any location where examinations and testing are performed, shall be defined if the conditions are critical for the outcome of the results. The specified conditions shall be monitored and recorded.The effects of the environmental conditions shall be considered to avoid loss or deterioration of exhibits. When significant environmental conditions are not possible to control, e.g. weather conditions at a scene of crime, the actual conditions shall be recorded.

ILAC G19 (4.4.2)

Documentation of the scene of crime shall be made before the examination starts and throughout the investigation. Documentation can be made, for example: in writing or drawing, by voice recording,

by photographs, in video or 3D laser scanning

ILAC G19 (4.4.3)

All conducted activities, observations, findings and conclusions reached during the scene examination shall be recorded. The records shall be sufficient so that another competent person could understand and evaluate the scene of crime examination.

The forensic unit should perform a search pattern according to a structured procedure, at least in the area of major crime. Records of this should be maintained.

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ILAC G19 (4.7.5)

The records of the checks on critical findings shall indicate that each critical finding has been checked and by whom the checks were performed and when. This may be indicated in a number of ways, including entries against each finding, entry on a summary of findings or a statement to this effect in the records. The records shall indicate if the critical finding has been agreed, or the action taken if this was not the case.

Where a critical findings check is the only quality control procedure, such as blood pattern analysis, footwear comparison, scene of crime interpretation or damage identification and interpretation, then this check shall be performed without knowledge of the original result and this independence shall be identifiable from the records.

ILAC G19 (4.9)

The forensic unit may give an oral report, if required by the customer and permitted by laboratory policy and, where applicable, by legislation. An oral report should only be given by suitably competent staff and should always be recorded and followed by a written report.

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.

7.4.2 Any inspection report/certificate shall include all of the following:a) identification of the issuing body; b) unique identification and date of issue; c) date(s) of inspection; d) identification of the item(s) inspected; e) signature or other indication of approval, by

authorized personnel; f) a statement of conformity where applicable; g) the inspection results, except where detailed in

accordance with 7.4.3.ILAC-P15 (7.4.2a)

(7.4.2a)ILAC P8 requires accreditation bodies to specify rules for the use of accreditation symbols on reports and certificates. It should be noted that for endorsed reports and certificates, that is reports and certificates making reference to accreditation, such rules shall include the requirement that inspection bodies include a clear disclaimer;

- when not accredited for services/tests listed on reports and certificates

- (see full text in section 8.1), and - when reports and certificates include or are based

on results from unaccredited subcontractors (see full text in section 9.3).

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

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when both the inspection certificate and inspection report are traceable to each other.

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.

ILAC-P15 (7.4.4a)

(7.4.4a) It may be useful to identify the inspection method in the inspection report/certificate when this information supports an appropriate interpretation of the inspection results.

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 sub clause (7.4). An amended report or certificate shall identify the report or certificate replaced.

ILAC G19 (4.9)

The type and amount of information required in the report may depend on the legal system. However, in all cases, there shall be a clear indication of which parts are background information, which are facts and which are interpretations or opinions. The output given to the customer shall not in any way be misleading. The report should contain all the results of examinations/test and observations as well as the findings and, where appropriate and admissible, conclusions drawn from these results. The reports issued by the forensic unit shall be complete and shall contain the information on which an interpretation might be made. The forensic unit shall have a procedure and criteria to decide when and to what extent a technical review of a report needs to be performed. Technical review should be performed by a qualified person with the appropriate competence to confirm the validity of the results. Conclusions shall be properly qualified.

ILAC G19 (4.9)

For oral results, the identity and appropriateness of the recipient shall be established. All oral reports shall be recorded in a traceable manner, including: - The customer’s name, the date and time the oral

report is conveyed, and identification check (if relevant) shall be recorded.

- The information conveyed in the oral report relevant to the case, shall be recorded.

7.5 Complaints and appealsILAC G19 (3.2)

Note: The term “appeal” in this document should not be confused with the use of “appeal” in a legal sense. Appeals and the appeals process in the context of this document is an internal process of the forensic unit whose result is being appealed against. The decision on the appeal remains that of the forensic unit that is being appealed against, and does not require a hearing or decision on the appeal by some external agency or court.

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

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

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.

ILAC G19 3.2

Responses to any complaints, appeals or opportunities for improvement shall include examination of the potential impact on any work that has been undertaken by the forensic unit. In the event that it is shown that there could have been an impact on any work this shall be dealt with through the non-conforming work process.

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

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

7.6 Complaints and appeals processILAC G19 (3.2)

Complaints may be received from many sources including customers, victims of crime, police forces, other departments within the same organization e.g. laboratory, scene of crime unit, law enforcement investigation unit and the judiciary.In addition, when a court decision is successfully challenged and this reflects on any work performed by the forensic unit this shall be handled through the corrective action process or other improvement processes.

