LAC.part 1. 2022_Nota Nisah

MS ISO IEC17025:2017
Lead Auditor Training

(understanding requirement of the standard)
13-16 June 2022

Nexis, Kota Damansara, Selangor

By Mr K L Ng
Lab Consult Plt





Conformity assessment and accreditation

4

Conformity assessment accreditation hierarchy

5

What are CABs?

Conformity Assessment Bodies (CABs) are testing and calibration laboratories,
certification bodies as well as inspection bodies that provide conformity
assessment services.

After being assessed on their competence, impartiality and performance
capability to offer specified conformity assessment services, CABs gain the
stamp of international approval through accreditation by the Standards
Malaysia.

Accreditation provides customers and regulatory authorities with added
confidence. Certificates regarded as higher credibility.

Standards Malaysia: (MRA) Signatory to various international organisations
including ILAC, IAF, APLAC, PAC.

Standards Malaysia logo on test, calibration, inspection reports and certificates
means report is recognised among the MRA partners.
6

International Recognition

International Laboratory Accredition Council MS/ISO/IEC 17025
Mutual Recognition Agreement CALIBRATION / TESTING

SAMM NO. 000

This entry into the ILAC MRA signifies international endorsement of confidence
on the competence and integrity of laboratory accreditation provided by

STANDARDS MALAYSIA.The signing of the ILAC MRA further enhances
STANDARDS MALAYSIA's role as the national accreditation body within the

country’s conformity assessment infrastructure

7

Mutual Recognition Arrangements (MRAs)

- uniform approach allows countries to establish agreements among themselves,
- based on mutual evaluation and acceptance of each other’s accreditation

systems.
- crucial in enabling test and calibration data to be accepted between these

countries.
- partner recognises the other partner’s accredited laboratories as if they

themselves had undertaken the accreditation of the other partner’s
laboratories.
- World Trade Organisation and Agreement on Technical Barriers to Trade (TBT)

“Once tested accepted everywhere”

8

Audit, Auditor, Auditee 17025:2017

Assessment, Assessor, CAB

Audit vs Assessment

Can you audit competence?

ISO17025: General requirements for the competence of testing and calibration
laboratories
This document has been developed with the objective of promoting confidence in the
operation of laboratories. This document contains requirements for laboratories to
enable them to demonstrate they operate competently, and are able to generate valid
results. Laboratories that conform to this document will also operate generally in
accordance with the principles of ISO 9001.
The use of this document will facilitate cooperation between laboratories and other
bodies, and assist in the exchange of information and experience, and in the
harmonization of standards and procedures. The acceptance of results between
countries is facilitated if laboratories conform to this document.

11



Requirements of the ISO 17025 :2017 standard

4 General requirements 7 Process requirements 8 Management requirements

4.1 Impartiality 8.1 Options (A &B)
8.2 Management system
4.2 Confidentiality 7.1 Review of requests, tenders and
contract documentation
8.3 Control of management system
5 Structural requirements 7.2 Selection, verification and validation
of methods documents
8.4 Control of records
6 Resource requirements 7.3 Sampling 8.5 Actions to address risks and
7.4 Handling of test or calibration items
opportunities
6.1 General 7.5 Technical records 8.6 Improvement
8.7 Corrective action
6.2 Personnel . 7.6 Evaluation of measurement 8.8 Internal audits
8.9 Management reviews
6.3 Laboratory facilities and uncertainty

environmental conditions. 7.7 Assuring the validity of results
7.8 Reporting of results
6.4 Equipment
6.5 Metrological traceability 7.9 Complaints
7.10 Management of nonconforming
6.6 Externally provided
work
products and services
7.11 Control of data – Information

management

13

Figure B.1 — Possible schematic representation of the operational processes of a laboratory

key requirements

key requirements

key requirements

key requirements

ISO 17025 accredited labs are considered “approved” subcontractors for ISO 9001 certified companies

4 General requirements 4.1 Impartiality

4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard
impartiality.
Look for:- refer to job description , organization chart, letter of declaration

