WELCOME
INAB ASSESSOR FORUM
22nd and 29th January 2008
Role of INAB and INAB
Accreditation
Tom Dempsey
INAB Assessor Forum
 Welcome
 Thanks to the INAB Assessors
 Agenda and Programme
 Purpose and objectives of Assessor Forum
 Key issues for Assessor Forum
 Background to INAB
Agenda and Programme
10.05
11.00
11.15
12.45
14.00
14.45
15.30
15.45
16.00
Role of INAB and INAB Accreditation
Break – Coffee/tea
Assessing Competence
Lunch
Aspects of the Assessment Process
New Developments
Break – Coffee/tea
Administration issues (Invoicing, Fees etc)
Final Discussion
Close of Workshop
Key issues for the Assessor Forum
 Exchange of information
 Role of INAB assessment team/Board etc.
 Harmonisation of assessment process
 Results of INAB Client Survey
 Focus on Assessing competence
 Specific aspects of assessment process
 New Developments-internal and external
 Administration issues (invoicing, fees, etc.)
INAB Background
 Established in 1985 - permanent staff 13
 Independent Board with expert committees
 70 contracted technical experts/assessors
 125 Accredited Organisations
 Annual Running Costs €1.7m
Department of Enterprise, Trade and
Employment
Forfás
The National Policy and Advisory Board for
Enterprise, Trade, Science,
Technology & Innovation
The Irish National
Accreditation Board
Board Of INAB
12 Board
Members
INAB Executive
Staff of 13
INAB Board – Current Board Members
Dr Maire C. Walsh
Former State Chemist, Chairperson
Mr Tom Dempsey
Manager INAB
Dr Nuala Bannon
Inspector, Department of Environment, Heritage and Local
Government
Mr Tom O’Neill
Site Leader, Pfizer Little Island API manufacturing Plant
Dr Fiona Kenny
Consultant Microbiologist, Sligo General Hospital
Mr Martin O’Halloran CEO Health and Safety Authority
Mr Richard Howell
Agriculture Inspector, Department of Agriculture and Food
Mr Neil McGowan
Regulatory Affairs Executive, Food and Drink Industry, IBEC
Mr Michael Maloney
Director of Horticulture, Bord Bia
Mr Vagn Andersen
Manager of International Affairs, Danish Accreditation Body
(DANAK)
Mr Pat O’Mahony
CEO, The Irish Medicines Board
Dr John O’Brien
CEO, Food Safety Authority of Ireland, FSAI
Irish National Accreditation Board
Tom
Dempsey
Brid
Burke
Adrienne
Duff
Andrew
Stratford
Sinead
Guckian
Orla
Doyle
Emma
Scott-McGrane
Pat
O’Brien
Marie
O’Mahony
Frank Crowe
Anna
Stepien
Katerina
Asprou
James
Stapleton
Key Roles

Accreditation of organisations in accordance with European and
International Standards

Statutory monitoring body for OECD/EU GLP (Good Laboratory
Practice) regulations - S.I. No. 4 of 1991 and S.I. No. 294 of 1999

Competent Authority for:

EMAS ( Council Reg. 761/2001)

Carriage of Dangerous Goods by Road (S.I. 290/2007)

Maintenance of EA and ILAC Multilateral Agreements membership
which provides international recognition

Participation at European/International level in developing
accreditation policy and criteria
Irish National Accreditation Board
Services
Accreditation of
Medical
Testing
Laboratories
ISO 15189
Accreditation
of Calibration
and Testing
Laboratories
ISO 17025
Competent Authority
Carriage of Dangerous
Goods by Road
S.I. No. 290 of 2007
Accreditation of
Certification Bodies
EN 45011, 12,
ISO 17024
ISO Guide 66
E-Signatures
Directive
Accreditation and
Supervision of
EMAS VerifiersCouncil
Reg. No. 761/2001
Competent
Body EMAS
EU Scheme
Council
Reg. 761/2001
Accreditation of
Attestors/
Attestation
Bodies
for Public
Procurement
EN 45503
Accreditation of
Inspection
Bodies
ISO 17020
Enforcement of GLP
(Good Laboratory Practice)
Requirements S.I. No. 4 of
1991 as amended
by S.I. No 294 of 1999
Role of INAB Assessment Team/Board etc.
 Assessment team
 Assesses competence and not just conformance
 Provides professional judgment
 Raises factual non-compliances
 Makes recommendations but not decisions on
accreditation
Role of INAB Assessment Team/Board etc.
 INAB Officer
 Manages portfolio of organisations
 Represents INAB on Assessment team
 Communicates and Interprets INAB policy
 Monitors assessment process
 Safeguards harmonisation
Role of INAB Assessment Team/Board etc.
 INAB Board and Manager
 Considers assessment team recommendations
 Decides on accreditation
Decision making Process
Decisions made by the INAB Board:
 New Accreditations Granted
 Extensions to Scope in a new area
 Termination of Accreditation
Decisions made by the Manager:
 Extensions to Scope in the same field
 Suspension of Accreditation
Decision making Process
Decisions made by the Board
 6 – 7 Meetings held annually
 ALL non-compliances to be cleared before recommendations submitted
to Board
 Report prepared by INAB Officer to include:
 Summary of assessment process
 Proposed Scope of Accreditation
 Forms:
Summary & Recommendation- F118
Assessment Trail – F116
Clearance of Non- compliances – F121
 Circulated to Board 1 week before meeting
 INAB Officer presents report to Board
Harmonisation of Assessment Process
Background
 Worldwide several surveys identify harmonisation as an
issue.
