questions are in File QAQC..
© ISO 2015
Quality management systems —
Requirements
Systèmes de management de la qualité — Exigences
INTERNATIONAL
STANDARD
ISO
9001
Fifth edition
2015-09-15
Reference number
ISO 9001:2015(E)
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ISO 9001:2015(E)
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ISO 9001:2015(E)
Foreword ………………………………………………………………………………………………………………………………………………………………………………………………………………v
Introduction ……………………………………………………………………………………………………………………………………………………………………………………………………..vi
1 Scope ……………………………………………………………………………………………………………………………………………………………………………………………………… 1
2 Normative references ……………………………………………………………………………………………………………………………………………………………….. 1
3 Terms and definitions ………………………………………………………………………………………………………………………………………………………………. 1
4 Context of the organization ………………………………………………………………………………………………………………………………………………….. 1
4.1 Understanding the organization and its context …………………………………………………………………………………………. 1
4.2 Understanding the needs and expectations of interested parties …………………………………………………….. 2
4.3 Determining the scope of the quality management system ………………………………………………………………….. 2
4.4 Quality management system and its processes ……………………………………………………………………………………………. 2
5 Leadership ………………………………………………………………………………………………………………………………………………………………………………………… 3
5.1 Leadership and commitment ………………………………………………………………………………………………………………………………….. 3
5.1.1 General……………………………………………………………………………………………………………………………………………………………….. 3
5.1.2 Customer focus ……………………………………………………………………………………………………………………………………………… 3
5.2 Policy ……………………………………………………………………………………………………………………………………………………………………………………… 4
5.2.1 Establishing the quality policy …………………………………………………………………………………………………………….. 4
5.2.2 Communicating the quality policy …………………………………………………………………………………………………….. 4
5.3 Organizational roles, responsibilities and authorities……………………………………………………………………………… 4
6 Planning ………………………………………………………………………………………………………………………………………………………………………………………………. 4
6.1 Actions to address risks and opportunities ……………………………………………………………………………………………………. 4
6.2 Quality objectives and planning to achieve them ………………………………………………………………………………………… 5
6.3 Planning of changes ………………………………………………………………………………………………………………………………………………………. 5
7 Support ………………………………………………………………………………………………………………………………………………………………………………………………… 6
7.1 Resources …………………………………………………………………………………………………………………………………………………………………………….. 6
7.1.1 General……………………………………………………………………………………………………………………………………………………………….. 6
7.1.2 People …………………………………………………………………………………………………………………………………………………………………. 6
7.1.3 Infrastructure ………………………………………………………………………………………………………………………………………………… 6
7.1.4 Environment for the operation of processes ………………………………………………………………………………. 6
7.1.5 Monitoring and measuring resources …………………………………………………………………………………………….. 7
7.1.6 Organizational knowledge ……………………………………………………………………………………………………………………… 7
7.2 Competence ……………………………………………………………………………………………………………………………………………………………………….. 8
7.3 Awareness …………………………………………………………………………………………………………………………………………………………………………… 8
7.4 Communication ……………………………………………………………………………………………………………………………………………………………….. 8
7.5 Documented information …………………………………………………………………………………………………………………………………………… 8
7.5.1 General……………………………………………………………………………………………………………………………………………………………….. 8
7.5.2 Creating and updating ………………………………………………………………………………………………………………………………. 9
7.5.3 Control of documented information ………………………………………………………………………………………………… 9
8 Operation …………………………………………………………………………………………………………………………………………………………………………………………… 9
8.1 Operational planning and control ………………………………………………………………………………………………………………………… 9
8.2 Requirements for products and services ………………………………………………………………………………………………………. 10
8.2.1 Customer communication ……………………………………………………………………………………………………………………. 10
8.2.2 Determining the requirements for products and services ……………………………………………….10
8.2.3 Review of the requirements for products and services ……………………………………………………..10
8.2.4 Changes to requirements for products and services ……………………………………………………………11
8.3 Design and development of products and services ………………………………………………………………………………….11
8.3.1 General…………………………………………………………………………………………………………………………………………………………….. 11
8.3.2 Design and development planning …………………………………………………………………………………………………. 11
8.3.3 Design and development inputs ………………………………………………………………………………………………………. 11
8.3.4 Design and development controls …………………………………………………………………………………………………..12
8.3.5 Design and development outputs …………………………………………………………………………………………………… 12
8.3.6 Design and development changes …………………………………………………………………………………………………… 12
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ISO 9001:2015(E)
8.4 Control of externally provided processes, products and services …………………………………………………..13
8.4.1 General…………………………………………………………………………………………………………………………………………………………….. 13
8.4.2 Type and extent of control …………………………………………………………………………………………………………………… 13
8.4.3 Information for external providers ………………………………………………………………………………………………… 13