4.1.2 The laboratory management shall be committed to impartiality.
Look for: - refer to quality policy or vision statements

4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow
commercial, financial or other pressures to compromise impartiality.
Look for:- refer to implementation of “code of ethical conduct”, no conflict of interest in terms of employment
4.1.4 The laboratory shall identify risks to its impartiality on an onN-gewociunstgom beras sis. This shall include those
risks that arise from its activities, or from its relationships, or from the relationships of its personnel.
However, such relationships do not necessarily present a laboratory with a risk to impartiality.
Look for: - refer to implementation of “code of ethical conduct”, NDA, contract review records

1. Declaration in each request
2. Alternative: by default signing NDA from the begining of the work unless new
requirements arises

Look for:

Examples of “Threats to impartiality”
» Owning shares of a customer’s organisation could create financial self-interest for personnel of
the laboratory. Employment relationships between family members could create emotional or
financial self-interest.
» When reviewing their own work, judgement or decisions, a self-review threat could occur.
» Close personal or professional relationships with a customer can result in a threat to impartiality
because of familiarity or trust, being not sufficiently skeptical.
» When the laboratory’s personnel feel openly or secretly coerced by a customer or by any other
interested party (e.g. threatened with being replaced or reported over a disagreement with a
customer) their impartiality can be affected by intimidation.
» When personnel being responsible for the source to act on behalf of the organization to a
customer (e.g. in course of resolving a complaint) this self interest can threaten impartiality.

4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or
minimizes such risk.
L-oockofonr:tract review policy and procedure to address this risk e.g. decline the work, stop test, review
results etc. Input into Risk Assessment Register, CAR

4.2 Confidentiality
Look for: The contract is signed and authenticated by Suruhanjaya Sumpah (external)
or legal department (internal)

4.2.1 The laboratory shall be responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of laboratory activities. The
laboratory shall inform the customer in advance, of the information it intends to place in the public
domain. Except for information that the customer makes publicly available, or when agreed between the
laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as confidential.

- commitment of the lab to ensure that it will maintain customer’s confidential information (e.g. specify
in contract agreement). Lab staff undertaking (esp. for confidentiality) shall be legally binding e.g.
witnessing of signing and stamping by legal department.

Look for: NDA

4.2.4 Personnel, including any committee members, contractors, personnel of external bodies,
or individuals acting on the laboratory’s behalf, shall keep confidential all information obtained
or created during the performance of laboratory activities.

Look for:

- signing of non disclosure agreements by individuals which represents the laboratory or
contractors, (e.g. visitors, consultants, assessors ) while performing work in the lab.

5 Structural requirements

Look for: 5.1 The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally
responsible for its laboratory activities

Professional indemnity (company insurance)

- ROC certificate, establishment through Act of Parliament, purchase of professional indemnity
against liabilities (mitigate RISK of legal action and cost)

5.2 The laboratory shall identify management that has overall responsibility for the laboratory.
Look for: - refer to organizational chart and job description

5.3 The laboratory shall define and document the range of laboratory activities for which it
conforms with this document….- scope of laboratory services which meets accreditation
Look for: requirements (excluding subcontracted test) Look for: on going basis external provided lab ; if happen remove from scope

accreditation due to lab unable to demonstrate competency

5.4 Laboratory activities shall be carried out in such a way as to meet the requirements of this
document, the laboratory’s customers, regulatory authorities and organizations providing
recognition. This shall include laboratory activities performed in all its permanent facilities, at sites
away from its permanent facilities, in associated temporary or mobile facilities or at a customer’s
facility.
Look for: Statement of intention and commitment to be found in Quality Policy, including its location

5.5 The laboratory shall:

a) define the organization and management structure of the laboratory, its place in any parent
organization, and the relationships between management, technical operations and support
services;
Refer to organization chart Look for:
2 org charts: 1. Organization level relationship with parent company

2. Lab org chart demonstrating ISO 17025 requirement

b) specify the responsibility, authority and interrelationship of all personnel who manage, perform
or verify work affecting the results of laboratory activities;
Look for: Refer to organization chart and job description

c) document its procedures to the extent necessary to ensure the coLinnkswiitshtlaebncotn saisptenpcylication of its
laboratory activities and the validity of the results.

