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 I’ve 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 customer’s requirement by the laboratory.
I’m sure if you even tried reading the standard, let alone tried to memories 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. I feel 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 routine.
You might say that one doesn’t 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 adhering to, and practicing 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 article I have tried to make 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 let’s 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.
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 the technical 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 Manual
Once you have an organisation, you need a management system based on quality objectives of the laboratory. Defining the systems a their adherence 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 contracts there might arise a need to outsource or sub contract some of the test parameters. The task should be outsourced only with client’s 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 you have to have supplies like chemicals glassware and services like calibration in place. There must be a procedure to purchase the right quantity and quality of these supplies and services and to evaluate them on a regular basis. Claus 4.6 covers exactly this.
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-a satisfied customer is free marketing
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. Create specialist teams for identification, implementation 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 feed back, 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 records. 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.
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 requirements 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 in-house 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 non-standard 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 comparable 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 this 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 degradation of the samples and procedures for reviewing any abnormalities or problems with the sample received in the laboratory.
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 is 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.
What do you think about the ISO 17025 standard? What tricks do you use to comply? Let us know in the comments below.