8.5 Production and service provision ………………………………………………………………………………………………………………………. 14
8.5.1 Control of production and service provision …………………………………………………………………………….14
8.5.2 Identification and traceability …………………………………………………………………………………………………………… 14
8.5.3 Property belonging to customers or external providers ……………………………………………………15
8.5.4 Preservation …………………………………………………………………………………………………………………………………………………. 15
8.5.5 Post-delivery activities …………………………………………………………………………………………………………………………..15
8.5.6 Control of changes …………………………………………………………………………………………………………………………………….15
8.6 Release of products and services ……………………………………………………………………………………………………………………….. 15
8.7 Control of nonconforming outputs ……………………………………………………………………………………………………………………. 16
9 Performance evaluation ……………………………………………………………………………………………………………………………………………………….16
9.1 Monitoring, measurement, analysis and evaluation ………………………………………………………………………………..16
9.1.1 General…………………………………………………………………………………………………………………………………………………………….. 16
9.1.2 Customer satisfaction ……………………………………………………………………………………………………………………………..17
9.1.3 Analysis and evaluation ………………………………………………………………………………………………………………………… 17
9.2 Internal audit ………………………………………………………………………………………………………………………………………………………………….. 17
9.3 Management review …………………………………………………………………………………………………………………………………………………… 18
9.3.1 General…………………………………………………………………………………………………………………………………………………………….. 18
9.3.2 Management review inputs ………………………………………………………………………………………………………………… 18
9.3.3 Management review outputs …………………………………………………………………………………………………………….. 18
10 Improvement …………………………………………………………………………………………………………………………………………………………………………………19
10.1 General ……………………………………………………………………………………………………………………………………………………………………………….. 19
10.2 Nonconformity and corrective action ……………………………………………………………………………………………………………… 19
10.3 Continual improvement …………………………………………………………………………………………………………………………………………… 19
Annex A (informative) Clarification of new structure, terminology and concepts ……………………………………..21
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 ……………………………………………………………………………………………….25
Bibliography …………………………………………………………………………………………………………………………………………………………………………………………………..28
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ISO 9001:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.
This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically
revised, through the adoption of a revised clause sequence and the adaptation of the revised quality
management principles and of new concepts. It also cancels and replaces the Technical Corrigendum
ISO 9001:2008/Cor.1:2009.
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ISO 9001:2015(E)
Introduction
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.
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ISO 9001:2015(E)
0.2 Quality management principles
This International Standard is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for the
organization, some examples of benefits associated with the principle and examples of typical actions
to improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3 Process approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.
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ISO 9001:2015(E)
Figure 1 — Schematic representation of the elements of a single process
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
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ISO 9001:2015(E)
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies, and identify
and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
0.3.3 Risk-based thinking
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking has been implicit in previous editions of this International Standard
including, for example, carrying out preventive action to eliminate potential nonconformities, analysing
any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new products
and services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.
0.4 Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems (see Clause A.1).
This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, or
financial management.
Sector-specific quality management system standards based on the requirements of this International …
Designation: D 6792 – 07 An American National Standard
Standard Practice for
Quality System in Petroleum Products and Lubricants
Testing Laboratories1
This standard is issued under the fixed designation D 6792; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This practice covers the establishment and maintenance
of the essentials of a quality system in laboratories engaged in
the analysis of petroleum products and lubricants. It is de-
signed to be used in conjunction with Practice D 6299.
NOTE 1—This practice is based on the quality management concepts
and principles advocated in ANSI/ISO/ASQ Q9000 standards, ISO/IEC
17025, ASQ Manual,2 and ASTM standards such as D 3244, D 4182,
D 4621, D 6299, D 6300, E 29, E 177, E 456, E 548, E 882, E 994,
E 1301, E 1323, STP 15D,3 and STP 1209.4
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use.
