Dexter Laboratories LLC / 7 Aug 2019

ISO/IEC 17025:2017 Checklist Complete

Inspection score Failed items Created actions

99.28% 1 0
Laboratory/Site

Dexter Laboratories LLC

Conducted on

7th Aug, 2019 2:12 PM +08

Prepared by

Deirdre Smith, MHA

Location

133 S Hickory St
Dexter, MO 63841
United States
(36.79162942590022, -89.95177454143651)

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Failed items 1 Failed

Internal Assessment / 6. Resource Requirements / 6.3 Facilities and Environmental Conditions

6.3.4 Measures to control facilities

• to be implemented, monitored and periodically reviewed, including
but not limited to
a) access to and use of areas affecting laboratory activities
Non-Compliant
b) prevention of contamination, interference or adverse influences
on laboratory activities
c) effective separation between areas with incompatible laboratory
activities

— Notes

We had an issue on temperature control and discovered a monitoring gap that we cannot allow to
continue. I contacted Minnie to address the gap in temperature control and monitoring.

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Internal Assessment 1 Failed 99.28%

4. General Requirements

4.1 Impatiality

4.1.1 Laboratory activities

• shall be undertaken impartially and structured and safeguarded to Compliant
ensure impartiality

4.1.2 Laboratory management

Compliant
• shall be committed to impartiality

4.1.3 Laboratory responsibility

• commercial, financial or other pressures must not compromise Compliant
impartiality with regard to laboratory activities

4.1.4 Risk identification

the laboratory to undertake this on an on-going basis and include
those arising from:
Compliant
• its activities
• its relationships
• relationships of personnel

4.1.5 Risk mitigation

• the laboratory shall demonstrate how risk to impartiality is Compliant
eliminated or minimized

4.2 Confidentiality

4.2.1 Laboratory responsibility

• through legally enforceable commitments, manage all information
obtained or created during the performance of laboratory activities
• inform the customer in advance of the information it intends to
Compliant
place in the public domain
• maintain all customer information as confidential, except for that
information the customer makes public or that agreed to be made
public

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 4.2.2 Release of customer information
• must not occur unless
- when required by law
Compliant
- authorized by contractual arrangements
• customer to be notified of information provided (unless prohibited
by law)

4.2.3 Customer information from other sources

• shall be confidential between the customer and laboratory
Compliant
• the source of this information shall remain confidential to the
laboratory

4.2.4 Confidentiality obligations of personnel

• shall keep confidential all information obtained or created during Compliant
the performance of laboratory activities, except as required by law

5. Structural Requirements

5.1 Legal status

• the laboratory shall be a legal entity, or a defined part of a legal Compliant
entity, that is legally responsible for its laboratory activities

5.2 Laboratory management

• identify management that has overall responsibility for the Compliant
laboratory

5.3 Scope of laboratory activities

• the laboratory to define and document the range of activities
which it claims conformity to the Standard Compliant
• cannot include laboratory activities which are provided externally
on an ongoing basis

5.4 Conduct of laboratory activities and premises

• to be performed to meet the requirements of
- the ISO 17025:2017 standard
- customer requirements
- regulatory authorities
Compliant
• activities include those conducted at
- permanent facilities
- sites away from permanent facilities
- temporary or mobile facilities
- customer premises

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 5.5 Structure, personnel and documentation
a) define the laboratory’s place in any parent organisation, the
relationship between management, technical operations and
support services
b) specify the responsibilities, authorities and interrelationships of Compliant
those who manage, perform or verify work affecting the results of
laboratory activities
c) document procedures to the extent necessary to ensure
consistent conduct of laboratory activities and the validity of results

5.6 Personnel authorities and resources

a) available to implement, maintain and improve the management
system
b) able to identify deviations in the management system or
laboratory activity procedures Compliant
c) able to initiate actions to prevent or minimize deviations
d) report to laboratory management the performance of the
management system and needs for improvement
e) ensure the effectiveness of laboratory activities

