Question 27.1 Type A Independence: IB applying fines

According to National law, the inspection body is empowered to apply administrative and financial fines.
Does this company meet the requirements for Type A inspection body?

March 2014

The requirements of Annex A, A.1 (Type A) to independence are valid for governmental inspection bodies, too. If this governmental organisation or its personnel are not engaged in the design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items / services it inspects then it is type A body.

In the context of this question there is no impediment to the inspection body being Type A:

There isn´t any clause in the ISO/IEC 17020:2012 standard that forbids Type A inspection bodies to apply fines.

The problem of applying administrative and financial fines is linked to its impartiality (in reference of chapter 4.1.2 and 4.1.3). This state enterprise has to identify risks to its impartiality. The fact that it can apply financial fines after making inspection is a factor that has to be considered.

Question 27.2 Type A independence: IB filling and supplying gas cylinders

If an organization is filling gas cylinders and keeping gas cylinders in stock, as an exchange system, can it be a type A inspection body for periodic inspection of gas cylinders?

The filling is done after the inspection is completed, the inspection report is issued, and inspection label has been attached to the cylinder.

Relevant requirement of ISO/IEC 17020:2012:

Annex A, A.1 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 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.

March 2014

The inspection body is part of an organization that is a supplier of gas cylinders. This means that the inspection body inspects the same items that the organization later supply.

Even if the inspection is carried out after the filling of the gas cylinders, there is an interest of the inspection body for the inspection to be positive as the organization to which it belongs is providing cylinders.

This inspection body could be accredited as type B or C not as type A.

Question 28.2 Type A independence: IB filling and supplying gas cylinders

ISO/IEC 17020:2012, 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.

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

According to ILAC P15:05/2020: “4.1.3 n1 “on an ongoing basis” means that the inspection body identifies a risk whenever events occur which might have a bearing on the impartiality of the inspection body”.

What is the real meaning of this clarification? How do you interpret the term “whenever events occur…”?

September 2014

It is not automatically sufficient if risks are analyzed once a year during management review. Events should be defined in the risk analysis (e.g. change of personnel or owner, merging/take-over of companies etc). Control measures against these risks shall be carried out regularly (when necessary).

Threads to impartiality can be divided into two groups: those that can be eliminated and those that need to be managed.

Only threads that need to be managed can be addressed by the ongoing analysis. Non repairable will lead to NCs with need to changes.

There should still be regular reviews of the risks that are deemed to be eliminated but those that need to be managed would require more frequent reviews and timescales for these would be commensurate with the level of risk.

Proactive analysis – before the event occurs – is recommended.

Question 29.1 Independence: A1.c items inspected, installation and its components

An inspection body provides inspection of electrical installations (items inspected). In general, the inspection item (electrical installation) consists of various electrical equipment (for example switchboards). This means that the inspection body also inspects switchboards and its documentation as a part of installation.

ILAC P15:05/2020 3.1n1 The term “installation” may be defined as “a collection of components assembled to jointly achieve a purpose not achievable by the components separately”.

The accredited inspection body forms a part of bigger legal entity. The other part of the same legal entity is engaged in the manufacturing of electrical equipment (e.g switchboard) to be included to electrical installations. Electrical installations have been built by another legal entity, which is not related to the inspection body. However electrical equipment included to the installations can be produced by the legal entity that is an accredited inspection body.

Can such accredited inspection body be Type A?

March 2015

Referring to Annex A, A.1 c) of the ISO 17020:2012: “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”

Items inspected are the installation and its components. If an IB is a part of a legal entity engaged in the manufacture of the items inspected, it cannot be a Type A inspection body.

Question 31.3 Independence (4.1.6.a, A.1). Other activities performed by the inspection body

An inspection body that applies to become accredited as Type A performs inspection activities in the field of cleanroom and also performs testing, adjusting and balancing of environmental systems activities that have common application areas with cleanroom inspections. The inspection body makes risk analyses by taking into account this risk and declares not to offer inspection services to clients which it has already performed testing, adjusting and balancing of environmental systems activities.