2. Referenced Documents
2.1 ASTM Standards: 5
D 3244 Practice for Utilization of Test Data to Determine
Conformance with Specifications
D 4182 Practice for Evaluation of Laboratories Using
ASTM Procedures in the Sampling and Analysis of Coal
and Coke
D 4621 Guide for Quality Management in an Organization
That Samples or Tests Coal and Coke
D 6299 Practice for Applying Statistical Quality Assurance
Techniques to Evaluate Analytical Measurement System
Performance
D 6300 Practice for Determination of Precision and Bias
Data for Use in Test Methods for Petroleum Products and
Lubricants
D 6617 Practice for Laboratory Bias Detection Using
Single Test Result from Standard Material
E 29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
E 177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
E 456 Terminology Relating to Quality and Statistics
E 548 Guide for General Criteria Used for Evaluating
Laboratory Competence6
E 882 Guide for Accountability and Quality Control in the
Chemical Analysis Laboratory
E 994 Guide for Calibration and Testing Laboratory Ac-
creditation Systems General Requirements for Operation
and Recognition6
E 1301 Guide for Proficiency Testing by Interlaboratory
Comparisons
E 1323 Guide for Evaluating Laboratory Measurement
Practices and the Statistical Analysis of the Resulting Data
2.2 ISO Standards:7
ISO Guide 30 Terms and Definitions Used in Connection
with Reference Materials
ISO/IEC 17025 General Requirements for the Competence
of Testing and Calibration Laboratories
ISO 4259 Petroleum Products—Determination and Appli-
cation of Precision Data in Relation to Methods of Test
ANSI/ISO/ASQ Q9000 Quality Management System Stan-
dards
3. Terminology
3.1 Definitions:
3.1.1 accepted reference value, ARV, n—a value that serves
as an agreed upon reference for comparison, and which is
derived as: (1) a theoretical or established value, based on
scientific principles, (2) an assigned value, based on experi-
mental work of some national or international organization
1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum
Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on
Coordinating Subcommittee on Quality Assurance and Statistics.
Current edition approved July 1, 2007. Published August 2007. Originally
approved in 2002. Last previous edition approved in 2006 as D 6792–06.
2 “Quality Assurance for The Chemical and Process Industries: A Manual of
Good Practices,” 1987, available from American Society for Quality (ASQ), 600 N.
Plankinton Ave., Milwaukee, WI 53203. www.asq.org.
3 ASTM STP 15D, ASTM Manual on Presentation of Data and Control Chart
Analysis, ASTM International, W. Conshohocken, PA.
4 ASTM STP 1209, ASTM Manual on Total Quality Management, ASTM
International, W. Conshohocken, PA.
5 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [email protected] For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
6 Withdrawn.
7 Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
1
*A Summary of Changes section appears at the end of this standard.
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such as the U.S. National Institute of Standards and Technol-
ogy (NIST), or (3) a consensus value, based on collaborative
experimental work under the auspices of a scientific or
engineering group. E 456
3.1.2 accuracy, n—the closeness of agreement between a
test result and an accepted reference value. E 456
3.1.3 audit, n—a systematic examination of a laboratory’s
quality system procedure and related activities by an internal or
external team to determine whether these procedures or activi-
ties are implemented according to the documented system.
3.1.4 bias, n—the difference between the population mean
of the test results and an accepted reference value. E 456
3.1.5 calibration standard, n—a material with a certified
value for a relevant property, issued by or traceable to a
national organization such as NIST, and whose properties are
known with sufficient accuracy to permit its use to evaluate the
same property of another sample.
3.1.6 certified reference material, CRM, n—a reference
material one or more of whose property values are certified by
a technically valid procedure, accompanied by a traceable
certificate or other documentation which is issued by a certi-
fying body. ISO Guide 30
3.1.7 measurand, n—the measurable quantity subject to
measurement.
3.1.8 outlier, n—a result far enough in magnitude from
other results so as to be considered not a part of the set.
D 6300
3.1.9 precision, n—the closeness of agreement between test
results obtained under prescribed conditions. E 456
3.1.10 proficiency testing, n—determination of a laborato-
ry’s testing capability by evaluating its test results in interlabo-
ratory exchange testing or crosscheck programs.
3.1.10.1 Discussion—One example is the ASTM D02 com-
mittee’s proficiency testing programs in a wide variety of
petroleum products and lubricants, many of which may involve
more than a hundred laboratories.
3.1.11 quality assurance (QA), n—a system of activities, the
purpose of which is to provide to the producer and user of a
product, measurement, or service the assurance that it meets
the defined standards of quality with a stated level of confi-
dence.
3.1.11.1 Discussion—Quality assurance includes quality
planning and quality control.
