This document gives guidance and requirements for the assessment of conformity of compounds, products, joints and assemblies in accordance with the applicable part(s) of the ISO 16486 series which are intended to be included in the manufacturer’s quality plan as part of the quality management system and for the establishment of certification procedures.
NOTE 1    A basic test matrix in Annex B provides an overview of the testing scheme.
It is recommended for the manufacturer to have a management system such as ISO 9001[4] or equivalent.
NOTE 2    If certification is involved, certification bodies and inspection bodies operating according to ISO/IEC 17065 and ISO/IEC 17020 are considered to be competent.
In conjunction with the other parts of the ISO 16486 series (see Clause 2), this document is applicable to unplasticized polyamide (PA-U) piping systems intended to be buried and used for the supply of gaseous fuels. It is applicable to PA-U pipes, fittings and valves, as well as to their joints and to joints with components of other materials intended to be used under the following conditions:
a)    a maximum operating pressure (MOP) up to and including 18 bar[1] (the MOP is limited to 16 bar for CEN member countries, where ISO 16486-6 is replaced by CEN/TS 12007-6[1]);
b)    an operating temperature of 20 °C as the reference temperature.
NOTE 3    For operating temperatures different to 20 °C, derating coefficients can be used (see ISO 16486-6). CEN member countries use CEN/TS 12007-6[1] and ISO/TS 16486-7 (this document) as a basis, but they can also request additional requirements. For non-CEN member countries, information for dealing with special cases for PA-U can be found in ISO/TS 16486-7 (this document) and PPI TR-3.[7]
For mechanical fittings conforming to ISO 17885, guidance for assessment of conformity is not given in this document. When requested, a quality plan based on the tests mentioned can be set up in agreement between user and manufacturer.
The ISO 16486 series covers a range of maximum operating pressures and gives requirements concerning colours.
NOTE 4    It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.
[1] 1 bar = 0,1 MPa = 105 Pa; 1 MPa = 1 N/mm2.

  • Technical specification
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies the general principles of certification, including common procedures and requirements, for the certification of air quality monitoring equipment (AQME).
This document applies to the certification of AQME for ambient air quality and emissions from stationary sources for which performance criteria and test procedures are available in European Standards.
This document provides for the certification of AQME according to the requirements of EN ISO/IEC 17065:2012.
This document elaborates and supplements the requirements of EN ISO/IEC 17065:2012 for bodies certifying AQME. It specifies requirements on testing laboratories as well as the manufacturer’s quality management system (QMS) and the surveillance for the manufacturing process as part of the certification process.

  • Standard
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This Standard specifies the processing and quality assurance requirements for
brazing processes for space flight applications. Brazing is understood as the
joining and sealing of materials by means of a solidification of a liquid filler
metal.
The term brazing in this standard is used as equivalent to soldering, in cases that
the filler materials have liquidus temperatures below 450 °C.
Brazing and soldering are allied processes to welding and this standard is
supplementing the standard for welding ECSS-Q-ST-70-39.
This standard does not cover requirements for:
• Joining processes by adhesive bonding (ECSS-Q-ST-70-16),
• Soldering for electronic assembly purposes (ECSS-Q-ST-70-61),
• Soldering used in hybrid manufacturing (ESCC 2566000).
The standard covers but is not limited to the following brazing processes:
• Torch brazing,
• Furnace brazing,
• Dip Brazing and Salt-bath brazing,
• Induction Brazing.
This Standard does not detail the brazing definition phase and brazing pre-
verification phase, including the derivation of design allowables.
This standard may be tailored for the specific characteristic and constraints of a
space project in conformance with ECSS-S-ST-00.

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document — introduces conditions, constraints and resources necessary to evaluate a measurement method or a result; — defines an organizational scheme for the acquisition of trueness and precision data by study; — provides the necessary definitions, statistical model and principles for ISO 5725 (all parts). — is not applicable to proficiency testing or production of the reference item that has their own standards (ISO 13528, respectively and ISO Guide 35). This document is concerned exclusively with measurement methods which yield results on a continuous scale and give a single value as the test result, although this single value may be the outcome of a calculation from a set of observations. It defines values which describe, in quantitative terms, the ability of a measurement method to give a true result (trueness) or to replicate a given result (precision). Thus, there is an implication that exactly the identical item is being measured, in exactly the same way, and that the measurement process is under control. This document may be applied to a very wide range of test items, including gas, liquids, powders and solid objects, manufactured or naturally occurring, provided that due consideration is given to any heterogeneity of the test item. This document does not include methods of calculation that are described in the other parts.

