ISO 17025-Training PPT.pdf

AWRENESS TRAINING
ISO 17025: 2017
Saikiran Koyalkar
Saikiran.koyalkar89@gmail.com

WHAT ISTHE IMPORTANCETO FOLLOWING
STANDARD REGULATIONS?
Saikiran.Koyalkar89@gmail.com

HISTORY

THALIDOMIDETRAGEDY

•Thalidomide it is anticancer drug and it is used mainly as
a treatment of certain cancers.
•Thalidomide was first marketed in 1957 in West Germany
under the trade-name Contergan
•It is also having the side effect of anti allergic nature and
due to lack of awareness and control it was used
against nausea (vomiting sensation ) and morning
sickness in pregnant women

•It caused between 5,000 and 7,000 infants were born
with phocomelia (malformation of the limbs). Only 40%
of these children survived throughout the world,
•About 10,000 cases were reported of infants with
phocomelia due to thalidomide.

.

WHY IT WAS HAPPENED ?

FRAUD
• One of the labs that went under such an investigation made
headline news.
• The name of the Lab was Industrial Bio Test. This was a big
lab that ran tests for big companies such as Procter and Gamble.
• It was discovered that mice that they had used to test cosmetics
such as lotion and deodorants had developed cancer and died.
• Industrial Bio Test lab threw the dead mice and covered results
deeming the products good for human consumption.

• Those involved in production, distribution and sales for the lab -
served jail time.

WHY IT WASHAPPENED ?

MALNUTRITION

QUALITY AND SAFETY OF PRODUCTS

WHY IT IS HAPPENING ?

• No standard practices
• Lack of awareness of consequences of human health
• Poor Manufacturing practices
• No Monitoring bodies for compliance to standard or regulatory requirements
• Non compliance to regulatory requirements / standards

WHO ISTHE SUFFERE ?

CONSUMER

TO AVIOD MALPRACTICES IN THE FOOD AND
PHARMACEUTICAL INDUSTRIES DIFFERENT
REGULATORY AUTHORITIES CAME IN TO PICTURE
SUCH AS:
1) USFDA ( UNITED STATES FOOD AND DRUG ADMINITRATION)
2) ICH (INTERNATIONAL CONFERENCE ON HORMINIZATION)
3) ISO ( INTERNATIONAL ORGANIZATION FOR STANDARDIZATION)
4) MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORYAGENCY) - UK
5)EMEA ( EUROPEAN MEDICINES AGENCY) – Europe, middle east and Africa
6) CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION) - India
ETC….

• ILAC (International Laboratory Accreditation Cooperation)
• APLAC ( Asian Pacific Laboratory Accreditation Cooperation)
• NABL ( National Accreditation Board for Testing and Calibration Laboratories)
• DCGI ( Drug control General of India)
• EIC ( Export inspection council)
• BIS ( Bureau of Indian Standards)
• FSSAI ( Food safety standards authority of India)
• Ayush
• Agmark
• APEDA ( Agriculture process food export development authority )
• Notifying Bodies
• Certification Bodies
• Etc...

WHAT IS ROLE OF LABORATORIES?

ISO - International Organization for Standardization
• Founded on 23 February 1947
• Headquartered in Geneva, Switzerland
• ISO has published 22046 International standards and related documents,
covering almost every industry, from technology, to food safety, to agriculture
and healthcare.

WHAT IS ISO 17025

GENERAL REQUIREMENTS FOR COMPETENCY OF
TESTING AND CALIBRATION LABORATORIES
First Edition : ISO 17025: 1999
Second edition: ISO 17025: 2005
Third Edition : ISO 17025: 2017

ISO 17025 : 2017
Clauses
• 1) Scope
• 2) Normative references
• 3) Terms and definitions
• 4) General – Impartiality , confidentiality
• 5) Structural requirements

Clause 6.0 Resource requirements
(Sub clauses 6.1 to 6.6)
6.1 General
6.2 personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 metrological Traceability
6.6 Externally provided products and services

Clause 7.0 Process requirements
Sub clauses 7.1 to 7.11
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Assuring the validity of results

7.8 Reporting of results
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data , Information management

Clause 8.0 Management system requirements
Sub clauses 8.1 to 8.9
8.1 Options
8.2 Management system documentation
8.3 Control of management system documents
8.4 Control of records
8.5 Actions to address risk and opportunities
8.6 Improvement
8.7 Corrective action

8.8 Internal audits
8.9 Management review

Clause 4.0
General

4.1 Impartiality
Conflict (Influence of external factor on Employees)
Without knowing the management for personal benefits – Malpractices.
• Accepting Gifts
• Accepting money
• Any other offers
to support malpractices
• Note: Each employee is liable to HR Policies and Procedures

• Impartiality of its laboratory activities and shall not allow
commercial, financial or other pressures to compromise
impartiality.
• Identify risks to its impartiality on an on-going basis and
eliminate and or minimize the risk

If conflict of interest identifies ?