5.7 Laboratory management responsibilities

a) ensure communication on the
effectiveness of the management system
Compliant
and meeting customers’ and other requirements
b) ensure integrity of the management system is maintained when
changes are planned and implemented

6. Resource Requirements

6.1 General

6.1 Available resources

• laboratory to have available personnel, facilities, equipment,
Compliant
systems and support services necessary to manage and perform its
laboratory activities

6.2 Personnel

6.2.1 Competence and impartiality

• all personnel (internal or external) associated with the laboratory
Compliant
that could influence the laboratory activities to be competent and
act impartially in accordance with the management system

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 6.2.2 Documentation of competency requirements
• to include education, qualification, training, technical knowledge,
Compliant
skills and experience for each role which influence the laboratory
activities

6.2.3 Competency
• ensure personnel are competent to perform laboratory activities
Compliant
for which they are responsible and to evaluate the significance of
deviations

6.2.4 Duties, responsibilities and authorities

Compliant
• ensure these are communicated

6.2.5 Procedures and records

a) for the determination of the competence requirements
b) for the selection of personnel
c) for training Compliant
d) for supervision
e) for authorisations
f) for the monitoring of competence

6.2.6 Authorisations to perform specific activities

a) develop, modify, verify and validate methods
b) analyse results, including statements of conformity or opinions Compliant
and interpretations
c) report, review and authorise results

6.3 Facilities and Environmental Conditions 1 Failed

6.3.1 Suitability of facilities and environmental conditions

Compliant
• appropriate and not adversely affect the validity of results

6.3.2 Document
• the requirements for facilities and environmental conditions to Compliant
perform laboratory activities

6.3.3 Monitor, control and record

• the environmental conditions in accordance with the relevant
Compliant
specifications, methods and procedures or when they influence the
validity of results

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 6.3.4 Measures to control facilities
• to be implemented, monitored and periodically reviewed, including
but not limited to
a) access to and use of areas affecting laboratory activities
Non-Compliant
b) prevention of contamination, interference or adverse influences
on laboratory activities
c) effective separation between areas with incompatible laboratory
activities

— Notes

We had an issue on temperature control and discovered a monitoring gap that we cannot allow to
continue. I contacted Minnie to address the gap in temperature control and monitoring.

6.3.5 Sites outside laboratory’s permanent control

• ensure facilities and environmental conditions comply with Compliant
requirements of the Standard

6.4 Equipment

6.4.1 Availability of equipment

• laboratory has access to equipment for correct performance of Compliant
laboratory activities

6.4.2 Equipment outside control of laboratory

Compliant
• the requirements of the Standard are met

6.4.3 Procedure
• is available for handling, storage, use and planned maintenance to
Compliant
ensure proper functions and to prevent contamination or
deterioration

6.4.4 Verification
• ensure equipment conforms to specified requirements before Compliant
being placed or returned into service

6.4.5 Accuracy and/or measurement uncertainty (MU)

• to provide a valid result, equipment must be capable of achieving
the required Compliant
- measurement accuracy; and/or
- MU

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6.4.6 Calibration
• equipment shall be calibrated when
• measurement accuracy or MU affects the validity of the results;
Compliant
and/or
• the equipment is necessary to establish metrological traceability
of the results

6.4.7 Calibration program

• shall be established and reviewed and adjusted as necessary in Compliant
order to maintain confidence in the status of calibration

6.4.8 Labelling
• all equipment which requires calibration or has a defined period of Compliant
validity shall be labeled, coded or otherwise identified

6.4.9 Out-of-service
• overloaded, mishandled or poorly functioning equipment shall be
isolated and not reused until verified that it performs correctly
Compliant
• the effect of such defective equipment
shall be investigated and the management of non-conforming work
initiated

6.4.10 Intermediate checks

• shall be carried out when necessary to confirm performance of the
Compliant
equipment
• in accordance with a procedure