7.6.1 The handling process for complaints and appeals shall include at least the following elements and methods: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;

b) tracking and recording complaints and appeals, including actions undertaken to resolve them;

c) ensuring that any appropriate action is taken.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.

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.

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.

7.6.5 Whenever possible, the inspection body shall give

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formal notice of the end of the complaint and appeals handling process to the complainant or appellant.

8 Management system requirements8.1 Options

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

8.1.2 Option A The management system of the inspection body shall address the following:

- management system documentation (e.g. manual, policies, definition of responsibilities, see 8.2);

- control of documents (see 8.3);- control of records (see 8.4);- management review (see 8.5);- internal audit (see 8.6);- corrective actions (see 8.7);- preventive actions (see 8.8);- complaints and appeals (see 7.5 and

7.6).8.1.3 Option B(ILAC-P15 (8.1.3a)

(8.1.3a) The expression “this International Standard” is a reference to ISO/IEC 17020.

(ILAC-P15 (8.1.3b)

(8.1.3b) Option B does not require that the inspection body's management system is certified to ISO 9001. However, when determining the extent of required assessment, the accreditation body should take into consideration whether the inspection body has been certified against ISO 9001 by a certification body accredited by an accreditation body which is a signatory to the IAF MLA, or to a regional MLA, for the certification of management systems.

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 fulfillment of this International Standard and shall ensure the policies and objectives are acknowledged and implemented at all levels of the inspection body's organization.

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 fulfillment of this International Standard.

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:a) ensuring that processes and procedures needed for

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the management system are established, implemented and maintained; and

b) Reporting to top management on the performance of the management system and any need for improvement.

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

ILAC-P15 (8.2.4a)

For easy reference, it is recommended that the inspection body indicates where the requirements of ISO/IEC 17020 are addressed, e.g., by means of a cross reference table.

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.

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 fulfillment of this International Standard.

8.3.2 The procedures shall define the controls needed to:a) approve documents for adequacy prior to issue;b) review and update (as necessary) and re-approve

documents;c) ensure that changes and the current revision

status of documents are identified; d) ensure that relevant versions of applicable

documents are available at points of use; e) ensure that documents remain legible and readily

identifiable;f) ensure that documents of external origin are

identified and their distribution controlled; g) Prevent the unintended use of obsolete

documents, and apply suitable identification to them if they are retained for any purpose.

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

ILAC G19(3.1)

The requirements for the accessibility and control of documents apply to permanent facilities and also to all sites or locations where work is performed, e.g. scene of crime.

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 fulfillment of this International Standard.

ILAC-P15 (8.4.1a)

(8.4.1a) This requirement means that all records needed to demonstrate compliance with the requirements of the standard shall be established and retained.

ILAC-P15

(8.4.1b) In cases where electronic seals or authorizations are used for approvals, access to the

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(8.4.1b) electronic media or seal should be secure and controlled.

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.

ILAC G19 (3.5)

The forensic unit’s retention policy shall consider the legal requirements and customer expectations of the applicable economy or region. Each page of every document in the case record should be traceable to the case. There should be a mechanism by which the integrity of the documentation is maintained. This means, for example, that it should be easy to detect if a document is added to the file at a later date or goes missing from the file. Manual calculations and data transfers that do not form part of a validated electronic process should be checked by a second person. The case record should include an indication that such checks have been carried out, by whom and when. Hard copy records generated by the forensic unit, used as part of the case file, should be paginated using a page numbering system that indicates the total number of pages.

‘Chain of custody’ records that detail each person or organization that takes possession of an item/exhibit shall be maintained from the receipt of the items/exhibits through processing to storage and where applicable to return to submitting client, or disposal. The acceptable definition and procedure for ‘chain of custody’ needs to be adapted to the legal provisions of each country. Any transfer of material shall be recorded. Records relating to the chain of custody shall be retained in accordance with the requirements for other case records.

8.5 Management review (Option A)8.5.1 General

ILAC-P15 (8.5.1a)

(8.5.1a)A review of the impartiality risk identification process and its conclusions (clauses 4.1.3/4.1.4) should be part of the annual management review.

ILAC-P15 (8.5.1b)

(8.5.1b)The management review should take into account information on the adequacy of current human and equipment resources, projected workloads and the need for training of both new and existing staff.

ILAC-P15 (8.5.1c)

(8.5.1c)The management review should include a review of the effectiveness of systems established to ensure adequate competence of the personnel.

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 fulfillment of this International Standard.