• NECESSARY ACTION:

What is conflict of interest ?

4.2 CONFIDENTIALITY
Ensure the confidentiality of its customer’s information and
proprietary rights, including procedures for protecting the
electronic storage and transmission of results.
Use of customer confidential information only when it is
requested by law or it is necessary for any legal obligations.

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

Why Confidentiality is very important ?

Can we reveal other customer information to other customer who is in
visit ?

Case Study :1
Customer visiting the chemical lab, while we are offering to wear the Lab coat
customer said its ok not required , what would be your further action ?

Case study : 2
Customer during the visit he is asking other customer information such as what
are the samples your are receiving for testing, how many products failed, what is
the parameter is failing frequently. What would be the further action on this ?

Case study : 3
While taking the customer feedback, Customer Saying that you are not
providing the quality of results everytime, you are failing my samples every
time, how can you handle the situation ?

5.0 Structural Requirements

•Legal Identity (Eg: Registration under company act )
• Identify management that has overall responsibility for the
laboratory.
• Define and document range of laboratory activities.
• permanent and / or mobile facilities
• Carry out its testing in such a way as to meet the requirements
ISO 17025: 2017 standard and to satisfy the needs of the
customer, the regulatory authorities or recognition bodies

• Organization chart
• Document its procedures to ensure the consistent application
of its laboratory activities and the validity of the results

• Define responsibilities, authorities provide resources to carry out laboratory
activities.
Eg:
• Role of Quality Manager
• Role of Technical Manager
• Role of Technical and Non Technical Staff
• Role of Top Management/Decision Makers
• Appropriate communication processes are established eg: emails,
telecommunication, discussions for effective implementation of Quality systems

• The integrity of the management system is maintained when
changes to the management system are planned and
implemented.
• QMS & laboratory activities should be system dependent not
person dependent

Questionnaires
•If organization not defined the organization structure , what
may happen?

• If responsibilities, authorities not defined and not provided
resources the resources to perform laboratory activities what
may happen ?

6.0 Resource requirements

• 6.1 General –
The laboratory shall have available the
personnel, facilities, equipment, systems
and support services necessary to manage
and perform its laboratory activities
6.2 personal:
• Education qualification, training
• Experience and demonstration skills
• Supervision of contract employee/ New Joinees
• Job Responsibilities
• Maintenance of Training records is each
individual employee
Employee
Education
.
Experiene
Trained

TRAININGS
• Induction training
• Training needs identification
• Training schedule
• Training evaluation
• Analyst Qualification
• Analyst authorization
• Allotment of samples for analysis

• Authorization for specific tasks
a) Development, modification, verification and validation of methods;
b) Analysis of results, including statements of conformity or opinions and
interpretations;
c) Report, review and authorization of results.
Etc...

Retention of records
a) determining the competence requirements
b) selection of personnel
c) training of personnel
d) supervision of personnel
e) authorization of personnel
f) monitoring competence of personnel

What are the minimum requirements for an employee to perform specific tasks ?

Maintenance and updation of training records is the responsibility of ___?
1) HOD
2) Supervisor
3) QA
4) Concern employee

What is the importance of supervision of contract employee/ new joinees ?

Case study: 1
If new employee joined in the organization as analyst , what is the
procedure to allot the samples for analysis independently ?

Case study : 2
• If new employee joined and he is having more than 4 years of experience in
the same filed , how to authorize the employee to perform the independent
sample analysis.

6.3 Accommodation and Environmental conditions
• Facilities of laboratory (lighting, Energy,
Environmental conditions etc..)
• Monitoring the Environmental conditions and recording
• Authorized access to the laboratory areas
• Separation of incompatible activities
• Specific areas for specific testing activities
• Good house keeping practices

If chemical lab and Microbiology labs are not separated what may happen?