Can this Inspection body be accredited as Type A?

March 2016

If the “adjusting and balancing of environmental systems activities” are considered as an activity that is a conflict of interest with inspection activities of cleanrooms, then the solution presented by the inspection body of “not offering inspection services to the customers…” does not fulfill the requirement of:

17020:2012, Annex A: clause A.1. 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 items inspected.

Question 38.2 ISO/IEC 17020:2012 Annex A.3b) – Meaning of ‘regulatory requirements’ providing exception to independence requirements

ISO/IEC 17020:2012 Annex A. b) relating to a Type C inspection body describes how design//manufacture/supply etc and the inspection of the same item can be carried out by the same person where explicitly allowed by a ‘regulatory requirement’.

In this context, does the reference to ’regulatory requirement’ mean that this exception has to be written into a relevant regulation or does it also include where a Regulator provides guidance stating that this exception is permissible when undertaken as part of the regulated inspection activity?

September 2019

September 2019

The wording of A.3 b) says “where a regulatory requirement explicitly allows”. Normally exceptions will be set up within the regulation or in related authorized guidance documents.

Question 43.2 Inspection bodies, Type A: Engagement of inspectors (full time employee and freelance) with the item inspected

In ILAC P15, Annex 2, (informative) it is stated: Inspection Bodies and its inspectors shall not be engaged with the items inspected as mentioned on the scope of accreditation, thus in general and not restricted to only the specific/ unique/ individual items that are subject of an inspection by the Inspection Body.
Question: Most Type A inspection bodies have many inspectors, full time employee and freelance. Inspectors that are full-time employee cannot have any conflict of interest with the items inspected as mentioned on the scope of accreditation with any companies and in particular they shall not be involved in consultancy and in the design, construction, maintenance, etc. What about freelance inspectors?

March 2022

External inspectors (or freelance inspectors) are considered personnel of the inspection body (see 6.1.2 of ISO/IEC 17020). If the inspection body is a type A, external inspectors cannot be engaged in any activities that may conflict with their independence. And items inspected must be considered as “general”, that is the meaning of ILAC P15. Type A needs strict independence between inspection and design or consultancy for design.

If a type A body wants to hire an external inspector that had been engaged in the past in design etc., it is the task of the inspection body to demonstrate that now this external inspector is no longer involved in design (in general and not for a specific item, for example pressure vessel). The time needed for the conflict to prescribe cannot be fixed because sometimes 2 years will be sufficient and sometimes it needs more time, it depends on the situation.

Please see related paragraphs of ISO/IEC 17020 and Annex A, An1 and Annex 2 of ILAC/IAF P15:05/2020.

Question 44.2 C type inspection body and organization

Is it possible to locate a type C inspection body in an industry company that performs other activities (e.g. design) for similar items of the items inspected and in the same department (same head of department)?

Can impartiality be compromised in that case, as mentioned in the requirements of ISO/IEC 17020:2012, clauses 4.1.2 and 5.2.1?

September 2022

The clause 4.1.6c) from ISO/IEC 17020:2012 standard that is related to Type C inspection bodies says: “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…”

Then it is possible for a Type C inspection body to be part of an industry company that performs other activities for similar items of the items inspected.

The independence requirements for Type C are stated in Annex A, part A.3: what is necessary to be assured is that the inspection of the same item is not undertaken by the same person that performs the design / manufacture / supply / installation/servicing/maintenance of the item (except if it is allowed by a regulatory requirement). The inspection body shall provide safeguards to assure the segregation of responsibilities and accountabilities between inspection and these other activities.

And also fulfill the requirements of impartiality (4.1.1 to 4.1.5 and other clauses related to impartiality as 5.2.1, 6.1.12).

Question 45.1 Impartiality, ISO/IEC 17020:2012; 4.1.3n

ISO/IEC 17020 clause 4.1.3 states that: The inspection body (A type) shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, from its relationships, or from the relationships of its personnel.

Question: how deep relationship of inspection body owner/shareholder (family relationship) should be analyzed in order to ascertain potential influence on impartiality?

