iso 17025 2017 free download pdf

This Guide to ISO 17025:2017 describes implementation of the requirements for the revamped standard for laboratories,

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MS/ISO/IEC 17025:2017

DR. MD. SANI IBRAHIM

PERSATUAN MAKMAL AKREDITASI MALAYSIA

Table of Content

1. Scope

2. Normative Reference

3. Terms and Definitions

4. General Requirement ( 2 clauses)

5. Structural Requirement

6. Resources Requirement (6 Clauses)

7. Process Requirement (11 Clauses)

8. Management Requirement (9 Clauses)

9. Annex A – Metrological Traceability

10. Annex B – Management System Options

Introduction

General terms use

•"shall" indicates a requirement

•"should" indicated a recommendation

•"may" indicates a permission

•"can" indicates a possibility or a capability

1.0 Scope

•The Document specifies the general requirements for laboratory to be

•Competence

•Impartial

•Consistent operation

•Applicable to all organization performing laboratory activities including

•Testing

•Calibration

•Sampling and subsequent testing

•Laboratory customers, regulatory authorities, organizations, accreditation bodies, and

others use this document in confirming or recognizing the competence of laboratories.

2. Normative References

•ISO/IEC Guide 99 (also known as JCGM 200) – International vocabulary of metrology.

•ISO/IEC 17000-Conformity assessment – Vocabulary and General principles

3. Terms and Definitions

3.1 Impartiality means Presence of objectivity

Objectivity means that conflicts of interest do not exist or

Conflicts of interest are resolved so as not to influence subsequent decision of

laboratory.

Other terms that convey the meaning of impartiality include

Independence

Freedom from conflicts of interest

Freedom from bias

Lack of prejudice

Neutrality, fairness, open-mindedness

Even-handedness, detachment, balance

3. Terms and Definitions

3.2 Complaint

Expression of dissatisfaction by a person or organization to a laboratory, relating to the activities or

results of the laboratory, where a response is expected.

3.3 Interlaboratory Comparison

Organization, performance and evaluation of measurements or tests on the same or similar items by

two or more laboratories in accordance with predetermined conditions

3.4 Intralaboratory Comparison

Organization, performance and evaluation of measurements or tests on the same or similar items within

the same laboratory in accordance with predetermined conditions

3.5 Proficiency Testing

Evaluation of participant performance against pre establish criteria by means of interlaboratory

comparison

3.6 Laboratory

Body that performs one or more of the following : testing, calibration and sampling and subsequent

testing.

3. Terms and Definitions

3.7 Decision rule

Rule that describes how measurement uncertainty is accounted for when stating conformity

with specified requirement.

3.8 Verification

Provision of objective evidence that a given item fulfills specific requirement

3.9 Validation

Verification where the specified requirements are adequate for an intended use

4.0 General Requirement

4.1 Impartiality

4.1.1 Lab activities shall be undertaken impartially

4.1.2 Lab management shall be committed to impartiality

4.1.3 Lab shall be responsible for the impartiality of its activities

4.1.4 Lab shall identify risks to the impartiality of its activities.

4.1.5 If a risk to impartiality is identify, lab shall be able to demonstrate how it eliminates or

minimizes such risk.

How to demonstrate impartiality in laboratory operation

Have written policy of impartiality

Have documented procedure (or SOP) on identifying risk to impartiality and handling impartiality.

Have a written Code of Conduct for all levels of personnel including management.

See ISO 14065 guidance on impartiality

(https://ec.europa.eu/clima/sites/clima/files/ets/monitoring/docs/good_practice_iso_14065_impartiality_and_

management_en.pdf)

4.0 General Requirement

4.2 Confidentiality

4.2.1 Lab is responsible for the management of all information acquired during its activities.

Customer's approval must be obtained prior to release of information to third party.

4.2.2 Customer shall be informed when confidential information are to be released by law.

4.2.3 Information about customer from third party sources shall be confidential between

customer and lab. The third party shall remain unknown to customer unless agreed.

4.2.4 Lab personnel and any other related individual shall keep confidential all information

obtained during lab activities they are involved in.

How to manage confidentiality in laboratory operation

Have written policy of confidentiality in laboratory operation.

Have confidentiality agreement with all employees

Restrict access to CONFIDENTIAL documents

Training on Confidentiality procedure and handling of data and records.

No specific requirement for Risk Management System such as ISO 31000 : Risk Management - Principles and Guidelines

5 Structural Requirement…

5.1 Lab shall be a legal entity. A governmental lab is deemed a legal entity on the basis of its

governmental status.

5.2 Lab shall identify management that has overall responsibility for the laboratory.

5.3 Lab shall define and document and only claim conformity, a range of its activities which it conform

with this document ( as in the scope of accreditation).Externally provided laboratory activities on an

ongoing basis shall be excluded.

5.4 Laboratory activities shall be carried out in such a way as to meet requirements of;

- this document (MS/ISO/IEC 17025:2017)

- laboratory's customers

- regulatory authorities and organizations providing recognition

in all its permanent facilities, sites away from permanent facilities, in associated temporary or mobile

facilities or at customer's facility.