  • Standard
    19 pages
    English language
    sale 15% off
  • Standard
    20 pages
    French language
    sale 15% off
  • Draft
    19 pages
    English language
    sale 15% off
  • Draft
    23 pages
    French language
    sale 15% off

This document gives guidance and requirements for the assessment of conformity of compounds, products, joints and assemblies in accordance with the applicable part(s) of the ISO 16486 series which are intended to be included in the manufacturer’s quality plan as part of the quality management system and for the establishment of certification procedures.
NOTE 1    A basic test matrix in Annex B provides an overview of the testing scheme.
It is recommended for the manufacturer to have a management system such as ISO 9001[4] or equivalent.
NOTE 2    If certification is involved, certification bodies and inspection bodies operating according to ISO/IEC 17065 and ISO/IEC 17020 are considered to be competent.
In conjunction with the other parts of the ISO 16486 series (see Clause 2), this document is applicable to unplasticized polyamide (PA-U) piping systems intended to be buried and used for the supply of gaseous fuels. It is applicable to PA-U pipes, fittings and valves, as well as to their joints and to joints with components of other materials intended to be used under the following conditions:
a)    a maximum operating pressure (MOP) up to and including 18 bar[1] (the MOP is limited to 16 bar for CEN member countries, where ISO 16486-6 is replaced by CEN/TS 12007-6[1]);
b)    an operating temperature of 20 °C as the reference temperature.
NOTE 3    For operating temperatures different to 20 °C, derating coefficients can be used (see ISO 16486-6). CEN member countries use CEN/TS 12007-6[1] and ISO/TS 16486-7 (this document) as a basis, but they can also request additional requirements. For non-CEN member countries, information for dealing with special cases for PA-U can be found in ISO/TS 16486-7 (this document) and PPI TR-3.[7]
For mechanical fittings conforming to ISO 17885, guidance for assessment of conformity is not given in this document. When requested, a quality plan based on the tests mentioned can be set up in agreement between user and manufacturer.
The ISO 16486 series covers a range of maximum operating pressures and gives requirements concerning colours.
NOTE 4    It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.
[1] 1 bar = 0,1 MPa = 105 Pa; 1 MPa = 1 N/mm2.

  • Technical specification
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document gives guidance and requirements for the assessment of conformity of compounds, products, joints and assemblies in accordance with the applicable part(s) of the ISO 16486 series which are intended to be included in the manufacturer’s quality plan as part of the quality management system and for the establishment of certification procedures. NOTE 1 A basic test matrix in Annex B provides an overview of the testing scheme. It is recommended for the manufacturer to have a management system such as ISO 9001[4] or equivalent. NOTE 2 If certification is involved, certification bodies and inspection bodies operating according to ISO/IEC 17065 and ISO/IEC 17020 are considered to be competent. In conjunction with the other parts of the ISO 16486 series (see Clause 2), this document is applicable to unplasticized polyamide (PA-U) piping systems intended to be buried and used for the supply of gaseous fuels. It is applicable to PA-U pipes, fittings and valves, as well as to their joints and to joints with components of other materials intended to be used under the following conditions: a) a maximum operating pressure (MOP) up to and including 18 bar[1] (the MOP is limited to 16 bar for CEN member countries, where ISO 16486-6 is replaced by CEN/TS 12007-6[1]); b) an operating temperature of 20 °C as the reference temperature. NOTE 3 For operating temperatures different to 20 °C, derating coefficients can be used (see ISO 16486-6). CEN member countries use CEN/TS 12007-6[1] and ISO/TS 16486-7 (this document) as a basis, but they can also request additional requirements. For non-CEN member countries, information for dealing with special cases for PA-U can be found in ISO/TS 16486-7 (this document) and PPI TR-3.[7] For mechanical fittings conforming to ISO 17885, guidance for assessment of conformity is not given in this document. When requested, a quality plan based on the tests mentioned can be set up in agreement between user and manufacturer. The ISO 16486 series covers a range of maximum operating pressures and gives requirements concerning colours. NOTE 4 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. [1] 1 bar = 0,1 MPa = 105 Pa; 1 MPa = 1 N/mm2.

