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ISO / IEC 17020 : 2012

Conformity assessment Requirements for the operation of


various types of bodies performing inspection

Katerina Bouranta
Physicist
MSc. Dynamics of Engineering Structures

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Introduction

Promoting confidence in bodies performing inspection

Requirements document for accreditation, or peer assessment or


other assessment.

Requirements can be interpreted when applied to particular


sectors

Shall, should, may and can

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Introduction

Inspection bodies carry out assessments on behalf of:


private clients,
their parent organizations,
authorities,

with the objective of providing information about the conformity of


inspected items with:

regulations,
standards,
specifications,
inspection schemes or
contracts.

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Introduction

Inspection parameters include matters of:


quantity,
quality,
safety,
fitness for purpose, and
continued safety

compliance of:
installations or
systems in operation.

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Introduction

The general requirements with which these bodies are required to


comply in order that their services are accepted by clients and by
supervisory authorities are harmonized in this International
Standard.

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Introduction

The International Standard covers the activities of inspection


bodies whose work can include:
the examination of:
o materials,
o products,
o installations,
o plants,
o processes,
o work procedures or
o services and
the determination of their conformity with requirements and
the subsequent reporting of results of these activities to:
o clients and, when required,
o to authorities.

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Introduction

Inspection can concern all stages during the lifetime of these


items, including the design stage. Such work normally requires
the exercise of professional judgment in performing inspection,
in particular when assessing conformity with general
requirements.

Inspection activities can overlap with testing and certification


activities where these activities have common characteristics.
However, an important difference is that many types of
inspection involve professional judgment to determine
acceptability against general requirements, for which reason the
inspection body needs the necessary competence to perform the
task.

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Introduction

Inspection can be an activity embedded in a larger process


(surveillance in a product certification scheme)

Inspection can be an activity that precedes maintenance

Inspection can simply provides information about the inspected


item with no determination of conformity with requirements. In
such cases further interpretation might be needed.

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Introduction

The categorization of inspection bodies as type A, B and C is a


measure of independence.

Demonstrable independence of inspection body can strengthen


the confidence of the inspection bodys client with respect to the
bodys ability to carry out inspection work with impartiality.

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ISO / IEC 17020 : 2012
Contents
1.Scope
2.Normative references
3.Terms and definitions
4.General requirements
5.Structural requirements
6.Resource requirements
7.Process requirements
8.Management system requirements
Annex A ( Normative) Independence requirements
Annex B ( informative )

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ISO / IEC 17020 : 2012

1. Scope
Competence of bodies performing inspection, impartiality
and consistency of inspection activities

The stages of inspection (design, type examination, initial


inspection, in-service inspection, surveillance)

2. Normative references
ISO/ IEC 17000 Conformity assessment Vocabulary
and general principles

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ISO / IEC 17020 : 2012

3. Terms and Definitions

Inspection (product, process, service, installation)


Products are not only engineering products
Process, service
Inspection body
Inspection system and inspection schemes
Impartiality
Appeal and complaint

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ISO / IEC 17020 : 2012

4. GENERAL REQUIREMENTS

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4.1 Impartiality & independence

4.1.1. Inspection activities undertaken impartially


4.1.2. Commercial, financial or other pressures to compromise
impartiality
4.1.3. Identify Risks to impartiality on an on going basis risks
that arising from IBs activities, its relationships, or from the
relationships of its personnel.
NOTE: A relationship that compromises the impartiality of the
Inspection Body can be based on ownership, governance,
management, personnel, shared resources, finances,
contracts, marketing (including branding), and payment of a
sales commission or other inducement for the referral of
new customers, etc.
4.1.4. Demonstrate how it eliminates or minimizes such risk

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4.1 Impartiality & independence

4.1.5. Top management commitment to impartiality


4.1.6. Independent to the extent that is required with
regard to conditions under which it performs
inspection
Third party Type A meets the requirements Annex A.1
First party or second party or both separate,
identifiable and supplies to parent - Type B (in house IB
Annex A.2
First party or second party or both identifiable but not
necessarily separate - supplies to parent/ others Type
C meets the requirements Annex A.3

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4.2 Confidentiality

4.2.1. Legally enforceable commitment for the management of


information obtained or created during the performance of
inspection activities.

Information placed in the public domain - inform the client in


advance.

Except for information that the customer makes publicly


available, or when agreed between the inspection body and
the customer (e.g. for the purpose of responding to
complaints).