 One standard for accreditation depending on conformity
assessment activity
 Internationally harmonised interpretation documents.
 Assessors trained in assessing to relevant accreditation
standard
 International monitoring of Accreditation Bodies.
Harmonisation of Assessment Process
Perception
 Different assessors impose different requirements
 Different assessors impose conflicting requirements
Harmonisation of Assessment Process
Areas where inconsistent interpretations are perceived
 Laboratories
 Detail required for method validation
 Expectations for estimation of uncertainty of
measurement
 Media QC requirements
 Temperature control requirements
 Attitude to participation in PT schemes
Harmonisation of Assessment Process
Areas where inconsistent interpretations are perceived
 General
 Variation in content of Quality Manual
 Variation in number of assessor days
 Scope of accreditation – generic vs. specific
 Variation in approach to assessments
 Training requirements
Harmonisation of Assessment Process
Areas of Concern for Certification Bodies
 Accreditation is too expensive
 CBs want the Accreditation Yesterday
 CBs want to influence the decision making process
Harmonisation of Assessment Process
Why inconsistencies may occur
 Interpretation of the Standard is required
 Assessors are human and may have hobby horses
 Organisations are different and scopes of activity are
diverse
Harmonisation of Assessment Process
Organisations are different
 Activity fit for purpose
 Resources differ -small one man operations to large
organisations
 Different approaches used by organisations to demonstrate
competence
 Level of monitoring influenced by performance
 Environment is different
 Type of work -large volume routine testing/inspection vs.
infrequent testing
Harmonisation of Assessment Process
What is not acceptable?
 Different assessors imposing conflicting requirements
 Assessors imposing requirements that are not justified
Harmonisation of Assessment Process
Routine mechanisms to promote consistent
application of the requirements
 Ongoing assessor training and feedback by AB
 Ongoing monitoring of assessors by AB
 Assessors are rotated between organisations
 AB staff participate in assessments
 Policy documents published by AB to harmonise criteria
Harmonisation of Assessment Process
Other mechanisms to promote Consistency
 Assessor workshops
 Feedback from organisations on assessments
 Laboratory networks
Accreditation Process Survey 2006
Findings
What is most important to our clients?





93% Staff attitude /helpfulness
88% Access to information
88% Openness and Transparency
86% Value for money/added
81% Speed of Service
Relationship with INAB
 95% agree that achieving accreditation is a
significant accomplishment
 93% agree INAB provide a quality professional
service
 66% agree that INABs membership of the MLAs is
important to their business
 53% agree that INAB is a client focussed
organisation
Personnel and Service Handling
 89% INAB is easy to contact
 84% Staff competent and well informed
 84% Respond in timely manner
 81% Friendly and Helpful staff
 70% Accreditation Officers justify and take
responsibility for decisions made
Enquiry and Application Stage
 72% agree INAB provide a professional information
pack/brochure
 89% agree that the Accreditation officer dealt with
initial queries adequately
 71% agree that Application Form was clear and
unambiguous
 89% agree that a good standard of service was received
 89% agree that Applications for accreditation are
processed in a timely manner.
 76% agree that extensions to scope are processed in
timely manner
Visits - Planning
Respondents agreed that…
 94% Purpose and nature of visit clearly explained
 95% Visit arrangements handled efficiently and
effectively
 95% Assessment team prepared well for visit
 87% Assessment team had skills and knowledge
 92% Meetings scheduled and well timed
Visit - Conduct
Respondents agreed that…
 66% - Assessment team resolved our concerns on the
day
 97% -Assessment team assessed our competence for a
specific range of activities
 90% - Assessment team communicated in a controlled
and professional manner
 81% - Assessor understood our business
 89% - Findings presented in a calm and factual
manner
 92% - Assessor demonstrated current competence in
activity being assessed
Visit - Outcome
 Decision on our accreditation promptly relayed (90%)
 Registration number and certificate received
promptly (79%)
 INAB promotes our accreditation appropriately on
the website, newsletter and press (57%)
Experience of Service over last 2 years
•Others applicants with under 2 years service
Assessing Competence
Marie O’Mahony
Assessing Competence
• Focus of Technical Assessment
• Quality Management Systems within technical activities
• Vertical Audits
• Scope Matrix and Visit Plans – Accreditation Cycle
• INAB Officer Key Roles
• Outcome
Focus of Technical Assessment
• Peer Review Process – independent 3rd party assessment
- Verification of applicants/accredited organisation’s claim
of technical competence
• Key focus is technical competence and compliance with
INAB Regulations/Policies (EA/ILAC/IAF; e.g. Use of
Accreditation Symbol)
• Assess Competence of Organisation for Scope of
Accreditation
• -Documentation Review/Discussions/Witnessing/Records
review/Vertical Audits
Focus of Technical Assessment
• Clarify Scope
- Methods/Matrices/Ranges/ Level of Validation
-
Personnel
Qualifications/Experience/Performance
-
Facilities/Equipment/Sample handling
Space/environmental conditions
Performance qualification/calibration/maintenance
storage/Labelling/separation
-
Analytical Quality Control
Internal Quality Control / External PT Schemes/ILCs
-
Reporting the results
Focus of Technical Assessment
Quality Management Systems in technical activities?