March 2023
ISO/IEC 17020:2012 A.1 “a) The inspection body shall be independent of the parties involved.”

The ability to influence the outcome of the inspection is probably given by a family relationship.

The impartiality analysis of the inspection body must be sufficiently deep and identify any relationships of its personnel (4.1.3) which includes family relationships of its owner. (A.1 d) 4) says: The inspection body shall not be linked to a separate legal entity … by … other means that may have an ability to influence the outcome).

There is no general “model/rule”, it needs to be assessed on case-by-case basis with regard to the possible impact on the subject of the inspection/possible influence on the inspection process.

The risk of impartiality depends on the ability to influence the outcome of the inspection. It must be declared and analyzed by the inspection body.

Comment: ILAC P15:2020 (informative annex 2) allows to mitigate the risks of clause A.1 d by control measures.

Question 47.2 Type A Independence: ownership or use of items

An inspection body which is part of a larger entity, carries out inspections of clean rooms and related controlled environments (biosafety cabinets, LAF cabinets, etc.) for third party clients.
That entity also provides sterilization and testing services other than inspection activities. The entity owns and uses clean rooms and controlled environments (cabinets) in order to provide sterilization and test services.
ISO/IEC 17020:2012 Annex A-A1-(c)-NOTE 2 reads as “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.”
IEC 17020:2012 Annex A-A1-(b) reads as “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 items inspected.”
Is it correct to say that this inspection body would be considered in line with ISO/IEC 17020:2012 as type-A inspection body considering exceptions described in Annex-A-A1-(c)-NOTE 2?

March 2024
ISO/IEC 17020:2012 standard, in the Annex A, clause A.1.b) states that “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 items inspected”.

There is also the NOTE 2: “This does not preclude the purchase, ownership or use, of the 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 personnel”.

In the case of the FAQ, the inspection body cannot provide inspection of clean rooms as type A inspection body because it belongs to a larger entity which provides sterilization services and testing services for clean rooms/cabinets because there is a clear conflict of interest. The Note 2 cannot be applied here: these cabinets are not necessary for the operations of the inspection body nor for personal purposes by the personnel.

Question 47.3 Type A Independence: personnel

A person who is the owner, technical manager, or inspector of a type-A inspection body that carries out LPG tank inspections also serves as the LPG responsible manager (legally responsible person for safety according to national legislation) of a gas distribution company. The gas distribution company owns the LPG tanks and rents the LPG tanks to fuel stations. The responsibility for inspecting the rented tanks remains with the distribution company.
ISO/IEC 17020:2012 Annex A-A1-(b) reads as “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 items inspected.”
Does employing such a person, contradict Annex A-A1-(b)?

March 2024
Personnel of a Type A inspection body cannot be engaged in activities of design, manufacture, supply, purchase, ownership, use or maintenance of the type of item inspected.

The requirement for the personnel in the ISO/IEC 17020:2012 standard specifies a restriction in activities. In the case of the FAQ there is a clear conflict of interest because the technical manager of the inspection body is performing activities of responsible manager in a company that owns, maintains, and supplies the type of item inspected.

It is not allowed for type A inspection bodies.

Question 27.3 Contract of inspectors through employing company

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

 Current ILAC P-15:2020 requires:

 5.2.5 n1 In order to be considered as “available”, the person shall be either employed or otherwise contracted.

 6.1.2 n1 All requirements of ISO/IEC 17020 apply equally for both employed and contracted persons.

 The question is: is it possible to contract inspectors through an employing company?

March 2014

Employing personnel shall be related to particular personnel. Mixing up with subcontracting shall be avoided.

ISO/IEC 17020:2012, Clause 6.3.1, NOTE 3 Where the inspection body engages individuals or employees of other organizations to provide additional resources or expertise, these individuals are not considered to be subcontractors provided they are formally contracted to operate under the inspection body’s management system (see 6.1.2).