All other information considered proprietary information and


regarded as confidential.
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4.2 Confidentiality

4.2.2. Releasing confidential information (by law or contractual


commitments)- the client, unless prohibited by law, is
notified of the information provided

4.2.3. Information about the client obtained from other sources -


treated as confidential

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ISO / IEC 17020 : 2012

5. STRUCTURAL REQUIREMENTS

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5.1 Administrative requirements

5.1.1. Legal entity or defined part of a legal entity

NOTE: A governmental inspection body is deemed to


be a legal entity on the basis of its governmental
status

5.1.2. Part of a legal entity involved in activities other


than inspection identifiable within that entity

5.1.3. Documentation which describes the activities for


which it is competent

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5.1 Administrative requirements

5.1.4. Adequate provision to cover liabilities arising from


its operations (e.g. insurance or reserves)

NOTE: The liability can be assumed by the State in


accordance with national laws or by the
organization of which the inspection body forms
a part.

5.1.5. Documentation describing the contractual


conditions
Except when it provides inspection services to
the legal entity of which it is a part

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5.2 Organisation and management

5.2.1. Structured and managed to safeguard impartiality

5.2.2. Organised and managed to maintain capability to


perform inspection
NOTE: Inspection schemes can require that the inspection body
participates in the exchange of technical experience with
other inspection bodies to maintain this capability.

5.2.3. Define and document the responsibilities and reporting


structure of the organization

5.2.4. Define relationship between legal entity activities and IB


(part of legal entity) activities

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5.2 Organisation and management

5.2.5. Availability of one or more person(s) as technical


manager(s), that have overall responsibility to
ensure that the inspection activities are carried
out in accordance with this International Standard.
Technically competent and experienced in the
operation of the inspection body

5.2.6. Deputies in the absence of any technical


manager responsible for on-going inspection
activities

5.2.7. Description of the job(s) or other documentation


for each position category within its organization
involved in inspection activities
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ISO / IEC 17020 : 2012

6. RESOURCE REQUIREMENTS

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6. 1 Personnel

6.1.1. Defined competence requirements for all


personnel involved in inspection activities.

NOTE: The competence requirements can be part of the


job description or other documentation mentioned
in 5.2.7.

6.1.2. Sufficient number of persons (employ or have


contracts) - with the required competencies,
including, where needed, the ability to make
professional judgements, to perform the type,
range and volume of its inspection activities

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6. 1 Personnel

6.1.3. Personnel responsible for inspection - Qualifications,


training, experience and knowledge (relevant knowledge in
details)- manufacturing of products, operation of process,
delivery of services.
Relevant knowledge of:
the technology used for the manufacturing of the
products inspected, operation of processes and
delivery of services

the way in which products are used, processes are


operated and services delivered and

any defects which may occur during the use of the


product, any failures in the operation of the process
and any deficiencies in the delivery of services
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6. 1 Personnel

6.1.4.Each person knows clearly their:


duties
responsibilities and
authorities

6.1.5. Documented procedure for:


selecting
training
formally authorising and
monitoring

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6.1 Personnel

6.1.6. Documented procedures for training


a) an induction period;
b) a mentored working period with experienced
inspectors; and
c) continuing training to keep pace with developing
technology and inspection methods.

6.1.7. Training required depends upon the ability,


qualifications and experience of each inspector and
other personnel involved in inspection activities and
upon the results of monitoring

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6. 1 Personnel

6.1.8 Personnel familiar with the inspection methods and


procedures monitor all inspectors and other
personnel involved in inspection activities for
satisfactory performance.
Results of monitoring used as one means to identify
training needs
NOTE: Monitoring can include a combination of techniques
such as on-site observations, report reviews,
interviews, simulated inspections and other
techniques to assess performance and will depend
on the nature of inspection activities.

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6. 1 Personnel

6.1.9. Each inspector observed on-site unless there is


sufficient supporting evidence that the inspector is
continuing to perform competently
NOTE: It is expected that on-site observations are performed in a
way that minimizes the disturbance of the inspections,
especially from the customers viewpoint.

6.1.10. Records of monitoring, education, training, technical


knowledge and experience

6.1.11. Personnel involved in inspection activities remunerated


preventing influence of inspection results

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6. 1 Personnel

6.1.12. All personnel of the Inspection Body, either


internal or external, that could influence the
inspection activities, act impartially

6.1.13. All personnel of the inspection body including


sub-contractors, personnel of external bodies, or
individuals acting on the IBs behalf keeping
confidential all information obtained or created
during the performance of the inspection activities,
except as required by law - Reduce the potential
of compromises by pressures- and maintain
confidentiality.

