ISO/IEC 17020 INSPECTION BODY

ACCREDITATION
REQUIREMENTS

AUTHORITY: VICE PRESIDENT

EFFECTIVE DATE: 2015/07/13
DOCUMENT NUMBER: MA 2004

TABLE OF CONTENTS

Foreword........................................................................................................................................ 3
1. Application ................................................................................................................................ 4
2. Surveillance Assessment ........................................................................................................... 5
3. Witnessed Inspections............................................................................................................... 5
4. Locations Performing Key Activities ...................................................................................... 6
5. Scope of Accreditation .............................................................................................................. 6
6. Traceability and Measurement Uncertainty .......................................................................... 6
7. Proficiency Testing.................................................................................................................... 8
8. Guidance on the Application of ISO/IEC 17020 .................................................................... 9
9. IFS Food Store Inpsection Body Accreditation Program Requirements ............................ 9
Example of ANAB Inspection Body Scope of Accreditation .................................................. 11

Page 2 of 11

FOREWORD
This manual and MA 2001, ANAB Accreditation Manual for Laboratory-related Programs, define all
mandatory requirements for ISO/IEC 17020 accreditation (except for forensics1). This manual is based on
the current versions of ISO/IEC 17020, Conformity assessment Requirements for the operation of
various types of bodies performing inspection, and ILAC P15, Application of ISO/IEC 17020 for the
Accreditation of Inspection Bodies.
For more information, contact the ANSI-ASQ National Accreditation Board, 500 Montgomery Street,
Suite 625, Alexandria, Virginia, 22314, USA, telephone 703-836-0025, facsimile 703-836-0040,
www.anab.org.
See also ANAB Guidance on ISO/IEC 17020 Inspection Body Accreditation.
All references to ISO, ILAC, and ANAB documents and other controlled materials are to the current
issues of the documents. Most ANAB documents are accessible free of charge at www.anab.org. ILAC
documents are accessible free of charge at www.ilac.org.

Requirements for forensic inspection bodies are found in MA 3012, ANAB ISO/IEC 17020 Accreditation Requirements for
Forensic Inspection Bodies.

Page 3 of 11

1. APPLICATION
1.1. Inspection areas for which accreditation may be applied include but are not limited to:

Agricultural Products
Bulk Cargoes (e.g., petroleum, coal)
Cargoes in Containers and Packages
Cast Products
Chemical
Construction Materials, Products and Processes (e.g., wood, roofing material, composite material)
Cranes
Electrical and Electronic Products, Systems, Components
Foods
Forged Products
Gas
Mechanical/Machinery
Pipelines
Protective Coatings
Rolled Products
Structures (Fabrication Shop, Pre-shipments and In-situ inspections, Steel, Concrete)
Textiles
Welding
Other

1.2. An application is required and should be submitted in electronic format when possible and include the
following:

Locations to be covered by the accreditation, which should include all locations from which key
activities are performed (see IAF/ILAC A5, section M 7.5.7.1, for guidance)
Proposed scope of accreditation
Quality manual and associated operating procedures, however named
Inspection methods and procedures for each category of inspection
Organizational structure
List of proficiency testing activities, if applicable
Completed draft scope of accreditation for inspection bodies
List of all equipment used for inspection services (the inspection services that you wish to have
accredited) and note the equipment calibrated in-house and the equipment calibrated externally by a
commercial calibration laboratory; if the equipment is calibrated externally, all available information
on the calibrating organization
Matrix showing names of inspection staff, date of employment, initial date of acquiring a
particular technical competency, and renewal/ongoing revalidation, if any

1.3. ANAB accreditation activities shall be confined to the draft scope of accreditation.

Page 4 of 11

2. SURVEILLANCE ASSESSMENT
2.1. ANAB accreditation is for two years. After the initial year of accreditation, each inspection body
shall undergo, at a minimum, a one-day surveillance assessment to ensure that the inspection bodys
organizational management system is maintained and remains effective.

3. WITNESSED INSPECTIONS
3.1. To ascertain the effectiveness of the inspection bodys procedures and technical competence in the
scope of accreditation, ANAB witnesses the inspection activities. To ensure the integrity of the process,
for each witnessed inspection, the ANAB assessor at a minimum must be able to determine that the
inspector:

Has the competence required for the inspection performed.