The requirement of the standard (“The inspection body shall employ, or have contracts with, a sufficient number of persons”.) can be achieved by a contract via an employing company, if the contract ensures at least:

• the access to a particular inspector and his sufficient availability
• that the contract ensures clearly that the inspector will work under the inspection body management system.
• the control (education, training, monitoring – the “competence management”) is by the contracting inspection body.
• confidentiality and obligation to announce conflicts of interest to the inspection body.

Question 33.2 Measure equipment: ISO/IEC 17020:2012, clause 6.2.6 and 6.2.7

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.
6.2.7 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 measure¬ment, 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.

In an inspection body, the inspectors use thermometers to measure the ambient temperature or to measure the temperature of raw milk in a cisterna or the temperature of hot water used to sterilize equipment in a slaughterhouse.

The inspection body gives its thermometers to a related accredited testing laboratory for calibration. The calibration is performed by means of an internal reference thermometer, which is calibrated by an external accredited calibration laboratory. Acceptance criteria are set by the testing laboratory but there is no indication of measurement uncertainties.

The result of the testing laboratory is a report of confirmation that the individual thermometer can be used again for above stated purposes.

Question: Is this approach acceptable. If not, why?

March 2017
There are certain aspects to be regarded:

1. The Inspection procedure shall clarify whether the temperature measurements have significant influence (ISO/IEC 17020:2012, clause 6.2.6 and ILAC P15 §6.2.6 n3)
2. Calibration needs to calculate calibration uncertainties. If this is not done, it is not a calibration.
3. Acceptance criteria need some information about calibration uncertainty.
4. External calibration has to follow rules from ILAC P10: Calibration by NMI or accredited calibration laboratory has to be preferred.
5. Internal calibration using a traceably calibrated reference thermometer is allowed. The internal calibration procedure shall be assessed by a competent person of the accreditation body. Remarks:
a. The mentioned related test laboratory is certainly not entitled to sell accredited calibrations.
b. The “related accredited testing laboratory” might be a part of an internal calibration procedure. In this case the calibration has to be assessed by the accreditation body. This would be ok.

Question 39.2 Equipment not owned by the IB used in inspections

In the clause 6.2.1 of the standard EN ISO/IEC 17020 there is the following note:

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

What evidence should an inspection body maintain to the for equipment having a significant influence on the results of the Inspection, if the equipment is not owned by the inspection body and is out of the control of the inspection body? This happens in very few situations e.g.:

• Equipment provided by another party: when the inspection body uses equipment that is fixed in the client installation, e.g. manometers in hydraulic elevators or boilers that do not have another outlet to allow the inspection body to fix another manometer of its property in the same installation in parallel.
• Equipment rented: It can occur in very specific inspections that the inspection body does not perform normally and in which the equipment is very expensive, e.g. in High voltage, check of the main insulation of the cover of the cables.

March 2020

Clause 6.2.1 of the ISO/IEC 17020 and ILAC P15 are applicable. For measurements ILAC P10 is applicable.

It is up to the particular inspection program or to the inspector to decide if calibration is required or whether an indication during a function test (see 6.2.6) is sufficient.

The use of external equipment may bear some risks, the inspection body stays responsible.

Question 41.4 ISO/IEC 17020:2012 6.2.1, 7.3 Clients facilities and equipment

Clients equipment, including measurement devices, is used by the inspection body in the inspection process. If inspection body using client equipment then in the inspection protocol it is just mentioned what client equipment has been used. No evidences (e.g. calibration certificate, proof of traceability, assessment of uncertainty) of the equipment are kept.

The inspection body says that everything is checked during the inspection and no documentation related to the customer’s equipment is stored.

Is it acceptable?

March 2021

No it is not acceptable, the inspection body need to prove the conformity to the requirements of ISO/IEC 17020:2012 even if it uses equipment or facilities of its client.
The inspection body is always responsible for the measuring equipment used and must be able to provide evidence of this (e.g. proof of metrological traceability).

Question 29.4 Subcontracting methodology

If an inspection body has no mechanism or methodology to be able to demonstrate that subcontractor is competent and clearly declares that it will not use subcontractors, can it be assumed that requirements of 6.3 are met?

