FAQ 53c

The question is related to requirement 8.6.4 where it establishes that “internal audits must be carried out at least once every 12 months” It also defines that the frequency can be adjusted based on the proven effectiveness of the management system and its stability proven”.

An Accreditation Body may ignore situations such as those described in Q 2 and demand or declare non-compliance with requirement 8.6.4 of the minimum frequency of 12 months, regardless of whether the Inspection Body has adequately documented and justified based on the effectiveness of the system. of management and proven stability and by situations of care of the global contingency of COVID 19?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.6.4  ·  TOPIC: Internal Audits

Answer:

The accreditation body will evaluate the effectiveness of your management system based on the results of their accreditation activity, and other factors such as turn over of key personnel, changes in location or ownership, major updates to the ISO or ILAC standards, etc.

FAQ 53b

The question is related to requirement 8.6.4 where it establishes that “internal audits must be carried out at least once every 12 months” It also defines that the frequency can be adjusted based on the proven effectiveness of the management system and its stability proven”. Valid justifications for expanding the audit frequency can be situations such as pandemics (covid 19), legal situations, country regulations, natural situations (hurricanes, earthquakes, other), war situations, death of key personnel, contagion of key personnel, illness of key personnel, among others?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.6.4  ·  TOPIC: Internal Audits

Answer:

While pandemics, wars and illness can certainly affect the timing, those are not the justifications the standard is referencing. Internal audits can be completed remotely or delayed temporarily. The exception is more of a systemic change in frequencies, not an emergency event.

FAQ 53a

The question is related to requirement 8.6.4 where it establishes that “internal audits must be carried out at least once every 12 months” It also defines that the frequency can be adjusted based on the proven effectiveness of the management system and its stability proven”. Is it possible for audits to be carried out at frequencies greater than 12 months, if there is justification based on the effectiveness of the management system and proven stability?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.6.4  ·  TOPIC: Internal Audits

Answer:

Yes, as stated in clause 8.6.4, it is possible to go longer than a 12 month frequency for your Internal Audits. The valid reasons are stated as “demonstrable effectiveness of the management system and its proven stability”. That has to do with if you have had stability with key personnel, have had little or no findings during your internal & external evaluations, and you have a generally stable QMS in place with no major changes.

FAQ 52

Does the requirement in clause 8.2.5 (ISO/IEC 17020) restrict the “personnel involved in inspection activities” from having access to parts of the management system documentation and related information that are not applicable to their responsibilities?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.2.5  ·  TOPIC: Management System Documentation

Answer:

No. Clause 8.2.5 only requires access to those parts of the QMS that apply to their responsibilities, e.g. Inspection Procedures, Reporting Templates, Quality Manual, applicable Standards, etc. It does not require access to everything. That is determined by the IB.

FAQ 51

For Inspection Body company is it mandatory to make authorisation record for technical manager. If yes how to make the authorisation.  

STANDARD: ISO/IEC 17020  ·  CLAUSE: 6.1.5  ·  TOPIC: Authorising inspectors

Answer:

Yes, clause 6.1.5 requires the IB to have a documented procedure for authorising all personnel involved in inspection activities. That would include the Technical Manager. The procedure developed under 6.1.5 would provide the specific details for how this would apply to the Technical Manager. 

FAQ 50

A large company supplies services and products to many industrial and retail clients. Can they also supply inspection services to these clients as a type b inspection body? They have a financial interest in that it is based on the outcome of these inspections whether the supply of product can be done or not. The installation and equipment remain the property of the company and the client only pays for the gas that the receive. The company designs the installations and also submits to the local authority for approval along with their report that is done as per the Type B inspection body. The body is accredited as per ISO/IEC 17020.  

STANDARD: ISO/IEC 17020  ·  CLAUSE: Annex A.3  ·  TOPIC: Independence

Answer:

Yes. A Type B Inspection Body is for an “In-House Inspection Body” per 4.1.6b. The scenario provided would indicate that this would be a Type C Inspection Body per 4.1.6c. In order to become an accredited Type C Inspection Body, the IB would have to meet all of the requirements of ISO/IEC 17020, and would be evaluated against the requirements for a Type C IB as outlined in Annex A.3 

FAQ 49

In bullet a) of Annex A.3 it is stated that the inspection body shall provide safeguards within the organisation to ensure adequate segregation of responsibilities and accountabilities between inspection and other activities. Could you give examples of such safeguards?

STANDARD: ISO/IEC 17020  ·  CLAUSE: Annex A.3  ·  TOPIC: Independence Type C

Answer:

Safeguards that ensure adequate segregation can include e.g.
– Maintenance of separate instructions for, or clear demarcation between, activities performed in different roles;
– Reporting arrangements; or
– Communication and maintenance of policies; or
– Rules or code of conduct of inspectors; or
– Remittance and review procedures

FAQ 48

The wording of bullet b) in Annex A.1 indicates that there may be more activities than those listed in the 2nd sentence that may conflict with the inspection body’s and/or its personnel’s independence of judgment and integrity. Could you give examples of such activities?

STANDARD: ISO/IEC 17020  ·  CLAUSE: Annex A.1  ·  TOPIC: Independence Type A

Answer:

In many cases, activities like project management and support activities related to the items inspected may also conflict with the independence of judgment and integrity. Also, consultancy engagements related to the items inspected may, depending on their nature and character, conflict with the independence of judgment and integrity.

FAQ 47

In clause 6.2.13, bullet b) it is stated that the inspection body shall ensure that procedures are established and implemented to protect the integrity and security of data. Could you give examples of such procedures?

STANDARD: ISO/IEC 17020  ·  CLAUSE: Clause 6.2.13  ·  TOPIC: Facilities and Equipment

Answer:

Procedures for protecting the integrity and security of data may include:
– Backup practices and frequencies
– Actions to effectively restore data from backup
– The maintenance of virus protection
– The maintenance of password protection
– Protection of data collected on-site
– Protection of ICT tools to carry out inspection
– Encryption of data
– Protection and access control of internally stored inspection records and reports
– Protection of electronically issued inspection reports

FAQ 46

In clause 5.2.5/section 6.1.1 of the standard it is stated that the technical manager shall be technically competent. What type of technical competence should the technical manager have?

STANDARD: ISO/IEC 17020  ·  CLAUSE: Clause 5.2.5  ·  TOPIC: Management

Answer:

Examples of competencies a technical manager may need are to;
– Understand the requirements for the items inspected
– Understand the risks pertaining to failure of inspected items to fulfil the requirements
– Understand the possibilities and limitations of the inspection process and the relevant inspection techniques/technologies used for inspection
– Determine the type of technical competence required for performance of inspection activities
– Plan and organise inspection activities
– Understand and judge the ramifications of inspection outcomes
– Understand the type of technology developments that may influence the inspection activities