Introduction

to ISO 17025
Laboratory Quality Management
29 August 2016,
Bangi Putrajaya Hotel

By Mr K L Ng
Standards Malaysia, SAMM Lead Assessor,
 Evolution of ISO 17025
ISO 17025 ISO 9000

NATA 1947

ILAC 1975

ISO G25 Ed -1
1978

ISO G25 Ed -2
1982
Ed-1 1987
ISO G25 Ed -3
1990
Ed-2 1994
ISO 17025
1999
Ed-2 2000
ISO 17025
ISO 17025 2005 2008 ISO 9001
2017 ? 2015
 What is ISO 17025 ?
General requirements for the competence of testing
and calibration laboratories

developed with the objective of promoting confidence in the

operation of laboratories

requirements for laboratories to enable them to

demonstrate they operate competently, and are able to
generate valid results

facilitates acceptance of results between countries if

conforming laboratories obtain accreditation from bodies
which have entered into mutual recognition agreements
with equivalent bodies in other countries
 Structure of ISO 17025
4. Management Requirements - management
elements applicable to most quality system in any
type of organization

5. Technical Requirements - includes specific

technical/technical competence elements

used by laboratories in developing their quality,

administrative and technical requirements

used by laboratory clients, regulatory authorities and

accreditation bodies for confirming or recognizing its
competence
Difference between certification and accreditation

standard

Certification Quality System

Activities Accreditation

Evaluate (expert) technical competence

Proficiency
Difference between certification (ISO 9001) and
accreditation (ISO 17025)

ISO 17025:2005

1.6 If testing and calibration laboratories comply with the

requirements of this International Standard, they will
operate a quality management system for their testing and
calibration activities that also meets the principles of ISO
9001.

ISO 17025 accredited labs are considered certified

subcontractors for ISO 9001 certified companies
What is conformity assessment?

Conformity assessment: processes that show your product, service

or system meets the requirements of a standard.

Benefits:
It provides consumers and other stakeholders with added
confidence.
It gives your company a competitive edge.
It helps regulators ensure that health, safety or environmental
conditions are met.

The main forms of CA : testing, certification and inspection

ISO (CASCO) develops standards and addresses issues related to
conformity assessment
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.
Conformity assessment and accreditation
Conformity assessment accreditation hierarchy
ILAC MRA Signatories
Accreditation Bodies
 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
countrys conformity assessment infrastructure
 Mutual Recognition Arrangements (MRAs)

-uniform approach allows countries to establish agreements among

themselves,
- based on mutual evaluation and acceptance of each others
accreditation systems.
- crucial in enabling test and calibration data to be accepted between
these countries.
- partner recognises the other partners accredited laboratories as if they
themselves had undertaken the accreditation of the other partners
laboratories.
- World Trade Organisation and Agreement on Technical Barriers to
Trade (TBT)

Once tested accepted everywhere

 PLAN
Say what you do
policy, objectives, standard
procedures, test methods
DO
Do what you say
provide equipment, accommodation,
training personnel, control documents,
calibration traceability, sampling
Record what you do
reports, test data, MU, management records

ACTION CHECK
Act on the difference Check the difference

corrective, preventive action, Customer feedback, internal audit,

continuous improvement management review, QA activities,
proficiency testing

Basic Approach to Laboratory Quality Management

4.1 Organization
Organization Chart (QM direct access to top management)

CEO

Technical
Manager

Quality Lab
Manager Supervisor
(DTM)

Quality Technical Technical

Officer Officers 1 Officer 2
(DQM)
 Code of ethical conduct
Undue management financial pressures
e.g. financial quotas
Personnel refraining from bribes and
favors
Declaration of non conflict of interest in
daily work
Confidentiality agreement (NDA)
Letter of undertaking to be signed by both
parties
 Top Management Commitment
Authorize quality statement
Communicate quality policy and objectives
Participates regularly in Quality Meetings
Awareness of his/her role in the lab
Set clear goals and targets for the lab
Motivates staff to achieve objectives
Directs lab during the management review
How does management make personnel
aware of their work contribution to the
achievement of the objectives of the
management system?