  • Technical specification
    33 pages
    English language
    sale 15% off
  • Draft
    33 pages
    English language
    sale 15% off
  • Draft
    33 pages
    English language
    sale 15% off

This document provides a) a discussion of alternative experimental designs for the determination of trueness and precision measures including reproducibility, repeatability and selected measures of intermediate precision of a standard measurement method, including a review of the circumstances in which their use is necessary or beneficial, and guidance as to the interpretation and application of the resulting estimates, and b) worked examples including specific designs and computations. Each of the alternative designs discussed in this document is intended to address one (or several) of the following issues: a) a discussion of the implications of the definitions of intermediate precision measures; b) a guidance on the interpretation and application of the estimates of intermediate precision measures in practical situations; c) determining reproducibility, repeatability and selected measures of intermediate precision; d) improved determination of reproducibility and other measures of precision; e) improving the estimate of the sample mean; f) determining the range of in-house repeatability standard deviations; g) determining other precision components such as operator variability; h) determining the level of reliability of precision estimates; i) reducing the minimum number of participating laboratories by optimizing the reliability of precision estimates; j) avoiding distorted estimations of repeatability (split-level designs); k) avoiding distorted estimations of reproducibility (taking the heterogeneity of the material into consideration). Often, the performance of the method whose precision is being evaluated in a collaborative study will have previously been assessed in a single-laboratory validation study conducted by the laboratory which developed it. Relevant factors for the determination of intermediary precision will have been identified in this prior single-laboratory study.

  • Standard
    57 pages
    English language
    sale 15% off

This document provides detailed descriptions of statistical methods for proficiency testing providers to use to design proficiency testing schemes and to analyse the data obtained from those schemes. This document provides recommendations on the interpretation of proficiency testing data by participants in such proficiency testing schemes and by accreditation bodies.
The procedures in this document can be applied to demonstrate that the measurement results obtained by laboratories, inspection bodies, and individuals meet specified criteria for acceptable performance.
This document is applicable to proficiency testing where the results reported are either quantitative measurements or qualitative observations on test items.
NOTE The procedures in this document can also be applied for the assessment of expert opinion where the opinions or judgments are reported in a form which can be compared objectively with an independent reference value or a consensus statistic. For example, when classifying proficiency test items into known categories by inspection - or in determining by inspection whether proficiency test items arise, or do not arise, from the same original source - and the classification results are compared objectively, the provisions of this document that relate to nominal (qualitative) properties can be applied.

  • Standard
    100 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    93 pages
    English language
    sale 15% off
  • Standard
    100 pages
    French language
    sale 15% off

This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document establishes the principles for describing the quality of geographic data. It:
—    defines a well-considered system of components for describing data quality;
—    defines the process for defining additional, domain-specific components for describing data quality;
—    specifies components and the content structure of data quality measures;
—    describes general procedures for evaluating the quality of geographic data;
—    establishes principles for reporting data quality.
This document is applicable to data producers providing quality information to describe and assess how well a dataset conforms to its product specification and to data users attempting to determine whether or not specific geographic data are of sufficient quality for their particular application.
This document does not attempt to define minimum acceptable levels of quality for geographic data. Such information is usually present as a requirement in a data product specification, defined in accordance with ISO 19131, for example.

  • Standard
    112 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    108 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies general requirements for the competence and impartiality of proficiency testing (PT) providers and consistent operation of all proficiency testing schemes. This document can be used as a basis for specific technical requirements for particular fields of application. Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies and others can use these requirements in confirming or recognizing the competence of proficiency testing providers.