5 Structural Requirement…

5.5 Laboratory shall:

a) define organization & management structure of the laboratory, its place in any parent organization &

the relationships between management, technical operations & support services;

b) specify responsibility, authority & interrelationship of all personnel who manage, perform or verify

work affecting the results of laboratory activities;

c) document its procedures to the extent necessary to ensure consistent application of its laboratory

activities & the validity of the results.

Document its procedures = have all procedures documented, similar to having the Quality Manual and

SOPs/QPs

5 Structural Requirement..

5.6 The laboratory shall have personnel who have the authority and resources needed to

carry out their duties, including:

a) implementation, maintenance and improvement of the management system (Laboratory Manager? );

b) identification of deviations from the management system (Quality Manager?) or from the procedures

for performing laboratory activities (Technical Manager? );

c) initiation of actions to prevent or minimize such deviations;

d) reporting to laboratory management on the performance of the management system and any need

for improvement;

e) ensuring the effectiveness of laboratory activities.

Even though LM, QM and TM positions are NOT specified, Their job functions are Appoint them.

Deputies may not be appointed.

Laboratory Management replaces Top management

5 Structural Requirement

5.7 Laboratory management shall ensure that:

a) communication takes place regarding the effectiveness of management system and the importance of

meeting customers' and other requirements;

b) the integrity of the management system is maintained when changes to the management system are

planned and implemented.

Laboratory Management are Top management

6 Resource Requirements

6.1 General – Laboratory shall have available Personnel, Facilities, Equipment, Systems and Support

Services necessary to manage and perform its laboratory activities.

6.2 Personnel

6.2.1 All personnel of the Lab (that could influence lab activities) shall act impartially, be competent and

work in accordance with Lab management system.

6.2.2 Lab shall document competence requirements for each function influencing result. qualification,

training requirement etc.

6.2.3 Lab shall ensure personnel have the competence to perform laboratory activities competency

assessment include ability to evaluate significance of deviations.

6.2.4 The Lab Management shall communicate to personnel their duties, responsibilities and authorities.

6 Resource Requirements

6.2.5 Laboratory shall have procedure(s) and retain records for:

(a) determining the competence requirements;

(b) selection of personnel;

(d) supervision of personnel;

(e) authorization of personnel;

(f) monitoring of competence of personnel.

Competence - The ability to do something successfully or efficiently – Oxford. (BM  Kecekapan)

Competency Framework including monitoring of competency -

https://www.mindtools.com/pages/article/newISS_91.htm

6 Resource Requirements

6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but

not limited to, the following:

a) development, modification, verification and validation of methods;

b) analysis of results, including statements of conformity or opinions and interpretations;

c) report, review and authorization of results.

6 Resource Requirements

6.3 Facilities and environmental conditions

6.3.1 The facilities and environmental conditions shall be suitable for laboratory activities and shall not

adversely affect validity of results.

6.3.2 The requirements for facilities and environmental conditions necessary shall be documented.

6.3.3 Laboratory shall monitor, control & record environmental conditions as required.

6.3.4 Measures to control facilities shall be implemented, monitored and periodically reviewed But not

limited to ;

(a) control of access, (b) prevention of contamination and

6.3.5When working at site or facilities outside its permanent control, Lab shall ensure that requirements

related to facilities and environmental conditions are met.

6 Resource Requirements

6.4 Equipment

6.4.1 Lab shall have access to equipment and their supporting accessories.

6.4.2 When using equipment outside its permanent control, Lab shall ensure that requirement for

equipment are met.

6.4.3 Lab shall have a procedure for handling, transport, storage, use and maintenance of equipment.

6.4.4 Lab shall verify that equipment conform to specified requirement before being placed into services.

6.4.5 The equipment shall be capable of achieving the measurement accuracy and/or measurement

uncertainty.

6.4.4 Requirement for Operational Qualification (OQ)

6.4.5 Requirement for Performance Qualification (PQ)

6 Resource Requirements

6.4 Equipment

6.4.6 Measuring equipment shall be calibrated

- when the measurement accuracy or measurement uncertainty affects the result and/or

- calibration of equipment is required to establish the metrological traceability.

6.4.7 Lab shall establish a calibration programme which shall be reviewed and adjusted as necessary.

6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled, coded

or otherwise identified.

6.4.9 Equipment that has been

- subjected to overloading or mishandling,

- gives questionable result

- has been shown to be defective or outside specified requirements,

# Shall be taken out of services.

# Shall be isolated to prevent its use

# Clearly marked as being out of service.

Then Lab shall examine the effect of the defect and shall initiate nonconforming work procedure.

6 Resource Requirements

6.4 Equipment

6.4.10 When intermediate check are necessary to maintain confidence in the performance of the

equipment , a procedure is required. (requirement for a procedure on Intermediate Check)

6.4.11 When calibration and reference material data include reference values or correction factors, the

laboratory shall ensure the reference values and correction factors are updated and implemented, as

appropriate, to meet specified requirements.

6.4.12 Laboratory shall take measures to prevent unintended adjustments of equipment from

invalidating results.

