PROCESS REQUIREMENTS

1
1. Review of requests, tenders and contracts

◎ The laboratory shall have a procedure for the review of requests,

tenders and contracts.
○ The requirements are adequately defined, documented and
understood;
○ The laboratory has the capability and resources to meet the
requirements;
○ Where external providers are used, gain the customers approval;
○ Appropriate method and procedure are selected to meet the
customers requirements
○ When the customer requests a statement of conformity to a
specification or standards for the test or calibration, the decision
rule shall be clearly defined.
3
2. Selection verification of methods

◎ The laboratory shall use appropriate methods and procedures

for all laboratory activities.
◎ All methods, procedures and supporting documents such as WDI,
SoP, Standards, Manuals and reference data relevant to the
laboratory activities shall be kept up to date and shall be made
readily available to the personnel.
◎ When the customer does not specify the method to be used, the
laboratory shall select the appropriate method and inform the
customer of the method chosen.

4
3. Validation of methods

◎ The laboratory shall validate non-standard methods, laboratory –

developed methods and standard method used outside their
intended use.
○ Technique validation
○ Performance characteristics
◎ The laboratory shall retain the following records of validation
○ The validation procedure
○ Specifications of the requirements
○ Determination of the performance characteristics of the
method
○ Result obtained
○ Statement on the validity on the method 5
4. Sampling
◎ The laboratory shall have a sampling plan and method when it
carries out sampling of substances, materials or products for
subsequent testing or calibration.
◎ The sampling method shall address the factors to be controlled to
ensure the validity of subsequent testing and calibration.
◎ The laboratory shall retain records of sampling data;
○ Reference to sampling method used
○ Date and time of sampling
○ Data to identify and describe the sample
○ Identification of personnel performing the sample
○ Identification of equipment used
○ Environmental or transport conditions
○ Identify the sampling location
○ Deviations from sampling method or sampling plan 6
5. Handling of test or calibration items
◎ The laboratory shall have a procedure for the transportation,
receipt, handling, protection, storage, retention, and disposal or
return of test of calibration items.
◎ Precautions shall be taken to avoid deterioration, contamination,
loss or damage to the item during handling, transportation,
storing/ waiting and preparation for testing or calibration.
◎ The laboratory shall have a system for the unambiguous
identification of the test or calibration items.
◎ Upon receipt of the test or calibration item, deviations from the
specified conditions shall be recorded.
◎ When items need to be stored or controlled under specified
conditions, the se conditions shall be maintained, monitored and
recorded. 7
6. Technical records
Data
◎ Technical records shall include
the date and the identity of
personnel responsible for each
laboratory activity and for
checking data and results. Records
◎ The laboratory shall ensure that
the amendments to the technical
records can be tracked to
previous versions or to original
observations.
Documents
8
7. Evaluation of measurement uncertainty

◎ Laboratories shall identify the contributions to measurement

uncertainty.
◎ Uncertainty Calculations
○ Type A Evaluation: is evaluated using statistical means.
○ Type B Evaluation: is evaluated using other than statistical
means.
◎ Standard Uncertainty
◎ Combined Uncertainty
◎ Expanded Uncertainty

9
8. Ensuring the validity of the result

◎ The laboratory shall have a procedure for monitoring the validity of

results. It shall include;
○ Quality control materials
○ Use of traceable instrumentation
○ Use of working standard and charts, where applicable
○ Intermediate checks on measuring equipment
○ Replicate tests or calibration using different methods
○ Retesting or recalibration of retained items
○ Correlation of results for different characteristics of an item
○ Review of reported results
○ Intralaboratory comparison
○ Testing of blind samples
10
9. Reporting of results

◎ The results shall be reviewed and authorized prior to release

◎ The results shall be provided accurately, clearly, unambiguously
and objectively.
◎ The laboratory shall be responsible for all the information
provided in the report, except when information is provided by
the customer.
◎ Where the laboratory has not been responsible for the sampling
stage, it shall state in the report that the results apply to the
samples as received.

11
 10. Requirements of reports
◎ Title (test/ calibration report/
certificate)
◎ The name and address of the
laboratory
◎ The location of activity
◎ ULR number and clear indication of
the end of report
◎ The name and contact information
of the customer
◎ Identification of the method used
◎ Condition of the item on receipt
◎ Date of receipt of item
◎ Dates of performance of the
laboratory activity
◎ The date of issue of report
◎ The results with unit of
measurement
◎ Authorizing signatory with stamp
◎ Environmental conditions
◎ Statement of conformity with
specified requirements
◎ Measurement uncertainty
◎ Traceable information
◎ Calibration interval 12
11. Statement of conformity

◎ When a statement of conformity to a specification or standard is

provided, the laboratory shall document the decision rule
employed taking into account of level of risk.
◎ It shall also report;
○ To which result the statement of conformity applies
○ Which specification, standard or parts thereof are met
○ The decision rule applied