Is competent consistent with the competence criteria.
Has been provided the necessary procedures, inspection methods, and equipment.
Fulfills all requirements of the inspection procedures.
Reports the findings truthfully and accurately.
Completes the inspection records in accordance with ISO/IEC 17020, ILAC P15, any applicable
conformity assessment scheme2 requirements, and the procedures of the inspection body.

3.2. The ANAB assessor acts as an observer and takes no action to influence the outcome of the
inspection.
3.3. An ANAB Accreditation Manager determines the number of witnessed inspections required at the
beginning of each accreditation cycle. Unless specified by a scheme owner or agreed on by the
Accreditation Manager, ANAB will conduct at a minimum two witnessed inspections per scope area for
initial accreditation and one witnessed inspection per scope area for reassessment.
3.4. The number of required witnessed inspections is decided based on:

Fields and types of inspection

Key locations of the inspection body
Extent of technical judgment required
Number of inspectors
Frequency of inspections
Required competence of inspectors (e.g., professional certification)

3.5. All required witnessed inspections must be completed within the reassessment cycle.

As defined in ISO/IEC 17000:2004, a conformity assessment system related to specified objects of conformity assessment, to
which the same specified requirements, specific rules, and procedures apply. Conformity assessment schemes may be operated at
international, regional, national, or sub-national level. The scheme owner, typically an organization, determines the requirements
of the scheme.

Page 5 of 11

3.6. Selection of inspections to be witnessed depends on:

Experience and qualification of the inspector

Geographical locations
Extent of technical judgment required
Previous witnessed inspections
Results of the on-site assessment
Any complaints received
Scheme requirements

3.7. ANAB reserves the right to increase the number of required witnessed inspections if there is evidence
at any time indicating the inspection body may not be competent to carry out its activities.
3.8. The inspection body shall have enforceable arrangements with its customers to ensure ANAB access
to conduct witnessed inspections.
3.9. The inspection body shall notify ANAB when an organization refuses a witnessed inspection.
Depending on the reason for the refusal, the inspection body may not be allowed to conduct the activity as
an ANAB-accredited inspection.
3.10 During ANABs witnessing of an inspection activity, the ANAB assessor shall not agree to any
release of responsibility for safety, and is expected to take immediate action to avoid injury, including
leaving the area if necessary.

4. LOCATIONS PERFORMING KEY ACTIVITIES

4.1. The head office and all locations from which key activities (defined in IAF/ILAC A5, section M
7.5.7.1) are performed shall be visited during the initial assessment.
4.2. Locations that conduct activities described in IAF/ILAC A5, section M 7.5.7.1, shall be assessed at
least once during every four-year period after the initial assessment.

5. SCOPE OF ACCREDITATION
5.1. The scope of accreditation is a document specifically stating the disciplines or parameters that have
been verified by ANAB.
5.2. ANAB requires scopes of accreditation to meet the current version of NIST SP 811, Guide for the
Use of the International System of Units (SI), which was prepared to assist in the use of SI, including the
reporting of results of measurements. NIST SP 811 can be accessed on ANABs website.

6. TRACEABILITY AND MEASUREMENT UNCERTAINTY

6.1. All equipment used for measurements and/or tests, where the results of such measurements and/or
tests have a significant influence on the results of the inspection (i.e., the conclusion about conformance
with requirements) shall be traceably calibrated. In such instances, the ANAB policy on traceability shall
apply.

Page 6 of 11

6.2. Definitions
6.2.1. Metrological traceability: Property of a measurement result whereby the result can be related to
a reference through a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty. [JCGM 200:2012]
6.2.2. Measurand: Quantity intended to be measured. [JCGM 200:2012(E/F)]
6.2.3. Measurement uncertainty (MU): Non-negative parameter characterizing the dispersion of the
quantity values being attributed to a measurand, based on the information used. [JCGM
200:2012(E/F)]
6.2.4. Calibration and measurement capability (CMC): Calibration and measurement capability
available to customers under normal conditions (a) as published in the BIPM key comparison
database (KCDB) of the CIPM MRA or (b) as described in the laboratorys scope of accreditation
granted by a signatory to the ILAC Arrangement. [CIPM MRA-D-04, Version 2 (2011), Calibration
and Measurement Capabilities in the context of the CIPM.]
6.3. Traceability
6.3.1. Traceability is a process whereby the indication of a measuring instrument (or a material
measure) can be compared with a national standard for the measurand in question in one or more
stages.
6.3.2. Traceability is characterized by a number of essential elements:

There must be an unbroken chain of comparisons going back to a standard acceptable to the
parties, usually a national or international standard, and ending with laboratory working
reference standards used in a metrology laboratory.
MU for each step in the traceability chain must be calculated according to defined methods
and must be stated so an overall uncertainty for the whole chain can be calculated.
Each step in the chain must be performed according to documented and generally
acknowledged procedures. The results must be equally documented (calibration certificate or
test report).
Laboratories performing one or more steps in the chain must supply evidence of their
technical competence. Accreditation by an ILAC signatory accreditation body is considered
evidence of technical competence within the scope of accreditation.

6.3.3. Use of Non-accredited Laboratories for Traceability

6.3.3.1. Laboratories could receive calibration certificates from non-accredited laboratories
(including OEMs) when there is no other source or economical means to have a standard
calibrated. In this case, the laboratory should encourage the provider to achieve accreditation to
ISO/IEC 17025. The provider may be considered acceptable for traceability if the laboratory
submits acceptable information to ANAB for review (see below).
6.3.3.2. The provider must meet a number of essential elements for traceability. At a minimum,
the laboratory seeking permission to use the non-accredited provider must provide to ANAB:

An unbroken chain of comparisons going back to a standard acceptable to the parties,

usually a national or international standard.

Page 7 of 11

Proof that measurement uncertainty throughout the traceability chain has been calculated
according to accepted methods and stated so an overall uncertainty for the whole chain
can be calculated.
Proof that each step in the chain has been performed according to documented and
generally acknowledged procedures, including documenting results (before and after
data).
Evidence of technical competence of the non-accredited providers.
Proof that traceability is to SI units.
Evidence that calibrations have been repeated at appropriate intervals.

6.3.3.3. ANAB shall invoice the laboratory for review based on current assessment-day rates.
6.3.3.4. For additional guidance, see ANAB Guidance on Metrological Traceability and the
current version of ILAC P10, ILAC Policy on Traceability of Measurement Results.
6.3.4. Nonconformities for Traceability
6.3.4.1. ANAB shall issue a nonconformity (NC) against clause 5.6 of ISO/IEC 17025 if
evidence exists that instruments have been calibrated using a provider not compliant with the
traceability requirements of ILAC P10 and this document. An NC also shall be issued against
the same element if evidence exists that instruments have been calibrated by a laboratory
accredited by an accreditation body that is not a signatory of an ILAC or ILAC-approved
regional cooperation MRA or by a laboratory that has not provided an accredited certificate
of calibration or is not accredited specifically for the parameter calibrated. The severity of the
NC depends on the effect on the resultant calibrations done with that device and other
considerations.

7. PROFICIENCY TESTING
7.1. While proficiency testing is an integral part of laboratory accreditations worldwide, it is not
necessarily relevant in many circumstances in the inspection body arena. However, inspection bodies are
expected to participate in proficiency testing where relevant.
7.2. For inspection bodies where it is relevant and where available proficiency testing programs exist,
annual participation is expected. In addition, for inspection bodies accredited for multiple major sub-areas
(see Inspection Body Major Areas of Accreditation on the ANAB ISO/IEC 17020 application),
proficiency testing participation is required in each major sub-area at least once every four years. If
governmental or industry-specific requirements dictate that other testing comparisons or other frequency
of comparisons be performed, the inspection body is held to those requirements as well. Such
participation may replace the annual and four-year requirements.
7.3. During the accreditation process, surveillance, and reassessments, ANAB assessors review all related
proficiency testing activities and nonconformities and corrective action that arise from these activities.
The inspection body needs to provide reports, data, and evidence of related activities at each ANAB visit.
ANAB requires the inspection body to take prompt action on any issues or problems identified through
proficiency testing comparisons.