6 Resource Requirements

6.4 Equipment

6.4.13 Records shall be retained for equipment which can influence laboratory activities. The records shall

include the following, where applicable:

a) the identity of equipment, including software and firmware version;

b) the manufacturer's name, type identification, and serial number or other unique identification;

c) evidence of verification that equipment conforms with specified requirements;

d) the current location;

e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the

next calibration or the calibration interval;

f) documentation of reference materials, results, acceptance criteria, relevant dates and the period of

validity;

g) the maintenance plan and maintenance carried out to date, where relevant to the performance of

the equipment;

h) details of any damage, malfunction, modification to, or repair of, the equipment.

Equipment list and inventory

Equipment logbook and maintenance record

6 Resource Requirements

6.5 Metrological traceability (See also Annex A)

6.5.1 The laboratory shall establish and maintain metrological traceability of its measurement results by

means of a documented unbroken chain of calibrations, each contributing to the measurement

uncertainty, linking them to an appropriate reference.

6.5.2 The laboratory shall ensure that measurement results are traceable to the International System of

Units (SI) through one of the following:

a) calibration provided by a competent laboratory;

b) certified values of certified reference materials provided by a competent producer with stated

metrological traceability to the SI;

c) direct realization of the SI units ensured by comparison, directly or indirectly, with national or

international standards.

6.5.3 When metrological traceability to SI units is NOT technically possible, Lab shall demonstrate

metrological traceability to an appropriate reference.

https://en.wikipedia.org/wiki/Realisation_(metrology)

6 Resource Requirements

6.6 Externally Provided Products and Services

6.6.1 Lab shall ensure that only suitable externally provided products and services are used when such products

and services:

a) Are intended for incorporation into Lab own activities

b) Are provided directly to customer as received from external provider

c) Are used t support the operation of the Lab.

6.6.2 Lab shall have procedure and retain records for:

a) defining, reviewing and approving laboratory requirement for externally provided P&S.

b) Defining criteria for evaluation, selection, monitoring of performance of external providers

c) ensuring that external provides conform to Lab's established requirements

d) Taking any actions arising from evaluation, monitoring of performance and re-evaluation of external providers.

6 Resource Requirements

6.6 Externally Provided Products and Services

6.6.3 Lab shall communicate its requirement to external providers for:

a) The products and services to be provided

b) The acceptance criteria

c) Competence, including any required qualification of personnel

d) Activities that Lab or its customers intend to perform at external provider's premises

7 Process Requirements

7.1 Review of Requests, Tenders and Contracts

7.1.1 Lab shall have a procedure for review of requests, tenders and contracts. Shall include;

a) Requirements are adequately defined, documented and understood,

b) Lab has the capability and resources to meet the requirements,

c) When external providers are used, Lab advised customer of specific activities to be performed by

external provider and gains customer's approval.

d) Appropriate methods or procedures are selected and are capable of meeting customer's requirements.

SOP on Review of requests, tenders and contracts.

7 Process Requirements

7.1 Review of Requests, Tenders and Contracts

7.1.2 Lab shall inform customer when the method requested by customer is considered inappropriate or

out of date.

7.1.3 When customer requests a statement of conformity to a specification or standard, the specification

or standard and the decision rule shall clearly be defined. The decision rule selected shall be communicated

to and agreed with customer unless it is clearly defined.

7.1.4 Any differences between the request and the contract shall be resolved before Lab activities

commence. Each contract shall be acceptable to both Lab and customer. Deviation requested by customer

shall not impact integrity of Lab or validity of results.

7.1.5 The customer shall be informed of any deviation from contract.

Decision Rule – a rule that describes how measurement uncertainty will be accounted for when

stating conformity with a specified requirement.

Good guide ref; http://www.eurolab.org/documents/EUROLAB%20Technical%20Report%20No.1-

2017_Final.pdf

7 Process Requirements

7.1 Review of Requests, Tenders and Contracts

7.1.6 If a contract is amended after work has commenced, the contract review shall be repeated and any

amendments shall be communicated to all affected personnel.

7.1.7 Lab shall cooperate with customers (or their representatives) in clarifying customer's request and in

monitoring Lab performance in relation to the work performed.

7.1.8 Records of reviews shall be retained. Records of all related discussions with customer shall also be

retained.

7 Process Requirements

7.2 Selection, verification and validations of methods

7.2.1 Selection and verification of methods

7.2.1.1 The laboratory shall use appropriate methods and procedures for all laboratory activities and, for

evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.

7.2.1.2 All methods, procedures and supporting documentation shall be kept up to date and shall be made

readily available to personnel.

7.2.1.3 The laboratory shall ensure that it uses the latest valid version of a method unless it is not

appropriate or possible to do so.

Note: International, regional or national standards (methods) that contain sufficient and concise

information on how to perform laboratory activities need not be rewritten if these standards are written in

a way that can be used by the operating personnel in the Lab. If necessary, write a work instruction of

procedure steps.

7 Process Requirements

7.2 Selection, verification and validations of methods

7.2.1 Selection and verification of methods

7.2.1.4 When method is not specified by customer, Lab shall select an appropriate method and inform the

customer of the method chosen. Standard methods are preferred.