-
Roles/responsibilities
-
Documentation control
-
Contract Review with client – Records
-
Critical consumables/services
-
Non-conforming work / investigation reports/root cause analysis/CAPA
-
Technical Records access/storage/audit trail
-
Vertical audits
Vertical Audit
Why?
• Good indicator of level of implementation of Quality
Management Systems and Technical Management systems
• Review quality of vertical audits done by organisation
• Perform vertical audit – snap-shot of systems from receipt
to reported results
• Feedback to Lead Assessor
• Pre-assessment/surveillance/extension to scope
Scope Matrix and Visit Plans
Accreditation Cycle
ISO 17011 “Conformity assessment – General requirements
for accreditation bodies accrediting conformity assessment
bodies”
•
Clause 7.11.3 “The accreditation body shall design its plan for
reassessment and surveillance of each accredited CAB so that
representative samples of the scope of accreditation are assessed
on a regular basis.”
• Clause7.11.1 “Re-assessment is similar to an initial assessment
except that experience gained during previous assessments shall be
taken into account. Surveillance on-site assessments are less
comprehensive than re-assessments.”
Scope Matrix and Visit Plans
EA-3/09 “Surveillance and Reassessment of Accredited
Organisations”
• (2.4) Surveillance assessment plan:- Plan made by the AB in
which it schedules surveillance activities and visits, in
particular based upon areas of competence, for a particular
organisation between the initial assessment and
reassessment”
•
(3.6.2) “The AB should aim at assessing a representative
sample of the accredited activities, covering all areas of
competence, during the period between reassessments or
between accreditation and the first re-assessment.”
Scope Matrix and Visit Plans
• 5 year Accreditation Cycle
• Scope Matrix – Record of scope elements covered in cycle
• Visit Plan – Record of each visit
• Review Visit Plan on annual basis against Scope and scope
matrix to ensure all elements are covered in cycle.
• Highlight on AF118 specific areas to be assessed at the next
visit.
INAB Officer Key Roles
• Manage relationship with applicant/accredited organisation
•
Monitor Process
Harmonisation of the process
- Ensure fair/objective/thorough assessment activities
• Balanced Reporting – Categorisation
• Assist team – Management Systems
• Principal focus on Management Systems and INAB
Regulations/Policies
• INAB Officer is not Technical Assessor/Expert
• Prepare recommendation for decision post-visit
Outcome
• Provision of a value-added service to the organisation
• Verification of Technical Competence for scope
• International recognition and acceptance of Accredited
reports/certificates
• Independent 3rd Party Objective Assessment
• Confirmation of continued technical competence
INAB Policies
PS10/PS10a / PS12
Adrienne Duff
PS10 - Laboratories and PS10 (a) –
CBs and IBs
• Submission of Documentation in preparation of an
INAB Visit
• Purpose
• Effectively prepare for a visit
• Efficient time management on site
PS10 Content - Laboratories
•
•
•
•
•
•
•
•
Quality manual
Identified changes to test methods and QM
PT/ILC Summary
Audit Schedule
Minutes of mgt review
Medical lab information
Flexible scope information
In-house calibrated equipment
PS10 Content - Laboratories
• Review of legislation (see PS12)
• Audit of effectiveness of corrective actions
(AF118)
• Insurance declaration
• Submitted by lab 4-6 weeks in advance of a visit
• Sent to lead assessor and others
• Extensions to scope
PS10 Content - Laboratories
• Information used to prepare visit plan and prepare for the
visit
• Identify (potential) issues in advance
• Use with information provided from scope matrix and/or
previous visit documentation (F116, AF118) to prepare visit
plan
• Any member of assessment team can request
documentation from lab via INAB officer
PS10a Content – CBs and IBs
• QM and documented procedures, identifying
changes
• Minutes of mgt. review
• Schedule of internal audits
• Audit of effectiveness of corrective actions
• Legislative review
• Changes to structure, impartiality committee,
related bodies
PS10a Content – CBs and IBs
• New certificates issued
• Insurance declaration
•
•
•
•
Audit plan
Previous client report
Competency justification and records
Technical review
• Extensions to scope (PS16)
PS12
Policy for accredited organisations undertaking work in an area
which is regulated by legislation
Organisations undertake work which may be required to be
undertaken in an area regulated by legislation
Regulated
• Directives (transposed into national legislation)
• Statutory Instruments (SI)
• Regulations
PS12
Policy
• Obligations on accredited organisations to be aware of
customer legislative requirements
• Review capability
• Inform customer accurately and clearly of it’s capability
and how this relates to scope of accreditation
PS12
CAB has responsibility with Customer to:
• Regulatory requirements
• Limitations or otherwise of INAB scope
• Extent to which CAB can meet the needs of the
customer
• Reporting formats, if specified in legislation
CAB has responsibility with Regulator to:
• Clarify issues regulated by the legislation
• Utilise guidance, where available, or justify alternative
PS12
INAB expects this to be assessed through the
Contract Review Process
Central to this is CAB’s understanding of the purpose
for which customer requires work and
understanding of their own capability
PS12
INAB Technical Assessment……..for Labs
• Appropriate contract review
• Impact assessment
• Assess and confirm that accredited method
meets requirements
PS12
INAB Technical Assessment……..for CBs and IBs
• Appropriate contract review
• Impact assessment
• Has organisation competence to meet
requirements?
