How can a very small inspection body, e.g. a one-man inspection body, fulfil the requirement for monitoring inspectors and other personnel involved in inspection activities?
STANDARD: ISO/IEC 17020 · CLAUSE: 6.1.8 · TOPIC: Monitoring inspectors and other personnel involved in inspection activities ·
Answer:
The standard does not require that monitoring is carried out by internal personnel. ILAC P15 gives examples on other solutions.
How can a very small inspection body, e.g. a one-man inspection body, fulfil the requirement for authorising inspectors and other personnel involved in inspection activities?
STANDARD: ISO/IEC 17020 · CLAUSE: 6.1.5 · TOPIC: Authorising inspectors and other personnel involved in inspection activities
Answer:
This is not a problem limited to small inspection bodies. No matter how many employees, the first person has to be self-authorized or authorized by somebody who is not authorized himself/herself.
How can a very small inspection body, e.g. a one-man inspection body, fulfil the requirement for deputies for technical manager(s)?
STANDARD: ISO/IEC 17020 · CLAUSE: 5.2.6 · TOPIC: Assigning deputies for technical manager(s)
Answer:
The requirement is there to ensure that all work is competently performed, not to ensure that delivery times are honored. Therefore, as is pointed out in ILAC P15, the requirement only applies to ongoing activities. In a one-man inspection body, the activity presumably ceases to be ongoing as soon as the one man is absent.
Clause 7.1.2 mandates that the inspection body shall have “adequate instructions of inspection planning, sampling and inspection techniques”. What is the meaning of “inspection planning, sampling and inspection techniques”? Please provide examples of each of these.
STANDARD: ISO/IEC 17020 · CLAUSE: 7.1.2 · TOPIC: Documenting instructions on inspection planning, sampling and inspection techniques
Answer:
First, the Standard does not mandate that the inspection body shall have adequate instructions of inspection planning, sampling and inspection techniques. The only situation where these are required is where the absence of such instructions could jeopardize the effectiveness of the inspection process. So e.g., for a typical in-service inspection of a crane it would seem inappropriate to have any detailed planning of which welds to inspect or which parts of the crane to sample. These decisions are best left to the inspector’s professional judgment, on-site after talking to the operator and based on the inspector’s experience of similar equipment. An example of an inspection type where inspection planning would be appropriate would be inspections during construction or fabrication. Inspection points/hold points should be agreed before the project starts, probably in collaboration between the design engineer, the site engineer and the inspection body. Day-to-day scheduling of inspections also constitutes inspection planning. An example of sampling would be where a design requires a percentage of welds to be examined. In addition to the percentage there may be such terms as “representative sample”, “random sample”, “worst case sample”, “risk based sample” etc. All of these terms require technically appropriate sample choosing procedures, if the contract is to be met correctly. As an example, the inspector personally choosing which welds to examine cannot be considered random. Appropriate inspection techniques relate to choosing between techniques for a particular project where more than one technique is available. This may be part of contract review (see clause 7.1.5 of ISO/IEC 17020), and may also be referenced to the final sentence of clause 7.1.1. So, e.g., if a company offering non-destructive testing is asked to test for cracking in a fabricated metal item, they must have appropriate procedures for determining whether radiography, ultrasonic examination, magnetic particle or some other technique is appropriate, depending on details of the project. In a non-engineering situation, if you are inspecting a process, the aspects of the process that needs to be sampled need to be planned. The inspection techniques used for inspecting a process may include auditing, verification, interviewing of personnel etc.
Clause 6.2.6 in ISO/IEC 17020 states that “where appropriate measurement equipment having a significant influence on the results of the inspection shall be calibrated before being put into service”. What about cases where no calibration services are available in the market? Would verification from a manufacturer be enough in such cases? In this context; what is the meaning of “appropriate”?
STANDARD: ISO/IEC 17020 · CLAUSE: 6.2.6 · TOPIC: Calibration of measurement equipment
Answer:
In ISO/IEC 17020 clauses 6.2.6 and 6.2.7 there occur the phrases “where appropriate”, “having a significant influence on the results”, “wherever applicable”, “where available” and “where traceability to national standards is not applicable”. In all of these cases the need to calibrate or not depends on the assessment of the appropriateness and the applicability or the availability of traceable calibration. It is not possible for ILAC to provide specific guidance on specific fields of measurement in specific economies. Reference should be made to the ILAC P15 application note 6.2.6 a: “The justification for not calibrating any equipment that has a significant influence on the on the outcome of inspection should be recorded.” Accreditation bodies should encourage inspection bodies to record the rationale for their decisions on the appropriateness or applicability or availability of calibration for a particular measurement. By doing this the inspection body will reveal their level of understanding of measurement systems and the criticality of a particular measurement for a particular inspection result. It will then be for a technical expert member of the assessment team to assess the technical appropriateness of the decisions made by the inspection body. This may also be used as one factor in determining their level of competence in the inspections they undertake. In general, decisions should always be taken primarily on technical grounds. If the main reason for deciding that traceable calibration is not appropriate, or applicable is on the basis of cost then this implies inherent differences in the quality and reliability of the same inspections from different economies. This goes against the intent of Mutual Recognition Arrangements (MRAs). It may be that some inspections cannot be performed appropriately, and therefore not under accreditation, in some economies until the infrastructure is improved sufficiently to support the activity. On the other side it would be inappropriate for accreditation bodies to insist on traceable calibration for measurements that are not critical to particular inspections. The reasons for decisions on these issues are always critical. Under these circumstances the accreditation body should review each set of circumstances on a case by case basis and have a discussion with the inspection body concerned.
