checkliste zur iso/iec 17065_englisch - egac · web viewby definition (iso/iec 17011, clause 3.1),...

CAB Self-Assessment & Document Review according to ISO/IEC17020:2012 & ILAC-P15:2016 requirements

for the operation of various types of bodies performing inspection

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 Re-Assessment ExtensionThis report covers: Self-Assessment Document review

Case numberFor/toAnd

IB has several locations: Yes NoAssessed locations:(Name)/Address:(Name)/Address:

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

Details of the team member Team leader Assessor Technical expert ObserverName / Institution / Telephone / Fax / E-Mail

General remarks/notes to the use of the checklist for inspection bodiesThis checklist for inspection bodies is based on the standard text of ISO/IEC17020.The notes are not requirements.The first column refers to the ISO/IEC17020:2012 and the second column to the related standard text. In c o l u m n 3 , t h e a pp lica n t s h all fill in t h e f o l l o wi n g i n f o r m ati o n , Column 4 & 5 will be filled by the assessor indicating the compliance on Non-compliance of the requirement subjected with objective evidences.*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) 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 are in italics & indicated as Std. The order of assessment need not follow the order of the checklist. Assessors 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 FOR DETAIL AND FOR CLARIFICATION NOTES.

Clause Requirements Inspection BodySelf-Assessment

CNC Team Leader Comments

4 General requirements4.1 Impartiality and independence 4.1.1 Inspection activities shall be undertaken impartially 4.1.2 The inspection body shall be responsible for the

impartiality of its inspection activities and shall not allow commercial, financial or other pressures to compromise impartiality

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

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relationships, or from the relationships of its personnel. However, such relationships do not necessarily present an inspection body with a risk to impartiality.4.1.3a (ILAC-P15) 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. 4.1.3b (ILAC-P15) 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.

4.1.5a (ILAC-P15) The 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. 4.1.5b (ILAC-P15) One 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

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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 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.

2) common ownership appointees on the boards or equivalent of the organizations,

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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 any decision-making.

3) 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.

4) 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

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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 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 Confidentiality 4.2.1 The inspection body shall be responsible, through

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

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

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 requirements

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5.1 Administrative requirements 5.1.1 The inspection body shall be a legal entity, or a

defined part of a legal entity, such that it can be held legally responsible for all its inspection activities.

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.5.1.3a (ILAC-P15) The 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.

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

5.1.4a (ILAC-P15) 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.

5.2 Organization and management 5.2.1 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.

5.2.2a (ILAC-P15) 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. 5.2.2b (ILAC-P15) “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. 5.2.2c (ILAC-P15) 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

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responsibilities and reporting structure of the organization.5.2.3a (ILAC-P15) 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.5.2.4a (ILAC-P15) 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 inspection body has more than one technical manager, the specific responsibilities of each manager shall be defined and documented.5.2.5a (ILAC-P15) In order to be considered as “available”, the person shall be either employed or otherwise contracted.5.2.5b (ILAC-P15) 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.5.2.6a (ILAC-P15) 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.5.2.7a (ILAC-P15) 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.5.2.7b (ILAC-P15) The job description or other documentation shall detail the duties, responsibilities and authorities for each position category referred to

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in 5.2.7a.6 Resource requirements6.1 Personnel 6.1.1 The inspection body shall define and document the

competence requirements for all personnel involved in inspection activities, including requirements for education, training, technical knowledge, skills and experience.

6.1.1a (ILAC-P15) Where appropriate, inspection bodies shall define and document competence requirements for each inspection activity, as described in 5.1.3a. 6.1.1b (ILAC-P15) For “personnel involved in inspection activities”, see 5.2.7a. 6.1.1c (ILAC-P15) 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. 6.1.1d (ILAC-P15) 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.

6.1.2a (ILAC-P15) All requirements of ISO/IEC 17020 apply equally for both employed and contracted persons.

6.1.3 The personnel responsible for inspection shall have appropriate qualifications, training, experience and a satisfactory knowledge of the requirements of the inspections to be carried out. They shall also have relevant knowledge of the following:

- the technology used for the manufacture of the products inspected, the operation of processes and the

- delivery 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.

