Examples of Inspection requirements

and ISO/IEC 17020

ISO REGIONAL WORKSHOP

on
CONFORMITY ASSESSMENT
12/13 June 2008
Kiev
Dr. H. Eberhardt
 Content of the presentation

• TÜV Austria
• CEOC International
• History of Inspection
• What is Inspection
• Borderline to Certification and Testing
• Content of the standard ISO/IEC 17020
• Question of independence
• Practical experience
• Future of Inspection
R.B. Grover & Company – 1905
R.B. Grover & Company – 1905
Crandon – 1908
Crandon – 1908
Fredonia – 1910
Brick Yard – 1913
Ringwood – 1894
Sultana – 1865
Sultana Gedenktafel – 1865
 TÜV AUSTRIA (1)

• Established as inspection body and insurance

company in 1872
• In average about 600 casualties a year because of
boiler explosions in Austria
• Neither authorities nor manufacturers were able to
reduce the number of catastrophic explosions with
enormous damages and economic damages
• Relevant industry established a company -TÜV
AUSTRIA - in order to collect experience by inspection
and testing
• Already in 1900 reduction of boiler explosions to a
minimum
 TÜV AUSTRIA (2)

• Expanding the inspection activities in other fields like

lifts, electrical installation etc.
• In 1908 the first testing laboratory was established in
and formed the basis for a law for authorisation of
laboratories which came 1910 into force
• Today TÜV AUSTRIA is an inspection body,
certification body, testing and calibration laboratory in
a wide range of activities and a great number of
accreditations and notifications according to
European directives
 CEOC International

• .
 CEOC
International

• Created in Switzerland in 1961 with the aim to

harmonize safety requirements for technical
installations
• Voluntary group of independent private, semi-private or
governmental third party organisations, or associations
of such organisations, for testing, technical inspection,
for certification of personnel, products and (quality)
management systems and for risk prevention.
Most of the members operate on a non-profit basis.
• International not for profit association (AISBL) under
Belgian law since 1996.
• 32 members
• 21 countries
• 3 associates
• presence in 51 additional countries

• Through its members CEOC International

represents some 60.000 employees (among them
some ¾ are engineers)
• 2 new members in 2008 expected
 Technical committees

• Conformity Assessment « CC »
• CEOC-Eurolab « JTCPTC »
• Non-destructive Testing « CND »
• Machines, Lifts and Cranes « CML »
• Pressure Equipment « CP »
• Environment & Major Hazards « CR »
• Electrotechnology « CE »
• Inspection « CI »
• Occupational Health « COH »
 Mission Statement

Promoting safety, quality and the environment world-

wide through independent inspection and certification
 History of Inspection (1)

• Technical inspections have been carried out for more

than 100 years in a systematically manner.
• One of the main items was to gain experience in order
to reduce accidents caused by deficiencies in designee,
manufacturing, operation and maintenance.
• Human factors and material are important points.
• ISO Guides for inspection (Guide 39)
• Development of EN 45004
 History of Inspection (2)

• ISO Guide 39 “General requirements for the

acceptance of inspection bodies for inspection
(Guide 39-1983)”
• Definition: Inspection body: An impartial body having
the organisation, staffing, competence and integrity to
perform to specified criteria functions such as
assessing, recommending for acceptance and
subsequent audit of manufacturers´ quality control
operations, and selection and evaluation of products on
site or in factories or elsewhere as directed, to specified
criteria.
 What is Testing?
Definition in ISO 17000/17025

• Testing: Determination of one or more characteristics

of an object of conformity assessment, according to a
procedure
• Procedure: specified way to carry out an activity or a
process
• Note : “Testing” typically applies to materials, products
or processes
 What is Certification?
Definition in ISO 17000
• Certification: Third-party attestation related to
products, processes, systems or persons
• Attestation: Issue of a statement, based on a
decision following review (verification of the
suitability, adequacy effectiveness of selection and
determination activities, and the result of these
activities, with regard to fulfilment of specified
requirements by an object of conformity assess-
ment), that fulfilment of specified requirements has
been demonstrated.
 Distinction between three types of
inspection

• Inspection of new products etc.