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6.2 Facilities & equipment

6.2.1. Available suitable and adequate facilities and equipment


competent and safe manner

NOTE: The inspection body need not be the owner of the facilities or equipment
that it uses. Facilities and equipment can be borrowed, rented, hired,
leased or provided by another party (e.g. the manufacturer or installer of
the equipment). However, the responsibility for the suitability and the
calibration status of the equipment used in inspection, whether owned by
the inspection body or not, lies solely with the inspection body.

6.2.2. Rules for the access to and the use of specified facilities and
equipment

6.2.3. Ensure continued suitability of the facilities and the equipment

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6.2 Facilities & equipment

6.2.4. Define equipment having a significant influence on the


results of the inspection, and, where appropriate,
uniquely identified

6.2.5. All equipment (6.2.4) properly maintained, in


accordance with documented procedures and
instructions

6.2.6. Measurement equipment having a significant influence


on the results of the inspection calibrated:
before being put into service and
thereafter according to an established programme

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6.2 Facilities & equipment

6.2.7. Overall programme of calibration of equipment


designed and operated to ensure that, wherever
applicable, measurements traceability to national,
international standards.
Where traceability is not applicable - evidence of
correlation or accuracy of inspection results

6.2.8. Reference standards used for calibration only -


reference standards of measurement calibrated
providing traceability to a national or International
Standard of measurement

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6.2 Facilities & equipment

6.2.9. Equipment subjected to in service checks between


recalibration

6.2.10. Reference materials traceable to national or


International Standard reference materials

6.2.11. Procedure for the outcome of inspection activities for:


a) selection and approval of suppliers;
b) verification of incoming goods and services
c) ensuring appropriate storage facilities

6.2.12. Condition of stored items assessed at appropriate


intervals to detect deterioration

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6.2 Facilities & equipment

6.2.13. Ensure:
a) computer software is adequate for use
b) integrity and security of data
c) computer and automated equipment is maintained

6.2.14. Documented procedure for defective equipment


appropriate corrective action in case the defective
equipment effected previous inspections

6.2.15. Records for calibration - maintenance

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6.3 Sub contracting

6.3.1. IB shall itself normally perform inspections that it contracts to undertake.


Sub contractor must be competent
NOTE 1 Reasons to sub-contract can be
I. an unforeseen or abnormal overload,
II. key inspection staff members are incapacitated or
III. key facilities or items of equipment are temporarily unfit for use
or
IV. part of the contract from the client involves inspection not
covered by the inspection bodys scope or
V. is beyond the capability or
VI. resources of the inspection body.
6.3.2. Inform the customer for sub contracting
6.3.3. Responsibility for determination of conformity rests with the inspection
body
6.3.4. Records of competence of sub contractors (list for subcontractors)

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ISO / IEC 17020 : 2012

7. PROCESS REQUIREMENTS

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7.1 Inspection methods & procedures

7.1.1. Methods and procedures which are defined in specific


inspection requirements, (laws, standard, or developed by IB)

7.1.2. Documented instructions on inspection planning, sampling


procedures and inspection techniques, where the absence of
such instructions could jeopardize the effectiveness of the
inspection process

7.1.3. Inspection methods or procedures which are Non-standard -


appropriate and fully documented

7.1.4. Instructions, standards or written procedures, worksheets,


check lists and reference data relevant to the work of the
inspection body maintained up-to-date and be readily
available to the personnel

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7.1 Inspection methods & procedures

7.1.5. Contract or work order control system ensures that:


a. Work to be undertaken is within its expertise and that the
organization has adequate resources to meet the
requirements;

b. The requirements of those seeking the inspection body's


services are adequately defined and that special conditions
are understood so that unambiguous instructions can be
issued to personnel performing the duties to be required

c. Work being undertaken is controlled by regular review and


corrective action

d. The requirements of the contract or work order have been


met

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7.1 Inspection methods & procedures

7.1.6. Verification of integrity of information supplied


by any other party as part of the inspection
process

7.1.7. Observations or data obtained in the course of


inspections recorded in a timely manner to
prevent loss of relevant information

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7.1 Inspection methods & procedures

7.1.8. Calculations and data transfer shall be


subjected to appropriate checks

NOTE: Data can include textual material, digital data


and anything else that is transferred from one
location to another where errors could be
introduced.