7.2.1.5 Lab should verify that it can properly perform methods before introducing them. Record of

verification shall be retained. If method is revised by issuing body, verification shall be repeated to the

extent necessary.

7.2.1.6 When method development is required, this shall be a planned activity and assigned to a

competent personnel. Any modification to the development plan shall be approved and authorized.

7.2.1.7 Deviations from methods for all Lab activities shall occur only if the deviation has been

documented, technically justified, authorized and accepted by customer.

7 Process Requirements

7.2 Selection, verification and validations of methods

7.2.2 Validation of methods

7.2.2.1 The laboratory shall validate non-standard methods, laboratory-developed methods and standard

methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is

necessary to meet the needs of the given application or field of application.

7.2.2.2 When changes are made to a validated method, the influence of such changes shall be determined

and where they are found to affect the original validation, a new method validation shall be performed.

7.2.2.3 The performance characteristics of validated methods as assessed for the intended use, shall be

relevant to the customers' needs and consistent with specified requirements.

Validation of non-standard method: The Fitness of Purpose of Analytical Method

https://www.eurachem.org/images/stories/Guides/pdf/MV_guide_2nd_ed_EN.pdf

7 Process Requirements

7.2 Selection, verification and validations of methods

7.2.2 Validation of methods

7.2.2.4 The laboratory shall retain the following records of validation:

a) the validation procedure used;

b) specification of the requirements;

c) determination of performance characteristics of the method;

d) results obtained;

e) a statement on the validity of the method, detailing its fitness for the intended use.

7 Process Requirements

7.3 Sampling

7.3.1 Lab shall have sampling plan and method when it carries out sampling of substances, materials and

products for subsequent testing/calibration.

- Sampling method shall address factors to be controlled.

- Sampling plan and method shall be available at the sampling site.

- Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.

7.3.2 The sampling method shall describe;

a) The selection of samples or sites,

b) The sampling plan,

c) Preparation and treatment of samples .

7 Process Requirements

7.3 Sampling

7.3.3 The laboratory shall retain records of sampling data that forms part of the testing or calibration

that is undertaken. These records shall include, where relevant:

a) reference to the sampling method used;

b) date and time of sampling;

c) data to identify and describe the sample;

d) identification of personnel performing sampling;

e) identification of the equipment used;

f) environmental or transport conditions;

g) diagrams or other equivalent means to identify the sampling location when appropriate;

h) deviations, additions to or exclusions from the sampling method and sampling plan.

7 Process Requirements

7.4 Handling of test and calibration items

7.4.1 Lab shall have a procedure for the transportation, receipt, handling, protection, storage, retention

and disposal or return of test/calibration items.

- To include all provision necessary to protect integrity of items

- to protect interest of Lab and customer.

- Precautions shall be taken to avoid deterioration, contamination, loss or damage of item.

- Handling instructions provided with items shall be followed.

7.4.2 Lab shall have a system for the unambiguous identification of test/calibration items.

- The identification shall be retained while under the responsibility of Lab

- The system shall ensure that items will not be confused physically or when referred to.

- The system shall, if appropriate, accommodate a sub-division of an items, group of items or

transfer of items.

7 Process Requirements

7.4 Handling of test and calibration items

7.4.3 Upon receipt of test/calibration item, deviations from specified conditions shall be recorded.

-When there is doubt about suitability of an item or calibration or when an item does not conform to the

description provided, Lab shall consult the customer for further instructions before proceeding and shall

record results of this consultation.

-When customer requires the item to be tested or calibrated acknowledging a deviation from specified

conditions, Lab shall include a disclaimer in the report indicating results may be affected by the

deviation.

7.4.4 When items need to stored or conditioned under specified environmental conditions, these

conditions shall be maintained, monitored and recorded.

7 Process Requirements

7.5 Technical record

7.5.1 Lab shall ensure that technical records for each activity contain the results, report and sufficient

information to facilitate:

- identification of factors affecting the result and its associated MU

- enable the repetition of Lab activity under conditions as close as possible

Technical records shall include date and identity of personnel responsible for each activity and for checking

data and results.

Original observations, data and calculations shall be recorded at time they are made – requirement for

work-sheet.

7.5.2 Lab shall ensure that amendments to technical records can be tracked to previous versions or to

original observations. Both the original and amended data and files shall be retained, including;

- date of alteration

- an indication of altered aspects

- the personnel responsible for the alterations.

7 Process Requirements

7.6 Evaluation of measurement uncertainty

7.6.1 Lab shall identify the contributions to measurement uncertainty. When evaluating MU, all

contributions which are of significance, including those arising from sampling, shall be taken into account

using appropriate methods of analysis.

7.6.2 Lab performing calibrations, including its own equipment, shall evaluate the MU for all calibrations.

7.6.3 Lab performing testing shall evaluate MU. Where test method precludes rigorous evaluation of MU,

an estimation shall be made based on an understanding of the theoretical principles or practical experience

of the performance of the method.

NOTE 2 For a particular method where the measurement uncertainty of the results has been established

and verified, there is no need to evaluate measurement uncertainty for each result if the laboratory can

demonstrate that the identified critical influencing factors are under control.