3.1.12 quality control (QC), n—a planned system of activi-
ties whose purpose is to provide a level of quality that meets
the needs of users; also the uses of such a system.
3.1.13 quality control sample (QC sample), n—for use in
quality assurance program to determine and monitor the
precision and stability of a measurement system; a stable and
homogenous material having physical or chemical properties,
or both, similar to those of typical samples tested by the
analytical measurement system. The material is properly stored
to ensure sample integrity, and is available in sufficient quantity
for repeated long-term testing. D 6299
3.1.14 reference material (RM), n—a material with ac-
cepted reference value(s), accompanied by an uncertainty at a
stated level of confidence for desired properties, which may be
used for calibration or quality control purposes in the labora-
tory.
3.1.14.1 Discussion—Sometimes these may be prepared
“in-house” provided the reference values are established using
accepted standard procedures.
3.1.15 repeatability, n—the quantitative expression of the
random error associated with a single operator in a given
laboratory obtaining repetitive results with the same apparatus
under constant operating conditions on identical test material.
It is defined as the difference between two such results at the
95 % confidence level. D 6300
3.1.16 reproducibility, n—a quantitative expression of the
random error associated with different operators using different
apparatus, and so forth, each obtaining a single result on an
identical test sample when applying the same method. It is then
defined as the 95 % confidence limit for the difference between
two such single and independent results. D 6300
3.1.17 site precision (R8), n—the value below which the
absolute difference between two individual test results obtained
under site precision conditions may be expected to occur with
a probability of approximately 0.95 (95 %). It is defined as 2.77
times the standard deviation of results obtained under site
precision conditions. D 6299
3.1.18 site precision conditions, n—conditions under which
test results are obtained by one or more operators in a single
site location practicing the same test method on a single
measurement system using test specimens taken at random
from the same sample of material over an extended period of
time spanning at least a 15 day interval. D 6299
3.1.19 traceability, n—property of the result of a measure-
ment or the value of a standard whereby it can be related to
stated references, usually national or international standards,
through an unbroken chain of comparisons all having stated
uncertainties.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 precision ratio (PR), n—an estimate of relative mag-
nitude of repeatability and reproducibility. The PR for a given
standard test method can provide information on the relative
significance between variation caused by different operators
and laboratories compared to a single operator in a laboratory
performing the standard test method.
3.2.2 test performance index (TPI), n—an approximate
measure of a laboratory’s testing capability, defined as the ratio
of test method reproducibility to site precision.
3.3 Acronyms:
3.3.1 NIST—National Institute of Standards and Technol-
ogy (formerly called National Bureau of Standards), Gaithers-
burg, MD.
4. Significance and Use
4.1 A petroleum products and lubricants testing laboratory
plays a crucial role in product quality management and
customer satisfaction. It is essential for a laboratory to provide
quality data. This document provides guidance for establishing
and maintaining a quality system in a laboratory.
D 6792 – 07
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5. General Quality Requirements for the Laboratory
5.1 Establishment and maintenance of a quality system shall
include stated objectives in the following areas: a laboratory’s
adherence to test method requirements, calibration and main-
tenance practices, and its quality control program. Laboratory
quality objectives should encompass the laboratory’s continu-
ous improvement goals as well as meeting customer require-
ments.
5.2 Management shall appoint a representative to imple-
ment and maintain the quality system in the laboratory.
5.3 Laboratory management shall review the adequacy of
the quality system and the activities of the laboratory for
consistency with the stated quality objectives at least annually.
5.4 The quality system shall have documented processes
for:
5.4.1 Sample management (see Section 6),
5.4.2 Data and record management (see Section 7),
5.4.3 Producing accurate, reliable, and properly represented
test results (see Section 8),
5.4.4 Audits and proficiency testing (see Section 9),
5.4.5 Corrective and preventive action (see Section 11),
5.4.6 Ensuring that procured services and materials meet the
contracted requirements, and
5.4.7 Ensuring that personnel are adequately trained to
obtain quality results.
6. Sample Management
6.1 The elements of sample management shall include at a
minimum:
6.1.1 Procedures for unique identification of samples sub-
mitted to the laboratory.