7.1.9. Documented instruction for carrying out


inspections safely

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7.2 Handling inspection samples & items

7.2.1. Items and samples to be inspected are uniquely


identified to avoid confusion regarding the identity of
such items and samples

7.2.2. Establishment whether the item to be inspected has


been prepared (equipment, personnel etc. )

7.2.3. Notifying abnormalities


Where there is any doubt as to the item's suitability for the
inspection to be carried out, or where the item does not
conform to the description provided, the IB shall contact the
customer and record the outcome before proceeding

7.2.4. Documented procedures to avoid deterioration and


damage

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7.3 Inspection Records

7.3.1. Maintain record system to demonstrate the effective


fulfillment of the inspection procedures and enable an
evaluation of the inspection

7.3.2. Traceability of reports and certificates


traceable to the inspector(s) who performed the
inspection?

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7.4 Inspection reports &certificates

7.4.1. The work carried out by the Inspection Body covered by


retrievable reports / certificates

7.4.2. Content of inspection reports


a) identification of the issuing body;
b) unique identification and date of issue;
c) date(s) of inspection;
d) identification of the item(s) inspected;
e) signature or other indication of approval, by authorized
personnel;
f) a statement of conformity where applicable; and
g) the inspection results except where detailed in
accordance with clause 7.4.3.
Note: (see Annex B for optional elements)
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7.4 Inspection reports &certificates

7.4.3. Conditions for issuing inspection certificates without


including results - traceability has to be assured

7.4.4. Information (7.4.2) reported correctly, accurately, and


clearly - clearly identified results supplied by sub-
contractors

7.4.5. Corrections or additions to an inspection report or


inspection certificate - the amended report or
certificate identifying the report or certificate it replace

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7.5 Complaints & appeals

7.5.1. Documented processto receive, evaluate and make


decisions on complaints and appeals

7.5.2. Availability to interested parties on request - description of


the handling process

7.5.3. Confirmation whether the complaint relates to inspection


activities responsible

7.5.4. Responsibility for decisions at all levels of the handling


process

7.5.5. Investigation and decision shall not result in any


discriminatory actions

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7.6 Compliant & appeals process

7.6.1. The handling process


a) a description of the process for receiving, validating,
investigating the complaint or appeal, and deciding what actions
are to be taken in response to it
b) tracking and recording complaints and appeals, including
actions undertaken to resolve them
c) ensuring that any appropriate action is taken

7.6.2. Gathering & Verifying all information to validate the


complaint / appeal
7.6.3. Acknowledging receipt, reporting progress and outcome
to complainant
7.6.4. Independence of personnel who make decisions
7.6.5. Giving formal notice of the end of the process

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ISO / IEC 17020 : 2012

8 MANAGEMENT SYSTEM
REQUIREMENTS

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8.1 Options

8.1.1. A management system that is


capable of achieving the consistent
fulfilment of the requirements of this
international standard ( i.e. ISO / IEC
17020)

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8.1 Options

8.1.2. Option A
Specified requirements ( 8.3 8.8 and 7.5 and
7.6)

8.1.3. Option B
A management system in accordance with the
requirements of ISO 9001, and that is capable of
supporting and demonstrating the consistent
fulfilment of the requirements of this international
standard (i.e. ISO / IEC 17020) - fulfils the
management system section (Section 8.2-8.8)
requirements

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8.1 Options

8.1.2. Option A
General management system documentation
(e.g., manual, policies, definition of
responsibilities 8.2);
Control of documents (8.3);
Control of records (8.4);
Management review (8.5);
Internal audit (8.6);
Corrective actions (8.7);
Preventive actions (8.8);
Complaints and appeals (see 7.5 and 7.6).

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8.2 Management system documentation
(Option A)

8.2.1. Establish, document, and maintain policies and


objectives
8.2.2. Top management commitment to the development
and implementation of the management system
8.2.3. Member of management appointed for
a) Ensuring that processes and procedures needed for
the management system are established,
implemented and maintained, and
b) Reporting to top management on the performance of
the management system and any need for
improvement.
8.2.4. Documentation of the management system
8.2.5. Personnel involved in inspection activities have
access to the parts of the management system
documentation their responsibilities .