PS12
• Adequate records to demonstrate contract objective review
process
• QS which permits regular updates
• Ext to scope
• Suitably validated (labs)
• Technical review (CBs and IBs)
INAB scopes make reference to legislation in various ways
• Blood Banks
• CBs/IBs
PS10, PS10(a) and PS12
Questions and Feedback
Categorisation of non-compliances,
corrective actions and timescales
Andrew Stratford
Non-compliances
• Feedback to the organisation
• Add value
• Factual observation, supported by comments to
explain
• Clear and specific, using examples
• Agreement from organisation on the factual
nature of the observation
Non-compliances
• Address system issues not just numerous isolated
issues
• Quantity not important
• Categorisation of non-compliances:
• Major
• Minor ( both equivalent to UKAS ‘M’ Mandatory
Improvement Action)
• Observation (equivalent to UKAS ‘R’ Recommended
Improvement Action)
• Difference between INAB and UKAS…
Non-compliances
• A minor non-compliance is allocated for a minor
failure to comply with INAB requirements
• E.g. not providing an up-to-date specification for
one particular test or for not providing adequate
operating instructions for the staff using a
particular piece of equipment (Such incidents
might be indicative of a more widespread lack of
control, and they should prompt the assessor to
probe more deeply).
(taken from INAB P7)
Non-compliances
• A major non-compliance is allocated when the quality
arrangements are demonstrably inadequate, or totally
absent for a major aspect of the CAB’s work. An example of
this would be the complete absence throughout a
laboratory, or in several parts of a laboratory, of a system
for calibrating the laboratory’s testing and measuring
equipment.
• A major non-compliance may also be allocated when a
number of similar minor non-compliances have been raised
and where this indicates a possible weakness in a particular
area of the quality or technical systems.
(taken from INAB P7 – guide to INAB assessment procedures)
Non-compliances
• A minor non-compliance is the failure to comply
with the scheme requirements.
• A major non-compliance is the failure to comply
with the scheme requirements to the extent that
could compromise the confidence that is placed
in the accredited activity.
(Taken from INAB Regulations)
Non-compliances - consequences
Consequences of raising a major NC:
• May not recommend award of accreditation (if
initial assessment)
• May recommend suspension of accreditation (if
surveillance visit)
• If suspension or additional visit not
recommended, justification for this must be
entered on AF118 Summary Report.
Consequences of a major Non
Compliance
•
In the event of a major non-compliance being raised, the
lead assessor in consultation with the INAB officer shall:
•
•
•
•
consider recommending suspension/termination/refusal of
accreditation for part or all of the scope of accreditation;
decide if an additional and/or unannounced visit is required
to witness the clearance of the non-compliance or to address
any issues relating to its clearance;
review the reports from previous surveillance/other visits to
the organisation to ascertain if the history of the
organisation, when taken together with the major noncompliance, indicates an underlying problem with the
maintenance of accreditation;
ensure that the integrity of INAB accreditation is not
compromised by any action or timeframe agreed to address
the major non-compliances.
Consequences of a major Non
Compliance
• In any case, INAB shall require corrective action
evidence to be submitted and to include:
• Immediate correction of the issue giving rise to the
major non-compliance. This may involve notifying
customers and/or withdrawing test results or
certificates,
• Root cause analysis and investigation,
• Corrective action and, where appropriate, preventive
action.
• The timeframe for receipt of this evidence shall
not exceed 2 weeks from the date of the visit.
• In exceptional circumstances, INAB may alter this
timeframe.
• AF 117 – Detail report
• Section for corrective
action proposed by the
organisation
• Section for identification of
evidence to be supplied by
the organisation.
Corrective Action(s) proposed by the
organisation
•
•
•
•
Normally agreed at time of the assessment to ensure that
both INAB and customer understand reported issue
May need time to analyse and establish root cause; action
may be an outline proposal to address the finding rather
than the specific corrective action itself
In exceptional circumstances INAB will allow a 2 week
period for proposed corrective actions. The proposed
corrective actions must be accompanied with a root cause
analysis and investigation of the non-compliance.
If clarity is required, identification of what sort of
evidence will be supplied by the organisation
Corrective Action Evidence
Responsibility is with the assessor to accept and to
• Ensure it will address the issue
• Ensure it will address system issues not just
the isolated case
Timescales
• 1 month/3 months for organisations.
• 15 days for assessors to complete F121 and
respond to each corrective action separately
• Responsibility is with assessor to ensure it
addressed the issue
• Verification of effective implementation at next
visit.
Timescales
Timescales
Timescales
• INAB may in exceptional circumstances permit an
extension to these timeframes where the
organisation can establish that more time is
justified. In such circumstances the extension to
the timeframe will apply only to the clearance of
the particular non-compliance(s) requiring the
extension to the timeframe. All other noncompliances must be cleared within the normal
timeframes
Timescales
• INAB may decide to set a new timeframe for the
satisfactory clearance of outstanding non-compliance(s) and
in such cases, shall inform the organisation in writing of the
decision taken
• The new timeframe shall not exceed one month except
where the organisation (or element of scope of
accreditation) is suspended in which case a timeframe of up
to 3 months will apply
• Where an organisation under suspension fails to clear all
non-compliances within the agreed timeframe that
organisation’s accreditation may be terminated.