6.1.2 Criteria for sample acceptance.
6.1.3 Procedures for sample handling.
6.1.4 Procedures for sample storage and retention. Items to
consider when creating these procedures include:
6.1.4.1 Applicable government—local, state, or national—
regulatory requirements for shelf life and time-dependent tests
that set product stability limits,
6.1.4.2 Type of sample containers required to preserve the
sample,
6.1.4.3 Control of access to the retained samples to protect
their validity and preserve their original integrity,
6.1.4.4 Storage conditions,
6.1.4.5 Required safety precautions, and
6.1.4.6 Customer requirements.
6.1.5 Procedures for sample disposal in accordance with
applicable government regulatory requirements.
NOTE 2—This may be handled through a separate chemical hygiene or
waste disposal plan.
7. Data and Record Management
7.1 Reports of Analysis:
7.1.1 The work carried out by a laboratory shall be covered
by a certificate or report that accurately and unambiguously
presents the test results and all other relevant information.
NOTE 3—This report may be an entry in a Laboratory Information
Management System (LIMS) or equivalent system.
7.1.2 The following items are suggested for inclusion in
laboratory reports:
7.1.2.1 Name and address of the testing laboratory,
7.1.2.2 Unique identification of the report (such as serial
number) on each page of the report,
7.1.2.3 Name and address of the customer,
7.1.2.4 Order number,
7.1.2.5 Description and identification of the test sample,
7.1.2.6 Date of receipt of the test sample and date(s) of
performance of test, as appropriate,
7.1.2.7 Identification of the test specification, method, and
procedure,
7.1.2.8 Description of the sampling procedure, where rel-
evant,
7.1.2.9 Any deviations, additions to or exclusions from the
specified test requirements, and any other information relevant
to a specific test,
7.1.2.10 Disclosure of any nonstandard test method or
procedure utilized,
7.1.2.11 Measurements, examinations, and derived results,
supported by tables, graphs, sketches, and photographs as
appropriate, and any failures identified,
7.1.2.12 Minimum-maximum product specifications, if ap-
plicable,
7.1.2.13 A statement of the measurement uncertainty (where
relevant or required by the customer),
7.1.2.14 Any other information which might be required by
the customer,
7.1.2.15 A signature and job title of person(s) accepting
technical responsibility for the test report and the date of issue,
and
7.1.2.16 A statement on the laboratory policy regarding the
reproduction of test reports.
7.1.3 Items actually included in laboratory reports should be
specified by laboratory management or agreements with cus-
tomers, or both.
7.1.4 Procedures for corrections or additions to a test report
after issue shall be established.
7.2 Reporting and Rounding the Data:
7.2.1 The reporting requirements specified in the test
method or procedure shall be used (unless specifically required
otherwise by the customer or applicable regulations).
7.2.2 If rounding is performed, the rounding protocol of
Practice E 29 should be used unless otherwise specified in the
method or procedure.
7.3 Records of Calibration and Maintenance:
7.3.1 Procedures shall be established for the management of
instrument calibration records. Such records usually indicate
the instrument calibrated, method or procedure used for cali-
bration, the dates of last and next calibrations, the person
performing the calibration, the values obtained during calibra-
tion, and the nature and traceability (if applicable) of the
calibration standards (that is, certified values). Records may be
electronic.
7.3.2 Procedures shall be established for the management of
instrument maintenance records. Such records usually indicate
D 6792 – 07
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Not for ResaleNo reproduction or networking permitted without license from IHS
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the instrument maintained, the dates of last and next mainte-
nance, and the person performing the maintenance. Records
may be electronic.
NOTE 4—For instruments that require calibration, calibration and main-
tenance records may be combined.
7.4 Quality Control (QC) Testing Records:
7.4.1 The laboratory shall have documented procedures for
creating and maintaining records for analysis of QC samples. It
is recommended that such records include the sample name and
source, the test(s) for which it is to be used, the assigned values
and their uncertainty where applicable, and values obtained
upon analysis. Additionally, it is recommended that the receipt
date or date put into active QC use in the laboratory be
documented, along with the expiration date (if applicable).
7.4.2 Procedures for retaining completed control charts
should be established. It is recommended that these records
include the date the control charts were changed and the reason
for the change.
7.5 Record Retention:
7.5.1 The record system should suit the laboratory’s particu-
lar circumstances and comply with any existing regulations and
customer specifications.
7.5.2 All data shall be maintained according to laboratory,
company, or regulatory agency requirements, or a combination
thereof.
7.5.3 Procedures for retaining records of all original obser-
vations, calculations and derived data, calibration records, and
final test reports for an appropriate period shall be established.
The records for each test should contain sufficient information
to permit satisfactory replication of the test and recalculation of
the results.