  • Standard
    36 pages
    English language
    sale 15% off
  • Standard
    41 pages
    French language
    sale 15% off
  • Draft
    36 pages
    English language
    sale 15% off
  • Draft
    36 pages
    English language
    sale 15% off
  • Draft
    40 pages
    French language
    sale 15% off

This International Standard gives a number of optimized test plans, the corresponding border lines and characteristics. In addition the algorithms for designing test plans using a spreadsheet program are also given, together with guidance on how to choose test plans.
This standard specifies procedures to test whether an observed value of
- failure rate,
- failure intensity,
- mean operating time to failure (MTTF),
- mean operating time between failures (MTBF),
conforms to a given requirement.
It is assumed, except where otherwise stated, that during the accumulated test time, the times to failure or the operating times between failures are independent and identically exponentially distributed. This assumption implies that the failure rate or failure intensity is assumed to be constant.
Four types of test plans are described as follows:
- truncated sequential probability ratio test (SPRT);
- fixed time/failure terminated test (FTFT);
- fixed calendar time terminated test without replacement;
- combined test.
This standard does not cover guidance on how to plan, perform, analyse and report a test. This information can be found in IEC 60300-3-5.
This standard does not describe test conditions. This information can be found in IEC 60605-2 and in IEC 60300-3-5.

  • Standard
    92 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    83 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This International Standard gives a number of optimized test plans, the corresponding border lines and characteristics. In addition the algorithms for designing test plans using a spreadsheet program are also given, together with guidance on how to choose test plans. This standard specifies procedures to test whether an observed value of - failure rate, - failure intensity, - mean operating time to failure (MTTF), - mean operating time between failures (MTBF), conforms to a given requirement. It is assumed, except where otherwise stated, that during the accumulated test time, the times to failure or the operating times between failures are independent and identically exponentially distributed. This assumption implies that the failure rate or failure intensity is assumed to be constant. Four types of test plans are described as follows: - truncated sequential probability ratio test (SPRT); - fixed time/failure terminated test (FTFT); - fixed calendar time terminated test without replacement; - combined test. This standard does not cover guidance on how to plan, perform, analyse and report a test. This information can be found in IEC 60300-3-5. This standard does not describe test conditions. This information can be found in IEC 60605-2 and in IEC 60300-3-5.

  • Standard
    92 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    83 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document establishes a guide to the use and understanding of Shewhart control chart approach to the methods for statistical control of a process. This document is limited to the treatment of statistical process control methods using only Shewhart system of charts. Some supplementary material that is consistent with Shewhart approach, such as the use of warning limits, analysis of trend patterns and process capability is briefly introduced. However, there are several other types of control charts which can be used in different situations.

  • Standard
    48 pages
    English language
    sale 15% off
  • Draft
    48 pages
    English language
    sale 15% off
  • Draft
    48 pages
    English language
    sale 15% off

This document specifies single sampling plans for lot-by-lot inspection under the following conditions:
a) where the inspection procedure is applied to a continuing series of lots of discrete products, all supplied by one producer using one production process;
b) where only a single quality characteristic, x, of these products is taken into consideration, which is measurable on a continuous scale;
c) where production is under statistical control and the quality characteristic, x, is distributed according to a normal distribution or a close approximation to the normal distribution;
d) where a contract or standard defines a lower specification limit, L, an upper specification limit, U, or both. An item is qualified as conforming if its measured quality characteristic, x, satisfies as appropriate one of the following inequalities:
1) x ≥ L (i.e. the lower specification limit is not violated);
2) x ≤ U (i.e. the upper specification limit is not violated);
3) x ≥ L and x ≤ U (i.e. neither the lower nor the upper specification limit is violated).
Inequalities 1) and 2) are cases with a single specification limit, and 3) is a case with double specification limits.
Where double specification limits apply, it is assumed in this document that conformity to both specification limits is equally important to the integrity of the product. In such cases, it is appropriate to apply a single AQL to the combined percentage of a product outside the two specification limits. This is referred to as combined control.

  • Standard
    114 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    107 pages
    English language
    sale 15% off
  • Standard
    110 pages
    French language
    sale 15% off

IEC 61124:2023 gives a number of optimized test plans, the corresponding border lines and characteristics. In addition, the algorithms for designing test plans using a spreadsheet program are also given, together with guidance on how to choose test plans.
This document specifies procedures to test whether an observed value of
failure rate,
failure intensity,
mean operating time to failure (MTTF),
mean operating time between failures (MTBF),  conforms to a given requirement.
It is assumed, except where otherwise stated, that during the accumulated test time, the times to failure or the operating times between failures are independent and identically exponentially distributed. This assumption implies that the failure rate or failure intensity is assumed to be constant.