If there is no access controls what may happen ?

Why housekeeping is very important in the lab ?

Case study :1
While performing the test, temperature observed as 35⁰c but as per the method
requirement testing has to be done between 20 -25 ⁰C, what is your action in this
conditions ?

Case study : 2
Chemical testing area and biological testing areas are not separated , what are
the consequences may happen ?

Case study – 3
Customer requested aflatoxin analysis, As aflatoxins are light sensitive how to
prepare the samples and standards ?

Case study – 4
One day house keeping staff not attended the office , How to handle the situation ?

Case study : 5
During the monitoring of room temperature and humidity , it was observed that
Thermohygrometer is not working , What would be the further action ?

6.4 Equipment:
• Access to the sampling, measurement and test equipment for performing the
testing .
• Capable of achieving the accuracy required and comply with specifications
• Equipment Identification, make, model, serial no., Manuals, instructions ,
• Location and IQ,OQ,PQ documents ,
• calibration &Intermediate check schedule, maintenance plan
• Equipment out of control–Not in use label or status label

• Retention of Records
a) The identity of equipment, including software and firmware version;
b) The manufacturer's name, type identification, and serial number or other unique
identification;
c) Evidence of verification that equipment conforms with specified requirements;
d) The current location;
e) Calibration dates, results of calibrations, adjustments, acceptance criteria, and the
due date of the next calibration or the calibration interval;
f) Documentation of reference materials, results, acceptance criteria, relevant dates and
the period of validity;
g) The maintenance plan and maintenance carried out to date, where relevant to the
performance of the equipment;
h) Details of any damage, malfunction, modification to, or repair of, the equipment.

If equipment out of calibration or under maintenance , how to handle it ?

What is the importance of calibration of equipment's ?

What is intermediate checks ?

Case study : 1
In between analysis instrument stopped working, what would be the further
action on this ?

Case study :2
Instrument calibration due on 21 Feb 2018, but analysis has been performed on
22 Feb 2018 without calibration of equipment , what would be the further action
on this ?

Case study: 3
New instrument received in the laboratory, IQ, OQ, PQ is completed , Do we
need to calibrate the instrument after PQ ?

Case study: 4
Ms. Suma & Mr. Raghu are authorized to perform the Instrument, but Mr.
Raghu forgot the Login ID and password of instrument , Raghu used the Suma
user ID and Password in his absence and analysed the samples , what would be
the further action on this ?

6.5Measurement traceability:
• Unbroken chain of comparison going back to the highest
standards
Reference standards and Reference material
•Where traceability to SI units is not possible , traceability to
certified reference materials/ internal reference material as
technically and economically practicable provided by competent
producer
•results of reference measurement procedures, specified methods
or consensus standards that are clearly described and accepted
as providing measurement results fit for their intended use and
ensured by suitable comparison.

• safe handling, transport, storage and use in order to prevent contamination or
deterioration and to protect their integrity.
• List of Reference standards
• Intermediate check of standards

What is Traceability?

Case study :1
NIST traceable standards of pesticide residues checked for availability , but
those standards are not available with NIST traceability, What to do ?

Is all standards from sigma Aldrich and Merck are NIST traceable ?

6.6 Externally Provided Products and Services
1) Subcontracting
2) Purchasing

Subcontracting
Reasons for subcontracting
•Break down of equipment’s
•Suitability of the selected methods
•Temporary incapability and availability of the subcontract labs
•Overloading of instruments, Expected delay delivery schedules or any other
unforeseen events
• NABL/ ISO 17025 accredited subcontracting labs
• Approval from customer for subcontracting in written
• List of approved subcontracting labs
• Report of subcontracting results with a statement of subcontracted

What are the reasons for subcontracting of tests ?

Subcontracting can be done with any Lab ?

Can we subcontract the test without any customer approval ?

Case Study : 1
Customer requested test parameters protein , pesticide residues and Radio
active agents in the sample , but lab is having the capability of performing
Proteins, Pesticides only, what would the further actions ?

Case study : 2
• Customer Requested the test parameter aflatoxins as per the International
standard method, but laboratory having in house developed and validated
method what would be the further action in this ?

Purchasing services and supplies
• Vendor Evaluation
• Approved vendor list
• Physical verification of purchase material
• Critical consumables list and evaluation
• COA’s, MSDS
• Storage and issuance
• Minimum stock list ( MSL)

Key points for purchase
• Quality
• Quantity
• Time of Delivery
• Price

What are Critical Consumables and what is the importance of
verification before use ?