NOTE 3 – For further information, see ISO/IEC Guide 98-3, ISO 5725 and ISO 21748

7 Process Requirements

7.7 Ensuring the validity of results

7.7.1 Lab shall have a procedure for monitoring the validity of results. The resulting data shall be recorded

in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to

review the results. This monitoring shall be planned and reviewed and shall include,

where appropriate, but not be limited to:

a) use of reference materials or quality control materials;

b) use of alternative instrumentation that has been calibrated to provide traceable results;

c) functional check(s) of measuring and testing equipment;

d) use of check or working standards with control charts,

e) intermediate checks on measuring equipment;

f) replicate tests or calibrations using the same or different methods;

g) retesting or recalibration of retained items;

h) correlation of results for different characteristics of an item;

i) review of reported results;

j) intralaboratory comparisons;

k) testing of blind sample(s).

7 Process Requirements

7.7 Ensuring the validity of results

7.7.2 Lab shall monitor its performance by comparison with results of other laboratories, where available

and appropriate.

This monitoring shall be planned and reviewed and shall include, but not limited to, either or both

of the following;

a) Participation in proficiency testing;

b) Participation in interlaboratory comparisons.

7.7.3 Data from monitoring activities shall be analysed, used to control and, if applicable, improve the

laboratory activities.

If results of the analysis of data from monitoring activities are found to be outside predefined

criteria (OOS), appropriate action shall be taken to prevent incorrect results from being reported.

7 Process Requirements

7.8 Reporting Results

7.8.1 General

7.8.1.1 The results shall be reviewed and authorized prior to release.

7.8.1.2 The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report

(Calibration certificate, Certificate of Analysis) and shall include all the information agreed with the

customer and necessary for the interpretation of the results and all information required by the method

used. All issued reports shall be retained as technical records.

7.8.1.3 When agreed with the customer, the results may be reported in a simplified way. Any information

listed in 7.8.2 to 7.8.7 that is not reported to the customer shall be readily available.

7 Process Requirements

7.8 Reporting Results

7.8.2 Common requirements for reports (test, calibration or sampling

7.8.2.1 Each report shall include at least the following information, unless the laboratory has valid reasons

for not doing so:

a) a title (e.g. "Test Report", "Calibration Certificate" or "Report of Sampling");

b) the name and address of the laboratory;

c) the location of performance of Lab activities, including when performed at a customer facility or at

sites away from the laboratory's permanent facilities, or in associated temporary or mobile facilities;

d) unique identification that all its components are recognized as a portion of a complete report and a

clear identification of the end;

e) the name and contact information of the customer;

f) identification of the method used;

g) a description, unambiguous identification, and, when necessary, the condition of the item;

h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to

the validity and application of the results;

i) the date(s) of performance of the laboratory activity;

j) the date of issue of the report;

7 Process Requirements

7.8 Reporting Results

7.8.2.1 Each report shall include at least the following information, unless the laboratory has valid reasons

for not doing so:

k) reference to the sampling plan and sampling method used by the laboratory or other bodies where

these are relevant to the validity or application of the results;

l) a statement to the effect that the results relate only to the items tested, calibrated or sampled;

m) the results with, where appropriate, the units of measurement;

n) additions to, deviations, or exclusions from the method;

o) identification of the person(s) authorizing the report;

p) clear identification when results are from external providers.

7.8.2.2 Lab shall be responsible for all the information provided in the report, except when information is

provided by customer.

Data by customer shall be clearly identified.

A disclaimer shall be put on the report when information is provided by customer.

When Lab are not involved in sampling stage, it shall state in the report that results apply to

sample as received.

7 Process Requirements

7.8.3 Specific Requirement for Test Reports

7.8.3.1 In addition to the requirements listed in 7.8.2, test reports shall, where necessary for the

interpretation of the test results, include the following:

a) information on specific test conditions, such as environmental conditions;

b) where relevant, a statement of conformity with requirements or specifications

c) where applicable, the measurement uncertainty presented in the same unit as that of the measurand

or in a term relative to the measurand (e.g. percent) when:

- it is relevant to the validity or application of the test results;

- a customer's instruction so requires, or

- the measurement uncertainty affects conformity to a specification limit;

d) Where appropriate, opinion and interpretation

e) Additional information which may be required by specific methods, authorities or customers.

7.8.3.2 When Lab is responsible for sampling activity, test reports shall meet the requirements listed in

7.8.5 when necessary for interpretation of test results.

7 Process Requirements

7.8.4 Specific Requirement for Calibration certificates

7.8.4.1 In addition to the requirements listed in 7.8.2, calibration certificates shall include the following:

a) the measurement uncertainty of the measurement result presented in the same unit as that of the

measurand or in a term relative to the measurand (e.g. percent);

b) the conditions (e.g. environmental) under which the calibrations were made that have an influence

on the measurement results;

c) a statement identifying how the measurements are metrologically traceable (see Annex A);

d) the results before and after any adjustment or repair, if available;

e) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);

f) where appropriate, opinions and interpretations (see 7.8.7).