  • Standard
    182 pages
    English and French language
    sale 15% off

This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE            International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

  • Standard
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document, the audit data collection standard (ADCS), defines the functional requirements for exchanging audit data in flat file format. This document concerns the specification of technical exchange formats in extensible markup language (XML), JavaScript object notation (JSON) and comma-separated values (CSV) as output file formats for the functional content defined in ISO 21378. This document also contains the following schemas and sample files for tables in ISO 21378. — XML schema; — XML sample file; — JSON schema; — JSON sample file. To keep the three exchange formats (XML, JSON and CSV) consistent, this document also specifies how to use the technical solution in the CSV format.

  • Technical specification
    43 pages
    English language
    sale 15% off
  • Draft
    43 pages
    English language
    sale 15% off
  • Draft
    43 pages
    English language
    sale 15% off

This document provides statistical techniques for the determination of the reproducibility of the level of detection for a) binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and b) binary (qualitative) test methods for discrete measurands, e.g. the number of RNA copies in a sample. The reproducibility precision is determined according to ISO 5725 (all parts). Precision estimates are subject to random variability. Accordingly, it is important to determine the uncertainty associated with each estimate, and to understand the relationship between this uncertainty, the number of participants and the experimental design. This document thus provides not only a description of statistical tools for the calculation of the LOD reproducibility precision, but also for the standard error of the estimates.

  • Technical specification
    16 pages
    English language
    sale 15% off

1.1   General
This document is limited to the aerospace industry, where an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process, the approved manufacturer is responsible for assurance that the article conforms to type design information.
1.2   Purpose
This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s purchase document directly to a customer, commonly known as “Direct Ship”.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day

The current ISO 16355 series is written intentionally independent of industry because the principles of applying statistical methods for product and technology development are similar for all types of products. However, when applying the standard for the development of fully or partially digitized products in practice, specific characteristics of digital goods in product development (such as measurability, immateriality, economies of scale effects, etc.) are taken into account. This document gives guidelines for adapting the quality function deployment (QFD) process, its purpose, users, and tools as they are described in the ISO 16355 series that consider these specific characteristics for developing digitalized products and services. Table 1 illustrates the scope of this document by stating examples of the types of products the standard focuses on. Users of this document include all organization functions necessary to assure customer satisfaction, including business planning, marketing, sales, research and development (R&D), engineering, information technology (IT), manufacturing, procurement, quality, production, service, packaging and logistics, support, testing, regulatory, and other phases in hardware, software, service, and system organizations.

  • Standard
    25 pages
    English language
    sale 15% off

IEC 61123:2019 is intended to define a procedure to verify if a reliability of an item/system complies with the stated requirements. The requirement is assumed to be specified as the percentage of success (success ratio) or the percentage of failures (failure ratio). This document can be used where a number of items are tested (number of trials performed) and classified as passed or failed. It can also be used where one or a number of items are tested repeatedly. The procedures are based on the assumption that the probability of success or failure is the same from trial to trial (statistically independent events). Plans for fixed trial/failure terminated tests as well as truncated sequential probability ratio tests (SPRTs) are included. This document contains extensive tables with ready-to-use SPRT plans and their characteristics for equal and non-equal risks for supplier and customer. In the case of the reliability compliance tests for constant failure rate/intensity, IEC 61124 applies. This second edition cancels and replaces the first edition published in 1991. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: The sequential probability ratio test (SPRT) [1, 2][1] has been significantly developed in recent years [3, 4, 5]. This edition contains shorter and accurate tests, a wide range of test plans, and significant additional characteristic data, as follows: the tests are significantly truncated (the maximum trial numbers are low) without substantially increasing the expected number of trials to decision (ENT); the true producer’s and consumer’s risks (α', β') are given and very close to the nominal (α, β); the range of the test parameters is wide (failure ratio, risks and discrimination ratio); the test plans include various risk ratios (not restricted to equal risks only); the values of ENT are accurate and given in the relevant region (for practical use); guidelines for extension of the test sets (interpolation and extrapolation) are included. In Annex C, the use of the cumulative binomial distribution function of Excel that simplifies the procedure of designing has been added (Clause C.3). Keywords: verify if a reliability of an item/system complies with the stated requirements