What are the key Points need to be considered during the purchase ?

Can we purchase the material from the Non-Approved vendor ?

Approved Vendor list will be maintained by ?

• Case Study : 1
Laboratory has raised the Po for the Sodium hydroxide – GR grade with a purity
99.9% , make sigma Aldrich , Quantity 500gm X 10 packs but the vendor has
supplied the Sodium hydroxide – HPLC Grade with a purity 99.2%, make
Emplura, Quantity 100X 2 packs , what would be the action on this ?

Case Study: 2
Every time Vendor providing the materials very late not in agreed timelines and
less Quantity, Poor Quality, what would be the action ?

Case Study : 3
Where specific product required that is available with only one vendor and he is
not approved vendor, what would be the action ?

7.0 Process requirements

7.1 REVIEW OF REQUEST , TENDERS AND CONTRACTS
• Man
• Machine
• Method
• Material
• Covered under scope ?
• New requirement contact Technical Manager / HOD
• Subcontracting requirements
• Holding the samples, Physical verification
• Registration of sample , Distribution of sample for testing
• Acknowledgment
• If Additional test request received from customer in between the analysis – Same review process
as earlier
• Disposal of samples

Routine sample review can be done by ?

What is the process of review for Non-Routine sample test request ?

Case Study -1 :
• Customer Couriered the sample to the lab at 25⁰ C but as per the sample label
it has to be stored at 2⁰C. What is your action in this case ?

Case Study -2:
• Customer Couriered the sample to Laboratory but not provided any test
request form/ letter/ Email ,how to Handle it ?

Case Study -3 :
If sample received on holidays or on out of office hours , how to handled the
samples ?

7.2 Selection, verification and validation of methods
• Methods and procedures includes sampling, handling,
transport, storage and preparation of items to be tested
• Estimation of the measurement uncertainty.
Selection of method:
• which meet the needs of the customer - preferably use of published in
international, regional or national standards
• latest valid edition of a standard methods
• inform the customer if method proposed by the customer is inappropriate or
out of date.

Methods types:
• International, regional or national standards
• Laboratory Developed methods
• Non-standard methods (Journals , publications etc..)
• Laboratory developed method and Non-standard methods - validated
appropriately before use.
• Validation: SANTE, ICH Q2, EMEA, EC 657 Guidelines
• Validation is the confirmation by examination and the provision of objective
evidence that the particular requirements for a specific intended use are
fulfilled.
• Measurement uncertainty
• Control of records– raw data, instrument data

How many types of methods are there ?

Can we use old method which is obsolete/ Invalid ?

Case study: 01
Customer requested Nitrosamines‘ parameter, journal published method
available, can we use the method directly for analysis ?

7.3 Sampling
• sampling plan and procedures
• Sampling procedure availability at the location
• Appropriate statistical methods.
• Upon customer request deviation from the procedure
documentation
•Identification of sampler, procedure, Environmental
Conditions, sampling location –sampling record

Retain the records
a) Reference to the sampling method used;
b) Date and time of sampling;
c) Data to identify and describe the sample (e.g. number, amount, name);
d) Identification of the personnel performing sampling;
e) Identification of the equipment used;
f) Environmental or transport conditions;
g) Diagrams or other equivalent means to identify the sampling location, when
appropriate;
h) Deviations, additions to or exclusions from the sampling method and
sampling plan.

What is sampling ?

Case study :1
During the sampling by sampler customer instructed to take only 10gm of
sample instead of 100gm, what would be the further action on this ?

Case study: 2
Customer requested for sampling of product for microbiological analysis, what
is the procedure for the same ?

7.4 HANDLING OF TEST OR CALIBRATION ITEMS
• Procedures for the transportation, receipt, handling, protection, storage,
retention and/or disposal
• Verification of sample upon receipt
• If test request details not matching product received –
consult with customer.
• Storage facilities to maintain the integrity of samples
• Unique sample registration no. retained throughout the
life sample.
• Retention of samples – records & monitoring records

What is the importance of retention of samples after report release ?

If sample contains microbiology testing and chemical testing parameters
requirement, how will you handle the sample ?

Case Study : 1
Customer provided 10gm of sample and requested lab to return the remaining
quantity of sample after analysis, what is the further procedure ?