7.5.4 The records shall be held in a safe and secure storage.
A system shall exist that allows locating the required docu-
ments in a reasonable period of time.
8. Producing Accurate, Reliable, and Properly
Represented Test Results
8.1 The laboratory shall have documented test methods and
procedures for performing the required tests. These shall be
maintained up-to-date and be readily available to the laboratory
staff. The test methods that are stated in the product specifica-
tions or agreed upon with customers should be used for sample
analysis.
8.2 The laboratory shall have procedures for the approval,
documentation, and reporting of deviations from the test
method requirements or the use of alternative methods.
8.3 Procedures shall be established to ensure that measuring
and testing equipment is calibrated, maintained properly, and is
in statistical control. Items to consider when creating these
procedures include:
8.3.1 Records of calibration and maintenance (see 7.3),
8.3.2 Calibration and maintenance schedule,
NOTE 5—The calibration frequency may vary with the instrument type
and its frequency of use, some needing calibration before each set of
analyses, others requiring calibration at less frequent periods, or triggered
by a QC chart out-of-statistical-control situation.
8.3.3 Traceability to national or international standards,
NOTE 6—Where the concept of traceability to national or international
standards of measurement is not applicable, the testing laboratory shall
provide satisfactory evidence of test result accuracy (for example, by
participation in a program of interlaboratory comparisons).
8.3.4 Requirements of the test method or procedure,
8.3.5 Customer requirements, and
8.3.6 Corrective actions (see Section 11).
8.4 The performance of apparatus and equipment used in
the laboratory but not calibrated in that laboratory (that is,
pre-calibrated, vendor supplied) should be verified by using a
documented, technically valid procedure at periodic intervals.
8.5 Calibration standards shall be appropriate for the
method and characterized with the accuracy demanded by the
analysis to be performed. Quantitative calibration standards
should be prepared from constituents of known purity. Use the
primary calibration standards or CRMs specified or allowed in
the test method.
8.5.1 Where appropriate, values for reference materials
should be produced following the certification protocol used by
NIST8,9,10 or other standards issuing bodies, and, should be
traceable to national or international standard reference mate-
rials, if required or appropriate.
8.5.2 The materials analyzed in proficiency testing pro-
grams meeting the requirements of Practice D 6300 or
ISO 4259 may be used as reference materials, provided no
obvious bias or unusual frequency distribution of results are
observed. The consensus value is most likely the value closest
to the true value of this material; however, the uncertainty
attached to this mean value will be dependent on the precision
and the total number of the participating laboratories.
8.6 The laboratory shall establish procedures for the storage
of reference materials in a manner to ensure their safety,
integrity, and protection from contamination (see 6.1.4).
8.7 Records of instrument calibration shall be maintained
(see Section 7).
8.8 If an instrument is found to be out of calibration, and the
situation cannot be immediately addressed, then the instrument
shall be taken out of operation and tagged as such until the
situation is corrected (see Section 11).
8.9 Quality Control Practices:
8.9.1 Use appropriate quality control charts or other quality
control practices (for example, like those described in Practice
D 6299) for each test method performed by the laboratory
unless specifically excluded. Document cases where quality
control practices are not employed and include the rationale.
8.9.2 This practice advocates the regular testing of quality
control samples with timely interpretation of test results. This
practice also advocates using appropriate control charting
techniques to ascertain the in-statistical-control status of test
methods in terms of precision, bias (if a standard is being
used), and method stability over time. For details concerning
QC sample requirements and control charting techniques, refer
to Practice D 6299. The generally accepted practices are
outlined in 8.9.3 through 8.12.4.
8 Cali, J. P., Anal. Chem., 48, 802A, 1976.
9 Uriano, G. A., and Gravatt, C. C., CRC Crit. Revs, in Anal. Chem., 6, 361, 1977.
10 Alvarez, R., Rasberry, S. D., and Uriano, G. A., Anal. Chem., 54, 1226A, 1982.
D 6792 – 07
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8.9.3 Test QC samples on a regular schedule. Principal
factors to be considered for determining the frequency of
testing include: (1) frequency of use of the analytical measure-
ment system, (2) criticality of the parameter being measured
and business economics, (3) established system stability and
precision performance based on historical data, (4) regulatory
requirements, (5) contractual provisions, and (6) test method
requirements.
