Technical ISO standard for the

competence of testing and

calibration laboratories

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 2. Basics of a Lab- 3. Establishing 4. Managing the
1. Fundamentals MS and ISO 17025 your Lab-MS ISO 17025 Lab-MS

•Who is ISO? •What is a Lab-MS ? •Key Elements •Key elements of

•What is CA std? •What is ISO/IEC •Documenting your an ISO/IEC 17025
17025? Lab-MS Lab-MS
•Registration vs
accreditation •Benefits of •Implementing the •ISO/IEC 17025
accreditation MS in your accreditation
•What is a
Management •Elements of Organization
System? ISO/IEC •Training People
•Plan Do Check Act 17025:2017 •Auditing the MS
•Process approach •Accreditation
•Risk Based
Thinking
•Scope of
accreditation
•Technical
elements

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 Who is ISO?

 What are CA standards?

 Registration vs accreditation

 What is a Management System?

 Plan Do Check Act

 Process approach

 Risk Based Thinking

 Scope of accreditation

 Technical elements

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ISO is the International Organization for Standardization
 ISO develops Standards for use worldwide.
o Many are product based (types of coatings or hardware)
o Some of these are Management Systems Guidelines for
common operations in an organization like the Quality Systems,
Environmental Systems, Safety Systems, Financial System, etc.
o ISO 9001 is a familiar standard for a Quality Management
Systems (Lab-MS)
o ISO/IEC 17025 is a technical standard with Lab-MS supporting
technical testing or calibration scope of accreditation
 Global standards are needed so everyone can be equally measured.
o Different countries can compare “apples to apples”
 ISO Standards always defer to state, local and federal requirements.
o Different statutory and regulatory requirements will apply.

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ISO has a committee, CASCO, that develops standards
and addresses issues related to conformity
assessment
ISO / CASCO has standard 17000 that defines
conformity assessment.
Conformity is: "demonstration that specified requirements relating
to a product, process, system, person or body are fulfilled”
o The main forms of conformity assessment are testing,
calibration, certification, and inspection
o All require a supportive Management System for
common operations in an organization
o Global oversight of certification standards like ISO 9001 is
IAF (Int’l Accreditation Forum)
o Global oversight of testing, calibration and inspection
including ISO/IEC 17025 is ILAC (Int’l Lab Accreditation
Cooperation)
o There are over 21,000 ISO standards that have been
published. Only 35 of them are ISO/CASCO conformity
assessment standards.

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ILAC is the International Laboratory Accreditation
Cooperation
 ILAC develops global policies and guidance, through
its regions, for technical CA Standards for use
worldwide.
 Regional peer group representatives evaluate each
accreditation body every 4 years to assure the AB is
following good practices, approving and suspending
labs around the world appropriately.
 AN ILAC-signatory AB then can accredit labs for
testing or calibration who can then issue test reports
and CA certificates with both the AB symbol and the
ILAC mark . . . providing international confidence in
their results.

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 ILAC
 Global oversight entity for ISO/IEC 17025
 APLAC and IAAC
 Asia Pacific and Inter-American Accreditation
Cooperation
 ANAB, A2LA or other AB
 Representative accreditation body
 AB Customers
 Laboratories seeking accreditation

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 International Laboratory
Accreditation Cooperation (ILAC)

Inter-American
Asia Pacific Laboratory Accreditation
Cooperation (APLAC) Cooperation (IAAC)
European ANAB ( USA)
ANAB (USA) Cooperation for
A2LA (USA)
A2LA (USA) Accreditation
NVLAP (USA)
IAS (USA) (EA)
AIHA (USA)
NVLAP (USA)
South America
PJLA (USA)
Central
AIHA (USA)
America
Asia-Pac
Mexico
Countries

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 Registration / Certification is the formal designation
of an organization that has met requirements of a
Management System ISO standard.
 ISO-certified or registered organizations receive
regular audits by 3rd-party auditors. Their scope is
typically a single sentence on the certificate.
 Accreditation is the formal designation of a lab or
other organization that has met requirements of an
ISO technical std., verifying technical competence
for line items on their scope.
 ISO-accredited organizations receive regular
assessments by 3rd-party assessors. Scopes can be
half-page to 30 pages in length.

