This website presents questions and answers presented to the EA Inspection Committee (IC) by the participating committee members. The answers represent the consensus view of the IC – they are intended for informational purposes and aims for harmonisation between NABs.

When reading questions and answers take into consideration whether transition periods are on-going.

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Table of contents

IMPARTIALITY AND INDEPENDENCE

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.

PERSONNEL

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.

PROCESS REQUIREMENTS: METHODS AND PROCEDURES, INSPECTION ITEMS AND SAMPLES, RECORDS, REPORTS/CERTIFICATES

MANAGEMENT SYSTEM. AND COMPLAINS & APPEALS

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.

ACTIVITIES THAT CAN BE ACCREDITED UNDER 17020 & ACTIVITIES PERFORMED AS PART OF INSPECTION (E.G. TESTS, CERTIFICATION…)

PROFICIENCY TESTING (PT) ISSUES