– More detailed
– Focusing on weak points in designee /production
• Periodical inspection
– Orientation on points of wear, corrosion etc.
• Pre-shipment inspection
– Inspection of goods before and after shipment
– Conformity with delivery notes (letter of credit)
 What is Inspection?
Definition in ISO 17000/17020

• Examination of a product design, product, service,

process or plant/installation, and determination of
their conformity with specific requirements or, on the
basis of professional judgement, general
requirements
• Note 1: Inspection of processes includes personnel,
facilities, technology and methodology
• Note 2: The results of inspection may be used to
support certification
 What is Inspection?
Detail (1)

• Examination of a product design:

– Type approval e.g. Module B in the modular approach of
the EU
– Checking the drawings
– Calculation of values of material characteristics (Thickness
of the steel for a boiler, quality of the steel to be used)
– Checking of planned installations for safety (safety valve,
electronic measurement)
– Checking the static
 What is Inspection?
Detail (2)
• Examination of a product
• Initial inspection
– Inspection and sometimes testing against requirements, laid
down in a product related standard plus professional
judgement
• Periodical inspection
– Checking of all relevant items (laid down in a prescriptive
document) on a product
– Example: car inspection (Check list)
– Electrical installations in a plant/building (often randomised
inspection)
 What is Inspection?
Detail (3)

• Examination of a service
– Example: Performance of a maintenance service
– Note 2: The results of inspection may be used to support
certification
 What is Inspection?
Detail (4)
• Examination of a process
– Note 1: Inspection of processes includes personnel, facilities,
technology and methodology

– Example: Welding or solder procedures

 What is Inspection?
Detail (5)
• Examination of a plant/installation/assembly
• Final inspection after construction and installation
– Boiler, Refinery, Lift, Cable way, medical devices in hospitals
etc
• Periodical inspection
– Boiler, Refinery, Lift, Cable way, Cranes, electrical
installations, medical devices in hospitals etc
 What is Inspection?
Detail (6)

• Determination of their conformity with specific

requirements
– Standards, Guidelines, legal requirements, contractual
requirements etc.
• Determination of their conformity with general
requirements on the basis of professional judgement
(main difference to testing)
– General rules, expert knowledge, experience, checklists
 Borderline between Inspection,
Certification and Testing

• According ISO/IEC 17000 and 17025 testing is well

defined and the result of testing is normally a concrete
value with an uncertainty.
• Certification is following the four eyes principle and is
the comparison of a result with specified requirements.
• Inspection is normally based on professional
judgement.
 Requirements for an Inspection body
ISO/IEC 17020 (1)
• Administrative requirements
• Independence, impartiality, integrity
• Confidentiality
• Organisation and Management
• Quality system
• Personnel
• Facilities and equipment
• Inspection methods and procedures
 Requirements for an Inspection body
ISO/IEC 17020 (2)
• Handling of inspection samples and items
• Records
• Inspection reports
• Subcontracting
• Complaints and appeals
• Co-operation
Examples
 Administrative Requirements for an
Inspection body
• An inspection body shall be/have:
– Organisation or part of an organisation
– Legally identifiable
– Documented technical scope of activities
– Adequate liability insurance
– Independently audited accounts
Independence, impartiality, integrity

• Personnel shall be free from any pressure (effect on

judgement)
– Minimum number of staff (CEOC International 15 employees)
• Independence is one of the most crucial points
– As a compromise 3 types of bodies were laid down in this
standard
– Type A
– Type B
– Type C
 Independence
Type A Inspection body (1)

• The inspection body shall be independent of the

parties involved
– The inspection body, and its staff responsible for carrying out
the inspection shall not be the designer, manufacturer,
supplier, installer, purchaser, owner, user or maintainer of the
items which they inspect, nor the authorised representative of
any of these parties.
 Independence
Type A Inspection body (2)

• The inspection body, and its staff shall not engage in

any activities that may conflict with their independence
of judgement and integrity in relation to their inspection
activities. In particular they shall not become directly
involved in the design, manufacture, supply, installation,
user or maintenance of the items inspected, or similar
competitive items.
 Independence
Type A Inspection body (3)

• All interested parties shall have access to the services

of the inspection body. There shall not be undue
financial or other conditions. The procedures under
which the body operates shall be administered in a non-
discriminatory manner.
 Independence
Type B Inspection body (1)

• A clear separation of the responsibilities of the

inspection personnel from those of the personnel
employed in other functions shall be established by
organisational identification and the reporting
methods of the inspection body with the parent
organisation.
 Independence
Type B Inspection body (2)
• The inspection body, and its staff shall not engage in any
activities that may conflict with their independence of
judgement and integrity in relation to their inspection
activities. In particular they shall not become directly
involved in the design, manufacture, supply, installation,
user or maintenance of the items inspected, or similar
competitive items.
• Inspection service shall only be supplied to the
organisation of which the inspection body forms a part.
 Independence
Type C Inspection body