Link with lab competency

Outline all quality documents and its relationship between each other; procedures not mandatory
(as “necessary”) for consistency and validity of results Note: Quality manual not mandatory but if there is evidence unable to

demonstrate competency due to no proper manual/SOP then a nonconformity

5.6 The laboratory shall have personnel who, irrespective of other responsibilities, have the authority
and resources needed to carry out their duties, including:

a) implementation, maintenance and improvement of the management system; Technical manager
b) identification of deviations from the management system or from the procedures for performing
laboratory activities; Technical manager
c) initiation of actions to prevent or minimize such deviations; Technical manager
d) reporting to laboratory management on the performance of the management system and any
need
Quality manager responsibilites

for improvement; Technical manager could provide feedback for improvement
e) ensuring the effectiveness of laboratory activities.

-responsibilities must be found in the job description of laboratory management such as Technical or
Quality Manager or equivalent.

5.7 Laboratory management shall ensure that:
a) communication takes place regarding the effectiveness of the management system and the importance of
meeting customers’ and other requirements;
Look -for: agenda and minutes of meeting to include discussion of effectiveness of Lab Management System,
customer feedback

b) the integrity of the management system is maintained when changes to the management system are
planned and implemented.
- management review to be conducted to ensure integrity is preserved when significant changes are made

Look for:Example things impact of the management system: Extension of scope, new SAMM policies, new revision ISO, absence of approved signatory, change of ownership/stake holder

6 Resource requirements 6.2 Personnel

6.2.1 All personnel of the laboratory, either internal or external (contractors), that could influence the
laboratory activities shall act impartially, be competent and work in accordance with the laboratory’s
management system. Note: Understand JD
Look f-or:signing of letter of declaration, record in competence matrix, understand job description

Add: JD for internal auditors

6.2.2 The laboratory shall document the competence requirements for each function (to include internal
auditors) influencing the results of laboratory activities, including requirements for education, qualification,
training, technical knowledge, skills and experience.
Look fodr: ocument detail competence requirement of each job position, including legal requirements and
professional certification (e.g. IKM registration), refer to SP 6.

Evaluation: Some assessors may ask for written examination

6.2.4 The management of the laboratory shall communicate to personnel their duties, responsibilities
and authorities.
- detail job description to cover duties, responsibilities and authorities, get acknowledgement
from personnel Look for:

6.2.5 The laboratory shall have procedure(s) and retain records for:
a) determining the competence requirements;
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
f) monitoring of competence of personnel. Monitoring requirement in clause 8.9.2.(O) :Other factors monitoring activities training.

clause 7.7.1 (j) intralaboratory comparisons
Note: Monitoring is important to establish lab consistency. Period of review: at least once a year prior management review

L-ooDk foor:cumented policy and procedure (e.g. who is responsible, how often is the review of competence,
what is the criteria of competence) and records to show above requirements are met.
-Monitoring of competence – how and frequency of review.
-Matrix to show who are competent technical personnel and approved signatories authorized to
perform these activities

6.2.5 Monitoring Competence: Records/Matrix

C=competent, T=under training, N=training needed

Task/ 1 Staff 4
Equipment C 23 C
C CT T
Test C TC N
Equipment TN
Calibration & C N
Maintenance C TN N
Sampling TN
Internal Audit

Authorized by:____ Date:____ Next Date of review:_____

28

6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but
not limited to, the following:
a) danevaelylosips mofe rnets,u mltos,d iinficclautdioinng, vsetaritfeicmateinotns aonf dco vnafloidramtiiotyn oorf ompeinthioondss ;a Mmneodtshto oidfnthteetirmpe:rneottaapptliicoabnlesb;e cause
b) lab is adopting standard

c) report, review and authorization of results.

Look -for:Job description of the approved signatory or technical manager must cover the above..

