A simple way to understand

and practice the clauses

covered by ISO 17025:2005
I have been a part of an accredited laboratory for 10 years now and have successfully
faced more than 12 audits based on the ISO 17025 standard. In the early days I used to
think that the ISO standard is a complete waste of time and nothing but unnecessary
paperwork burdening the scientists and other team members in the lab, keeping them
away from the more important things.
But over the years Ive come to realise that in essence the standard provides a
comprehensive framework covering all the critical activities that must be carried out in a
systematic manner to run the laboratory and keep our customers happy.
The ISO 17025 standard is the outcome of the joint effort and combined knowledge and
wisdom of experts from all over the world, laying down the framework for successfully
meeting the customers requirement by the laboratory.
Im sure if you even tried reading the standard, let alone tried to memorise the clauses, it
can seem very dry, boring and somewhat overwhelming. To overcome this problem, I
have decided to present the clauses of the standard in the logical sequence making it
more fun and simpler to understand .Now I feel that it is more important that you
understand the logical flow in which the clauses have been presented in the standard
and put them in practice in your daily practice.
You might say that one doesnt need to remember all the clauses, and that one can
always refer back to the standard when there is a need. On the other hand if you can
identify the benefits that you can reap by adhereing to and practising the standard in
your laboratory you will over a period of time have the clauses on your fingertips without
the need for memorizing. It is more important to acquire the long term gains that will
come your way in earning respect of clients and acceptance of your analysis reports
anywhere in the world. In this topic I have made your task easy by simply presenting the
benefits of each clause of the standard in a logical succession without going into the
technicalities so that you can visualise the benefits from day one.
So now lets get started!
ISO 17025 is the first internationally accepted standard for laboratory quality systems
that provides a basis for accreditation .It comprises of two sub-sections of clauses
,namely Management requirements and technical requirements.

ISO 17025

Here is how the sequence flows.Visualise that you are going to set up a laboratory. The
objective is to provide analysis and contract service to your customers to their
satisfaction.To efficiently run the laboratory you will have to have a management team as
well as technical facilities.ISO 17025 precisely addresses the roles and responsibilities
of management as well as technical requirements..

Management Requirements

Management Requirements

Clause 4.1-Organization- your laboratory has its own identity

Before anything else there has to be an organisation and so the legal identity, type of
organisation and the scope of activities of the organisation are addressed in this clause.
Clause 4.2-Management system- Quality Policy manual

Once you have an organisation, you need a management system based on quality
objectives of the laboratory. Documents and their adherence in right earnestness is the
essence of clause 4.2.
Clause 4.3-Document Control- review and approval
To create the management system and implement it the first and foremost thing is need
to properly document the system and the procedures. Clause 4.3 covers document
control, issuance of document and changes to the documents.
Clause 4.4-Review of requests,tenders and contracts-accept challenges ahead
Now that the organisation management system and basic documentation are in place ,
you are all set to review requests, tenders and contracts under the clause 4.4.
Clause 4.5-Subcontracting of tests and calibrations-outsource if you need to
While reviewing the request tenders and contract that might arise you may need to
outsource or sub contract some of the test parameters. The task should be outsourced
only with clients consent to another accredited laboratory
Clause 4.6-Purchasing ,Services and supplies-Quality of inputs decides the
outputs
Now that you have reviewed the requests and contracts the laboratory is all set to start
working, but to work quickly to have supplies like chemicals glassware and services like
calibration seek approval of Quality Assurance Manager before releasing the orders.
Clause 4.7-Service to the customer-Customer feedback always matters
Now the contract is in place, materials are there in the lab and it is time to give the best
service to the customer. Maintain friendly customer relations through good
communication, timely execution of analysis, maintaining confidentiality and seeking
regular feedback.
Clause 4.8-Complaints-satisfied customer is you free of cost advertiser
While serving the customer there are bound to be complaints which must be addressed
and investigated properly and also the corrective action must be taken promptly.
Providing solutions will also enrich your experience.
4.9-Control of nonconforming testing and/ or calibration work-Keep options open
for fair investigations
As such there will always be complaints. There is also a possibility of other
nonconforming work being carried out by the laboratory. Thus it is important to control

nonconforming testing and calibration and procedures and policies to handle

nonconforming work. Powers should be delegated to manage such situations.
Clause 4.10-Improvements- sky is the limit for improvements
Complaints are a great way to identify potential areas for improvement.ICreate specialist
teams for identification and monitoring of improvement plans.
Clause 4.11-Corrective Action-always keep an open mind
Now that subsequent to a complaint immediate action has been taken on the
nonconforming work, it is critical to carry out the required correction, root cause analysis
and corrective actions. It is important to prevent the same mistakes from occurring again
in the future.
Clause 4.12-Preventive Action-Prevention is better than cure
A proactive approach based on feedbacks, quality checks, trend analysis, etc to prevent
complaints and customer dissatisfaction from occurring. Policies and procedures should
be in place to identify potential causes for nonconformity and solving them before the
nonconformity occurs.
Clause 4.13 Control of Records-records preserve the sequence of activities
All the activities relating to, purchase, service to the customer, complaints, improvement
and corrective and preventive action, audit reports,etc will generate a lot of documents.
There is a pressing requirement for policies and procedures pertaining to control of
records.
Clause 4.14 Internal audit- self inspection always pays
All these records generated and different activities carried out in the laboratory must be
periodically audited internally to ensure that the systems are being followed. To achieve
these goals policy and procedures need to be defined for carrying out internal audits.
Clause 4.15-Management Review-Involve your management in upkeep of quality
systems
Top-down and bottom-up communication in the organisation is the key to success. It is
important to discuss any new requirements, audit findings ,etc with the top management
in an open and interactive forum.
And with this we come to the end of the management requirement of ISO 17025 covered
under clauses 4.1 to 4.15.