Aspects of the Accreditation Process
Patrick O’Brien
Deviating Samples
Patrick O’Brien
Handling of Deviating Samples
•
•
•
•
•
•
Review what we understand to be a valid tests result
Accreditation and sampling - the practice
Typical samples of Deviating samples
Requirements of ISO / IEC 17025
INAB / EA Laboratory committee view
Conclusion
Handling of Deviating Samples by accredited
laboratories ISO / IEC 17025 & 15189
In order to obtain valid tests results, the quality of the
following shall be ensured:•
•
•
•
sampling,
sample pre-conservation and logistics,
analysis,
and reporting
Accredited laboratories
ISO / IEC 17025 and ISO/IEC 15189
• Very few laboratories accredited for sampling – Ireland/Europe
• Majority receive samples at the laboratory reception or in some
cases will collect them from clients premises or on-site.
• Accreditation Bodies have not focused on sampling, preservation,
transportation, and reception of samples.
Deviating Testing Samples – Examples
•
•
•
•
•
Exceeding maximum pre-conservation time
Date and time of Sampling not known
Not acidified (e.g. analysis of metals)
Filtered (analysis of wastewaters)
Not cured in controlled environmental conditions
- Not cooled (food)
- Not cured in water while on site (concrete cubes)
- Insufficient sample size,
- Deviating from test methods
etc, etc, …..
Requirements of ISO / IEC 17025
• Clause 5.8.3 Recording of deviating samples upon receipt
and subsequent consultation with the client.
• Clause 5.7.2 Deviation of a documented sampling procedure
(e.g. pre-conservation) on request of the client shall be
recorded and reported.
• Clause 5.10.1 Results of tests shall be reported accurately,
clearly, unambiguously and objectively.
Deviating Samples – EA / INAB policy
EA / Laboratory committee have concluded that:• Upon receipt of each sample, a competent laboratory shall
assess whether the sample is suitable with regard to the
requested test(s);
• When the sample is deviating, an accredited laboratory
shall contact the customer for further instructions;
• When the customer wants the deviating sample to be
analysed, an accredited laboratory shall included a
disclaimer in the report, clearly stating that the sample
was deviating and that, as a result, the test result(s) may
be invalid;
Conclusion
During assessment of laboratories the INAB team
is again reminded to ensure that, they strengthen
their focus on laboratories handling of deviating
samples and the inclusion of disclaimers by them
in the corresponding test reports.
EA peer evaluation of AB’s will be focusing on
how assessment teams assess deviating sample.
Use of INAB Policies / INAB Regulations /
Terms & Conditions during assessment
Patrick O’Brien
Use of INAB Policy statements, Regulations,
and Terms and Conditions during assessment
WHERE TO FIND?
• On the INAB Website, under publications,
• See DC1 document
DC1 lists mandatory, policy, and guidance documents that are
relevant to the various INAB accreditation schemes
Includes current INAB documents:• Policy Statements PS1 to PS16 (Mandatory)
• INAB R1 Regulations (Mandatory)
• Terms and Conditions (Mandatory)
Use of INAB Policy statements, Regulations, and
Terms and Conditions during assessment
We are now aware of their existence and where to find them !
What do we do with them:
• use together with the accreditation standards as part of the Inab
assessment criteria in the assessment of CABs
• Who should be aware of them and uses them !
• All of the team, including the technical assessors and technical
experts.
Use of INAB Policy statements, Regulations, and
Terms and Conditions during assessment
Examples when the INAB assessors may refer to clauses of INAB mandatory
documents:Clause 3.5 of INAB Regulations (R1)
“Where an organisation wishes to make reference to its INAB
accreditation rather than using the accreditation symbol”
Clause 3.6 of INAB Regulations (R1)
“An organisation claims accredited in respect of the activities which
are defined in the ‘scope of accreditation’.
Use of INAB Policy statements, Regulations,
and Terms and Conditions during assessment
Further Examples
Clause 3.15 of INAB Regulations (R1)
“An organisation use of the accreditation symbol.”
Clause 3.23 of INAB Regulations (R1)
“An INAB accredited organisation provide certification to
any standard used as a basis for accrediting Conformity
Assessment Bodies (CABs) (e.g. ISO 17025, ISO 15189)”
Use of INAB Policy statements, Regulations, and
Terms and Conditions during assessment
Further Examples
Clause 3.10 of Terms & Conditions
“Requirement for an accredited organisation to inform INAB of any
change affecting any matter affecting the Organisation’s ability to
comply with the Accreditation Criteria or the Contract….”
Clause 3.11 of Terms & Conditions
“The Organisation shall notify INAB in writing of any change of
ownership or control of the Organisation or any sale by the
Organisation of its business...”
Use of INAB Policy statements, Regulations, and
Terms and Conditions during assessment
Further Examples
Clause 3.11 of Terms & Conditions
“The Organisation shall notify INAB in writing of any change of
ownership or control of the Organisation or any sale by the
Organisation of its business...”