Induction/Orientation program
highlighting the syllabus e.g. Quality Policy and
Objectives, Quality Management documentation,
code of ethical conduct

Evaluation/acknowledgement after completion of

program as evidence of awareness
 4.2 Management System
Documented Quality Management system structure

QUALITY LEVEL I
MANUAL

OPERATING
PROCEDURE LEVEL II

WORK INSTRUCTION LEVEL III

Increased
details FORMS LEVEL IV
 QUALITY MANUAL
1) Direction - quality policy and objectives, address all
requirements of accreditation body

2) Organization Structure - organization charts, roles and

responsibility, summary of key functions

3) Document Structure - reference to master list, revision history,

authorization and approvals

4) How lab implements system/operates - policies, reference

to standard procedures and work instructions

5) Scope of Accreditation - standard, best measurement

capability, approved signatories
6) Address all the requirements of accreditation body
To Prepare A Quality System
If you do it, document it.
If you document it, do it.
If it moves, train it.
If it doesnt move,
calibrate it
If it isnt written down , it
never happened.
 Quality Objectives
Detailed, result orientated performance statements of
improvement that arises from the policy - Should be
measureable e.g. KPI

Customer complaints not more than 2 per month

Customer Satisfaction at least 80%

New scope increase one test/calibration per year

Staff training at least 30 hours per year

Delivery of report within 72 hours from reception of

samples
The Scope of the Laboratorys Accreditation

A clear and detailed statement of the nature and types of testing and
boundaries the laboratory
Geographical boundaries of the labs activities
: Sampling, mobile or branch labs, work at customers premises
Fields or disciplines of testing or calibration
; mechanical, medical, microbiology, chemical
Nature of the samples/ items/ specimens tested
Test methods or procedures performed
Standards for sample results compliance / acceptance
Limits of detection, accuracy range, CMC for calibration labs
http://www.jsm.gov.my/cab-directories
 "maintaining the integrity of the management system"?

relates to maintaining integrity of the management system when major

changes are made to the organizational structure, reporting structure or
management staff of a laboratory,

Also has the integrity of the laboratorys document control system

remained intact when certain areas have been changed or updated?

When a change is made to one laboratory policy, have corresponding

changes been made to other areas of the document control system to
avoid any contradictions and conflicts?

Are laboratory personnel appropriately informed of changes that affect

them?

Addressing these issues effectively shows the overall integrity of a

laboratorys management system is intact
 4.3 Document Control
Availability
Correct content and version
Details of document changes
Retention of obsolete document
Review of continuing suitability of documents
Identification of altered text
Control of softcopies
 Difference between
DOCUMENT & RECORD
Document
- instructional
- form (empty)
vs
Record
- evidence historical
- form (full)
 4.4 Contract Review
Evidence of review - labs capability
against customer requirements e.g. test
method, accuracy, detection limits, CMC
Records of review and agreement with
customer
E.g. issuance of quotation, test plan
(internal customer e.g. production)
 4.5 Subcontracting
Evaluation and selection of competent
subcontractors
Reference to directory of accredited
laboratories (with same scope), APLAC, ILAC
Establish agreement with customer
Maintain list (reference to SAMM
website directory of CAB)
Reporting of sub contractor result (SP3)
4.6 Purchasing
Purchases are clearly documented
and reviewed e.g. quotation, PO
Inspection of purchased supplies
e.g. checking COA, DO
Review of purchased services e.g.
ensuring calibration results are
within acceptable tolerances
Evaluation of suppliers (pre and post)
4.7 Service to Customer
Customer witnessing test/calibration
(ensure confidentiality of other customers)
Customer feedback/ satisfaction survey
Survey should focus on testing/calibration
activities and quality of reporting
Scoring system to reflect labs ability to
meet customers needs and expectations
4.8 Complaints

Record any feedback both positive

or negative, valid or invalid
Feeds into control of non-
conforming works
Corrective action/preventive action
to be clearly documented and
feedback to staff
4.9 Control of nonconforming work
Responsibility and authority clearly defined
Evaluation of severity
Implement corrective action, immediate fix, long
term prevention
Inform customer if necessary
Ensure root causes addressed in corrective
action
Corrective action logged and communicated
4.10 Improvement

The lab has implemented all the

following activities to show it is constantly
seeking to improve its management and
technical competence: quality policy,
quality objectives, audit results,
analysis of data, corrective and
preventive actions and management
review
4.11 Corrective action
Must address root cause(s)
Root cause analysis ( e.g. ask why?
cause and effect chart, brainstorming)
Address potential causes)
Involve relevant personnel
Corrective action must eliminate and
prevent recurrence (not preventive action)
Monitoring of effectiveness (after
implementation); escalate if necessary
Root Cause AnalysisAsk Why?