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Your organization is made up of several Management
Systems, which operate within your overall Business
Management System. Example:
 Financial (FMS)
 Quality (Lab-MS)
 Environmental (EMS)
 Safety (SMS)
 Energy (EnMS)
 IT (MIS) etc.

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 You may have a very limited or a very
extensive lists of tests and materials /
matrices you test . . . Or a large scope of
measuring equipment that you calibrate . . .
 If you are pursuing or maintaining ISO/IEC
17025 accreditation to provide accredited
testing or calibration services, you still need
a supportive management system.
 You also will need have what we call a
Technical System as the key part of your
Management System (Lab-MS).

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• Set Goal – • Implement • Validate – • Adjust plan
Lose weight the plan Step on the • Keep
• Metrics – • Exercise, eat scale – Are improving
10# per wisely, you meeting by raising
month until portion the goal? the bar
you reach control • No – (Continual
your target Why not? improvement)
weight • Yes –
• Set up Great!
exercise Can you
schedule, improve?
nutrition

Plan Do Check Act

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 Materials People
Process Process
A C

Input Process Output

Process Process
B D

Technology Equipment

 Look at your business as a series of interacting processes,

not departments.
 If you break down the process, you can improve them for
consistent results – like a recipe.
 Requires that your processes are controlled and managed
for continual improvement.

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A bakery is a system of processes

Quotation Process  Understanding what your

customers want
 Develop your recipe to meet these
requirements
 Select Providers, Buy ingredients,
Design Process (9001) etc.
 Mix Ingredients, Bake bread, etc.
 Determine risks and opportunities
Purchasing  Audit: Test results – were they
burned?
Process  Corrective Action: Adjust oven,
etc.
Production
Process

Quality Process

All of the processes directly / indirectly impact each other

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 Likelihood
Quite Very
Not Like Possible Likely
Possible Likely

Trivial
Trivial

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Impact
Significant
Major
Catastrophic
 Purchasing Process
 Single Source supplier is wiped out by Tsunami
 What is the impact?
 You are shut down
 What is the likelihood it will happen?
 Unlikely (But it happens)
 How do you mitigate the risk?
 Find another supplier
 Revise design to allow other options

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 Framework for every laboratory accredited to
ISO/IEC 17025
 In new 2017 version of the standard  can be for
Testing, Calibration, and/or Sampling
 Basis for the laboratory’s cost to secure and
maintain accreditation. Longer scopes require
longer verification visits
 Labs taking measurements need to understand the
errors of their measurements (uncertainty).
 Accredited Calibration labs need to report
measurement errors on their AB-published Scope of
Accreditation

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 Recognized and validated testing or calibration
methods used
 Quality assurance practices to ensure valid results
 Metrological traceability in measuring tool
calibrations
 Measurement confidence and ability to report
with 95% confidence the measurement error
(uncertainty)
 Regular participation in round-robin proficiency
testing/ inter-lab comparisons or approved
alternatives

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 What is a Lab-MS?
 What is ISO/IEC 17025?
 What are the requirements of ISO/IEC
17025:2017?
 Benefits of ISO/IEC 17025 accreditation

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A Management System (MS) determines and continuously improves a
laboratory’s quality performance.
 Applies to any organization throughout the world performing any
testing or calibration
 Does not mandate across-the-board criteria a company must meet,
like a certain “level of quality”
 Does not “rate” your company against others – but PT reassures
both you and the global technical community of your competence
and reliability
 It is about consistently meeting/exceeding your customers’
requirements and giving confidence to the technical community
 It requires that you seek continual improvement

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If you baked cookies... You have a recipe for success – it doesn’t
matter what it is. Your MS would ensure your processes are
controlled so you can meet your customers’ requirements by
producing your recipe consistently:
 Document Control – ensure everyone is using the same
recipe
 Customer Requirements – ensure you know what they
want
 Purchasing – the right ingredients matter
 Production – same size scoop, mix same way
 Environment – train people, control workplace, etc.
 Calibration – ensure oven is correct so they don’t burn
 Risk – put timer on oven to prevent burning
 Audit – review orders to see if there were errors
 Etc.