Clause 6.1 of Terms & Conditions
“Without prejudice to the Organisation’s general legal
obligations in relation to the maintenance of its records, the
Organisation shall keep, for a minimum period of 5 years…..”
Use of INAB Policy statements, Regulations, and
Terms and Conditions during assessment
Further Examples
INAB Policy PS 1: -proficiency testing / inter-laboratory
comparisons
“Accredited laboratories are required to participate and achieve
satisfactory performance on an annual basis for each round in an
appropriate proficiency testing scheme or inter-laboratory
comparison where such schemes are available and relevant to
their scope of accreditation.”
Etc, etc, ………………..
EA / IAF/ ILAC
Guidance Documentation
Patrick O’Brien
EA Documentation
The application of EA documents have been Categorised
into four categories 1 to 4.
EA Documentation
Categories of EA publications
1.
2.
3.
4.
EA MLA procedure documents
EA MLA support documents
EA MLA Sector specific documents
EA - Technical documents
Category 1
EA MLA procedure documents
•
EA MLA procedure documents lay down the
requirements for the operation of the MLA
•
EA-2/13 « EA Cross Frontier Policy for
Cooperation between EA Members «
•
Allows for an AB operating outside its
jurisdiction to subcontract to that countries AB
to undertake some of these activities in future
when EA 2/13 is implemented, it becomes
effective on a staged basis starting in May 2008
Category 2.
EA MLA support documents
EA MLA support documents are documents of a horizontal nature
that support the application of the standards used for accreditation.
(Mandatory) Examples:• EA- 4/02 - Expression of the Uncertainty of Measurement in Calibration.
• EA- 4/16 - EA guidelines on the expression of uncertainty in quantitative
testing
These documents must be implemented by EA member accreditation bodies
for use in their accreditation systems.
Their implementation are assessed as part of the EA MLA peer evaluation
process.
Category 3.
EA MLA Sector specific documents
EA Sector specific documents are sector specific and support the
implementation of the standards used for accreditation in sector
specific applications.
These documents must be implemented by EA member
accreditation bodies that provide accreditation in the sectors in
question for use in their accreditation systems.
Their implementation will be assessed as part of the EA MLA peer
evaluation process.
4. EA / Technical documents
Technical documents are documents that provide technical or
scientific guidance that defines recommended examples how
to fulfil the criteria. (Example….)
EA-4/09 « Accreditation for Sensory Testing Laboratories »
Also:- Under an EA/Euromet MoU,
Specific Calibration documents transfered to Euromet who
accepted to manage them in future.
IAF (International Accreditation
Forum)
Guidance Documentation (GD series)- IAF Guidance
documents are not intended to establish, interpret,
subtract from or add to the requirements of any ISO/IEC
Guidance but simply to ensure consistency application of
those Guides
IAF (International Accreditation
Forum)
Example:IAF – GD 5 : 2006 “Guidance on Guide 65:1996” (Product
Certification)
All IAF Members are required to comply with the IAF
guidance on the application of ISO/IEC Guide 65:1996
(Mandatory)
IAF – GD 8:2007 “Information Guidance on the Transition to
ISO/IEC 17021 Accreditation from Guide 62 and Guide 66
IAF/ILAC A4 “Guidance on the application of ISO/IEC 17020
(Mandatory)
ILAC Documents
(International Laboratory Accreditation Forum)
Examples:• ILAC G9:2005 Guidance for the Selection and Use of Reference
Materials
• ILAC G13:08/2007 Guidelines for the Requirements for the
Competence of Providers of Proficiency Testing Schemes
• ILAC G22:2004 Use of Proficiency Testing as a Tool for
Accreditation in Testing
• ILAC G24:2004 Guidelines for the determination of calibration
intervals of measurement instruments
Conclusion use of EA/ILAC/IAF
documentation
INAB assessors, including technical assessors, are
reminded that they need to be fully aware of current EA /
ILAC /IAF documentation and ensure that you assess
CAB’s accordingly to such documentation as appropriate.
In-house Calibrations PS 13
&
Sampling
by Patrick O’Brien
INAB Assessor Forum -January 2008.
INAB Policy on the Performance
of In-house Calibrations P.S. 13
It recognises that organisations accredited for
calibration, testing or inspection activities
may choose to carry out some calibration
activities in-house to support their
measurement activities rather than seek the
services of an external accredited laboratory.
When an in-house calibration is carried out
the calibrated equipment remains “fit for
purpose”
PS13
INAB Policy on the Performance of In-house
Calibrations PS13
The INAB team should ensure that where an organisation is
accredited for calibration, testing or inspection activities and carries
out in-house calibration these calibrations are
-
Carried out in an appropriate environment
by trained personnel
Using documented calibration procedure,
traceability of measurement is maintained
that uncertainty of measurement budget and procedure for
calculating same is in place.
INAB Policy on the Performance of In-house
Calibrations PS13
It is expected that wherever possible the assessment of
in-house calibrations will be covered as part of the
traceability and calibration aspects within normal
assessment/surveillance activities.
INAB Policy on the Performance
of in-house Calibrations PS13
•
Specialist calibration assessors will be used if the
in-house calibration is outside the area of expertise of
the assessment team.