  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day

1.1   General
This document is limited to the aerospace industry, where an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process, the approved manufacturer is responsible for assurance that the article conforms to type design information.
1.2   Purpose
This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s purchase document directly to a customer, commonly known as “Direct Ship”.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

  • Standard
    69 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    62 pages
    English language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    64 pages
    English, Spanish and Russian language
    sale 15% off

This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE            International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

  • Standard
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

  • Standard
    69 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    62 pages
    English language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    66 pages
    French language
    sale 15% off
  • Standard
    64 pages
    English, Spanish and Russian language
    sale 15% off

This document specifies requirements and provides guidance for bodies providing audit and certification of a privacy information management system (PIMS) according to ISO/IEC 27701 in combination with ISO/IEC 27001, in addition to the requirements contained within ISO/IEC 27006 and ISO/IEC 27701. It is primarily intended to support the accreditation of certification bodies providing PIMS certification.
The requirements contained in this document need to be demonstrated in terms of competence and reliability by anybody providing PIMS certification, and the guidance contained in this document provides additional interpretation of these requirements for any body providing PIMS certification.
NOTE     This document can be used as a criteria document for accreditation, peer assessment or other audit processes.

  • Technical specification
    18 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

  • Technical report
    65 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided.
This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

  • Technical specification
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Technical specification
    41 pages
    English language
    sale 15% off
  • Draft
    41 pages
    English language
    sale 15% off
  • Draft
    41 pages
    English language
    sale 15% off

This document specifies requirements for the management of farmed Angora rabbits in accordance
with animal welfare principles.
This document applies to the management and control of critical activities in Angora rabbit farming,
including accommodation, reproduction, feed and nutrients, health, fibre collection, ethical claims and
supporting information.

  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies requirements and provides guidance for bodies providing audit and certification of a privacy information management system (PIMS) according to ISO/IEC 27701 in combination with ISO/IEC 27001, in addition to the requirements contained within ISO/IEC 27006 and ISO/IEC 27701. It is primarily intended to support the accreditation of certification bodies providing PIMS certification.
The requirements contained in this document need to be demonstrated in terms of competence and reliability by anybody providing PIMS certification, and the guidance contained in this document provides additional interpretation of these requirements for any body providing PIMS certification.
NOTE     This document can be used as a criteria document for accreditation, peer assessment or other audit processes.

  • Technical specification
    18 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies experimental procedures and statistical analysis for the determination of measurement uncertainty in situations where the following conditions are fulfilled: Condition 1: The level of the measurand is non-negative, e.g. concentration level of a contaminant in a sample. Condition 2: Measurement error consists of two independent components: for one of these components the relative standard deviation is constant (that is, the absolute deviation is proportional to the level of the measurand), whereas for the other component the absolute standard deviation is constant (that is, independent of the level of the measurand). Condition 3: Samples for different levels of the measurand can be made available; if the level of the measurand is the concentration of a chemical substance, samples could be obtained e.g. by fortifying (spiking) blank samples. Conditions 1 and 2 are met for most applications of instrumental chemical analyses. Condition 3 can be met for chemical analyses if blank samples are available. This document can also be used to determine precision data for a particular laboratory for different technicians, different environmental conditions, the same or similar test items, with the same level of the measurand, over a certain period of time.

  • Technical specification
    26 pages
    English language
    sale 15% off
  • Technical specification
    27 pages
    French language
    sale 15% off

This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

  • Technical report
    65 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies requirements for the management of farmed Angora rabbits in accordance with animal welfare principles.
This document applies to the management and control of critical activities in Angora rabbit farming, including accommodation, reproduction, feed and nutrients, health, fibre collection, ethical claims and supporting information.