6.4.11 Correction factors

• when calibration and reference material data include reference
Compliant
values or correction factors, these are to be updated and
implemented, as appropriate, to meet specified requirements

6.4.12 Unintended adjustments

• practicable measures are taken to prevent these from occurring Compliant
and invalidating results

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 6.4.13 Records
• shall be retained for equipment which can influence laboratory
activities, including:
- identity, including software/firmware version
- manufacturer’s name, type and serial number or other
identification
- evidence of verification
Compliant
- location
- calibration dates and results, results of adjustments, acceptance
criteria, due date of next calibration or interval
- documentation of reference materials, results, acceptance criteria,
relevant dates and the period of validity
- maintenance plan and maintenance performed;
- details of damage, malfunction, modifications or repair

6.5 Metrological Traceability

6.5.1 Establish metrological traceability

• the laboratory shall establish and maintain metrological
traceability of its measurement results by means of a documented Compliant
unbroken chain of calibrations, each contributing to the
measurement uncertainty, linking them to an appropriate reference

6.5.2 Measurement results traceable to SI units

• to be established through
a) calibration provided by a competent laboratory; or
b) certified values of CRMs from a competent producer with stated Compliant
traceability to SI units; or
c) direct realization of the SI units
ensured by comparison with national or international standards

6.5.3 Traceability to SI not technically possible

• where this occurs, metrological traceability to an appropriate
reference shall be demonstrated, for example
a) certified values of CRMs provided by a competent producer to
non SI values Compliant
b) results of reference measurement procedures, specified methods
or consensus standards that are accepted as providing
measurement results fit for their intended use and ensured by
suitable comparison

6.6 EXTERNALLY PROVIDED PRODUCTS AND SERVICES

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 6.6.1 Use of externally provided products and services
• Only suitable products and services are used when
a) incorporated into the laboratory’s own activities
Compliant
b) provided directly to the customer by the laboratory as received
from the external provider
c) used to support the operation of the laboratory

6.6.2 Procedure and records for

a) defining, reviewing and approving the laboratory’s requirements
for externally provided products and services
b) defining criteria for evaluation, selection, monitoring of
performance and re- evaluation of external providers
Compliant
c) ensuring that prior to laboratory use or supply to customers, the
products and services conform to the laboratory’s requirements or
where relevant to the Standard
d) actions to take arising from evaluations, monitoring or re-
evaluations of external providers

6.6.3 Communication of requirements to external providers

• These include
a) the products and services to be provided
b) the acceptance criteria Compliant
c) competence, including any required qualification of personnel
d) activities that the laboratory, or its customer, intends to perform
at the external provider’s premises

7. Process Requirements

7.1 Review of Requests, Tenders, and Contracts

7.1.1 Procedure
Shall ensure
a) requirements are defined, documented and understood
b) laboratory has the capability and resources to meet the
Compliant
requirements
c) where external providers are used, the customer is advised and
approves;
d) appropriate methods or procedures are selected

7.1.2 Inappropriate method requested

Compliant
• customer is informed, including if method is out-of-date

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 7.1.3 Statement of conformity requested
• specification or standard and the decision rule are clearly defined
Compliant
• unless inherent in the specification or standard, the decision rule is
agreed with the customer

7.1.4 Differences between requests and contract

• are resolved prior to laboratory activities commencing
• contract to be acceptable to both the laboratory and customer Compliant
• deviations requested do not impact on the laboratory’s integrity or
the validity of results

7.1.5 Deviations from the contract

Compliant
• customer is informed

7.1.6 Amendments to contracts

• contract review is repeated after work commences and Compliant
amendments communicated to all affected personnel

7.1.7 Cooperation with customers

• laboratory to clarify requests and to allow the customer to monitor Compliant
its performance

7.1.8 Records of reviews

• are retained, including changes to contracts and discussions had Compliant
with the customer