•
The assessment procedures will include document review and
on-site witnessing as appropriate.
•
On-site witnessing of in-house calibration activities can be
expected at least at initial assessment and reassessment visits
•
An organisation may be required to participate in measurement
audits for the in-house calibration activities
Accreditation of Sampling activities
INAB’s policy on sampling activities
•
Accredit only if sampling activity is carried
out in accordance with standard methods.
Flexible Scopes of
Accreditation
Sinead Guckian
Outline
•
•
•
•
•
•
•
Scope of Accreditation
Flexibility categories
Requirements
Application Procedure
Assessment
Presentation of a Flexible scope
Constraints
Accreditation
Accreditation is the formal recognition of a
body’s competence to conduct a specific activity
such as testing/ calibration, inspection or
certification
Scope of Accreditation
• Scope of accreditation
• Establish accurately
and unambiguously the
range of activities
• Accurate description
• Guarantees an
appropriate evaluation
of competence
• Fixed scopes of
accreditation
Fixed Scopes
• Listing specific activities v’s defining its
competence
• New or modified tests added to a labs scope
• Competence in this general area has already been
demonstrated.
• Timescales involved in applying for Extensions
“Flexible Scope”
• Tests may not initially be explicitly stated on
their INAB scope of accreditation
• Competence in the development and validation of
tests has been evaluated
• List of Additionally Accredited Tests (LAAT)
• Claim accreditation without prior approval from
INAB
• Added post surveillance visit
“Flexible Scope”
•
EA-2/05: “The Scope of Accreditation and Consideration of
Methods and Criteria for the Assessment of the Scope in
Testing”, EA, European co-operation for Accreditation,
August 2001.
•
ILAC-G18: 2002: “The Scope of Accreditation and
Consideration of Methods and Criteria for the Assessment
of the Scope in Testing”, ILAC, International Laboratory
Accreditation Cooperation
•
The European Co operation Laboratory Committee
Terminology
• Flexible in their entirety
• Combination of fixed and flexible methods,
• Primarily fixed scopes that include one or two
flexible methods
Flexibility Categories
• Flexibility for materials/products tested i.e P9
category, matrix
• Flexibility concerning test parameters - analytical
parameter, accredited range
• Flexibility concerning the performance of the
method - sample preparation, clean-up procedure
Requirements
• Laboratory will be required to demonstrate
• Fixed scope is too restrictive
• An extended management system capable of
controlling the flexible scope
• The technical competence and experience –
first reassessment
Requirements
• Management System
• Authorise technically competent individuals
• the development and revision of the testing methods
• validation of methods
• authorisation to approve implementation of new
methods
• Establish a validation Strategy
• criteria for the acceptance of validation results
• confirm that the method is suitable for the intended
purpose
• inform the client of the results of the validation.
Requirements
• One individual with responsibility for each
validation job
• Can assess suitability of a method – customer
needs
• Can draw up a specific validation plan
• Can assess the performance of the method
• Results from validation shall be documented in a
report
Requirements
• Maintain record of any changes
• Procedure for processing requests, tenders and contracts
• Implications
• Possibility unable to issue accredited test results
• Protocol for applications for test under flexible scope
• Reference material, Equipment
• Suitably qualified personnel
• Responsibilities are assigned
• Necessary validation activities are carried out
• Implementation of new tests is authorised
Requirements
• If validation procedure inability to issue
accredited test reports – corrective action
• Informing it client
• Revision of the relevant procedures or method
• Maintaining a record of the occurrence
• Internal audit & Management reviews
Application
• Fulfilling the requirements
• Extensive experience in performance of specific
tests
• Adequate experience in development and
validation of testing methods
• Acceptable results in internal and external
quality assurance, INAB assessments
• Measurement equipment to operate within the
full testing category
Application
• Preliminary Evaluation Process
• Experience in testing category – development
and validation
• Experience in the specific tests - Annual
number of analysed samples
• Internal & external Quality assurance
• Justification of the requirements for a flexible
scope
Application
• Extension to scope application form
• Protocol for dealing with request for tests
• Validation protocol
• Proposed test procedures
• List of Key personnel authorised
• 3 months
Assessment visit
• The implementation of the Management
System
• The competence of the individuals
• Specific examples of the tests for which the
laboratory has applied a flexible scope
• Reporting
• Means of informing clients
Presentation
• Similar fashion to that
used for fixed scopes
• List of Additionally
Accredited Tests
• Controlled by the
laboratory
• Publicly available
Presentation
• List of Additionally
Accredited Tests
• Laboratory Reg. No.
• Current edition of the INAB
schedule
• Matrices and P9
classification that apply to
the flexible scope of
accreditation
• The group of tests and the
list of additional tests
within each group
• The date on which each
test was added
• Measurement range and/or
limits of detection
Maintenance
• Implementation and effectiveness of controls
• Technical competence and use of the established
management system
• PS10
• LAAT
• Full validation reports
• Summary of changes
• Added to the laboratories scope of accreditation
Constraints
• A reflection of the competence of the Lab
• Generalised issue of reports outside accreditation
within a category may question accreditation for
flexible scope.
• Not enable a Lab to move into a new field of
accreditation – cannot jump P9 Category
• Chemical Testing Laboratories
Thank you
Quoting Measurement Ranges And
Detection Limits
On Microbiological Scopes
FRANK CROWE
Measurement Ranges And Detection Limits
INAB Policy
•Methods must be validated for specific measurement ranges.