In other words; is subcontracting an option for inspection bodies, which can be used or never used?

March 2015

If the inspection body never subcontracts because it doesn’t want or because it is forbidden by law, the inspection body may have no mechanism or methodology for this.
An inspection body that is not going to subcontract doesn’t need to define a methodology to demonstrate that a subcontractor is competent.

Question 33.5 Subcontracting of tests

ISO/IEC 17020:2012 Clause 6.3.1 Note 1 says that reasons to subcontract can include the following: an unforeseen or abnormal overload, key inspection staff members being incapacitated, key facilities or items of equipment being temporarily unfit for use, part of the contract from the client involving inspection not covered by the inspection body’s scope or being beyond the capability or resources of the inspection body.

Can an inspection body use the same laboratory as a subcontractor on an ongoing basis for specific tests?

March 2017

It is common practice that inspection bodies make their professional judgement based on the results of tests and the inspection body may subcontract always the same test laboratory. The applicable requirement of the ISO/IEC 17020:2012 is chapter 6.2.11 about selection and approval of suppliers.

Question 38.1 Subcontracting: requirements for subcontractors

In practice: where an inspection body subcontracts any part of inspection, the competence of its should be assessed, as well as if appropriate equipment is used by subcontractor and many others aspects should be taken into account to demonstrate that the requirements of the clause 6.3.4 of ISO/IEC 17020:2012 are fulfilled.

The question is: shall the inspection body document a procedure, that includes criteria for assessing the competence of subcontractors, of used equipment, as well as describe the evaluation process of conformity to these criteria and the final approval process, as the basis why the current subcontractor is chosen?

September 2019

There is not specific requirement of a documented procedure, the inspection body should analyze if it needs a documented procedure for subcontracting.

6.3.4 requires records about investigation of the competence of a subcontractor.

The clauses 6.3.1 and 6.3.4 refer to this International standard (it is ISO/IEC 17020:2012) or other relevant conformity assessment standards (like ISO/IEC 17025:2017). It is up to the competence of the Inspection Body to determine which are the applicable requirements and how to assess them.

That means that when subcontracting tests for the inspection, the inspection body should ask for a laboratory accredited under ISO/IEC 17025:2017 or has to assess that the subcontractor fulfils ISO/IEC 17025:2017 for the test subcontracted and keep the records about this assessment.

Subcontracting of parts of the inspection is allowed only in exceptional cases (see Note 1 of 6.3.1).

Question 48.5 Subcontracting to non-accredited bodies

Is an inspection body allowed to subcontract activities under the provisions of ISO/IEC 17020, clause 6.3.1 and ILAC P15 clause 6.3.1 n1 to a subcontractor which does not hold an ISO/IEC 17020:2012 accreditation?

In other words, is an accreditation an indispensable condition to demonstrate competence of a subcontractor or one option to be considered by the inspection body?

September 2024

The ISO/IEC 17020:2012 clause 6.3 Subcontracting says:

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 P15:2020 states the following: 6.3.4 n1 Accreditation is the preferred means to demonstrate the competence of the subcontractor, but in justified situations (on the basis of qualified evaluation/professional judgement) results from non-accredited bodies could be accepted.

It could be accepted in justified situations (ILAC P15:2020, 6.3.4n1) that the subcontractor is not accredited. In this case, the accreditation body assesses how the inspection body has assessed the compliance of the subcontractor with the relevant standard.

Always consider the clause 6.3.3 of the standard: “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.”

Question 32.5 Inspection records, software used in inspection

As a part of an inspection scheme, a Regulatory Authority has established a central IT-system for the recording and storing of the inspection data and all accredited inspection bodies must use that tool.

That IT-system is provided and developed by the Regulatory Authority and it is consisting of authorization system using electronic ID infrastructure, user interface for data entry, database storage for the inspection related information and interface to access the data and generate official inspection reports. The IT-system is out of control of the inspection bodies.