7.2 Selection, Verification, and Validation of Methods

7.2.1 Selection and Verification of Methods

[Link] Methods and procedures

• to be appropriate for all laboratory activities, including where
Compliant
necessary, for evaluation of measurement uncertainty and
statistical techniques for data analysis

[Link] Currency of methods and procedures

Compliant
• to be kept up-to-date and made available to personnel

[Link] Method version

• latest valid versions to be used unless it is not appropriate or
possible Compliant
• where necessary, supplemented with additional details for
consistent application

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 [Link] Method selection
• the laboratory to select an appropriate method and inform the Compliant
customer when the customer has not specified the method

[Link] Method verification

• before introducing methods, the laboratory must verify that it can
achieve the required performance
Compliant
• records of verification must be kept
• verification to be repeated when changes to the methods are made
by the issuing body/ies

[Link] Method development

• as proceeds, periodic review to occur to confirm the needs of the
Compliant
customer are still satisfied
• changes to the development plan to be approved and authorized

[Link] Deviations from methods

• shall only occur if the deviation is technically justified, Compliant
documented, authorized and accepted by the customer

7.2.2 Validation of Methods

[Link] Validation
• non-standard methods, laboratory-developed methods and
Compliant
standard methods used outside their scope or modified shall be
validated

[Link] Changes made to validated method

• the influence of such changes shall be determined and if they Compliant
affect the original validation, then the method must be revalidated

[Link] Method performance characteristics

Compliant
• satisfy the customers' needs and specified requirements

[Link] Validation records

a) the validation procedure used
b) specification of the requirements
Compliant
c) performance characteristics of the method d) results obtained
e) a statement on the validity of the method, detailing its fitness for
the intended use

7.3 Sampling

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 7.3.1 Sampling plan and method
• method addresses factors to be controlled to ensure validity of
subsequent testing or calibration
Compliant
• plan and method available at sampling site
• sampling plans based on statistical methods whenever
reasonable

7.3.2 Method
• describes
a) selection of samples or sites
Compliant
b) sampling plan
c) preparation and treatment of samples from a substance, material
or product

7.3.3 Records of sampling data

• include
a) reference to the sampling method
b) date and time of sampling
c) data to identify and describe the sample
d) identification of the personnel
Compliant
e) identification of the equipment used
f) environmental or transport conditions
g) diagrams or other means to identify the sampling location when
appropriate
h) deviations, additions or exclusions from the method or sampling
plan

7.4 Handling of Test or Calibration Items

7.4.1 Procedure
• ensures the protection of integrity of the item and the interests of
the laboratory and customer and covers
- transportation
- receipt
- handling
Compliant
- protection
- storage
- retention and/or disposal
• precautions taken to avoid deterioration, contamination, loss or
damage
• handling instructions provided with the item to be followed

7.4.2 Identification
• system is in place for the unambiguous identification of items, Compliant
including, if relevant, the subdivision and transfer of items

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 7.4.3 Item deviations
• upon receipt, deviations from specified conditions are recorded
• if there is doubt about suitability of item, or
it does not conform to description provided, ensure that the
Compliant
customer is consulted and that the instructions are recorded
• when deviation is acknowledged and customer instructs to
proceed with testing or calibration, the laboratory is to include a
disclaimer in the report indicating that the results may be affected

7.4.4 Storage conditions

Compliant
• to be maintained, monitored and recorded

7.5 Technical Records

7.5.1 Records
• for each laboratory activity include
- results
- report
- factors affecting the results and its measurement uncertainty
- date Compliant
- identify of personnel conducting the laboratory activity and
checking data and results
• allow repetition of the laboratory activity
• original observations, data and calculations to be recorded at the
time they made and be identifiable with the specific task

7.5.2 Amendments
• can be traced to original observations or previous version of
records
• original and amended data
Compliant
- to be retained
- include the date
- an indication of the altered aspects
- the personnel responsible

7.6 Evaluation of Measurement Uncertainty (MU)

7.6.1 Contributions of MU
• shall be identified
Compliant
• significant contributions taken into account when evaluating MU,
including those from sampling