•Detection limits must be calculated where appropriate.
•Regular demonstration of laboratory capability to achieve
detection limits and measurement ranges.
•Detection limits and measurement ranges are clearly discussed
with customers at contract review.
Measurement Ranges And Detection Limits
The Rationale for not quoting Detection Limits
Microbiology unlike Chemistry does not have
clear certainties associated with detection limits.
•To quote LOD’s on the scope can be misleading, as the implication is that the
quoted LOD will apply to each test.
•To state a detection limit gives a strong message that "if it's there, we'll find it!“.
•There is no certainty that the target organism even if it is there, will be detected.
•Its more a case of we may find it, but there are no guarantees.
Measurement Ranges And Detection Limits
Assumptions
Even if the detection limit is not quoted on the scope, laboratories must undertake
practical work to show that their methods perform at levels close to the
theoretical limits.
LOD’s should be estimated as part of method validation where required.
Otherwise
•Not adhering to the requirements of ISO/IEC 17025 – 5.4.5.3, EA-04/10.
•Cannot carry out Contract Review.
•Establish customer requirements.
Measurement Ranges And Detection Limits
Requirements of the Assessment Team
Assessors must satisfy themselves that laboratories are
actively calculating detection limits for each test where required.
•Validation Records.
•Analytical Quality Control.
•Uncertainty of Measurement.
•Contract Review.
Measurement Ranges And Detection Limits
Summary
•It is important that laboratories calculate detection limits as part of their method validation.
•Laboratories must discuss detection limits with customers.
•Laboratories must ensure detection limits are appropriate for customer’s requirements.
•Assessors must be satisfied that laboratories can demonstrate their ability to achieve
detection limits.
•Assessors must be satisfied that laboratories can continue to demonstrate their ability
to achieve these detection limits.
Measurement Ranges And Detection Limits
Discussion & Questions
Professional Fees and
Expenses
INAB Assessor Forum - January 2008
Emma Scott McGrane
Assessor Claim Form – IR04 F1
• Assessor Claim Form must be accessed via
Extranet.
• Complete “Assessor Claim Form for Professional
Fees and Expenses – IRO4 F1”.
• Return Forms to Forfas Accounts, Forfas, Wilton
Park House, Wilton place, Dublin 2.
Accessing the INAB Extranet
•All Users have a Password & Username
•Log on to the website – https://www.lgp.ie/inab
Accessing the INAB Extranet
Accessing the INAB Extranet
Assessor Claim Form – IRO4 F1
Part A:
Professional Fees (As per
Schedule 3 of Assessor contract).
Part B:
Assessor Expenses (As per
Schedule 4 of Assessor Contract).
Compliance
Assessor Claim Form must comply with Schedule 4
of the Assessor Contract.
 All corresponding receipts and actual airline tickets
must be submitted.
 Evidence of Exchange Rate must be documented.
Compliance
Assessor Claim Form must comply with Schedule 4
of the Assessor Contract.
 A Current Tax Clearance Certificate is required.
 A Purchase Order Number must be quoted on form.
 A Separate Assessor Claim Form must be completed
for every job invoiced.
Invoice Processing
•A
Invoice
Forfas Accounts
INAB Officer
•B
•C
INAB Manager
Professional Services Withholding Tax
(PSWT)
- Applies to Payments made by Public Bodies in
respect of all persons who provide Professional
Services.
- All professional services are subject to PSWT.
- PSWT is deducted at the Standard Rate of Income
Tax from the total amount of the payment.
- It is not an additional Tax.
Professional Services Withholding Tax
(PSWT)
- A Public Body is obliged to deduct the PSWT from
the total amount of the payment due:
-Including any amount in respect of
expenses
-Excluding any VAT charged by the
taxpayer etc.
Professional Services Withholding Tax
(PSWT)
Payments to Non Residents
-
-
PSWT must be deducted from all relevant
payments to non-residents.
Where PSWT is deducted from a payment to a
non-resident, a F45 form must be issued in
respect of that payment.
Amount on forms is always in Euro.
Professional Services Withholding Tax
(PSWT)
Where a non-resident is NOT chargeable to tax
in the state:
Repayment claimed from:
The Revenue Commissioners, International
Claims Section, Collector General, Government
Offices, Nenagh, Co. Tipperary.
E-Mail: intclaims@revenue.ie
Professional Services Withholding Tax
(PSWT)
Where a non-resident IS chargeable to tax in
the state:
- Claims for credit, refund, or interim refunds of
PSWT are made to:
The Revenue District to whom they make their
tax returns.
E-Mail: intclaims@revenue.ie
Tax Clearance Certificate
-Written confirmation from Revenue that Tax Affairs
are in order at the date of issue of Cert.
- A current TCC is required as a condition of
obtaining a Public Sector Contract.
Tax Clearance Certificates
• Applicants can download application form TC1 at:
http://www.revenue.ie/forms/webtc1.pdf
Completed forms to be forwarded to the appropriate
address having regard to the category type of
applicant (resident / non resident).
• Appropriate addresses can be accessed at:
http://www.revenue.ie/index.htm?/services/bus_guides7.htm
Thank you