In addition to the generation of the inspection reports, and to avoid duplication several inspection bodies have begun to rely on the service of IT-system for inspection data storage and archival (time limits, liquidation and access to data are defined by law). Inspection bodies have no control over the database and there are no agreements between either inspection body and the Regulatory Authority to enforce any additional requirements from inspection body (i.e. longer storage time).

In the context of ISO/IEC 17020:2012 cl 7.3.1 and the fact that inspection bodies rely fully on previously described service from the Regulatory Authority for the management of inspection records and reports, could that be enough for being in compliance with ISO/IEC17020:2012? Or should the inspection body still duplicate some functions to get them under their own control?

Does such IT-system qualify as a “computer software used in inspection” and therefore must be validated (cl. 6.2.13) before use and revalidated when system is changed?

What additional aspects may be relevant for the case?

September 2016
The Technical Regulatory Authority has established an inspection scheme which requires the inspection bodies to use a “central IT system” that is used by the inspections bodies for directly record the data during the inspections and for central storage of the records and database function. This “central IT system” is out of control of the IB.

In this case the inspection body needs to have an “agreement” with the National Authority to comply with requirements of ISO/IEC 17020:2012. The agreement should assure accessibility and maintenance of the records e.g.: the access during an accreditation body assessments (if accreditation is mandatory), the access for the inspection body to resolve claims and appeals, later checks, etc.

Question 45.2 7.4 Inspection reports and inspection certificates – signature or other indication of approval, by authorized personnel

ISO/IEC 17020:2012, 7.4.2e states:

Any Inspection report/certificate shall include all of the following:
…
e) signature or other indication of approval, by authorized personnel.

Is possible to adopt the solution presented in EN ISO/IEC 17065, p. 7.7.2, Note: The name and title of an individual whose agreement to be responsible for certification documentation is on record at the certification body is an example of a “defined authorization” other than a signature, to approve inspection report/certificate?

March 2023

Yes. The phrase “other indication of approval, by authorized personnel” seems to be equivalent as what it is written in the ISO/IEC 17065. The inspection body must demonstrate that the authorized personnel has indeed been involved (So it will not be acceptable if anyone can include the name of the authorized personnel into the report).

Question 24.3 Definition of appeal – who can submit an appeal?

For the purpose of the application of the definition of “appeal”:
ISO/IEC 17020:2012, clause 3.9 appeal: request by the provider of the item of inspection to the inspection body for reconsideration by that body of a decision it has made relating to that item.

It seems that only the provider of the item to be inspected can submit an appeal or request the inspection body to reconsider the decision it has taken relating to that item.

It must be considered that in some cases the provider of the item to be inspected is different to the client of the inspection body (or persons seeking the inspection body’s services) and the results of the inspection are not necessarily given to the provider of the item to be inspected.

In this last case, who can submit an appeal to the inspection body? How can the definition of appeal in the ISO/IEC 17020:2012 standard (3.9) be interpreted?

September 2012

The EA IC concluded that it is the “party directly affected by the decision” or the “party who contracted the inspection” that will be involved.

In the current ISO/IEC 17000:2000, the definition of appeal is in the clause 8.6 appeal: request by the person or organization that provides, or that is, the object of conformity assessment […]

Question 27.6 Procedures vs Documented procedures

ISO/IEC 17020:2012 Clauses:

 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.

 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.

What is the difference between documented procedures and procedures?

March 2014

In 17000:2020 standard (Conformity assessment — Vocabulary and general principles) procedure is defined as:

3.2. procedure: Specified way to carry out an activity or a process.

 Note 1 to entry:17000 in this context, a process is defined as a set of interrelated or interacting activities that use inputs to deliver an intended result.

[SOURCE: ISO 9000:2015, 3.4.5 modified – the original Note to entry has been replaced with a new Note to entry]

And in 9000:2015 standard (Quality management systems — Fundamentals and vocabulary), clause 3.4.5, which has the same definition, there is the note:

Note 1. Procedures can be documented or not.

Then it can be understood that where ISO/IEC 17020:2012 standard asks for “documented procedures” then the procedures have to be documented.