7.6.2 Calibration
Compliant
• MU for all calibrations performed shall be evaluated

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 7.6.3 Testing
• where the test method precludes rigorous evaluation, an
estimation shall be made based on an understanding of the Compliant
theoretical principles or practical experience of the performance of
the method

7.7 Ensuring Validity of Results

7.7.1 Procedure
• for monitoring validity of results is in place
• data from monitoring activities are recorded in a manner which
allows the detection of trends with statistical methods applied,
where possible, for review of the results
• monitoring is to be planned and reviewed and include, where
appropriate
a) use of reference materials or quality control materials
b) use of alternative calibrated instrumentation providing traceable
results Compliant
c) functional checks of measuring and testing equipment;
d) use of check or working standards with control charts
e) intermediate checks on measuring equipment
f) replicate tests or calibrations
g) retesting or recalibration of retained items
h) correlation of results for different characteristics of an item
i) review of reported results
j) intra-laboratory comparisons
k) testing of blind sample(s)

7.7.2 Comparison of results with other laboratories

• shall be used to monitor the laboratory’s performance
• monitoring shall be planned and reviewed and include
Compliant
participation in either or both
a) proficiency testing
b) inter-laboratory comparisons

7.7.3 Analysis of monitoring data

• used to control and improve, where applicable, laboratory activities
• appropriate action is taken to prevent incorrect results from being Compliant
reported when monitoring data is found to be outside of pre-defined
criteria

— Notes

We have recently used this Analytics of iAuditor and it gives us a quick overview of our monitoring
activities and allows us to do a deep dive of frequently missed items. We will use the data to improve our
refresher trainings and reinforce best practices in the lab.

7.8 Reporting of Results

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7.8 Reporting of Results

7.8.1 General

[Link] Review and authorization of results

Compliant
• shall occur prior to release

[Link] Reports
• results are provided accurately, clearly, unambiguously and
objectively
Compliant
• include all the information agreed with the customer and
necessary for the interpretation of the results
• issued reports are retained as technical records

[Link] Simplified reports

• when agreed with the customer
Compliant
• all information not reported to customer and covered by 7.8.2 to
7.8.7 must be readily available

7.8.2 Common Requirements for Reports (Test, Calibration or Sampling)

[Link] Report content

a) title
b) name and address of the laboratory
c) location where the laboratory activities were performed
d) unique identification that all components are recognised as a
portion of a complete report and a clear identification of the end
e) name and contact information of the customer
f) method used
g) a description, unambiguous identification, and if necessary, the
condition of the item
h) date of receipt of the item or date of sampling of the item where
Compliant
critical to the validity and application of the results
i) date(s) of the performance of the laboratory activity
j) date of the issue of the report
k) reference to the sampling plan and sampling method if relevant
to the validity and application of the results
l) statement to the effect that results only relate to the item tested,
calibrated or sampled
m) the results with the units of measurement, where appropriate
n) additions, deviations or exclusions from the method
o) identification of the person authorising the report
p) clear identification when the results are from external providers

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 [Link] Laboratory responsibility
• for all information provided in the report except when provided by
the customer
- customer information to be clearly identified and a disclaimer
Compliant
included when information supplied can affect the
validity of results
• when customer is responsible for sampling, the report is to state
that the results apply to the sample as received (also refer to 7.4.3)

7.8.3 Specific Requirements for Test Reports

[Link] Additional information

• for the interpretation of the test results, in addition to 7.8.2, reports
to include where necessary
a) information on specific test conditions, such as environmental
conditions
b) where relevant, a statement of conformity with requirements or
specifications
c) where applicable, the MU in the same units as the measurand or Compliant
in a term relative to the measurand when
- relevant to the validity or application of the results
- customer’s instruction
- MU affects conformity to a specification limit
d) where appropriate, opinions and interpretations;
e) additional information which may be required by specific
methods, authorities, customers or groups of customers