LEAVES Error in Result ( N/C )

short cut
lazy ? procedure

too much work training

equipment/matl

? Poor time m/ment

ROOTS poor planning
m/ment too busy
 4.12 Preventive action
Proactive as oppose to reactive
(corrective action)
Anticipate potential problems before it
occurs e.g. safety
Involve all personnel through brainstorming
and suggestions
involve analysis of data, including trend
risk analyses and proficiency-testing
results.
 Difference between
CORRECTIVE & PREVENTIVE
ACTION

reactive
vs
proactive
4.13 Control of records
Facilities/environment for storage
suitable for retention through its period
Protect, back-up, unauthorized access
and amendments
Retention period defined ( SP 1)
Retained records to form audit trail & facilitate
repetition of test (close to original)
Amendment of records procedure (hard and
soft copies)
 AUDIT TRAIL
REPORT issuing authority
signatory

maintenance RECORD calibration of monitoring

of equipment equipment
training-who environment
procedure QC

material prep,purchase

doc control validation REGISTRATION of Samples

SAMPLING RECORDS who

sample procedure
environment
STORAGE
 4.14 Internal Audit
Responsibility of the Quality Manager
Independent, trained & qualified auditors
Audit plan, audit checklist to address all
requirements of SAMM including SP, SC, STR etc.
Record evidence of compliance or NCR
Monitor effectiveness of corrective action
before closure
Audit report must indicate labs ability to
comply with SAMM requirements
 4.15 Management Review
Top management participation
Agenda must be complete
Review labs ability to achieve its objectives (KPI)
Actions to be taken clearly documented for follow
up and timely implementation
Conclusion on suitability, effective & improvement
to implementation of current QMS by top
management
 Difference between Internal Audit & Management Review

Done by Where Questions Answered

Internal Technical Laboratory - are procedures followed

Audits Personnel and Site - can we improve practices and
procedures
- details focused
- cost is not a factor
Manage Senior Board - how effective is the overall system
ment Managem Room with respect to quality system
Review ent - what updating needed due to
changes (internal/external)
- overview focused
- COST is an important factor
 TECHNICAL REQUIREMENTS

personnel (5.2)
accommodation and environmental (5.3)
test and calibration methods and validation (5.4)
equipment (5.5)
measurement traceability (5.6)
sampling (5.7)
handling of test/calibration items (5.8)
assuring the quality of the test result (5.9)
test reporting (5.10)
 TECHNICAL REQUIREMENTS
Personnel (5.2)

lab only as good as the staff (competency is the critical)

understanding and training in both management and

technical requirements - able to conduct effective
internal audit, otherwise internal audit could not highlight
what was found during SAMM assessment
- staff do not have clear understanding of principles of
test, MU

records of personnel training and competency must have

input from management e.g. comment on staff
competency during and after training.
 TECHNICAL REQUIREMENTS

Personnel (5.2)

records must be able to show authorization of staff to carry out test

training need analysis, forward training program must be planned

effectiveness of training on the staff not on the training program

(provides feedback to management on training requirements and staff
progress)

competency matrix to indicate level of staff competency

competency in conducting infrequently performed test

 Training Records/Matrix
C=competent T=intraining N=training needed

Task/ Staff
Equipment 1 2 3 4
Test C C T C
Equipment C T C T
Calibration & C T N N
Maintenance
Sampling C T N N
Internal Audit C T N N

Authorization:____ Date:____
 TRAINING NEEDS MATRIX
course Employee requiring training Source of training Duration Frequency

ISO 17025 All laboratory technical LAB Consult 2 days once a

awareness personnel year

Internal All personnel from QA SIRIM 2 days once in 2

Quality Audit department years

Measurement All personnel involved in In house training 1 day twice a

& Calibration testing department year

Measurement All supervisory personnel Check with

Uncertainty and signatories Standards - -
Malaysia
 SAMM Approved Signatory (SP6)

Maintain competency, have authority

Meet legal requirements of the signatory
Education SPM, 8 years working experience in
relevant field; STPM or diploma, 3 years; degree, 1 year
Knowledge conversant with ISO 17025 and SAMM
requirements, at least 3 months current lab,
knowledgeable with lab operations, familiar with
principles of calibration, measurement, test, standards,
test methods, measurement uncertainties etc
Registration with regulatory authorities or organizations
providing recognition e.g. IKM Registered Chemist
 TECHNICAL REQUIREMENTS
Environment (5.3)

technical manager must review the environment

needed for correct performance of test/calibration

need to ensure temperature and RH are met in the

testing area e.g. conduct temperature mapping

traceability of environmental monitoring equipment

separation of incompatible activities to prevent

contamination

stop and resume work when conditions are not met:

who is responsible? record kept?
 TECHNICAL REQUIREMENTS
Test and calibration method (5.4)

use the latest valid edition of standard (system to track

updates, revisions must be in place)

need to show evidence to properly operate standard

methods before introducing (refer to introduction of new
test to labs scope). Test method Performance checklist

validate in-house method (use of CRM, ILC, MA, PT)

initial uncertainty budget must be reasonable and need

procedure to update uncertainty values on a regular basis
Example of Test Method Review and Update

IE
5.4.2 The lab shall confirm that it can properly operate standard
methods before introducing the tests or calibrations.