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You operate a lab which tests your parent companies
cookies for 3 types of pathogenic bacteria and 6 nutrients
for their labels.
 Document Control – ensure all test methods are correct
and most current practices
 Customer Requirements – ensure all test accuracies and
non –metric units are defined
 Purchasing – the right lab equipment and materials
 Analysis – Two labs (chem, micro) both with + and –
controls
 Environment – train people, control incubators,
chambers
 Calibration – ensure all measuring devices and chambers
accurate
 Risk – run duplicates and double check all calculations
 Audit – review at least annually all docs and records and
methods

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 Outlines the basic elements of a laboratory management
system (Lab-MS) which support the defined testing or
calibration scope of accreditation.
 Was designed by global experts. After 12-year lag, updated in
late 2017.
 Has been implemented by over 70,000 organizations globally.

 Accreditations to this standard support the ILAC motto:

“Tested or Calibrated Once --

Accepted Everywhere”
Products in global trade do not need to be re-tested or
calibrated at import locations if they have been tested by labs
using ILAC-signatory AB’s.

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 Clause 1 – Scope
 Clause 2 – Normative References
 Clause 3 – Terms & Definitions
 Clause 4 – General requirements
 Clause 5 – Structural requirements
 Clause 6 – Resource requirements
 Clause 7 – Process requirements
 Clause 8 – Management system requirements
All requirements use the word “shall” and are only in sections 4 to 8.
None in Notes.

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The main clauses have more than one required sub-element.
Clause 4 – General requirements
• Impartiality and Confidentiality (including risk review)
Clause 5 – Structural requirements
• Legal entity with responsible management, defined range of lab
activity (scope) with no claim beyond it
• Activities to meet requirements of customers, regulators and
recognition bodies. Define if it includes sites beyond the fixed lab.
• Define the structure including support services, authorities of each
party, defined procedures, personnel to manage the Lab-MS
• Utilize effective communication especially during changes to the
Lab-MS

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Clause 6 -- Resource requirements
• Have adequate people, facilities, equipment systems and
services

• Competent and impartial staff, defined competency,

communicated duties and responsibilities

• Good records for staff and competencies, authorizations, and

training

• Proper facilities, environmental controls, equipment with

calibration and maintenance program for key ones

• Metrological traceability for key equipment

• Suitable purchasing and sub-contracting of services,

communicating requirements to service providers

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Clause 7 -- Process requirements
• Contract review for accredited work with possible sub-
contracting
• Selecting appropriate test/cal methods, validating as
needed
• Sampling test material properly
• Manage test or calibration items through all processing
• Maintain proper technical records
• Determine proper measurement errors (uncertainties)
• Perform appropriate QA and QC, particularly annual
PT/ILC or alternative
• Report accredited results appropriately
• Manage complaints in the system
• Handle non-conforming work appropriately
• Manage data and information systems properly

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Clause 8 -- Management system requirements
Option A and Option B (to allow credit for audit time in
future)
 Lab-MS documentation and document control
 Record control
 Risks and opportunities
 Improvement
 Corrective actions / Internal audits / Management
review

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Internal :
 Consistent results
 Improved operations
 Confidence of comparability with other global labs
External :
 Global and industry recognition
 Build international confidence in your competence,
thus business expansion

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 Improved communication with staff and management

 Clearly defined process requirements for employees

 Training on requirements

 Clear understanding of own roles and responsibilities

 Process to address problems

 Process to assess effectiveness of the Lab-MS

 Ideas for continual improvement

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• Ensure commitment by organization’s leadership

• Document the processes you need to control

• Implement these processes and train accordingly

• Run the system for 3 months to gather records,

perform internal audits, have management
review and make improvements

• Accreditation body assesses the system

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Top management must demonstrate leadership and
commitment with respect to the Lab-MS and to Customer
focus.