7.8.4.2 When Lab is responsible for the sampling activity, calibration certificate shall meet the

requirements listed in. 7.8.5 where necessary for interpretation of calibration results.

7.8.4.3 A Calibration Certificate or calibration label shall NOT contain any recommendation on the

calibration interval except where this has been agreed with customer.

7 Process Requirements

7.8.5 Reporting sampling – specific requirements

Where the laboratory is responsible for the sampling activity, in addition to the requirements

listed in 7.8.2, reports shall include the following, where necessary for the interpretation of results:

a) the date of sampling;

b) unique identification of the item or material sampled (including the name of the manufacturer, the

model or type of designation and serial numbers, as appropriate);

c) the location of sampling, including any diagrams, sketches or photographs;

d) a reference to the sampling plan and sampling method;

e) details of any environmental conditions during sampling that affect the interpretation of the results;

f) information required to evaluate measurement uncertainty for subsequent testing or calibration.

7 Process Requirements

7.8.6 Reporting statement of conformity

7.8.6.1 When a statement of conformity to a specification or standard is provided, Lab shall document the

decision rule employed, taking into account the level of risk associated with the decision rule employed

and apply the decision rule.

7.8.6.2 Lab shall report on the statement of conformity, such that the statement clearly identifies;

a) to which results the statement of conformity applies;

b) which specifications, standards or parts thereof are met or not met.

c) the decision rule applied (unless it is inherent in the requested specification or standard).

NOTE Where the decision rule is prescribed by the customer, regulations or normative documents, a

further consideration of the level of risk is not necessary.

7 Process Requirements

7.8.7 Reporting opinions and interpretations

7.8.7.1 When opinions and interpretations are expressed, the laboratory shall ensure that only personnel

authorized for the expression of opinions and interpretations release the respective statement. The

laboratory shall document the basis upon which the opinions and interpretations have been made.

7.8.7.2 The opinions and interpretations expressed in reports shall be based on the results obtained from

the tested or calibrated item and shall be clearly identified as such.

7.8.7.3 When opinions and interpretations are directly communicated by dialogue with the customer, a

record of the dialogue shall be retained. (Thus easier to use email communication)

7 Process Requirements

7.8.8 Amendments to reports

7.8.8.1 When an issued report needs to be changed, amended or re-issued, any change of information shall

be clearly identified and, where appropriate, the reason for the change included in the report.

7.8.8.2 Amendments to a report after issue shall be made only in the form of a further document, or data

transfer, which includes the statement "Amendment to Report, serial number... [or as otherwise

identified]", or an equivalent form of wording.

Such amendments shall meet all the requirements of this document.

7.8.8.3 When it is necessary to issue a complete new report, this shall be uniquely identified and shall

contain a reference to the original that it replaces.

7 Process Requirements

7.9 Complaints

7.9.1 Lab shall have a documented process to receive, evaluate and make decisions on complaints.

7.9.2 A description of the handling process for complaints shall be available to any interested party on

request. - Upon receipt of a complaint, Lab shall confirm whether the complaint relates to Lab activities

that it is responsible for and, if so, shall deal with it.

- Lab shall be responsible for all decisions at all levels of the handling process for complaints.

7.9.3 The process for handling complaints shall include at least the following elements and methods:

a) description of the process for receiving, validating, investigating the complaint, and deciding what

actions are to be taken in response to it;

b) tracking and recording complaints, including actions undertaken to resolve them;

c) ensuring that any appropriate action is taken.

7 Process Requirements

7.9 Complaints

7.9.4 Lab receiving the complaint shall be responsible for gathering and verifying all necessary information

to validate the complaint.

7.9.5 Whenever possible, Lab shall acknowledge receipt of the complaint, and provide the complainant

with progress reports and the outcome.

7.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and approved

by, individual(s) not involved in the original Lab activities in question.

NOTE This can be performed by external personnel (different department, section etc)

7.9.7 Whenever possible, Lab shall give formal notice of the end of the complaint handling to the

complainant.

7 Process Requirements

7.10 Nonconforming work

7.10.1 Lab shall have a procedure that shall be implemented when any aspect of its Lab activities or results

of this work do not conform to its own procedures or the agreed requirements of the customer.

The procedure shall ensure that:

a) the responsibilities and authorities for the management of nonconforming work are defined;

b) actions (including halting or repeating of work and withholding of reports, as necessary) are based

upon the risk levels established by the Lab;

c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on

previous results;

d) a decision is taken on the acceptability of the nonconforming work;

e) where necessary, the customer is notified and work is recalled;

f) the responsibility for authorizing the resumption of work is defined.

7.10.2 Lab shall retain records of nonconforming word and actions.

7.10.3 When the evaluation indicates that the nonconforming work could recur, Lab shall implement

corrective action.

7 Process Requirements

7.11 Control of data and information management

7.11.1 Lab shall have access to the data and information needed to perform Lab activities

7.11.2 Lab information management systems used for collection, processing, recording, reporting, storage

or retrieval of data shall be validated for functionality.

- Whenever there are changes, they shall be authorized, documented and validated before

implementation.