And where the standard asks for “procedures” there might not be a documented procedure. In this case the inspection body should have evidence to demonstrate that the procedure is known within the inspection body and that the implementation of the procedure fulfills the ISO/IEC 17020:2012 standard.

Question 31.1 Requirements for internal auditors

ISO/IEC 17020:2012 standard requires: 8.6.5.b) auditors do not audit their own work.

How ABs understand this requirement?

E.g. A technical director could not audit their technical department because he/she is not independent of the functions being audited and therefore it means that he/she is auditing his/her own work?,

Or the technical director could audit his/her technical department because he/she is not auditing their own work?, e.g. if he/she audits inspection activities in which the inspection is performed by other inspectors and the Technical manager has not done any work at all, neither supervise nor review or sign certificates …).

March 2016

The previous version of the standard ISO/IEC 17020:1998, required:

7.7 The inspection body shall carry out a system of planned and documented internal quality audits to verify compliance with the criteria of this standard and the effectiveness of the quality system. The personnel performing the audits shall be suitably qualified and independent from the functions being audited.

The current version of the standard ISO/IEC 17020:2012 requires: 8.6.5.b) auditors do not audit their own work.

This change in wording of the standard does give a greater degree of flexibility with regards to the auditor e.g. the technical manager can act as internal auditor to audit inspection works performed by inspectors from his own department, if the technical manager has not been involved in any way

Question 47.1 Internal Audits

Clause 8.6.4 of the standard says, “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.”.
a) E.g. The internal audit and external assessment results of the branch of a multi-site inspection body located in a country different from the country where its headquarters are located have been examined in the last 6 years. It is determined that there has been almost no non-conformity, and the management system has become stable and evidently mature. In this case, the inspection body argues that the frequency of the internal audits may be adjusted once every 2 years. Is it in line with the requirements of clause 8.6.4?
Note: This inspection body implements its management system according to “ISO/IEC 17020:2012 clause 8.1.3 Option B”, i.e., ISO 9001-based.
b) Which situations are possible regarding the second statement (the frequency of internal audits may be adjusted…)? Could the 12-month requirement be interpreted in a more flexible manner?

March 2024
ILAC P15:2020, clause 8.6.4 n1 The inspection body should ensure that all requirements of ISO/IEC 17020 are covered by the internal audit program within the accreditation cycle. The requirements to be covered shall be considered for all fields of inspection and for all premises where inspection activities are managed or performed.

The inspection body shall justify the choice of audit frequency for different types of requirements, fields of inspection and premises as part of audit planning performed.

The justification may be based on 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

Then the “adjustment” referred to in clause 8.6.4 may be to increase or decrease the frequency, if the inspection body can justify it as indicated in the standard and following the criteria of ILAC P15:05/2020.

It is unusual for inspection bodies to carry out internal audits for periods longer than 12 months, if they do, it must be well justified.

Question 48.4 EN ISO/IEC 17020 p.7.6 Complainant considered as anonymous by IB

A complaint has been submitted to an inspection body (IB) by a third party (no client, no installation owner) regarding the results of conformity assessment activities. The IB has specified the complainant as anonymous (only name and gmail address was provided), because the complainant made the same complaint under different names and CAB identified that no people with these names exist. The IB complaints procedure states, that anonymous complaints will not be responded to. CAB did not respond to the complainant.

The IB acted in accordance with its complaints procedure and decided that clause 7.6.3 of the standard ISO/IEC 17020:2012 “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” doesn’t apply for the anonymous complainant.

What is the criteria for handling such kind of requests?

September 2024

The standard ISO/IEC 17020:2012 mentions that:

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.

7.6.3 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.

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

Then the IB must deal with all the complaints anonymous or not (7.5.3) because this clause doesn’t include “whenever possible”. But if the claimer is anonymous, then it can be considered that it is not possible to “acknowledge receipt and provide with progress reports” (7.6.3) nor “give formal notice of the end of the complaint” (7.6.5).

The Inspection body should consider the risks of anonymous complaints, e.g. may be malicious.