• The inspection body shall provide safeguards within

the organisation to ensure adequate segregation of
responsibilities and accountabilities in the provision of
inspection services by organisation and/or documented
procedures.
 Confidentiality

• The inspection body shall ensure confidentiality of

information obtained in the course of its inspection
activities.
– Nowadays it is practice that inspectors have to sign a
declaration of confidentiality.
• Proprietary rights shall be protected.
– This point has become very important.
– Many operators require special agreements concerning
confidentiality.
 Organisation and Management

• Competent technical management (permanent

employee)
• Maintain capability to perform functions satisfactory
• Defined responsibilities and reporting structure
• Relationship to testing and certification to inspection
(if relevant)
• Named deputies
• Effective and competent supervision of activities
• Job descriptions
 Quality system

• Quality manual, kept up to date, and reviewed

(informative annex in the standard)
• Quality manager
• Management shall define and document the policy
and objectives for, and commitment to quality.
• Operate an effective quality system appropriate to the
type, range and volume of work.
• Internal audits
• Procedure for feedback and corrective actions
 Personnel (1)
• Sufficient number of competent and permanent
personnel
• Knowledge of the technology used for the
manufacturing of the products to be inspected
• Staff with the appropriate qualification, training
experience, knowledge of the requirements and ability
to make professional judgements
• Knowledge of the defects which may occur during use
or in service
• Personnel shall understand the significance of
deviations found with regard to the normal use of
products or processes concerned
 Personnel (2)

• The inspection body shall establish a documented

training system to ensure that the training of its
personnel is kept up-to-date in accordance with its
policy.
• The inspection body shall establish the necessary
stages of training for each of its personnel. These may
include
– an introduction period
– a supervised working period with experienced inspectors
– continuation training, throughout employment, to keep pace
with developing technology
 Personnel (3)

• The remuneration of persons engaged in inspection

activities shall not directly depend on the number of
inspections carried out and in no case on the results of
such inspections.
• Records of academic and other qualifications, training
and experience of each member of its personnel shall be
maintained by the inspection body.
• The inspection body shall provide guidance for the
conduct of its staff.
 Facilities and equipment (1)

• The inspection body shall have available to it suitable

and adequate facilities and equipment to permit all
activities associated with the inspection services to be
carried out
• Clear rules for access and use
• Ensure the suitability of facilities and equipment
• Identification, maintenance, calibration of equipment
according to a program which must kept up-to-date
• Reference standards of measurement (traceability)
 Facilities and equipment (2)

• Where relevant the inspection body shall have a

procedure for:
– Selection of qualified suppliers
– Issuing appropriate purchasing documents
– Inspection (testing) of received materials
– Ensuring appropriate storage facilities
• Condition of stored items shall be assessed at
appropriate intervals to detect deterioration
 Facilities and equipment (3)

• Use of computers: (not mandatory in the standard;

more information in ISO/IEC 17025, Eurolab
Guidance paper)
– Computer software shall be tested
– Data protection
– Maintenance of computers and automated equipment
• Condition of stored items shall be assessed at
appropriate intervals to detect deterioration
• Procedures for maintenance of security data
 Facilities and equipment (4)

• Documented procedures for dealing with defective

equipment
• Defective equipment shall be removed from service and
clearly identified
• Examination of the effect of defects on previous
inspections
• Relevant information on the equipment shall be
recorded
 Inspection methods and procedures (1)

• Use of defined methods and procedures for inspection

with defined requirements, against which conformity is
determined
• Documented instructions
– On inspection planning
– On standard sampling
– On inspection techniques
• In case of non-standardised methods procedures shall
be appropriate and fully documented
 Inspection methods and procedures (2)

• Instructions, standards, written procedures, work

sheets, check lists and reference data shall be
– maintained up-to-date
– readily available
 Inspection methods and procedures (3)

• Inspection body shall have a contract or work order

control system which ensures that:
– Work to be undertaken within its expertise
– Clear definition of the order
– Work being undertaken is controlled by regular review and
corrective actions
– Completed work is reviewed to confirm that the requirements
have been met
 Inspection methods and procedures (4)