Technical Requirements

Technical Requirements

Now that the management system is in place. The second, and perhaps even more
important part is the technical requirements.
Clause 5.1- General- workout the skills requiremets of your manpower in advance
The clause talks about the technical requirements in general, stating the different
headings under which the technical requirements are covered and emphasising that
these factors contribute to the total uncertainty of measurement and must be considered
as important factors while developing methods procedure, training, qualification of
personnel and in the selection and calibration of equipment.
Clause 5.2-Personnel- regular updation of technical skills is a must
The first and foremost technical component of any laboratory is the technical staff, so 5.2
starts by talking about the requirements related to personnel. The personnel must be

suitably qualified and trained. The laboratory must have a plan for ongoing training
based on the job descriptions and responsibilities of the personnel.
Clause 5.3-Accommodation and Environmental Conditions-good housekeeping
plans improve quality
After personnel, the accommodation and environmental conditions should be given a
serious thought. The laboratory staff and equipment require suitable accommodation
and environmental conditions to be able to carry out the testing and calibration activities.
Clause number 5.3 states that the facility should be neat and tidy, with controlled access
and adequate separation between incompatible activities. It is very important to provide
the necessary utilities like sufficient lighting, temperature, humidity control, etc so that
the work can be carried out accurately.
Clause 5.4-Test and Calibration methods and method validation- validate all inhouse methods before adopting
The personnel and the laboratory infrastructure are now in place, but for carrying out any
test or calibration activities there is need to have suitable methods for testing and
calibration. Clause number 5.4 talks about the selection of suitable methods be it
standard methods, laboratory developed methods or non-standard methods. When nonstandard or laboratory developed methods are used, they must be suitably validated.
Clause number 5.4 also talks about estimation of uncertainty of measurement for the
method used in the laboratory and control of data generated from the test and calibration
activities.
Clause 5.5-Equipment-keep your equipment maintained and calibrated at all times
Now that the personnel have suitable accommodation and the methods are in place to
meet to carry out the test or calibration activities, clause number 5.5 lays down the
requirements related to equipment such as the equipment should comply to the
specifications laid down in the methods, there should be a regular calibration program,
authorised personnel for using the equipment, proper identification of the equipment,
maintenance plan, etc.
Clause 5.6-Measurement Traceability and Calibration-establish traceability of
standards before calibration
Now we have all the required infrastructure in place, like a good team, proper
accommodation, suitable methods and equipment. It is essential to have measurement
traceability to national and international standards to make sure that the results
produced by the laboratory are compatible to the results produced by any other
competent laboratory anywhere in the world. Clause 5.6 talks about the requirements
specific for both testing and calibration laboratories for maintaining these measurement
traceability by using suitable reference standards, reference materials, and performing
regular intermediate checks as per defined procedures and schedules.
Clause 5.7-Sampling- always follow established norms for sample collection and
preparation

Laboratory with duly calibrated equipment, suitably validated methods and trained
personnel is ready for carrying out testing. But before testing the samples collection and
treatment must be based on established procedures.. This clause number 5.7 lays down
the requirements of sampling, stating that the laboratory must have suitable procedure
and plan for sampling and should also maintain proper records related to this activity.
Clause 5.8-Handling of Calibration and test samples-preserve integrity of
standards and samples.
After sampling the samples have to reach the laboratory and have to be appropriately
handled during transportation to the laboratory and also handled properly within the
laboratory to maintain their integrity. Clause number 5.8 clearly states that the laboratory
must have procedure for receiving samples and standards. Handling, storage and
retention should have a system for identifying the samples throughout the life of the item
in the laboratory. It also states the requirement for having suitable facilities for avoiding
incorrect analytical results.
Clause 5.9-Assuring the quality of test and calibration results-assure the validity
of data generated by the lab
Clause number 5.9 talks about ensuring the quality of testing calibration results, which is
an essential routine activity now that samples are in the laboratory and are being tested.
It suggests that this can be achieved by regular use of certified materials or participation
in into laboratory comparison and replicate testing , etc.
Clause 5.10-Reporting the results- your analysis report layout expresses your
level of professionalism
The last and final step of working in the laboratory generation of the report and the last
clause of the standard clause number 5.10 very elaborately explains what all must be
presented in the final test report. It states that the report must have information like a
title, name and address of the laboratory , unique identification number for the report,
etc.