Page 8 of 11

7.4. For proficiency testing programs that report results in the form of number of standard deviations from
the mean of all results, in most cases three or more standard deviations is considered an outlier and
requires corrective action. For inspection bodies that participate in proficiency testing and a failure or
outlier result, the inspection body in most cases is expected to repeat participation in such testing in a
reasonable timeframe. If the repeat participation results in unsatisfactory reporting a second time, this
may result in removal of that inspection area from the scope of accreditation. Subsequent satisfactory
results may initiate a process to reinstate an area on the scope of accreditation.

8. GUIDANCE ON THE APPLICATION OF ISO/IEC 17020

8.1. The current version of ILAC P15, Guidance on the Application of ISO/IEC 17020 for the
Accreditation of Inspection Bodies, provides guidance on the requirements of ISO/IEC 17020 and is
mandatory for all ANAB applicant and accredited inspection bodies.
8.2. The guidance and interpretations found in ILAC P15 form the basis of mutual recognition
arrangements between accreditation bodies, and are considered necessary for consistent application of
ISO/IEC 17020.
8.3. The term shall is used in ILAC P15 to indicate mandatory provisions. The term should indicates
non-mandatory provisions provided as a recognized means of meeting requirements.

9. IFS FOOD STORE INPSECTION BODY ACCREDITATION PROGRAM

REQUIREMENTS
9.1. This section contains additional mandatory program requirements for IFS Food Store inspection body
accreditation.
9.2. All organizations accredited under the IFS Food Store inspection body accreditation program shall
demonstrate compliance with ISO/IEC 17021, ILAC P15, and applicable requirements in the IFS Food
Store Inspection standard for evaluating the food safety in retail stores.
9.3. Only type A and type C inspection bodies as defined in ISO/IEC 17020 shall be accredited under this
program.
9.4. For purposes of the requirements in this section, the definition of sites where essential activities are
carried out is equivalent to the definition of locations with key activities in ISO/IEC 17011 and
IAF/ILAC A5.
9.5. Initial Accreditation
9.5.1. ANAB conducts an on-site assessment of the head office and all sites where essential activities
are carried out and at least one witnessed inspection of the IFS Food Store inspection performed by
the applicant.
9.5.2. During the on-site assessment, the ANAB assessment team reviews all previously performed
inspections and at least one full inspection process.

Page 9 of 11

9.5.3. The inspection body is allowed to perform only a maximum of five inspections before
obtaining accreditation. Approval must be obtained from International Featured Standards Food Store
program (the scheme owner) to perform more than five inspections before obtaining accreditation.
9.6. Maintenance of Accreditation
9.6.1. ANAB assesses all sites from which essential activities are carried out within the two-year
cycle, with no more than two years between each on-site visit.
9.6.2. A maximum of three months from the anniversary date of an on-site assessment is allowed in
scheduling the next activity for a location.
9.6.3. Reassessments
9.6.3.1. During reassessments, ANAB will sample the following at a minimum:

10% or two IFS Food Store qualified inspector files, in accordance with the sampling
method that provides the largest number
Two IFS Food Store inspection files or 2% of IFS Food Store inspections performed, in
accordance with the sampling method that provides the largest number
At least one full inspection process

9.6.4. Witnessed Inspections

9.6.4.1. ANAB will witness at least one IFS Food Store inspection every two years. The number
and frequency of witnessed inspections will be based at a minimum on the number of inspectors,
inspection activities, risk factors, and performance of the accredited organization.
9.6.4.2. ANAB will sample inspectors and inspections sites to ensure adequate coverage of the
inspection bodys operations.

Page 10 of 11

EXAMPLE OF ANAB INSPECTION BODY SCOPE OF ACCREDITATION

Scope of Accreditation to ISO/IEC 17020:[year]

[Inspection Body Name]
[Street address, City, State ZIP]
[Contact Name] Phone: [phone number]
INSPECTION
Valid to: [date]

Certificate number: AI xxxx

I. Type A (Third-Party) Body

Field of Inspection
Product Design

Type and Range of Inspection

Method and Procedures
1. Boilers and Pressure Vessels API 510, additional jurisdictional
2.
requirements and referenced
industry standards and
specifications

Notes:
1. This scope is part of and must be included with the Certificate of Accreditation No. AI xxxx.

Page 11 of 11

Key Equipment Used