8.9.3.1 If site precision for a specific test has not been
established as defined by Practice D 6299, then the recom-
mended frequency for analysis of QC samples is one QC out of
every ten samples analyzed. Alternatively, one QC sample is
analyzed each day that samples are analyzed, whichever is
more frequent.
8.9.3.2 Once the site precision has been established as
defined by Practice D 6299, and to ensure similar quality of
data is achieved with the documented method, the minimal QC
frequency may be adjusted based on the Test Performance
Index (TPI) and the Precision Ratio (PR).
(1) For standard test methods with PR (as defined in 10.2)
less than 4 and a TPI (as defined in 10.1) less than 0.8, consult
10.3 and the Standard Test Method for appropriate corrective
action.
(2) For standard test methods with PR (as defined in 10.2)
greater than or equal to 4 and a TPI (as defined in 10.1) less
than 1.6, consult 10.3 and the Standard Test Method for
appropriate corrective action.
8.9.3.3 Table 1 provides recommended minimal QC fre-
quencies as a function of PR and TPI. For those tests, which are
performed infrequently, for example less than 25 samples are
analyzed monthly, it is recommended that at least one QC
sample be analyzed each time samples are analyzed.
8.9.3.4 In many situations, the minimal QC frequency as
recommended by Table 1 may not be sufficient to ensure
adequate statistical quality control, considering, for example,
the significance of use of the results. Hence, it is recommended
that the flowchart in Fig. 1 be followed to determine if a higher
QC frequency should be used.
8.9.3.5 The TPI should be recalculated and reviewed at least
annually. Adjustments to QC frequency should be made based
on the recalculated TPI by following sections 8.9.3.2 and
8.9.3.4.
8.9.4 QC testing frequency, QC samples, and their test
values shall be recorded.
8.9.5 All persons who routinely operate the system shall
participate in generating QC test data. QC samples should be
treated as regular samples.
NOTE 7—Avoid special treatment of QC samples designed to “get a
better result.” Special treatment seriously undermines the integrity of
precision and bias estimates.
8.9.6 The laboratory may establish random or blind testing,
or both, of QC or other known materials.
8.10 Quality Control Sample and Test Data Evaluation:
8.10.1 QC samples should be stable and homogeneous
materials having physical or chemical properties, or both,
representative of the actual samples being analyzed by the test
method. This material shall be well-characterized for the
analyses of interest, available in sufficient quantities, have
concentration values that are within the calibration range of the
test method, and reflect the most common values tested by the
laboratory. For QC testing that is strictly for monitoring the test
method stability and precision, the QC sample expected value
is the control chart centerline, established using data obtained
under site precision conditions. For regular QC testing that is
intended to assess test method bias, RMs, or CRMs with
independently assigned ARVs should be used. The results
should be assessed in accordance with Practice D 6299 require-
ments for check standard testing. For infrequent QC testing for
bias assessment, refer to Practice D 6617.
NOTE 8—It is not advisable to use the same sample for both a calibrant
and a QC sample. It is not advisable to use the same chemical lot number
for both a calibrant and a QC sample.
8.10.2 If the QC material is observed to be degrading or
changing in physical or chemical characteristics, this shall be
immediately investigated and, if necessary, a replacement QC
material shall be prepared for use.
NOTE 9—In a customer-supplier quality dispute, it may be beneficial to
provide the customer with the laboratory’s test results on QC material to
demonstrate testing proficiency. Practice D 3244 may be useful.
8.11 Quality Control Charts:
8.11.1 QC sample test data should be promptly plotted on a
control chart and evaluated to determine if the results obtained
are within the method specifications and laboratory-established
control limits. The charts used should be appropriate for the
testing conditions and statistical objectives. Corrective action
should be taken and documented for any analyses that are
out-of-control (see Section 11).
NOTE 10—Charts such as individual, moving average and moving
range, exponentially weighted moving average, or cumulative summation
charts may be used as appropriate. Refer to Practice D 6299 for guidance
on plotting these charts.
8.11.1.1 The charts should indicate the test method, date
when the QC analyses were performed, and who performed
them. Test samples should not be analyzed or results for
samples should not be reported until the corresponding QC
data are assessed and the testing process is verified to be in
statistical control. (See 8.9.)
8.11.2 Adequate training should be given to the analysts to
enable them to generate and interpret the charts.
8.11.3 It is suggested that the charts be displayed promi-
nently near the analysis workstation, so that all can view and,
if necessary, help in improving the analyses.
8.11.4 Supervisory and technical personnel should periodi-
cally review the QC charts.