6.3 Facilities and environmental conditions

6.3.1 The facilities and environmental conditions shall be suitable for the laboratory activities and shall
not adversely affect the validity of results.
Look for:- floor plan or layout to show facilities and environmental conditions are adequately provided.

6.3.2 The requirements for facilities and environmental conditions necessary for the performance of
the laboratory activities shall be documented.

Look for:

- Policy to ensure requirements of test standards (e.g. Temperature, RH, dust free ) are reviewed,
records to show ability to meet the requirements

Note: If Internal Test method not stating environment condition but OEM state the requirement. Therefore, lab need to document the conditions.

6.3.3 The laboratory shall monitor, control and record environmental conditions in
accordance with relevant specifications, methods or procedures or where they
influence the validity of the results.
Look for: - Records are kept to show that it meets requirement of the test standard - temp,
RH, etc (e.g. use of data loggers with alarm system)

6.3.4 Measures to control facilities shall be implemented, monitored and
periodically reviewed and shall include, but not be limited to:
a) access to and use of areas affecting laboratory activities;
b) prevention of contamination, interference or adverse influences on laboratory
activities;
c) effective separation between areas with incompatible laboratory activities.

Look for: - policy to control lab facilities to ensure security is adequate; ventilation, exhaust
system, appropriate partition of rooms, ensure validity of results generated
through the existing accommodation and environment

Note: In management review, provide floor plan for re-approve

6.4 Equipment
6.4.1 The laboratory shall have access to equipment including, but not limited to, measuring
instruments, software, measurement standards, reference materials, reference data, reagents,
consumables or auxiliary apparatus which is required for the correct performance of laboratory
activities and which can influence the result. Note for software: Include latest firmware version in the record

Look for: Equipment masterlist that correct performance for testing/calibration. If for training purpose exclude from the masterlist or clearly remark if for use for other purposes.

NOTE : Reference materials from RMPs meeting the requirements of ISO 17034 are provided with
a product information sheet/certificate that specifies, amongst other characteristics, homogeneity
and stability for specified properties and, for certified reference materials, specified properties
with certified values, their associated measurement uncertainty and metrological traceability.
- review the requirements for equipment according to the standards and provide, capture info in a
master list for control. “Correct performance”- means use equipment of appropriate accuracy,
capability to meet requirements
6.4.2 When the laboratory uses equipment outside its permanent control, it shall ensure that the
requirements for equipment of this document are met.
-LoEoqk fuor:ipment used in these situation (taken out) is to undergo pre and post checks to ensure correct
performance at all times.

6.4.3 The laboratory shall have a procedure for handling, transport, storage, use and planned
maintenance of equipment in order to ensure proper functioning and to prevent contamination or
deterioration.

Look for:

- policy and procedure required to ensure equipment is performing correctly at all times (esp.
preventive maintenance)

6.4.4 The laboratory shall verify that equipment conforms to specified requirements before being placed
or returned into service.

Look for:

- records to show review is performed on equipment returned from external calibration (e.g. the
equipment performance range of values are within the acceptance criteria) and shown to be acceptable
before use.
What is RISK if not verified correctly?

6.4.5 The equipment used for measurement shall be capable of achieving the measurement accuracy or
measurement uncertainty required to provide a valid result.

Look for:

- How is “Equipment Capability” determined? The ratio between “Measurement accuracy requirement”
and “Equipment accuracy” (uncertainty from cal certificate) must show that it is adequate for purpose.
Test Uncertainty Ratio (e.g. 4:1 as a minimum -for calibration) should be considered to demonstrate
capability of equipment. What is the RISK if TUR is not applied?

6.4.4 Ensuring equipment conforms to specification before returning to service

(mm)

Nominal value: +/- acceptance 0.5mm

Note: Action after eqp calibration to review result must within acceptance criteria

6.4.5 The equipment used for measurement shall be capable of achieving the measurement accuracy or
measurement uncertainty required to provide a valid result.