Consider that an inspection body is found to be using an inadequate sampling procedure for selecting the number of samples inspected. The inspection body then claims that the sampling size was determined by its client and that it is the client who takes responsibility for determining conformity of the batch and subsequently certifying the batch containing the inspected items. The inspection body claims it is merely reporting the results of the examination of the samples as required by the client specification. According to 7.1.2 of ISO / IEC 17020:2012, IBs are required to use statistically sound sampling procedures for selecting samples of inspected items. Is it allowed to use an inadequate sampling procedure for selection of samples when the IB’s client has accepted the sampling procedure?
STANDARD: ISO/IEC 17020 · CLAUSE: 7.1.2 · TOPIC: Determining statistically sound sampling procedures
Answer:
ISO/IEC 17020 clause 7.1.2 requires inspection bodies to use statistically sound sampling procedures for selecting samples of inspected items only where the absence of such [procedures] instructions could jeopardize the effectiveness of the inspection process. As stated in Note 2 to clause 3.1 of the standard, “Inspection procedures or schemes can restrict inspection to examination only”. Where there is no conformity assessment, by the inspection body, there can be no criteria for making a decision on what constitutes an appropriate sampling procedure. • If the terms of the contract between the inspection body and its client states that the inspection body must inspect a sample suitable for establishing the compliance of a batch of product, then there may be a non-conformity against clause 7.1.2 of ISO/IEC 17020. • If the inspection body is aware of the use to which the client is going to put the inspection results, e.g. establishing compliance of a batch of product, then there may be a non-conformity against clause 7.1.1 of ISO/IEC 17020. • If the contract with the client clearly states, inspect a specified sample size and report observations, then there is no non-conformity. However, in this case it would be appropriate for the inspection body to make a declaration in the inspection report (or by other explicit means) to indicate that the inspection body is not taking any responsibility for any subsequent decisions on the conformity of the batch concerned, as the sampling was not based on a sampling procedure accepted by the inspection body.
While some clauses in ISO/IEC 17020 refer to “documented procedures”, other clauses refer to “established procedures” or just “procedures”. What is the difference between “documented procedures”, “established procedures” and “procedures”?
STANDARD: ISO/IEC 17020 · CLAUSE: 8.2.4 · TOPIC: Documenting the management system
Answer:
Where ISO/IEC 17020 requires a “documented (or written) procedure’ then those procedures shall be documented. Where the standard refers to a ‘procedure’, then there is no requirement in the Standard for that procedure to be documented (or written). Where the standard requires an “established ‘procedure”, again there is no requirement in the standard to document those established procedures. However, it is noted that clause 5.1.2 of ISO/IEC 17011:2004 states that to establish procedures means to ensure they are documented, implemented and maintained. The terms “documented” and “established” should not be understood to be limited to written descriptions of activities. Procedures could be in the form of pictures, flow charts, video recordings, audio recordings or in other formats and media. As stated in the Introduction to the standard, ISO/IEC 17020 can be used as a requirements document for accreditation. Therefore, from accreditation point of view accreditation bodies may agree with inspection bodies the extent to which procedures should be documented to enable accredited inspection bodies to demonstrate competence, impartiality and consistency of their inspection activities. To this end ILAC application documents or guidance documents may also identify specific procedures that require documenting for the purpose of accreditation. There is also a requirement in clause 8.2.1 of ISO/IEC 17020 for the inspection body’s top management to establish, document and maintain policies and objectives for fulfilment of ISO/IEC 17020. Therefore, the extent to which procedures should be documented in order to effectively implement documented policies and achieve documented objectives and to consistently fulfil the requirements of the standard, other than those mandated by the standard or by ILAC documents, is a matter for the inspection body to agree with the accreditation body.
Is it acceptable that the Technical Manager of the inspection body fulfils the standard’s requirements for the technical manager when the Business Manager has the disciplinary responsibility of the inspection body?
STANDARD: ISO/IEC 17020 · CLAUSE: 5.2.5 · TOPIC: Assigning technical manager(s)
Answer:
Regardless of job titles, the responsibilities of the manager(s) with overall responsibility for technical & inspection activities must be addressed in accordance with the requirements in clause 5.2.5. Those responsibilities must be described in job descriptions or other documentation in accordance with clause 5.2.7.
Referring to the note under clause 4.1.3; how could a relationship based on marketing (including branding) and payment of a sales commission threaten the impartiality of an inspection body?
STANDARD: ISO/IEC 17020 · CLAUSE: 4.1.3 · TOPIC: Identifying risks
Answer:
The marketing, branding or sales activities of inspections performed by the inspection body or of the items that are inspected by the inspection body could have an influence on those who are involved in developing strategies, policies and methods for inspection and on those who are managing or conducting inspections. E.g., the marketing and sales information could give the impressions to inspection clients that inspections could be performed more efficiently than it is possible to do without compromising the quality of inspections. Such information or commitments by sales/marketing could put undue pressure on those who are directly involved in inspections. This does not mean that sales/marketing activities are prohibited. ISO/IEC 17020:2012 clause 4.1.3 states that “However, such relationships do not necessarily present an inspection body with a risk to impartiality”. The inspection body has a responsibility to identify any risks to impartiality arising from such activities or relationships and demonstrate how it eliminates or minimises such risks.
ISO 17020:2012 clause 4.1.6c) states “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.” Which organizations are referred to by the term “other parties”?
STANDARD: ISO/IEC 17020 · CLAUSE: 4.1.6 · TOPIC: Maintaining independence
Answer:
The term “other parties” means any organisation other than the parent organisation.
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