[Link] Sampling
• when the laboratory is responsible for sampling, test reports shall Compliant
meet the requirements of 7.8.5 where necessary

7.8.4 Specific Requirements for Calibration Certificates

[Link] Additional information

• in addition to 7.8.2, calibration certificates to include
a) the MU of the measurement result presented in the same unit as
that of the measurand or in a term relative to the measurand
b) the conditions under which the calibrations were made that have
an influence on the measurement results
Compliant
c) a statement to indicate how the measurements are
metrologically traceable
d) results before and after any adjustments or repair
e) where relevant, a statement of conformity with requirements or
specifications
f) where appropriate, opinions and interpretation

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 [Link] Sampling
• when the laboratory is responsible for sampling, calibration Compliant
certificates shall meet the requirements of 7.8.5 where necessary

[Link] Calibration certificates or labels

• shall not include any recommendation on calibration intervals, Compliant
unless agreed with the customer

7.8.5 Reporting Sampling - Specific Requirements

7.8.5 Additional information

• when the laboratory is responsible for the sampling, in addition to
7.8.2, reports to include
a) date of sampling
b) unique identification of the item or material sampled
c) location of sampling, including any diagrams, sketches or
Compliant
photographs
d) reference to the sampling plan and sampling method
e) details of any environmental conditions that affect the
interpretation of the results
f) information required to evaluate MU for subsequent testing or
calibration

7.8.6 Reporting Statements of Conformity

[Link] Decision rule

• to be documented and applied, taking into account the associated Compliant
risk, when a statement of conformity is provided to a customer

[Link] Statement of conformity

• includes
a) which results the statement of conformity applies to
b) which specifications, standards or parts thereof are met or not Compliant
met
c) the decision rule applied (unless it is inherent in the requested
specification or standard)

7.8.7 Reporting Opinions and Interpretations

[Link] Authorized personnel

• opinions and interpretations are only made by authorized
Compliant
personnel and the basis upon which they have been made shall be
documented

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 [Link] Based on results
• opinions and interpretations are based on the results obtained and Compliant
clearly identified as such in reports

[Link] Direct verbal communication

• when opinions and interpretations are verbally communicated to Compliant
the client, a record is retained

7.8.8 Amendments to Reports

[Link] Amendments to reports

Compliant
• are clearly identified

[Link] Amendments to reports

• where appropriate, the reason for the change is included in the Compliant
report

[Link] Amendments to reports

• a further report is issued and referenced as amended, is uniquely Compliant
identified and makes reference to the original report it replaces

7.9 Complaints

7.9.1 Documented process

• is available for receiving, evaluating and making decisions on Compliant
complaints

7.9.2 Availability of documented process and responsibility

• is available to any interested party
• when a complaint is received, the laboratory is to confirm whether
Compliant
it relates to laboratory activities it is responsible for and action it
• laboratory is responsible for all decisions relating to complaints
handling

7.9.3 Content of complaints process

a) a description of the process for receiving, validating,
investigating and deciding what actions are to be taken in response
Compliant
to it
b) tracking and recording complaints, including actions taken
c) ensuring that any appropriate action is taken

7.9.4 Gathering and verifying information

Compliant
• the laboratory is responsible in order to validate the complaint

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 7.9.5 Acknowledging receipt
• whenever possible, the laboratory does this and provides the Compliant
complainant with progress reports and the outcome

7.9.6 Communication of outcomes

• to be made by, or reviewed and approved by, an individual(s) not Compliant
involved in the original laboratory activities in question.