The organizational roles, responsibilities and authorities for

the relevant functions must be assigned, communicated,
and understood within the company.

The lab policy and procedures must be established,

implemented, maintained, and communicated.

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Your Lab-MS must include the documented information
required
by ISO/IEC 17025:2017 and the documented information
that you
determine to be needed for an effective Lab-MS. The
extent of documented information for your MS will
depend on the:
 Complexity of your laboratory and the scope of
accreditation,
processes, areas of testing and services

 No formal quality manual or quality policy per se is

required, but sufficient documents and records to track
processes and yield high quality testing or calibrations
will be expected in your laboratory
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Your company must conduct internal audits to ensure
that the Lab-MS conforms to the requirements, is
effectively implemented and maintained, and
continues to be suitable, adequate and effective. It
should review 3 areas – all requirements of the ISO/IEC
17025 standard, each technology / area of your
accreditation scope, and all other requirements
specified by your AB or your customers.
You must plan, establish, implement and maintain an
audit program that includes the frequency,
responsibilities, methods, planning requirements and
reporting.

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 Need know
to

Your company must review the Lab-MS to ensure that

it continues to be suitable, adequate and
effective and is aligned with the strategic
direction.
Management reviews must be planned and conducted
and consider specific inputs defined in the
standard.
The outputs of the management review must include
decisions and actions related to improvement
opportunities, any need for changes to the Lab-MS
and to resources.
You must retain documented information as evidence
of the results of management reviews.

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 Be Helpful and Courteous
 The Assessors will be going to all technical scope and
support areas of your laboratory, talking to employees
and asking questions about how things are done,
witnessing competence and proper equipment and
practices on your scope methods.
 Their questions will be similar to those that your
Internal Auditors have been asking.

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 Internal & external issues relevant to the Lab-MS
 Lab-MS Planning - Risks & Opportunities / Objectives
 Resource Management
 Operational Plans and Controls
 Competence and Training
 Nonconformity and Corrective Actions
 Opportunities for Improvement

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To understand your organization and its context, you
must determine the external and internal issues that
are relevant and that affect the ability to achieve the
intended results of the Lab-MS.
The information regarding these external and internal
issues must be monitored and reviewed.
Remember to consider only Issues Relevant to your
Lab-MS.

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In the planning process, the risks and opportunities must be
determined to ensure that the Lab-MS can achieve its intended
results, prevent, or reduce, undesired effects, and achieve
continual improvement.
Since risks are new to the ISO/IEC 17025 community, it will take
a year or two for AB’s and labs to work out best practices here.
The lab should assure that at least two sessions per year are
devoted to risk management. One at management review and
another earlier in the year.
Quality-based (not financially-based) objectives must be
established at the relevant functions, levels and processes.
Changes to the Lab-MS must be planned and carried out in a
systematic way.

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Your company must determine and provide the resources needed
to establish, implement, maintain and continually improve the
Lab-MS.
For an effective MS, competent, knowledgeable, and aware
people must be trained and experienced to ensure that
requirements can consistently be met.
A suitable infrastructure and work environment must be
provided for the accredited lab services to achieve conformity
and accurate results.
Monitoring and measuring resources are maintained and
regularly reviewed to ensure valid and reliable results.

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You need to:

1. Identify what training is required for each scope

technology and support service. How and when
competence approvals are given to each
technician.