Checklist : Subject Availability Remarks

Reference Standards yes ISO 180:2013, ASTM D256:2010

Competent Staff yes Authorized testers xxx

Approved Signatories (SP6) xxx
Attach: Training records, qualifications
Test equipment/Reference yes UTM class 1, 0.1% accuracy
Standards/ CRM/ Calibration status
Environment CRM traceability NIST/ 20+/- 2 C
Test worksheets yes Document No. ABC 123

Test report format yes Refer to template

Measurement Uncertainty yes Refer to spreadsheet

PT and ILC yes ASTM PT program, JKM round robin studies

Conclusion Yes Lab test method complied with requirements

 TECHNICAL REQUIREMENTS

Test and calibration method (5.4)

validating of computer software programs configuration

(when validating software, the laboratory must be able to
demonstrate that the data generated by the software are
equivalent to manually generated data across the full
range of the equipment, including input and (as
applicable) display and printout

updating of software parameters when changes are

made to calculations
Test Method Validation
 Sources of Uncertainties
S.W.I.P.E

Standard Workpiece Instrument

Expanded U
From Cal Cert
(type B normal) N.A. Resolution
(typeB rect)
Resolution
Sources (type B rect)
of
Uncertainty Repeatability of Temperature
results difference
(type A normal)

Personnel Environment
 Measurement Uncertainty Requirements (SP5)

Test for which MU does not apply

- qualitative test, methods which specifies MU
Test for which MU applies
- quantitative test with numerical results
Reporting expanded uncertainty
- The result should be reported together with the
expanded uncertainty U calculated using coverage
factor k=2
 Measurement Uncertainty

Useful websites;
- www.measurementuncertainty.org
-www.a2la.org/guidance/est_mu_testing
-www.sac-accreditation.gov.sg/DOCs/SAC-
SINGLAS/Technical%20Guide%202,%20Mar%2008.pdf
-ww.eurachem.org/guides/pdf/QUAM2000-1.pdf
-www.ukas.com/library/Technical-Information/Pubs-
Technical-Articles/Pubs-List/M3003.pdf
- M3003The Expression of Uncertainty and Confidence
in Measurement (Jan 2007)
 TECHNICAL REQUIREMENTS
Equipment (5.5)
important to specify acceptance criteria (allowable
tolerance) in the records of the equipment file

records must show that equipment sent out for

external calibration had been verified against its
allowable tolerance and certified as fit for use before
returning to service

Test Accuracy Ratio (TAR or TUR) to show capability

of equipment to achieve required accuracy

record of equipment performance using statistical chart

appropriateness of calibration interval evaluated

 Test Accuracy (Uncertainty) Ratio

Selecting Standards of Appropriate Accuracy

Ratio of 3:1 between the standard and UUT
(ISO 10012, clause 4.3)
E.g. Uncertainty of the standard should be no
greater than 1/3 of the specified uncertainty of
the UUT.
ANSI , JIS states ratio of 4:1
 TECHNICAL REQUIREMENTS

Measurement traceability (5.6)

reference standards/materials used for calibration or

verification of testing equipment e.g. spectrophotometer,
must be traceable to international standards institute (use
of CRM)

expiry period of CRM or standard solution must be made

available

traceability chart of equipment and reference standards to

SI unit or international standards institute (e.g. NIST)
 Measurement Traceability
Physical Measurement Chemical Testing

BIPM specified method

or
National Standards CRM
Laboratory interlab

Accredited Test
Lab interlab
Laboratory

Test Lab
 Traceability Chart for Micrometer

PRIMARY STANDARD OF LENGTH

Established by laser interferometer at the BIPM

SECONDARY STANDARD OF LENGTH

Verified by laser interferometer at the SIRIM-NMC

CALIBRATION GAUGE BLOCKS

Verified by high magnification comparitor in SAMM lab

EXTERNAL MICROMETER
Verified against inspection gauge blocks in works lab.