Measurement Requirements
e.g. weighing accuracy to +/- 0.1 g

Electronic balance used with U = +/- 0.1 g TUR 1:1

TUR= Test uncertainty ratio 1:!
No safety factor due to risk of
measurement drifting.

SF SF

----------------------- ------------------------- TUR 4:1

Electronic balance used with U = +/- 0.025 TUR 1:4 is safe within risk

Which electronic equipment is capable of meeting the measurement requirement? Answer: TUR 1:1

“Risk” to generating invalid results due to usage of equipment
which is not capable of meeting the accuracy required should
be considered.

Testing lab should consider a minimum TUR 2:1 but definitely
not 1:1 due to absence of any built in safety factor during the
measurement.

Action:
1. Clear policy on measurement requirement vs eqp capability and make sure TUR not 1:1. For calibration lab TUR 4:1 and testing lab TUR 2:1

6.4.5 laboratory has the equipment capable of meeting the measurement requirements
(calibration labs)

Test Uncertainty Ratio ANSI/NCSL Z540-1-1994
• “The laboratory shall ensure that calibration uncertainties are sufficiently small so
that the adequacy of the measurement is not affected”
• “Collective uncertainty of the measurement standards shall not exceed 25% of the
acceptable tolerance (e.g. Manufacturer specifications)”.
• This 25% equates to a TUR of 4:1.
• Other quality standards have recommended TUR's as high as 10:1. For some, a TUR
of 3:1, 2:1 or even 1:1 is acceptable.
•Any of these may be acceptable to a specific user who understands the risks that
are involved with lower TUR's or builds these into his/her measurement process
•Reference: www.transcat.com/media/pdf/TUR.pdf

MU - Lab Consult 2016 36

Look for: 6.4.6 Measuring equipment shall be calibrated when:
— the measurement accuracy or measurement uncertainty affects the validity of the reported
results, or
— calibration of the equipment is required to establish the metrological traceability of the reported
result.
-All equipment used in the process of making final judgement on the acceptance of the result must
be calibrated. Calibration is required for traceability to SI units.

Look for: Calibration frequency
can be adjusted

6.4.7 The laboratory shall establish a calibration programme, which shall be reviewed and adjusted
as necessary in order to maintain confidence in the status of calibration.
- Calibration programme include the range, accuracy, frequency, trends from intermediate checks

6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled,
coded or otherwise identified to allow the user of the equipment to readily identify the status of
calibration or period of validity.
Look for: - Appropriate calibration identification e.g. labels, tags, color code; CRM expiry labelling

Note: Many means to do identification for calibrated eqp not necessary label

6.4.9 Equipment that has been subjected to overloading or mishandling, gives questionable results, or has
been shown to be defective or outside specified requirements, shall be taken out of service. It shall be
isolated to prevent its use or clearly labelled or marked as being out of service until it has been verified to
perform correctly. The laboratory shall examine the effect of the defect or deviation from specified
requirements and shall initiate the management of nonconforming work procedure

Look for:

- Policy and procedure to deal with equipment with questionable status. Policy must require recall of
affected reports. Linkage to procedure to control non-confirming work. Recall policy?

6.4.10 When intermediate checks are necessary to maintain confidence in the performance of the
equipment, these checks shall be carried out according to a procedure.

Look for:

- Procedure on in-service checks to ensure equipment is fit for purpose in between full calibrations. E.g. one-
point checks, blanks, use of secondary reference standards, plotting of statistical charts to monitor trends.
Reduce RISK of out of spec equipment being used. Records can be considered for risk assessment.

la6.b4o.1ra1t Worhy eshna clal leibnsrautrieo nth aen rde freerfeenrecnec vea mluaetse arniadl dcoartrae icntciolund fea rcetoferrse anrcee u vpadluaetesd o ar ncodr irmecptlieomn efanctteodr,s a, st h12e2 Actual
appropriate, to meet specified requirements.
115
110

Look for: value from CRM is used 105 115

- Reference in setting/adjusting the equipment. Correction factors from casleibttinrgaTtio10n0 110
report are considered in recording the final results e.g. testing temperature and RH. What is the RISK of not
applying correction factors?
Ex: If target 110C, then use

correction factor or correction

graft to determine the right

setting

6.4.10 EQUIPMENT INTERMEDIATE CHECKS – using control charts

What can the lab do about the calibration interval in each of the 2 cases above?