13
12. Complaints

◎ The laboratory shall have a documented process to receive,

evaluate and make decisions on complaints.
◎ A description of the handling process for complaints shall be
available to any interested party on request.
◎ The laboratory shall acknowledge receipt of the complaint, and
provide the complainant with progress reports and the outcome.
◎ The outcomes to be communicated to the complainant shall be
made by, or reviewed and approved by, individuals not involved
in the original laboratory activities in question.
◎ Whenever possible, the laboratory shall give formal notice to the
end of the complaint handling to the complainant.
14
13. Control of data and information management

◎ The laboratory shall have access to the data and information

needed to perform laboratory activities.
◎ The laboratory information management system used for the
collection, processing, recording, reporting, storage or retrieval of
data shall be validated for functionality.
◎ The Laboratory information management system shall;
○ Be protected from un-authorized access;
○ Be safeguarded against tampering and loss;
○ Be maintained in a manner that ensures integrity of the data
and information;
15
MANAGEMENT SYSTEM
REQUIREMENTS

16
1. Management System requirements

◎ Laboratory shall establish, document, implement and maintain a

management system that is capable of supporting and
demonstrating the consistent achievement of the requirements
of this document and assuring the quality of the laboratory
results.
◎ In addition to meeting the requirements of clauses 4 to 7, the
laboratory shall implement a management system in accordance
with option A or Option B.

17
2. Option A

◎ As a minimum, the management system of the laboratory shall

address the following;
○ Management system documentation
○ Control of management system documents
○ Control of records
○ Actions to address risks and opportunities
○ Improvement
○ Corrective action
○ Internal audits
○ Management reviews

18
3. Option B

◎ Laboratory that has established and maintains a management

system, in accordance with the requirements of ISO 9001, and is
capable of supporting and demonstrating the consistent
fulfilment of the requirements of clause 4 to 7, also fulfils at least
the intent of the management system requirements as per option
A.
◎ In case the laboratory is accredited in accordance with ISO
9001:2015 then clause 8 is exempted.

19
4. Management system documentation

◎ Laboratory management shall establish, document, and

maintain policies and objectives for the fulfilment of the
purposes of this document.
◎ Laboratory shall ensure that the policies and objectives are
acknowledged and implemented at all levels of the laboratory
organization.
◎ The policies and objectives shall address the competence,
impartiality and consistent operation of the laboratory.
◎ All personnel involved in laboratory activities shall have access to
the parts of the management system documentation and related
information that are applicable to their responsibilities.
20
5. Control of management system documents (Option A)
◎ The laboratory shall control the documents ( internal and
external) that relate to the fulfilment of this document.
◎ The laboratory shall ensure that;
○ Documents are approved for adequacy prior to issue by
authorized personnel.
○ Documents are periodically reviewed, and updated as
necessary;
○ Changes and the current version status of documents are
identified;
○ Relevant versions of applicable documents are available at
points of use and, where necessary, their distribution is
controlled;
○ Documents are uniquely identified and obsolete documents
are prevented from use. 21
6. Control of records (Option A)

◎ The laboratory shall establish and retain legible records to

demonstrate fulfilment of the requirements in the standard.
◎ The laboratory shall implement the controls needed for the;
○ Identification,
○ Storage,
○ Protection,
○ Back-up,
○ Archive,
○ Retrieval,
○ Retention time,
○ Disposal of its records.
22
7. Improvement (Option A)

◎ The laboratory shall identify and select opportunities for

improvement and implement any necessary action.
◎ The laboratory shall seek feedback, both positive and negative
from its customer.
◎ The feedback shall be analysed and used to improve the
management system, laboratory activities and customer service.

23
8. Corrective action (Option A)

◎ When a nonconformity occurs, the laboratory shall;

○ React to the nonconformity and, as applicable take action to

control and correct it. Address the consequences;
○ Evaluate the need for action to eliminate the causes of the
nonconformity, in order that it does not recur or occur
elsewhere by reviewing and analysing the nonconformity;
determining the cause; implement any action needed;
○ Review the effectiveness of corrective action taken;
○ Make changes in the management system, if necessary;

The laboratories shall retain record for corrective action. 24

9. Internal Audit
◎ Laboratory shall conduct internal audit at planned intervals to
provide information on whether the management system;
○ Conforms to the laboratory's own requirements for its
management system, including the laboratory activities;
○ The requirements of this standard
○ If effectively implemented and maintained.
◎ Laboratory shall:
○ Plan, establish, implement and maintain an audit
programme frequency, methods, responsibilities, planning
requirements, reporting, changes affecting the laboratory
and the results of previous audit
◎ Implement appropriate corrective action and retain record as an
evidence 25
10. Management Review (Option A)

◎ The laboratory shall review its management system at planned

intervals, in order to ensure its continuing suitability, adequacy
and effectiveness, including the stated policies and objectives
related to the fulfilment of this standard.

The inputs to management review shall be recorded and

shall include information related to the following:
○ 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;
26
The inputs to management review shall be recorded and
shall include information related to the following:
○ 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.
27
The outputs from the management review shall record all
decisions and actions related to at least:

◎ a) the effectiveness of the management system and its processes;

◎ b) improvement of the laboratory activities related to the
fulfilment of the requirements of this document;
◎ c) provision of required resources;
◎ d) any need for change.

28
Thanks!
Any questions?

29