Verified in production against PRODUCT

calibrated external micrometer

L1-8
 TECHNICAL REQUIREMENTS
Sampling (5.7)

If the laboratory is not involved in the collection of

samples, but rather merely tests the items as they arrive,
this section on Sampling is not generally applicable.

However, if the laboratory uses the results of their testing

to make a statement about a population, then Sampling
does apply

When a laboratory performs sub-sampling from a larger,

client-supplied test item, Section 5.7 applies
 TECHNICAL REQUIREMENTS
Handling of test/calibration items (5.8)

Provisions to protect the integrity of test or calibration

item and interests of the customer

System for identifying and tracking the test or calibration

item

Examination upon receipt to assess the condition of the

item and suitability for test or calibration

Appropriate facilities to avoid deterioration or loss during

storage, handling, and preparation
 TECHNICAL REQUIREMENTS
Assuring the quality of the test result (5.9)

initiative to conduct QC checks such as ILC. It is

expected that accredited laboratories will take every
opportunity to confirm the technical validity of the test
results being produced by them.

Statistical control charts to show consistency of results

correlation of results using other test methods

PT to be conducted at least once in 3 years for each

test (requirements of international MRA)

evaluation of QC results using e.g. En and z-score

 TECHNICAL REQUIREMENTS

Assuring the quality of the test result (5.9)

The use of reference materials/standards provides for

the monitoring of accuracy performance.

Replicate testing of duplicate test items and repeated

measurements provides for the monitoring of precision
performance.

The retention and re-rest of test items may be specified

in response to questionable results or complaints.

Evaluation of interrelated characteristics of individual

test items can aid in detecting errors.
 Proficiency Testing - Measurement Audit
Evaluation of Results: A laboratorys participation in a given
measurement audit is usually evaluated based on the following equation:

Lab Ref
En =
(U95Lab)2 + (U95Ref )2

where Lab and Ref indicate the laboratory and reference measurement
values respectively for the attribute in question and U95Lab and U95Ref
represent the expanded uncertainties expressed at the 95% confidence
level for the laboratory and reference laboratory respectively.

En values greater than 1 indicate that a laboratorys measurement result

and associated uncertainty deviate significantly from the reference
measurement result and associated reference uncertainty.
 Proficiency Testing Z score
In all proficiency tests (PT) is the use of a performance indicator to
quantify the analytical performance of each participant. The z score is
frequently used. The z score is a measure of the deviation of the result
from the assigned value for that determinant and is calculated as:
where s is a standard deviation which is chosen either as an estimate
of the actual variation between results encountered in a particular
round of the scheme, x is the score and x bar the mean of the round.

Assuming the individual z scores will have a Gaussian or normal

distribution with a mean of zero and a standard deviation of one.
z < 2 is considered Satisfactory
2 < z < 3 is considered Questionable
z > 3 is considered Unsatisfactory
 TECHNICAL REQUIREMENTS
Test reporting (5.10)

all information in a test report must be supported by the

records pertaining to the test

should include all information to allow repeating of test

results and obtain a comparable result (includes diagrams and sketches)

use of measurement uncertainties where a statement of compliance

is required. (compliance cannot be established in some cases)

confidentiality concerns, test reports converted to a non- editable

format that can also be encrypted. An example would be to use
Adobe PDF format and then a lab password to prevent changing or
editing the document. An additional customer password would then
be used to open the document
 Example of applying the confidence interval to test results

Test result A indicates there is more than 95% confidence that the product failed the specification.

Test result E at 95% confidence indicates an acceptable product.

For test results B, C and D, one cannot say with 95% confidence whether the product passed or failed.

For test result C, one is 50% confident that the product passed and 50% confident that it failed.

For result B, one is somewhere between 50% and 95% confident that the product failed. For result D,
one is somewhere between 50 and 95% confident that the product passed. The laboratory can calculate
the percentage of confidence that result B is a fail and result D is a pass.
 SAMM REQUIRMENT DOCUMENTS

MS/ISO/IEC 17025 SAMM Accreditation Standard

SP1 Terms and condition governing SAMM
SP2 Policy on traceability of measurement results
SP3 Condition on the use of the SAMM logo
SP4 Policy on Proficiency Testing Requirements
SP5 Policy on Measurement Uncertainty for Testing
Laboratories
SP6 Requirements for Approved Signatory
SP7 Specific requirement on the issues of SAMM
endorsed calibration report
 SAMM REQUIREMENT DOCUMENTS
SP8 Requirement for the accreditation of site testing
SP10 Grading of non-conformities

Specific Criteria Series e.g.1.5 for Accreditation in the

Field of Mechanical Testing and Non-Destructive
Testing (NDT)

STR 1.3 Specific Technical Requirements for

Accreditation of Electromagnetic Compatibility (EMC)
Testing Laboratories.