  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies two-stage (double) sampling plans by attributes for inspection for a proportion of nonconforming items in a target population of discrete units, in particular: a) the proportion of nonconforming items in a lot of product items; b) the proportion of nonconforming function instances of an internal control system (ICS); c) the proportion of misstatements in a population of accounting entries or booking records; d) the proportion of nonconforming test characteristics of an entity subject to an acceptance test, e.g. in product and process audits. The plans are preferable to single sampling plans where the cost of inspection is high or where the delay and uncertainty caused by the possible requirement for second samples is inconsequential. The statistical theory underlying the plans, tables and figures are provided in Annexes A through K.

  • Standard
    41 pages
    English language
    sale 15% off

This document specifies requirements for the management of farmed Angora rabbits in accordance with animal welfare principles. This document applies to the management and control of critical activities in Angora rabbit farming, including accommodation, reproduction, feed and nutrients, health, fibre collection, ethical claims and supporting information.

  • Standard
    19 pages
    English language
    sale 15% off
  • Standard
    20 pages
    French language
    sale 15% off

This document gives guidance on planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization.
It is applicable to any organization engaged in, or planning to be engaged in, a B2C ECT, regardless of size, type and activity. The focus of this document is on organizations that directly offer and provide products and services to consumers.
This document aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers’ confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers.
The guidance given in this document can complement an organization’s quality management system.

  • Standard
    40 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    33 pages
    English language
    sale 15% off
  • Standard
    35 pages
    French language
    sale 15% off
  • Draft
    40 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership.
The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides.
NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    17 pages
    English language
    sale 15% off
  • Standard
    18 pages
    French language
    sale 15% off
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document provides a framework that organisations can follow, and that can be used as the structure for market or sector specific schemes. It is intended to be a process certification.
The goal of this document is to have comparable attestations or certifications worldwide.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    16 pages
    English language
    sale 15% off
  • Draft
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided. This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

  • Technical specification
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Technical specification
    41 pages
    English language
    sale 15% off
  • Draft
    41 pages
    English language
    sale 15% off
  • Draft
    41 pages
    English language
    sale 15% off

This International Standard specifies requirements for a quality management system when an organization:
a)    needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b)    aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1    In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2    Statutory and regulatory requirements can be expressed as legal requirements.
This International Standard applies to organizations supplying ITNS products or services.
Application of this standard to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee.
Requirements specified in this International Standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.

  • Standard
    59 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    59 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership. The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides. NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    17 pages
    English language
    sale 15% off
  • Standard
    18 pages
    French language
    sale 15% off
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document provides detailed descriptions of statistical methods for proficiency testing providers to use to design proficiency testing schemes and to analyse the data obtained from those schemes. This document provides recommendations on the interpretation of proficiency testing data by participants in such proficiency testing schemes and by accreditation bodies. The procedures in this document can be applied to demonstrate that the measurement results obtained by laboratories, inspection bodies, and individuals meet specified criteria for acceptable performance. This document is applicable to proficiency testing where the results reported are either quantitative measurements or qualitative observations on test items. NOTE The procedures in this document can also be applied for the assessment of expert opinion where the opinions or judgments are reported in a form which can be compared objectively with an independent reference value or a consensus statistic. For example, when classifying proficiency test items into known categories by inspection - or in determining by inspection whether proficiency test items arise, or do not arise, from the same original source - and the classification results are compared objectively, the provisions of this document that relate to nominal (qualitative) properties can be applied.

  • Standard
    100 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    93 pages
    English language
    sale 15% off
  • Standard
    100 pages
    French language
    sale 15% off

This document specifies single sampling plans for lot-by-lot inspection under the following conditions: a) where the inspection procedure is applied to a continuing series of lots of discrete products, all supplied by one producer using one production process; b) where only a single quality characteristic, x, of these products is taken into consideration, which is measurable on a continuous scale; c) where production is under statistical control and the quality characteristic, x, is distributed according to a normal distribution or a close approximation to the normal distribution; d) where a contract or standard defines a lower specification limit, L, an upper specification limit, U, or both. An item is qualified as conforming if its measured quality characteristic, x, satisfies as appropriate one of the following inequalities: 1) x ≥ L (i.e. the lower specification limit is not violated); 2) x ≤ U (i.e. the upper specification limit is not violated); 3) x ≥ L and x ≤ U (i.e. neither the lower nor the upper specification limit is violated). Inequalities 1) and 2) are cases with a single specification limit, and 3) is a case with double specification limits. Where double specification limits apply, it is assumed in this document that conformity to both specification limits is equally important to the integrity of the product. In such cases, it is appropriate to apply a single AQL to the combined percentage of a product outside the two specification limits. This is referred to as combined control.