• Documented instructions for carrying out inspections

safely
• Observations and/or data obtained in the course of
inspections shall be recorded in a timely manner to
prevent loss of relevant information
• All calculations and data transfers shall be subject to
appropriate checks
 Handling of inspection
samples and items (1)
• Samples and items to be inspected shall be uniquely
identified
• Any apparent abnormalities shall be recorded before
commencement of inspection
• If there are any doubts if the item can be inspected the
client shall be consulted
• The inspection body shall establish whether the item
has received all necessary preparation, or whether the
client requires preparation to be undertaken or arranged
by the inspection body
• Procedures to avoid deterioration or damages of items
to be inspected
 Records

• A record system shall be maintained

• Sufficient information in order to evaluate the
inspection
• Safe storage for a defined period
 Inspection reports

• The work carried out shall be covered by a retrievable

inspection report and/or inspection certificate
• Report shall contain:
– Results of examinations
– Determination of conformity made from these results
– Information for understanding
– Involvement of subcontractors (if any)
• Reports shall be signed or approved by authorised
persons
• Corrections and additions after issuing shall be recorded
and justified
 Subcontracting

• Inspection body shall itself normally perform the

inspection
• Subcontractor must be competent to perform the
service in question and shall fulfil the relevant
requirements of this standard
• Information to the client about subcontracting
• When subcontracting specialised activities the
inspection body shall have an independent person or
body for the evaluation of the results
 Complaints and appeals

• Inspection body shall have documented procedures

for dealing with complaints (from clients or other
parties)
• Documented procedures for dealing with complaints
and appeals
• Documentation of all complaints and appeals
 Co-operation

• Inspection body is expected to participate in an

exchange of experience with other inspection bodies
and in the standardisation processes as appropriate
 Practical experience (1)

• Technical requirements differ from country to country

– Safety philosophy is not the same in all countries round the
world
– Thoroughness of inspection is not always the same
(example: crane inspection with a telescope)
– In periodical inspection periods between two inspections can
range from a half year to twelve years
 Practical experience (2)

• Problems with the competence

– Proof of competence is required (accreditation, authorisation,
notification)
– Proof of competence is not a prerequisite in many cases
– Inspection is carried out by maintenance companies,
workshops etc. (example: car inspection in workshops)
 Practical experience (3)

• Problems with the independence of inspection bodies

• Problems with the time for inspection
– Inspection often not possible during operation (e.g.: boiler,
crane, lorries etc.)
– Preparation for inspection is needed (emptying and cleaning of
the vessel, filling with water etc.)
• Working under dangerous conditions
 Future of Inspection

• Cost effectiveness is very important for plant operators

• Risk based inspection
– Expanding the inspection interval
– Measure of critical items (wall thickness, changes in the
material during operation)
• Problem of the periodical inspection of “black boxes”
like electronic controls in machines, cars etc.
• Problem of the periodical inspection of e.g. air bags in
cars
• Inspection of software
 Differences between Inspection
(ISO/IEC 17020) and Product
Certification (ISO/IEC Guide 65)
Activity Inspection Product
Certification

Nature of Inspection of Certification of series

operation individual products, of products and
and not necessarily always by third party
by third party (direct (indirect
determination of determination of
conformance) conformance)
 Differences between Inspection
(ISO/IEC 17020) and Product
Certification (ISO/IEC Guide 65)
Activity Inspection Product
Certification
Conformity Examined against Assessed against
standards or other standards or other
normative documents normative documents
and/or general
requirements
Assurance Report provides Certification normally
condition at the time provides continuing
of inspection assurance of
compliance
 Differences between Inspection
(ISO/IEC 17020) and Product
Certification (ISO/IEC Guide 65)
Activity Inspection Product Certification

Decisions No need for Certification decisions

separation of taken by a different
those taking person(s) from those who
inspection have carried out
decisions from evaluation
those performing
inspection
 Differences between Inspection
(ISO/IEC 17020) and Product
Certification (ISO/IEC Guide 65)
Activity Inspection Product Certification

Issuing of No licences Grants licence to

licences issued suppliers to issue
certificate
Marking of Marks put only on Marks may be put on a
products products covered certified product under
by inspection licence
 Differences between Inspection
(ISO/IEC 17020) and Product
Certification (ISO/IEC Guide 65)
Activity Inspection Product Certification

Surveillance Only where Normally necessary to

required in order provide continuing
to support assurance of
inspection compliance
In-service Always by Not by product
inspection of inspection certification
products