SAMM Technical Circular e.g. 1/2014; issues relating

to calibration (e.g. and Calibration Measurement
Capability (CMC) and Scope of Accreditation New
Format, MU statement, calibration due date
 SP1:Terms and Conditions of SAMM
Authority for granting accreditation
- conditions for competence, procedures & amendment
- processing and granting accreditation
- monitoring, surveillance & reassessment
- suspension, withdrawal & appeal
- inoperative accreditation
- confidentiality

Obligations
- impartiality, independence and integrity of labs
- SAMM endorsed reports and certificates requirements
- cooperation with DSM during assessment process
- liabilities of labs
- notification of change physical, personnel
- retain records, test reports including original data for min. 6 years
 SP2:Trceability of measurement results
Policy for traceability in calibration
not accept the service provided by:
a) a non-accredited calibration laboratory,
b) an accredited calibration laboratory by Accreditation Body that is
neither a signatory to the ILAC MRA nor Regional MRAs recognised by ILAC

Policy for traceability in testing

If the calibration of equipment used in testing contributes significantly to the
overall uncertainty, the same policy for traceability applies

Policy for traceability provided through reference materials (RMs) and

certified reference materials (CRMs)
The values assigned to CRMs produced by NMIs and included in the BIPM
KCDB or produced by an accredited RMP under its accredited scope of
accreditation are considered to have established valid traceability
 SP3: Condition for use of logo

Form, size, layout

Subcontracting - statement
Disclaimer - opinions outside scope
Disclaimer - regarding opinions,
interpretations
Calibration labels- design, control & use
Publicity material no false claims
No inference to product certification
Use of SAMM and ILAC logo
SP 4: PROFICIENCY TESTING REQUIREMENTS
FOR SAMM LABS
Achieve satisfactory results before accreditation
considered.
Participate in at least one PT relating to each field within
one accredited cycle.
Submission of suitable PT plan during compliance and
reassessment
Appropriateness and effectiveness of the corrective and
preventive actions implemented by the laboratory.
Poor results from a PT program may result - additional
PT, being reassessed, laboratorys scope inoperative, or
suspend of the laboratorys accreditation.
 SP5: Measurement Uncertainty Requirements

Test for which MU does not apply

- qualitative test, methods which specifies MU
Test for which MU applies
- quantitative test with numerical results
Reporting expanded uncertainty
- The result should be reported together with the
expanded uncertainty U calculated using coverage
factor k=2
 SP6: SAMM Approved Signatory

Maintain competency, have authority

Meet legal requirements of the signatory
Education SPM, 8 years working experience in
relevant field; STPM or diploma, 3 years; degree, 1 year
Knowledge conversant with ISO 17025 and SAMM
requirements, at least 3 months current lab,
knowledgeable with lab operations, familiar with
principles of calibration, measurement, test, standards,
test methods, measurement uncertainties etc
Registration with regulatory authorities or organizations
providing recognition e.g. IKM Registered Chemist
 SP7: Issue of SAMM Endorsed
Calibration Certificate

Format of first page logo, info of lab, dates of issue,

unique i.d. no., page no., signatories, statement of
confidence probability of measurement uncertainty,
copyright, statement of traceability

Technical content i.d. of items calibrated, parameter

used, method, environmental conditions, dates of cal,
results, uncertainty value, compliance to specific,
adjustment of instrument, indicate sub-contracted results
 SP8: SITE TESTING

Categories:
1)Site testing by staff sent from accredited
permanent laboratory

2)Site testing by mobile/ site lab under

responsibility of accredited permanent laboratory

3)Site testing by personnel with no permanent

laboratory
 SP10: Grading of non-conformities
Category 1 very serious, breakdown in the
management system, abuse of accreditation priviledeges
leading to suspension
Category 2 quite significant, corrective action within 3
months (a number of related minors judged to be
unacceptable quality risk w/o leading to overall system
failure), technical competence affected
Category 3 minor or isolated, does not affect the test
or calibration results, documentation issues, to be closed
before next assessment
Observations an area of concern, opportunity for
improvement (not considered as a non-conformity)