7.5 Technical Records
• Technical records contain the results, report and sufficient
information to facilitate, if possible, identification of factors
affecting the measurement result and its associated
measurement uncertainty and enable the repetition of the
laboratory activity under conditions as close as possible to the
original
eg: Raw data, calibration records etc..
• Identity of personnel responsible for each laboratory activity
and for checking data and results.
• Original observations, data and calculations shall be recorded
at the time they are made and shall be identifiable with the
specific task.

7.6 Evaluation of measurement uncertainty
• Identify the factors contributions to measurement uncertainty
including the sampling
• Evaluate the measurement uncertainty for all calibrations of own
equipment.
• Laboratory performing testing shall evaluate measurement
uncertainty. Based on theoretical principles or practical experience
of the performance of the method

• What is an Uncertainty ?

7.7 Ensuring Validity of results
• Defined procedure for monitoring the
validity of results.
• Trend analysis
• statistical techniques for review of
results.

Monitoring Includes :
a) Use of reference materials or quality control materials
b) Use of alternative instrumentation that has been calibrated to provide traceable
results;
c) Functional check(s) of measuring and testing equipment;
d) Use of check or working standards with control charts, where applicable;
e) Intermediate checks on measuring equipment;
f) Replicate tests or calibrations using the same or different methods;
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).
• Participation in PT and ILC’s
• QC chart – statistical trends
• CAPA for outliers

What is the full form of PT , ILC and IQC ?

Mention any five Quality control practices ?

Case study : 1
As per the SOP batch sequence should be after each 10 samples one blank and
spike sample should be analysed but analysis has been performed by injecting
one blank and spike sample for every twenty samples , Is it correct way and
what may happen ?

Case study : 2
As per the NABL requirements PT as to be performed before submitting the
application, But PT’s are not available for the particular scope, what would be the
action on this ?

7.8 REPORTING OF RESULTS
• Accurately,
• Clearly,
• Unambiguously and objectives
Test/ calibration Report must contains minimum following
a) Title
b) Name and address of the laboratory;
C) Location of performance of the laboratory activities,
including when performed at a customer facility or at
sites away from the laboratory’s permanent facilities, or
in associated temporary or mobile facilities;

d) Unique identification that all its components are recognized as a portion of a
complete report and a clear identification of the end;
e) Name and contact information of the customer;
f) Identification of the method used;
g) Description, unambiguous identification, and, when necessary, the condition
of the item;
h) Date of receipt of the test or calibration item(s), and the date of sampling,
where this is critical to the validity and application of the results;

i) Date(s) of performance of the laboratory activity;
j) Date of issue of the report;
k) Reference to the sampling plan and sampling method used by the laboratory
or other bodies where these are relevant to the validity or application of the
results;
l) Statement to the effect that the results relate only to the items tested,
calibrated or sampled;
m) Results with, where appropriate, the units of measurement;
n) Additions to, deviations, or exclusions from the method;
o) Identification of the person(s) authorizing the report;
p) Clear identification when results are from external providers.

• Compliances / Noncompliance statement – where necessary
• Measurement uncertainty – where applicable
• a disclaimer shall be put on the report when the information is supplied by the
customer and can affect the validity of results. Where the laboratory has not
been responsible for the sampling stage (e.g. the sample has been provided by
the customer), it shall state in the report that the results apply to the sample as
received.

Reporting sampling – specific requirements
a) Date of sampling;
b) Unique identification of the item or material sampled
c) Location of sampling, including any diagrams, sketches or photographs;
d) Reference to the sampling plan and sampling method;
e) Details of any environmental conditions during sampling that affect the
interpretation of the results;
f) Information required to evaluate measurement uncertainty for subsequent
testing or calibration.

Reporting statements of conformity
& Decision Rules
When a statement of conformity to a specification or standard is provided, the
laboratory shall document the decision rule employed, taking into account the
level of risk associated with the decision rule employed, and apply the decision
rule.
Report on the statement of conformity, such that the statement clearly identifies:
a) To which results the statement of conformity applies;
b) Which specifications, standards or parts thereof are met or not met;
c) Decision rule applied (unless it is inherent in the requested specification or
standard).

Opinion and Interpretation
• Only personnel authorized for the expression of
opinions and interpretations release the respective
statement based upon obtained results.
• And Document the basis upon which the opinions
and interpretations have been made.
• When opinions and interpretations are directly
communicated by dialogue with the customer, a
record of the dialogue shall be retained.