2. Provide the required training and keep records

3. The effectiveness of the training provided must

also be determined

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Your company needs to determine the methods for
internal and external communication of quality and
technical matters.
This includes:
 What it will communicate
 When to communicate
 With whom to communicate
 How to communicate.
As a communication tool, the Lab-MS documentation
provides for an understanding of the requirements
and of the ISO/IEC 17025 standard as a whole.

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Your company must establish, implement and
maintain a process to determine the requirements for
the accredited work and services to be offered to
potential customers. Test and calibration requests can
vary considerably. Customers may request
inappropriate or outdated methods, rush timeframes,
testing of damaged or suspect material, etc.
Your company must review customer requirements
prior to accepting an order.
Documented information describing the results of the
review, including any new or changed requirements
for the products and services are retained.

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Your company must ensure that externally provided
processes, products and services conform to requirements.

Purchases are verified before use to ensure that they do not

adversely affect the ability to consistently deliver
conforming
products and services to customers. Sub-contractors must
have clear documentation of your lab requirements.

Outsourced processes or functions remain within the scope

of your Lab-MS and your laboratory is ultimately responsible
for the products and services. Your report cannot hide
the fact that an external lab did part of the contracted
work.

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The release of products and services (typically test reports or
calibration certificates) must not proceed until verifications have
been satisfactorily completed, (unless otherwise approved by a
relevant authority or a customer).

Documented information must provide traceability to the persons

performing each step of the accredited work including signoff
and authorizing release for delivery to the customer.

Records must be maintained to provide evidence that the

products or services have passed final review.

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Your laboratory must determine:
 What needs to be monitored and measured,
 Methods for monitoring, measurement, analysis,
evaluation,
 When the monitoring and measuring is to be
performed,
 When the results from monitoring and measurement
are to be analyzed and evaluated.
You must ensure that monitoring and measuring
activities are implemented and associated records
retained.
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Your company must monitor the customer perceptions
of how well their needs and expectations are met.
Formal surveys are not always required.
You must obtain information relative to customer
views and opinions of the company and its accredited
work and services, both positive and negative.

Analysis and evaluation

You must analyze and evaluate the data and
information resulting from the monitoring of your
customer’s satisfaction.

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Your company must ensure that non-conformances are
dealt with as they occur and that corrective action is
taken to eliminate the cause or to reduce the
likelihood of recurrence. These often originate from
internal audits, external assessments and daily
problems that arise.
Corrective actions must be appropriate to the effects
of the non- conformances. Root cause analysis is key
to proper CAR work.
Documented information must be retained as evidence
of the nature of the nonconformities, of any
subsequent actions taken, and of the results of any
corrective action.
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Your company must determine and select opportunities
for improvement and take actions to meet customer
requirements and enhance customer satisfaction.
These take into consideration :
 Improving turn-around-time for services to meet
requirements and to address future needs and
expectations,
 Correcting, preventing or reducing undesired effects,
 Improving the performance and effectiveness of the
Lab-MS.

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Your company must continually improve the suitability,
adequacy, and effectiveness of the Lab-MS. You must
consider the results of analysis and evaluation, and the
outputs from management review to identify areas that
must be addressed as part of continual improvement.
Where applicable, you must select and use tools &
methods for investigation of the causes of
underperformance.
Statistical techniques may be used to identify trends
and problems to offer potential solutions that improve
the Lab-MS. Many laboratories utilize control charting
or trend analysis with Certified Reference Materials
when possible.

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 Laboratories will need to have highly trained
staff and well maintained, calibrated equipment
and good practices with their management
system.
 Financial and time commitments to the
accreditation process can be extensive.
Management dedication to the process is critical.
 Personnel need to get familiar with metrological
traceability, measurement uncertainty, and
regular participation in proficiency testing (or
approved alternatives). Labs will benefit from
inputs from your accreditation body.

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Thank you for your participation in this overview of
ISO/IEC 17025.

We hope you have gained helpful insight that will

enable you to play an active role in your Lab-MS
and most importantly, meet customer
requirements and enhance customer satisfaction.

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