6.4.12 The laboratory shall take practicable measures to prevent unintended adjustments of
equipment from invalidating results.
- Physical devises e.g. tags, temper-proof tapes are used to prevent unauthorized adjustments of
Look for: setting knobs; software programs are password protected to prevent unauthorized access.
What is the RISK of not protecting or not adequate protection?
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.
- information on acceptance criteria is often undocumented and neglected. Acceptance criteria may
Look for: be determined based on OEM recommendations or requirements of the test/calibration method
where the equipment is used.

6.5 Metrological traceability
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.
- the calibration program must ensure that equipment used in the measurement process are calibrated
using reference standards or materials which are traceable to the primary standards or CRM. Calibration
labs should document reference standards calibration hierarchy. Look for:
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;
- competent lab fulfilling requirements of this standard must be ISO 17025 accredited locally or
internationally by ILAC-MRA bodies. Look for:
b) certified values of certified reference materials provided by a competent producer with stated metrological
traceability to the SI;
Ensure certificate of analysis of the CRM are provided by the RMP and traceable to a recognized
international standard body e.g. NIST , NOTE 2 Reference material producers fulfilling the requirements of
ISO 17034 are considered to be competent. Look for:
c) direct realization of the SI units ensured by comparison, directly or indirectly, with national or international
standards.
Equipment are calibrated by accredited labs which can show traceability of their standards to SI units (e.g.
with NMIM) Refer SP 2, or e.g. use of laser equipment of meter calibration. Look for:

6.5.3 When metrological traceability to the SI units is not technically possible, the laboratory shall
demonstrate metrological traceability to an appropriate reference, e.g.

(a) certified values of certified reference materials provided by a competent producer;
eLonoksfour: re certificates of analysis of the CRM are traceable to an appropriate standard or an accredited RMP

(b) results of reference measurement procedures, specified methods or consensus standards that are
clearly described and accepted as providing measurement results fit for their intended use and ensured by
suitable comparison.
when comparison with consensus methods are used , the procedures must be clearly documented

Look for:

SI units May 2019,

Kilogram defined with respect to Planck’s constant,
Mole defined as being an amount of entities equal to Avogadro’s number.

Ampere defined respect to electric charge carried by a single proton, (“elementary electric charge,”)
Kelvin will be defined with respect to the Boltzmann constant.

candela

molar
Kelvin

1 kilogram prototype

6.6 Externally provided products and services
(Purchasing and subcontracting )

6.6.1 The laboratory shall ensure that only suitable externally provided products and services that affect laboratory
activities are used, when such products and services:
a) are intended for incorporation into the laboratory’s own activities;
Look for: consumables, externally sourced calibration results, results from subcontracting labs,

b) are provided, in part or in full, directly to the customer by the laboratory, as received from the external provider;
referring to subcontracting services; the lab is responsible for reporting of subcontracted results and must identify
Look for: the results as such in the report
Look for: 3 method for reporting clause 6.6.1 (b):

1. Take result and put in report

2. Cover page + full subcontractor report

c) are used to support the operation of the laboratory. 3. Subcontractor report directly send to customer

Must approve externally sourced products and services (calibration) and keep a list

6.6.2 The laboratory shall have a procedure and retain records for:

a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services;
Look for: procedure to evaluate and approve suppliers and subcontractors

b) defining the criteria for evaluation, selection, mMoonnitiotroinrgi:nNgo paopfe rpwoerrkfnoecremssaarny.cEeva lauantedb arsee-deovnaanluy caotmioplanin tof the external
providers;
Look for: e.g. of criteria of calibration supplier – SAMM accredited calibration lab; CRM supplier is accredited RMP or ISO
9001 certified. Subcontractors meets accreditation requirements.