Subcontracting results
• Clear identification of subcontracted results
NABLAccredited scope:
• Two Separate Reports for accredited parameters
and Non accredited parameters as per NABL 133
Transmission of test report :
Email , Fax and Hardcopy of Test report

• Amendment of test report:
• To only issued test report
• Only done when there is data transfer error , typo error in issued test report
• Supersedes statement to previously issued test report
• Unique identification of amended report

What are the minimum points to be there in the test report

Case study : 1
Report 1234 issued on 20 feb 2018, customer requested us to change the spelling
of sample in the test report and reissue the test report, what would be the further
action ?

Case study – 2
Customer requested to provide the partial reports of one sample as some of the
parameters not meeting the specification limit , what would be the further action
on this ?

Case study : 3
Customer requested to delete one parameter from the test report and release the
report as it is not meeting the specification limit , what would be the further
action on this ?

Case study : 4
Analysis has been done by using the SOP-123 but customer requesting to
mention the International standard method in the report and release ,what would
be the further action on this ?

NABL REQUIREMENTS
• Subcontracting parameter identification in report
• Accredited and non accredited parameter Separate reports
• NABL Approved Authorized signatories
• Use of NABL Symbol
• Refer : NABL 133

7.9 Complaints :
• Dissatisfaction of customer, communicated by any means ( Verbal, telephonic, email,
fax, letter etc..)
• Communication to QA immediately
• Validation of complaint (Genuine and non-Genuine )
• Acknowledgement of Complaints
• Compliant form
• Root cause investigation
• CAPA
• Communication to the customer on CAPA and retesting if required
• Closer of complaint
• Continuous monitoring the CAPA taken for implementation.
• List of all complaint
• Management Review Meeting

Customer complaints can be received by ?
A) Only mail
B) only letter
C) only email
D) only verbal
E) Any other ___________

What is the acknowledgement time of complaint ?

• Case Study : 1
Customer has expressed the dissatisfaction of results through email to sample
registration team , what would be immediate action by sample registration team ?

• Case study : 2
Customer expressed the dissatisfaction of results reported over phone which is
noncompliant to the specification limit, customer insisting to reanalyse the
sample and provide the results within specification limit, what would be the
action on this ?

7.9 NONCONFORMING WORK
• Identification of deviations/ departure from procedure
• Root cause investigation
• Corrective action or preventive action
• Verification for implementation of corrective or Preventive action
• Doubt on implementation - additional Internal audit

Case study : 1
Customer requested aflatoxin analysis by HPLC, same was analysed by using
Mr. Anand – Jr.analyst , during the review it was identified that he is not having
the authorization to handle the HPLC instrument , what would be the action on
this ?

Case study : 2
Analysis has been performed by using expiry mobile phase, what
would be the action on this ?

• Case study: 3
Sodium hydroxide (critical consumable) received at stores and
issued to the department for use and it was used by the department
without verification , results were generated , what would be the
action on the same ?

What is Non-conformance ?

7.11 Control of data , Information management
• Access to the data and information needed to perform laboratory activities.
• Validated LIMS
• LIMS used for collection, processing , recording, reporting , storage and retrieval of data
• LIMS should :
a) be protected from unauthorized access;
b) be safeguarded against tampering and loss;
c) be operated in an environment that complies with provider or laboratory specifications or, in
the case of non-computerized systems, provides conditions which safeguard the accuracy of
manual recording and transcription;
d) be maintained in a manner that ensures the integrity of the data and information;
e) include recording system failures and the appropriate immediate and corrective actions.

• If LIMS is managed by external party laboratory has to ensure in compliance
to ISO 17025:2017 and laboratory QMS
• Instructions, manuals and reference data relevant to the LIMS are made
readily available to personnel.
• Calculations and data transfers shall be checked in an appropriate and
systematic manner

What is LIMS and Why it is important?