  • Standard
    114 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    107 pages
    English language
    sale 15% off
  • Standard
    110 pages
    French language
    sale 15% off

This document specifies the requirements, common methodology and deliverables for energy audits. It is applicable to all forms of establishments and organizations, all forms of energy and energy uses.
This document covers the general requirements common to all energy audits. Specific energy audit requirements complete the general requirements in separate parts dedicated to energy audits for buildings, industrial processes and transport.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document is used in conjunction with and is supplementary to EN 16247-1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247-1 and is applied simultaneously.
The procedures described here apply to the different modes of transport (road, rail, marine and aviation), as well as the different ranges (local- to long-distance) and what is transported (i.e. goods and people).
This document specifies the requirements, methodology and deliverables specific to energy audits in the transport sector, every situation in which a displacement is made, no matter who the operator is (a public or private company or whether the operator is exclusively dedicated to transport or not), is also addressed in this document.
This document advises on both the optimization of energy within each mode of transport, as well as selecting the best mode of transport in each situation; the conclusions drawn by the energy audit can influence decisions on infrastructure and investment e.g. in teleconferencing or web meetings.
Energy audits of buildings and processes associated with transport can be conducted respectively with the EN 16247-2 Buildings and EN 16247-3 Processes, e.g. pipelines, depots and escalators/travelators. This part of the standard does not include the infrastructure which supplies energy e.g. the electricity generation of energy for railways.

  • Standard
    24 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document specifies the requirements, methodology and deliverables of an energy audit within a process. These consist of:
a)   organizing and conducting an energy audit;
b)   analysing the data from the energy audit;
c)   reporting and documenting the energy audit findings.
This part of the standard applies to sites or parts of sites where a significant part of the energy use is due to processes. It is used in conjunction with and is supplementary to EN 16247-1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247-1 and is applied simultaneously.
A process can include one or more production lines or services, offices, laboratories, research centres, packaging and warehouse sections with specific operational conditions and site transportation. An energy audit can include the whole site or part of a site.
If buildings are included in the scope of the energy audit, the energy auditor can choose to apply EN 16247-2, Energy Audits - Part 2: Buildings. If on-site transport on a site is included in the scope of the energy audit, the energy auditor can choose to apply EN 16247-4, Energy audits - Part 4: Transport.
NOTE   The decision to apply Parts 2 and/or 4 is expected to be made during the preliminary contact, see 5.1.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document is applicable to specific energy audit requirements in buildings. It specifies the requirements, methodology and deliverables of an energy audit in a building or group of buildings. It is applied in conjunction with, and is supplementary to, EN 16247 1, Energy audits - Part 1: General requirements. It provides additional requirements to EN 16247 1 and is applied simultaneously.
If processes are included in the scope of the energy audit, the energy auditor can choose to apply EN 16247 3, Energy audits - Part 3: Processes. If on-site transport on a site is included in the scope of the energy audit, the energy auditor can choose to apply EN 16247 4, Energy audits - Part 4: Transport.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This document sets out guidelines for checking conformity with quantifiable characteristics using the test or measurement result and its associated measurement uncertainty. This document is applicable whenever the uncertainty may be quantified according to the principles laid down in ISO/IEC Guide‑98‑3 (GUM). The term uncertainty is thus a descriptor for all elements of variation in the measurement result, including uncertainty due to sampling. This document does not give rules for how to act when an inconclusive result of a conformity test has been obtained. NOTE There are not limitations on the nature of the entity subject to the requirements nor on the quantifiable characteristic. Examples of entities together with quantifiable characteristics are given in Table A.1.

  • Standard
    14 pages
    English language
    sale 15% off