8.5.1.2 These reviews shall be conducted at least once a year.

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Alternatively, a complete review broken up into segments (a rolling review) shall be completed within a 12-month time frame.

8.5.1.3 Records of reviews shall be maintained.8.5.2 Review inputs:

The input to the management review shall include information related to the following:a) results of internal and external audits; b) feedback from clients and interested parties related

to the fulfillment of this International Standard; c) the status of preventive and corrective actions; d) follow-up actions from previous management

reviews; e) the fulfillment of objectives; f) changes that could affect the management system;

g) appeals and complaints.8.5.3 Review outputs:

The outputs from the management review shall include decisions and actions related to:

a) improvement of the effectiveness of the management system and its processes;

b) improvement of the inspection body related to the fulfillment of this International Standard;

c) Resource needs.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.

ILAC G19 (3.7)

The internal audit program shall, where relevant, include scene of crime investigation activities, examination/testing activities, interpretation process, and reporting.

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.

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.

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.

ILAC-P15 (8.6.4a)

(8.6.4a) The inspection body shall ensure that all requirements of ISO 17020 are covered by the internal audit program within the accreditation re-assessment cycle. The requirements to be covered shall be considered for all fields of inspection and for all premises where key activities are performed (see IAF/ILAC A5).

The inspection body shall justify the choice of audit frequency for different types of requirements, fields of inspection and premises where key activities are performed. The justification may be based on

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considerations such as; - criticality, - maturity, - previous performance, - organisational changes, - procedural changes, and - efficiency of the system for transfer of experience between different operational sites and between different fields of operation.

8.6.5 The inspection body shall ensure that:a) internal audits are conducted by qualified

personnel knowledgeable in inspection, auditing and the requirements of this International Standard;

b) auditors do not audit their own work; c) personnel responsible for the area audited are

informed of the outcome of the audit;d) any actions resulting from internal audits are

taken in a timely and appropriate manner; e) any opportunities for improvement are identified; f) the results of the audit are documented.

ILAC P15 (8.6.5)

(8.6.5a)Competent externally contracted personnel may carry out internal audits.

8.7 Corrective actions (Option A)8.7.1 The inspection body shall establish procedures for

identification and management of nonconformities in its operations.

ILAC G19 (3.9)

The forensic unit shall have policies and procedures to identify non-conforming work and, in addition, policies and procedures that are implemented when non-conforming work is identified. Ongoing monitoring can be carried out in a number of ways, e.g. by peer review, proficiency tests and collaborative exercises, auditing and customer complaints.

ILAC G19 (3.9)

Initially the significance of a non-conformity in relation to the validity of examination or test results shall be evaluated and its root cause identified. This shall include thoroughly investigating the review of casework already reported. The policies and procedures shall ensure that there are designated defined responsibilities for the management of non-conforming work and actions that shall be taken. This may include withdrawing or withholding test reports, informing the customer, halting examination and testing, re-testing or re-examination, modifying the procedures or methods or retraining.

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

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

8.7.4 The procedures shall define requirements for the following:a) identifying nonconformities;b) determining the causes of nonconformity;

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c) correcting nonconformities;d) evaluating the need for actions to ensure that

nonconformities do not recur;e) determining the actions needed and implementing

them in a timely manner;f) recording the results of actions taken;g) reviewing the effectiveness of corrective actions.

ILAC G19 (3.9)

The corrective action once identified and approved shall be implemented promptly. The designated authority shall then decide when work can resume. It is important to ensure that non-conforming work is effectively identified and associated corrective actions are implemented in all relevant areas of the forensic unit.

ILAC G19 (3.9)

Where it is found that the forensic unit has issued a report containing non-conforming work that is deemed to significantly affect the result, the customer shall be notified immediately, the work or report recalled (where possible) and additional work or report issued by the forensic unit.

ILAC G19 (3.9)

Where it has been identified that the non-conforming work could recur, appropriate corrective action shall be implemented. This shall include the potential review of casework already reported prior to the non-conforming work being identified and implications for other cases and other sections in the forensic unit as well as implications for the forensic unit’s own internal policies and procedures.

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.

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

8.8.3 The procedures for preventive actions shall define requirements for the following: a) identifying potential nonconformities and their

causes;b) evaluating the need for action to prevent the

occurrence of nonconformities;c) determining and implementing the action needed;d) recording the results of actions taken;e) reviewing the effectiveness of the preventive

actions taken.

IB representative (for IB self-assessment)

Name: Sign: Date:

General comments for document review (Filled by TL)Recommendations for document review (Filled by TL)Document review (TL) Name: Sign: Date:

N o t e : The signature of the assessor doesn’t confirm the complete correctness of the reference documents provided by the CAB.

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