Clause 8.0
Management system requirements

8.1 Options
• ISO 9001
• ISO 17025:2017 clause 8.0 to 8.9

4.2 Management system Documentation :
• Establishing Quality Policy
Quality policy is the expression of management for Quality Practices in the
Laboratory
• Establishing Quality Objectives
Quality Objectives is Main method used by companies to focus the goal(s)
from the Quality Policy for improvement
•Management Commitment for improvement and implementation of ISO
17025:2017

• Defining the levels of documents of Quality Systems
Eg:
Level- 1 Quality Manual
Level -2 Quality system procedures
Level- 3 Standard Operating procedures
Level -4 Forms and formats
• Access to the parts of the management system documentation and related
information that are applicable to their responsibilities
Level-1
QUALITY MANUAL
(QM)
Level-2
QUALITY SYTEM
PROCEDURES (QSP'S)
Level- 3
STANDARDOPERATING
PROCEDURES (SOP'S)
Level- 4
FORMS AND FORMATS

8.3 Control of management system documents
• Raise a document initiation/ Revision request
• Author ( Preparer)-
• Reviewer –
• Approver/ authorized –
• Identification no. allotment and controlled by QA
• Distribution to the concern department
• Master List of documents available with QA
• Receiving back invalid documents while issuing the revised document
• Obsolete stamp on invalid document
• Storing (Archival) the obsolete document as per retention procedure
• Disposal – tearing off, burning

• If invalid document found in the department , How will you handle it ?

• If uncontrolled documents/ procedures found in the department , how will you
handle it ?

Is it allowed take the controlled copy documents to home and read ?

Can we take a photo copy of controlled document and use it ?

Case Study : 1
• Laboratory has developed and validated the method for Poly aromatic
hydrocarbons , how can they use this method for the routine samples on
regular basis , what is the procedure ?

• Case study : 2
Customer requested the pesticide residual analysis as per the In house validated
method – SOP , The same SOP is revised on 19 Feb 2018 and Effective date is
on 24 Feb 2018 , can we use this revised SOP on 20 Feb 2018 ?

• 8.4 Control of records
• Identification , access, filling , indexing ,
• retention ,retrieval, disposal of records
• Legibility of documents and records
• Back-up records stored electronically
• Prevent unauthorized access
• On-time recording while performing the activity
• Retention of records as per contractual agreements
• Access to these records shall be consistent with the confidentiality
commitments, and records shall be readily available

Is electronic data backup important ?

How can we correct the mistakes in the records ?

What is the importance of Archiving / Retaining the documents/ records?

8.5 Actions to address risks and opportunities (Option A)
• The laboratory shall consider the risks and opportunities associated with the
laboratory activities in order to:
a) give assurance that the management system achieves its intended results;
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c) prevent, or reduce, undesired impacts and potential failures in the laboratory
activities;
d) achieve improvement.

• Laboratory has to plan
• a) actions to address these risks and opportunities;
• b) how to:
• — integrate and implement these actions into its management system;
• — evaluate the effectiveness of these actions.
• Actions taken on risk α potential impact on the validity of results.

• What is Risk ?

8.6 Improvement
• Review of Quality policy , Quality Objectives
• Customer feed backs & personnel feedbacks
• Complaints
• PT/ ILC
• Etc..
• Management Review meeting

8.7 Corrective action
• Sources : Noncoforming work, Internal audits, External audits, PT ILC
failures etc..
• Identification
• Root cause Investigation
• Actions taken to avoid recurrence of non-conformance
• Implementation of proposed corrective actions
• Doubt on implementation – Additional internal audits

What is Corrective action ?

What is Correction?

8.8 Internal audits
• Internal audit plan
• Audit circular
• Scope of audit
• Trained and Qualified auditors - independent of activity
• Identification of Nonconformity
• CAPA proposal and implementation
• Closure of CAPA
• Verification of CAPA closure
• Doubt on implementation – Additional audits
• Retention of records

Every one can perform the internal audit ?

8.9 Management Review Meeting
• MRM Frequency
• Minutes arising from the previous review meeting
a) changes in internal and external issues that are
relevant to the laboratory;
b) fulfilment of objectives;
c) suitability of policies and procedures;
d) status of actions from previous management
reviews;
e) outcome of recent internal audits;
f) corrective actions;

g) assessments by external bodies;
h) changes in the volume and type of the work or in the 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 the validity of results; and
o) other relevant factors, such as monitoring activities and training.

• Minutes of Meeting which includes
a) Effectiveness of the management system and its processes;
b) Improvement of the laboratory activities related to the fulfilment of the
requirements of ISO 17025:2017.
c) Provision of required resources;
d) Any need for change.

Explain minimum five agenda points of MRM ?

THANK YOU

ISO 17025-Training PPT.pdf

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