7.11.3 The Laboratory Information Management System shall;

a) be protected from unauthorized access

b) safeguarded against tempering and loss

c) be operated in an environment that complies with provider or Lab specification

d) be maintained in a manner that ensures the integrity of data and information;

e) include recording system failures and appropriate immediate and corrective actions.

7 Process Requirements

7.11 Control of data and information management

7.11.4 When a laboratory information management system is managed and maintained off-site or through

an external provider, the laboratory shall ensure that the provider or operator of the system complies with

all applicable requirements of this document.

7.11.5 The laboratory shall ensure that instructions, manuals and reference data relevant to the laboratory

information management system(s) are made readily available to personnel.

7.11.6 Calculations and data transfers shall be checked in an appropriate and systematic manner

Computerized Laboratory Information Management System (LIMS) versus Paper-based system or mixed?

8 Management Requirement

8.1 Options

8.1.1 General

The laboratory shall establish, document, implement and maintain a management system that is

capable of supporting and demonstrating the consistent achievement of the requirements of this

document and assuring the quality of the laboratory results. In addition to meeting the

requirements of Clauses 4 to 7, the laboratory shall implement a management system in

accordance with Option A or Option B.

Option A: comply to ISO/IEC 17025

Option B: comply to ISO 9001 + ISO/IEC 17025 Clause 4-7

8 Management Requirement

8.1 Options

8.1.2 Option A

As a minimum, the management system of the laboratory shall address the following:

— management system documentation (see 8.2);

— control of management system documents (see 8.3);

— control of records (see 8.4);

— actions to address risks and opportunities (see 8.5);

— improvement (see 8.6);

— corrective action (see 8.7);

— internal audits (see 8.8);

— management reviews (see 8.9).

8 Management Requirement

8.1 Options

8.1.3 Option B

A laboratory that has established and maintains a management system, in accordance with the

requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent

fulfilment of the requirements of clauses 4 to 7, also fulfils at least the intent of the

management system section requirements in 8.2 - 8.9.

8 Management Requirement

8.2 Management System documentation (Option A)

8.2.1 Laboratory management shall establish, document, and maintain policies and objectives for the

fulfilment of the purposes of this document and shall its implementation.

8.2.2 The policies and objectives shall address the competence, impartiality and consistent operation of

the laboratory.

8.2.3 Laboratory management shall provide evidence of commitment to the development and

implementation of the management system and to continually improving its effectiveness.

8.2.4 All documentation, processes, systems , records shall be included in reference from, or linked to

the management system.

8.2.5 All personnel involved shall have access to the parts of the management system documentation

and related information that are applicable to their responsibilities.

8 Management Requirement

8.3 Control of management system document (Option A)

8.3.1 Lab shall control the documents (internal and external) that relate to the fulfilment of this

document.

8.3.2 Lab shall ensure that:

a) documents are approved for adequacy prior to issue by authorized personnel;

b) documents are periodically reviewed, and updated as necessary;

c) changes and the current revision status of documents are identified;

d) relevant versions of applicable documents are available at points of use and, where necessary, their

distribution is controlled;

e) documents are uniquely identified;

f) the unintended use of obsolete documents is prevented, and suitable identification is applied to them

if they are retained for any purpose.

8 Management Requirement

8.4 Control of records (Option A)

8.4.1 Lab shall establish and retain legible records to demonstrate fulfilment of the requirements

in this document.

8.4.2 Lab shall implement the controls needed for the identification, storage, protection, back-up,

archive, retrieval, retention time, and disposal of its records.

The laboratory shall retain records for a period consistent with its contractual obligations.

Access to these records shall be consistent with the confidentiality commitments and records

shall be readily available.

SP1- retention of records as required by law, or national guidelines or at least 6 years

8 Management Requirement

8.5 Actions to address risks and opportunities (Option A)

8.5.1 Lab shall consider the risks and opportunities associated with the laboratory activities in

order to:

a) give assurance that the management system achieves its intended results;

b) enhance opportunities to achieve the purpose and objectives of the laboratory;

c) prevent, or reduce undesired impacts and potential failures in the laboratory activities;

d) achieve improvement.

8 Management Requirement

8.5 Actions to address risks and opportunities (Option A)

8.5.2 Lab shall plan:

a) actions to address these risks and opportunities;

b) how to:

- integrate and implement the actions into its management system;

- evaluate the effectiveness of these actions.

8.5.3 Actions taken to address risks and opportunities shall be proportionate to the potential

impact on the validity of laboratory results.

NOTE - there is no requirement for formal methods for risk management or a documented risk

management process.

Bibliography : ISO 31000, Risk management — Principles and guidelines

Other reference: IEC 31010:2009, Risk management – Risk assessment techniques

8 Management Requirement

8.6 Improvement (Option A)

8.6.1 Lab shall identify and select opportunities for improvement and implement any necessary

actions.

8.6.2 The laboratory shall seek feedback, both positive and negative, from its customers. The

feedback shall be analysed and used to improve the management system, laboratory activities

and customer service.

Pro-active approach to non-compliance and out-of-specification (OOS) requiring preventive actions and

improvement.