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

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personnel involved in inspection activities.6.1.5a (ILAC-P15) 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. 6.1.6a (ILAC-P15) 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).

6.1.7a (ILAC-P15) 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).

6.1.8a (ILAC-P15) A major aim of the monitoring requirement is to provide the inspection body with a tool to ensure the consistency and reliability of inspection 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. 6.1.8b (ILAC-P15) 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.

6.1.9a (ILAC-P15) 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),

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- 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.6.1.9b (ILAC-P15) 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 inspec-tor 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.6.1.9c (ILAC-P15) 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.

6.1.10a (ILAC-P15) 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.

6.1.11a (ILAC-P15) 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.

6.1.12a (ILAC-P15) Policies and procedures should assist inspection body personnel in identifying and

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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 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.

6.2.1a (ILAC-P15) 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.

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.6.2.3a (ILAC-P15) If controlled environmental conditions are needed, e.g. for the correct performance of the inspection, the inspection body shall monitor these and record the resultsIf 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. 6.2.3b (ILAC-P15) 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.

6.2.4 All equipment having a significant influence on the results of the inspection shall be defined and, where appropriate, uniquely identified.6.2.4a (ILAC-P15) 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. 6.2.4b (ILAC-P15) 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. 6.2.4c (ILAC-P15) When appropriate (normally for the equipment covered by clause 6.2.6) the

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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.6.2.6a (ILAC-P15) The justification for not calibrating equipment that has a significant influence on the outcome of inspection (see clause 6.2.4) should be recorded. 6.2.6b (ILAC-P15) 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.

6.2.7a (ILAC-P15) 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. 6.2.7b (ILAC-P15) 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. 6.2.7c (ILAC-P15) 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.

6.2.8a (ILAC-P15) When inspection bodies use reference standards of measurement to calibrate

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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.

6.2.9a (ILAC-P15) 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.6.2.10a (ILAC-P15) 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; c) ensuring appropriate storage facilities.6.2.11a (ILAC-P15) 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 by the term “services” used in this clause. 6.2.11b (ILAC-P15) 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 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.6.2.13a (ILAC-P15) 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

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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 Subcontracting6.3.1 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.6.3.1a (ILAC-P15) 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. 6.3.1b (ILAC-P15) 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.6.3.3a (ILAC-P15) 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

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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.6.3.4a (ILAC-P15) 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

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.

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.

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

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.7.1.5a (ILAC-P15) Where appropriate the contract or work order control system should also ensure that; - contract conditions are agreed

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- 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.7.1.5b (ILAC-P15) 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 client’s representative should be recorded. 7.1.5c (ILAC-P15) 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.7.1.6a (ILAC-P15) 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.

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

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.

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.

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7.3 Inspection records7.3.1 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.7.3.1a (ILAC-P15) 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.

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 7.4.3.7.4.2a (ILAC-P15) 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 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.7.4.4a (ILAC-P15) 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.

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

7.5 Complaints and appeals7.5.1 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.

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 process7.6.1 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 formal notice of the end of the complaint and appeals handling process to the complainant or appellant.

8 Management system requirements 8.1 Options 8.1.1 General

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

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8.1.2 Option A

8.1.3 Option B 8.1.3a (ILAC-P15) The expression “this International Standard” is a reference to ISO/IEC 17020. 8.1.3b (ILAC-P15) 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 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.

8.2.4a (ILAC-P15) 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;

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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.

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.

8.4.1a (ILAC-P15) This requirement means that all records needed to demonstrate compliance with the requirements of the standard shall be established and retained. 8.4.1b (ILAC-P15) In cases where electronic seals or authorizations are used for approvals, access to the 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.

8.5 Management review (Option A)8.5.1 General

8.5.1a A (ILAC-P15) 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. 8.5.1b (ILAC-P15) 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.8.5.1c (ILAC-P15) 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. Alternatively, a complete review broken up into segments (a rolling review) shall be completed within

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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.

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.8.6.4a (ILAC-P15) 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 considerations such as; - criticality, - maturity, - previous performance,

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- 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. 8.6.5a (ILAC-P15) 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.

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;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.

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:

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General comments for document review (Filled by TL)Recommendations for document review (Filled by TL)Document review (Team Leader/Assessor)

Name: Sign: Date:

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

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