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8.3 Control of documents

8.3.1. Procedures to control the documents


8.3.2. Definition of controls needed to:
a) Approve documents for adequacy prior to issue
b) Review and update as necessary and re-approve documents
c) Ensure that changes and the current revision status of documents
are identified
d) Ensure that relevant versions of applicable documents are available
at points of use
e) Ensure that documents remain legible and readily identifiable
f) Ensure that documents of external origin are identified and their
distribution controlled and
g) Prevent the unintended use of obsolete documents, and to apply
suitable identification to them if they are retained for any purpose.

NOTE: Documentation can be in any form or type of medium and includes


proprietary and in-house developed software.

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8.4 Control of records

8.4.1 Establish procedures to


define the controls needed for
the identification,
storage,
protection,
retrieval,
retention time and
disposition of its records
8.4.2. Establish procedures for retaining records for a
period consistent with its contractual and legal
obligations
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8.5 Management review

8.5.1 Procedures to review its management system ensure


its continuing suitability, adequacy and effectiveness
(conducted at least once a year, records)
8.5.2. Review inputs
a) Results of internal and external audits
b) Feedback from customers and interested parties
c) The status of preventive and corrective actions
d) Follow-up actions from previous management reviews
e) The fulfilment of objectives
f) Changes that could affect the management system and
g) Appeals and complaints.

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8.5 Management review

8.5.3. Review outputs decisions and actions related to:

a) Improvement of the effectiveness of the


management system and its processes

b) Improvement of the inspection body related


to the fulfilment of this international standard
and

c) Resource needs.

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8.6 Internal audits

8.6.1 Procedures for internal audits to verify that it


fulfils the requirements of this International
Standard and that the management system is
effectively implemented and maintained
NOTE: ISO 19011 provides guidelines for conducting
internal audits

8.6.2. Audit programm taking into consideration the


importance of the processes and areas to be
audited, as well as the results of previous audits

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8.6 Internal audits

8.6.3. Conduct periodic internal audits covering all


procedures in a planned and systematic manner,
to verify that the management system is
implemented and is effective.

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8.6 Internal audits

8.6.4. Least once every 12-months


8.6.5. Ensure that
a) Internal audits are conducted by qualified
personnel
b) Auditors do not audit their own work
c) Personnel responsible for the area audited are
informed
d) Actions resulting from internal audits - in a timely
& appropriate manner
e) Identified opportunities for improvement and
f) Documented results of the audit?

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8.7 Corrective actions

8.7.1 Procedures for identification and management of


non-conformities

8.7.2. Eliminate the causes of non-conformities in order


to prevent recurrence

8.7.3. Appropriate to the impact of the problems


encountered

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8.7 Corrective actions

8.7.4. Procedures define requirements for:


a) Identifying non-conformities
b) Determining the causes of non-conformity
c) Correcting non-conformities
d) Evaluating the need for actions to ensure that
non-conformities do not recur
e) Determining and implementing in a timely
manner, the actions needed
f) Recording the results of actions taken and
g) Reviewing the effectiveness of corrective
actions

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8.8 Preventive actions

8.8.1 Procedures for taking preventive actions to


eliminate the causes of potential non-conformities

8.8.2. Appropriate preventive actions taken to the


probable impact of the potential problems

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8.8 Preventive actions

8.8.3. Procedure defines requirements for:

a) Identifying potential non-conformities and their


causes
b) Evaluating the need for action to prevent the
occurrence of non-conformities
c) Determining and implementing the action
needed
d) Recording the results of actions taken and
e) Reviewing the effectiveness of the preventive
actions taken.
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Annex A ( Normative) Independence
requirements

Requirements for inspection bodies ( Type A)

Requirements for inspection bodies ( Type B)

Requirements for inspection bodies ( Type C)

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Annex B ( informative )

Optional elements of inspection reports and certificates

Designation of document

Description of the work ordered

What has been omitted

Inspection methods & procedures

Equipment

Sampling methods

TAIEX Workshop on Better Understanding the


Requirements for Accreditation
Cairo 7-8 September 2015
Annex B ( informative )

Optional elements of inspection reports and certificates


Where the inspection was carried out

Environmental conditions

Statement on inspection results

Statement on conditions for reproducing the report

Inspectors mark or seal

Names / identification of those who performed the


inspection

TAIEX Workshop on Better Understanding the


Requirements for Accreditation
Cairo 7-8 September 2015

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