7.9.7 Formal notice of end of complaint

Compliant
• whenever possible, the laboratory to advise the complainant

7.10 Nonconforming Work

7.10.1 Procedure
• is available and implemented when any aspect of the laboratories
activities does not conform to its own procedures or the agreed
requirements of the customer
a) defines the responsibilities and authorizations for the
management of non-conforming work
b) actions are based upon the risk levels established by the
Compliant
laboratory
c) an evaluation is made of the significance of the non-conforming
work, including an impact analysis on previous results
d) a decision is taken on the acceptability of the non-conforming
work
e) where necessary, the client is notified and work is recalled
f) defines the responsibility for authorizing the resumption of work

7.10.2 Records
Compliant
• are retained of non-conforming work and the actions taken

7.10.3 Implementation of corrective action

• shall be taken when the non-conforming work could recur, or there
Compliant
is doubt with the laboratory’s operations with its own management
system

7.11 Control Of Data and Information Management

7.11.1 Access to data and information

• data and information needed to perform laboratory activities is Compliant
available

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 7.11.2 Laboratory information management system
• the system for collecting, processing, recording, reporting, storing
and retrieving data is validated, including interfacing with other
Compliant
laboratory systems before being used
• changes to the system are authorized, documented and validated
before used

7.11.3 Protection, safeguard and maintenance

• the information system
a) is protected from unauthorized access
b) is safeguarded against tampering and loss
c) is operated in an environment that complies with supplier or
laboratory specifications or, for non-computerised systems,
Compliant
provides conditions which safeguard the accuracy of manual
recording and transcription
d) is maintained in a manner which ensures the integrity of the data
and information
e) includes the recording of system failures and the appropriate
immediate and corrective actions

7.11.4 Off-site systems

• laboratory ensures that the provider or operator complies with all Compliant
applicable requirements of the Standard

7.11.5 Instructions, manuals and reference data

Compliant
• are readily available to personnel

7.11.6 Calculations and data transfers

Compliant
• are checked in an appropriate and systematic manner

8. Management System Requirements

8.1 Options

8.1.1 Management system

• supports and demonstrates the consistent achievement of the
requirements of the Standard
Compliant
• assures the quality of the laboratory results
• allows the requirements of clauses 4 to 7 to be met
• is in accordance with either Option A or Option B

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 8.1.2 OPTION A, As a minimum, the laboratory management system
shall address the clauses 8.2 to 8.9

8.1.3 OPTION B, Laboratory that has established and maintains a

management system, in accordance with the requirements of ISO Option B
9001:2015 and that is capable of supporting and demonstrating the
consistent fulfillment of the requirements of clauses 4 to 7, also
fulfills at least the intent of the management system requirements
specified in clauses 8.2 to 8.9

If Option B, the following documentation is required

1) evidence the management system is certified by a certification

body, or by another signatory to the International Accreditation
Forum (IAF) Multilateral Recognition Agreement (MLA).
2) evidence that the certification body's accreditation covers
ISO/IEC 17021-3 i.e. the certification body can certify management
systems to ISO 9001:2015.
3) copies of the most recent certification audit report(s) issued by
the certification body covering the laboratory’s management Docs Available
system in full.
4) confirmation from the certification body of the closeout of any
non-conformities raised during certification audits.
5) evidence the certification of the management system covers the
laboratory activities covered by its scope of accreditation.
6) supports the facility fulfilling consistently the requirements of
ISO/IEC 17025:2017 to assure the quality of results.

— Notes

We are at an advantage because we already are certified for ISO 9001. It was during our efforts to get
certified for 9001 did we discover the auditing app.

8.2 Management System Documentation

8.2.1 Policies and objectives

• are established, documented for the fulfillment of the Standard Compliant
• are acknowledged and implemented at all levels of the laboratory

8.2.2 Competence, impartiality consistent operations

Compliant
• are addressed by the polices and objectives

8.2.3 Laboratory management

• provides evidence of commitment to the development of the
Compliant
management system
• continually improves the management system’s effectiveness

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 8.2.4 Reference to the management system
Compliant
• of all documentation, processes, systems and records

8.2.5 Access to parts of the management system

Compliant
• is available to personnel

8.3 Control of Management System Documents

8.3.1 Control of documents

• both internal and external documents relating to the fulfillment of Compliant
the requirements of the Standard

