14. inspection international requirements and auditing practices for iso iec 17020

Examples of Inspection requirements and ISO/IEC 17020

ISO REGIONAL WORKSHOP on

CONFORMITY ASSESSMENT12/13 June 2008

KievDr. 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

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

• .

CEOCInternational

• 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


• 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)


• Examination of a service – Example: Performance of a maintenance service– Note 2: The results of inspection may be used to support

certification


• Examination of a process – Note 1: Inspection of processes includes personnel, facilities,

technology and methodology

– Example: Welding or solder procedures


• 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


• 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 bodyISO/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 bodyISO/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.


• 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.


• 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)


• 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


• 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


• 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


• Instructions, standards, written procedures, work sheets, check lists and reference data shall be– maintained up-to-date– readily available


• 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


• 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


• 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)


• 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 operation

Inspection of individual products, and not necessarily by third party (direct determination of conformance)

Certification of series of products and always by third party (indirect determination of conformance)




Conformity Examined against standards or other normative documents and/or general requirements

Assessed against standards or other normative documents

Assurance Report provides condition at the time of inspection

Certification normally provides continuing assurance of compliance




Decisions No need for separation of those taking inspection decisions from those performing inspection

Certification decisions taken by a different person(s) from those who have carried out evaluation




Issuing of licences

No licences issued

Grants licence to suppliers to issue certificate

Marking of products

Marks put only on products covered by inspection

Marks may be put on a certified product under licence




Surveillance Only where required in order to support inspection

Normally necessary to provide continuing assurance of compliance

In-service inspection of products

Always by inspection

Not by product certification

14. inspection international requirements and auditing practices for iso iec 17020

Documents

inspection body

independent inspection

inspection guide

inspection activities

certification body

company tv austria

grover company

members ceoc international