TABLE 1 Minimal QC Frequency as a Function of
Test Performance Index
TPI for
Standard
Test Methods
with PR<4
TPI for
Standard
Test Methods
with PR$4
Nominal QC Frequency
(1 out of every
X Samples)
Values X
Approximate
Percentage
of Samples
Total Analyses
Not …
QA
Howto Create SQC Chart
Designation: D6299 − 13 An American National Standard
Standard Practice for
Applying Statistical Quality Assurance and Control Charting
Techniques Evaluate Analytical Measurement System
Performance1
This standard is issued under the fixed designation D6299; number immediately following indicates year of
original adoption or, in case revision, last revision. A parentheses reapproval. A
superscript epsilon (´) an editorial change since revision or reapproval.
1. Scope*
1.1 This practice covers information for design and
operation a program monitor control ongoing stability
and precision bias performance selected analytical
measurement systems using collection generally accepted
statistical quality (SQC) procedures tools.
NOTE 1—A complete list criteria selecting measurement systems
to which this should be applied determining frequency
at it beyond scope practice.
However, some factors considered include (1) frequency use of
the analytical system, (2) criticality parameter being
measured, (3) system stability based on
historical data, (4) business economics, (5) regulatory, contractual, or
test method requirements.
1.2 applicable stable measure-
ment that produce results on continuous numerical
scale.
1.3 laboratory test methods.
1.4 validated process stream
analyzers.
1.5 monitoring differences
between two purport to
measure same property provided both have
been assessed accordance with statistical methodology in
Practice D6708 appropriate applied.
NOTE 2—For validation univariate stream analyzers, see also
Practice D3764.
NOTE 3—One 1.5 can laboratory
test methods analyzers.
1.6 assumes normal (Gaussian) model
is adequate description prediction measurement
system behavior when state control.
NOTE 4—For non-Gaussian processes, transformations results
may permit proper application these tools. Consult statistician for
further guidance information.
2. Referenced Documents
2.1 ASTM Standards:2
D3764 Validation Performance Process
Stream Analyzer Systems
D5191 Test Method Vapor Pressure Petroleum Prod-
ucts (Mini Method)
D6708 Assessment Improvement
of Expected Agreement Between Two Methods that
Purport Measure Same Property Material
D6792 System Products
and Lubricants Testing Laboratories
D7372 Guide Analysis Interpretation Proficiency
Test Program Results
E177 Use Terms Precision Bias in
ASTM Methods
E178 Dealing With Outlying Observations
E456 Terminology Relating Statistics
E691 Conducting Interlaboratory Study to
Determine Method
3. Terminology
3.1 Definitions:
3.1.1 accepted reference value, n—a value serves as an
agreed-upon comparison derived (1)
a theoretical established scientific principles,
(2) assigned experimental work some
national international organization, such U.S. Na-
tional Institute Standards Technology (NIST), a
consensus collaborative work
under auspices engineering group. E177,
E456
3.1.2 accuracy, n—the closeness agreement between an
observed value. E177, E456
3.1.3 assignable cause, factor contributes varia-
tion feasible detect identify. E456
1 jurisdiction Committee D02 Petroleum
Products, Liquid Fuels, direct responsibility Subcom-
mittee D02.94 Coordinating Subcommittee Statistics.
Current edition approved Oct. 1, 2013. Published October Originally
approved 1998. Last previous 2010 – 10ε2. DOI:
10.1520 D6299-13.
2 For referenced standards, visit website, www.astm.org, or
contact Customer Service at [email protected] Annual Book ASTM
Standards volume information, refer standard’s Document Summary page on
the website.
*A Changes section appears end standard
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>1.2 the lab performance is satisfactory and within the Precision of Standard method.
For more detail refer to ASTM D6792 for TPI
Next is correlation sample , which is the inter laboratory testing scheme like Fapas or IIS. In this international organization arrange samples of interest and different lab participate in the program and z-score of each lab evalute to rate their perfromance
NOC is Notification of Change
When ever there is any change in procedure or schedule or any thing in the lab which need to communicate .It should be via NOC
QI stand for Quality investigation to investigate any quality incident in which any breach of quality investigated to find out the root cause
NCPR is Non Conformance Product Report
Internal Audit is the audit which done by internally to follow the Plan, do, act and Check cycle for quality assurance.
It mean we have to check internally that all procedures are valid and update and we are following to get the purpose.
High light any observation for improvement within the lab