c) ensuring that externally provided products and services conform to the laboratory’s established
requirements, or when applicable, to the relevant requirements of this document, before they are used or
directly provided to the customer;
Look for:records of relevant inspections and evaluation (COA or calibration report) to ensure it quality meets the
specified criteria; e.g. volumetric glassware conform to Class 1 specification; calibration of equipment
shows it conforms to Class 0.5 specification etc.

d)taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external
providers.
Look for: - policy on approving and reapproving of suppliers, records of (re-) evaluation

6.6.3 The laboratory shall communicate its requirements to external providers for:
a)the products and services to be provided;
b) the acceptance criteria;
Competence: SAMM Calibrated or OEM
c) competence, including any required qualification of personnel; (competence of subcontractors)
d) activities that the laboratory, or its customer, intends to perform at the external provider’s premises.

Look for:

-Information is clearly documented in the PO regarding the products and services required together with
the required specifications such as grade of consumables, accuracy/range of the calibration communicated
to supplier.
-The requirement to witness the activities performed at the suppliers’ premise should be noted (where
appropriate)

7 Process requirements 7.1 Review of requests, tenders and contract

7.1.1 The laboratory shall have a procedure for the review of requests, tenders and contracts. The
procedure shall ensure that:

a) the requirements are adequately defined, documented and understood;
procedure to show how the review is performed, records to show customer requirement adequately
documented e.g. test method edition, accredited services. Get acknowledgment from customer to
confirm information is correct (understood) Note: Acknowledgement by customer via form, email, communication

Look for:

b) the laboratory has the capability and resources to meet the requirements;
e.g. customer request is in the scope of accreditation, within range, accuracy, test-uncertainty ratio, CMC
(calibration measurement capability)

Look for:

c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the
customer of the specific laboratory activities to be performed by the external provider and gains the
customer’s approval; lab must advise customer on arrangements for subcontracting and gain approval

Look for:

d) the appropriate methods or procedures are selected and are capable of meeting the customers’
requirements. - Evidence of review and endorsement by authorized personnel

Look for:



7.1.2 The laboratory shall inform the customer when the method requested by the customer is
considered to be inappropriate or out of date.
- E.g. are obsolete test methods, method outside scope of lab’s accreditation, however, it
can be used if requested by the customer Look for:

7.1.4 Any differences between the request or tender and the contract shall be resolved before laboratory activities
commence. Each contract shall be acceptable both to the laboratory and the customer. Deviations requested by the
customer shall not impact the integrity of the laboratory or the validity of the results. Add disclaimer in the report if any deviation
- Records of communication between customer and lab complete and corresponds to the outcome of the review.
Any requested deviations must be reasonable and not affect validity of test results (protect interest of the lab).

Look for:

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

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 The laboratory shall cooperate with customers or their representatives in clarifying the customer ’s
request and in monitoring the laboratory’s performance in relation to the work performed.
- lab allows customer or their rep to witness the testing or calibration Look for:

7.1.8 Records of reviews, including any significant changes, shall be retained. Records shall also be retained of
pertinent discussions with a customer relating to the customer’s requirements or the results of the laboratory
activities

Statement of Conformity and decision rule
7.1.3 When the customer requests a statement of conformity to a specification or
standard for the test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance) the
specification or standard, and the decision rule shall be clearly defined. Unless
inherent in the requested specification or standard, the decision rule selected shall
be communicated to, and agreed with, the customer.
7.8.6.1 When a statement of conformity to a specification or standard is provided,
the laboratory shall document the decision rule employed, taking into account the
level of risk (such as false accept and false reject and statistical assumptions)
associated with the decision rule employed and apply the decision rule.
What is a decision rule ?
3.7 decision rule: rule that describes how measurement uncertainty is accounted for
when stating conformity with a specified requirement

Measurement Parameter Requirement Measured Value Compliance
statement

Minimum Breaking Force (N)

What is the risk of making a false pass (acceptance) statement in this example?
Note: No decision rule documented
Would the compliance statement be valid if the uncertainty is +/- 6 kN?