8.3.2 Document control process

a) documents are approved by authorized personnel prior to issue
b) documents are periodically reviewed and updated as necessary
c) changes and current revision status of documents are identified
Compliant
d) relevant versions of documents are available and their
distribution controlled as necessary
e) documents are uniquely identified
f) unintended use of obsolete documents is prevented

8.4 Control of Records

8.4.1 Records retention

Compliant
• to demonstrate fulfillment of the requirements of the Standard

8.4.2 Controls
• are implemented for
- identification
- storage
- protection
- back-up
- archive
Compliant
- retrieval
- retention times
- disposal
• are established for
- retention periods to satisfy contractual obligations
- confidentiality commitments
- access and availability

8.5 Actions to Address Risks and Opportunities

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 8.5.1 Risks and opportunities are considered
a) to assure the management system achieves its intended goals
b) to achieve the laboratory objectives Compliant
c) to prevent (or minimize) undesired impacts and potential failures
d) to achieve improvement

8.5.2 Plan
a) actions to address risks and opportunities
b) how to Compliant
- implement actions into the management system
- evaluate the effectiveness of actions

8.5.3 Actions to address risks and opportunities

• are proportional to the potential impact on the validity of the Compliant
laboratory results

8.7 Corrective Actions

8.7.1 Nonconformities
• when occur, the laboratory shall
a) react and, as applicable, take action, correct the issue and
address the consequences
b) evaluate the need for action to eliminate the cause so that it does
Compliant
not recur
c) implement any action necessary
d) review the effectiveness of any corrective action
e) update any risk and opportunities
f) makes any necessary changes to the management system

8.7.2 Corrective action taken

Compliant
• is appropriate to the effects of the nonconformity

8.7.3 Records retained

a) of the nature of the nonconformity, cause(s) and any action(s)
Compliant
taken
b) of the outcomes of corrective action

8.8 Internal Audits

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 8.8.1 Conducted at planned intervals
• to establish whether the management system
a) conforms to
- the laboratory’s requirements, including laboratory activities Compliant
- the requirements of the Standard
b) is effectively implemented and
maintained

8.8.2 Audit requirements

a) is planned and implemented, including frequency, defined
responsibilities and reporting, taking into account
- the importance of the laboratory activities concerned
- changes affecting the laboratory
Compliant
- the results of previous audits
b) audit criteria and the scope of each audit are defined
c) audit results are reported to relevant management
d) corrective actions, where necessary, are implemented promptly
e) records of the audit program, including outcomes, are retained

8.9 Management Reviews

8.9.1 Review of management system

• is conducted at planned intervals by laboratory management to
ensure
- continued suitability, adequacy and effectiveness Compliant
- covers the stated policies and
objectives related to the fulfilment of the
Standard

8.9.2 Records of inputs

• including information related to
a) changes in internal and external issues
b) fulfillment of objectives
c) suitability of policies and procedures
d) status of actions from previous reviews e) outcomes of recent
internal audits
f) corrective actions
Compliant
g) assessment by external bodies
h) changes in volume, type and range of laboratory activities
i) customer and personnel feedback j) complaints
k) effectiveness of any implemented improvements
l) adequacy of resources
m) results of risk identification
n) outcomes of the assurance of validity of results
o) any other relevant factors

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 8.9.3 Records of outputs
• include all decisions and actions relating to
a) effectiveness of the management system
Compliant
b) improvement of the laboratory activities relating to satisfying the
requirements of the Standard
c) provision of required resources d) any need for change(s)

Completion

Comments/Recommendations

We caught an issue with temperature control and monitoring and we are committed to fixing the issue
within this week. We are continuously monitoring our lab activities and we’re using the analyzed data
collected to improve the competency of our lab and staff. We are almost ready for our third-party audit
but until we fix the stability of temperature control, we will not be able to proceed.

Conducted by: Name and Signature

Deirdre York, MHA

7th Aug, 2019 2:19 PM +08

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