8 Management Requirement

8.7 Corrective Action (Option A)

8.7.1 When a nonconformity occurs, Lab shall:

a) react to the nonconformity and, as applicable:

- Take action to control and correct it

- address the consequences

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not

recur or occur elsewhere, by:

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the management system, if necessary

8.7.2 Corrective actions shall be appropriate to the effects of the nonconformities encountered.

8.7.3 The laboratory shall retain records as evidence.

8 Management Requirement

8.8 Internal audits (Option A)

8.8.1 Lab shall conduct internal audits at planned intervals to provide information on whether the

management system:

a) conforms to:

- Lab's own requirements for its management system, including Lab activities;

- the requirements of this document;

b) is effectively implemented and maintained.

•Silent on recommended frequency of Internal Audit

•Standards Malaysia Policy remained once a year (depend on AB's policy)

•coverage of internal audit : ISO/IEC 17025 including SAMM requirements

•Auditor competency and impartiality included in 6.2 Personnel.

8 Management Requirement

8.8 Internal audits (Option A)

8.8.2 Lab shall:

a) plan, establish, implement and maintain an audit programme including the frequency,

methods, responsibilities, planning requirements and reporting,

b) define the audit criteria and scope for each audit;

c) ensure that the results of the audits are reported to relevant management;

d) implement appropriate correction and corrective actions without undue delay;

e) retain records as evidence of the implementation of the audit programme and the audit

results.

•NOTE ISO 19011 provides guidance for internal audits.

8 Management Requirement

8.9 Management reviews (Option A)

8.9.1 Lab management shall review its management system at planned intervals, in order to

ensure its continuing suitability, adequacy and effectiveness, including the stated policies and

objectives related to the fulfilment of this document.

8.9.2 The inputs to management review shall be recorded and shall include information related to;

15 items, a) – o)

b) fulfilment of objectives

d) status of actions from previous management reviews

m) result of risk identification

8.9.3 The output from management review shall record all decisions and actions related to;

a) The effectiveness of the management system and its processes;

b) Improvement of the Lab activities related to fulfilment of requirement of this document;

c) Provision of required resources;

d) Any need for change

Summary of Requirements

PROCEDURES (SOP/QP)

6.2.5 Personnel records

6.4.3 Handling of laboratory equipment

6.4.10 Intermediate checks

6.5.3 b) Reference measurement

6.6.2 Externally provided products &

services

7.1.1 Review of requests, tenders & contracts

7.2.1.1 Evaluation of measurement uncertainty

7.2.2.4 Validation

7.4.1 Handling of customer equipment

7.7.1 Ensuring the validity of results

7.10.1 Nonconforming work

Summary of Requirements

POLICIES

8.2.2 Competence, impartiality and

consistent operation 7.9.1 Complaints

DOCUMENTED PROCESS

6.4.7 Calibration

8.8.2 Internal Audit

PROGRAM

Summary of Requirements

6.4.3 maintenance

6.4.13 g) Equipment maintenance

7.2.1.6 Method development

7.3.1 Sampling

7.3.2 Sampling method includes

7.7.1 monitoring the validity of results

8.5.2 Risks & opportunities

8.8.1 Internal audits

8.9 Management review

PLANS AND PLANNING

Summary of Requirements

6.2.5 Laboratory personnel

6.3.3 Environmental conditions

6.4.13 Equipment

6.6.2 External providers

7.1.8 Contract reviews and discussions

7.2.1.5 Verification of methods

7.2.2.4 Validations

7.3 Sampling data

7.3.3 Sampling records include deviations,

additions to or exclusions from

7.4.3 Deviations from specified conditions

7.4.3 Consultation

7.4.4 Specified environmental conditions

RECORDS

Summary of Requirements

7.5.1 Original observations

7.7.1 Resultant data

7.8.1.1 Reports

7.8.7.3 Dialog with customer on opinions

& interpretations

7.9.3 Complaints

7.10.2 Nonconforming work

7.11.3e)Information management system failures

8.7.3 Corrective action

8.8.2 Implementation of the internal audit

8.9.1 inputs to management review

RECORDS

Summary of Requirements

IDENTIFY

4.1.4 Risks to impartiality

5.2 Management responsible for the

laboratory

6.4.8 Period of validity

7.3.3 Sample

7.6.1 Contributions to measurement

uncertainty

7.8.4.1c) Metrological traceability

8.6.1 Opportunities for improvement

5.3 Range of activities

6.6.2a)Laboratory requirements for external

providers

6.6.2b) Criteria for evaluating….

7.1.1Requirements for the review requests,

tenders and contracts

DEFINE

Summary of Requirements

5.3 Range of activities

6.2.2 Competence requirements

6.3.2 Requirements for facilities and

environmental conditions

6..13f) Reference materials

7.1.1 Requirements for the review of

requests, tenders and contracts

7.2.1.2 Validation supporting

documentation

7.2.1.7Deviations

7.8.6.1 Decision rule

7.8.7.1 Opinions & interpretations

7.8.8.2 Amendments

7.9.1 Complaints

7.11.2 Laboratory software configuration or

modification of COTS

8.2.1 Policies and objectives

DOCUMENT

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