ISO 17025 Certification, the general requirements for the competence to carry out tests and calibrations, including sampling. It handles testing and calibration carried out using standard methods, non-standard methods and laboratory-developed methods. It applies to all organizations that tests and calibrations. These include, first, second and third – party laboratories, and laboratories where testing and calibration forms part of inspection and product certification.
When a lab applies to ISO 17025 Accreditation, one of the most important documents that define structure complete QMS is known as the quality manual. This is the document that outlines all quality control practices and supporting procedures in place. Making this manual is a daunting task, but if done right, will simply make it your accreditation process. So what makes a quality good enough for ISO 17025 accreditation? Here are four of the pillars:
- Make sure your practices are in order: A common problem with labs prepare resembles their first ISO 17025 accreditation processes is that they also focused on the accreditation itself rather than on the internal practices that the accreditation is based on become. This can lead to the creation of an ISO 17025 Quality Manual which looks much better than practicing self-but each ISO 17025 accreditation auditor goes to the different brands quickly. Thus, the best way to approach creating quality manual is an opportunity to review and improve its internal processes. In this way, this quality manual is much more than an item on a checklist – it is a leading force for improvement within the organization, which is exactly what it is intended.
- Use the right format: There is no single quality manual format is strictly required by the ISO 17025 standards, but most are more or less follow a standard format that all procedures in neat categories distributes and puts each in a simple way. The main advantage with respect to ISO 17025 Manual is fully editable MS Word format so that everyone shares to add based on their specific sector, but for the most part, will assist in response to a standard format for Organizational Quality Manual easier revised.
- Gather input from staff experienced with ISO 17025: As with all work in the lab, experience, transparency and peer discussion only improves the end product. If one single member of staff with the merging of all documentation and writing the manual task , the result will be better if they have input from people who have experience with the ISO 17025 standards . If necessary, consider using an outside consultant ISO 17025 experience to review materials as draft them.
- Double check all documentation: Just because a procedure is in manual or maybe even used on the floor does not mean it will be reflected in all policies and protocols. Consider a have a complete quality manual, pulling together all supporting documentation and make sure that the actual procedures match the quality of the progress of the manual.
ISO 17025 Standard is single most important for calibration and testing laboratories around the world. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and calibration data.
What is 17025 Accreditation?
Accreditation is an objective way to assure customers that demonstrated technical competence to provide reliable and accurate test or calibration results. Accreditation is objective because an independent, third party accreditation body performs annual assessments to verify whether system is meeting all of the requirements of ISO 17025 Certification or not. This independent evaluation is important to the customer; because it is an unbiased guarantee that laboratory is performing at its highest level. Accreditation is a voluntary, third party-reviewed process. As part of accreditation, a laboratory’s quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISO/IEC 17025. Laboratory accreditation can only be granted by an accreditation body.
Time to be taken for achieving ISO 17025 Accreditation:
Generally, the length of time required to complete an accreditation is determined by the desired scope of a laboratory, the number of employees and the complexity of a company’s operations. It takes for a laboratory six months to one year to prepare for the accreditation assessment. The assessment itself, from the day of closure of any applicable non conformance’s to the issuance of a certificate including Executive Committee review and administrative time required for paperwork and approval, takes approximately 8 weeks to complete.
Benefits by owning ISO 17025 Accreditation:
By achieving ISO 17025 Accreditation to your Laboratory Management System, Organization gain much benefits. One of the main advantages is that laboratory will gain international recognition for its commitment to quality, competency and reliable results. ISO 17025 Accreditation signifies that you are complying with an internationally recognized standard, thus easing the global exchange of valuable information. When any Organization achieves ISO 17025 Accreditation, Organization will be presented with a certificate of accreditation. This certificate can be used in advertising, promotional literature and stationary to show current and potential customers that your laboratory is committed to quality and has demonstrated technical competency to perform calibration or testing services.
ISO 17025 Accreditation certificate will show potential customers that laboratory values quality and that have taken steps to ensure that calibration or testing results are accurate and reliable. ISO/IEC 17025 Accreditation is available for both freestanding laboratories and for laboratories which are part of larger facilities. If anyone want to solidify their laboratory as a serious competitor, it is imperative that their laboratory management system comply with ISO/IEC 17025. ISO/IEC 17025 accreditation can be a valuable tool. By becoming accredited, one can look forward to an efficient management system, improved calibration or testing, fewer customer complaints and a strong competitive edge.
ISO 17025 Manual is key document used during testing and calibration laboratory accreditation to define the quality system, establish responsibilities of staff affected by the system, and to provide general procedures and policy statements for all activities comprising the quality system. In addition, this manual is used for the purpose of informing customers about the quality system and what the specific process controls are effectively implemented to ensure quality of service.
Importance of ISO 17025 Manual
- Regularly provide quality testing services that meet customer and regulatory requirements.
- Ensure that all personnel are competent and qualified for the tasks that organizations perform, and that all personnel become familiar with the documentation of the quality system to implement the policies and procedures in their work.
- Professionally and efficiently provide test services to produce accurate results.
- Consistently comply with ISO 17025 to ensure quality testing services, and to continually improve the effectiveness of the Quality Management System.
The management should nominate individuals from one or more functional area/ section of the laboratory and a Quality Manager, having a background of Management Systems. This group should get fully acquainted with all NABL documents and understand the assessment procedure & methodology of making Quality Manual for Lab Testing and Calibration. Relevant requirements for NABL accreditation should be discussed among-st concerned staff of the laboratory. The team should collectively make the effort to prepare the Quality Manual with the guidance of the Quality Manager.
The laboratory should examine that the existing management system is appropriate or it needs modification or it needs to be built from scratch. The laboratory will be able to decide. However, it is advisable that the laboratory writes the manual afresh, as the elements of ISO/ IEC 17025 are quite different from other Quality Management System standards, even though the system elements are similar.
It must be remembered that ISO 17025 Quality Manual is a policy document, which has to be supplemented by a set of other documents like procedure manuals, work instructions, forms, reports etc. to align the management system in accordance with ISO/IEC 17025, as applicable and relevant NABL specific criteria. Therefore, the management system of the laboratory needs to be structured.
The ISO 17025 is international quality standard for testing and calibration laboratories. The current version was published in 2005. The ISO 17025 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and calibration activities. When a laboratory does not undertake one or more activities covered by ISO 17025 as sampling and the design /development of new methods, the requirements of those clauses do not apply.
The ISO 17025 Certification confirmed that laboratories are developed their quality management system operations, administrative and technical as per accreditation standard requirements. Other clients, regulatory authorities and accreditation bodies may use it to confirm or recognizing the competence of laboratories.
Implementing a Quality Management System as per ISO/IEC 17025 has an impact on the organization and operation of the laboratory. This primer will discuss some of the specific requirements of the application, along with their implications for testing and calibration laboratories.
Steps for implementation of Laboratory Accreditation:
There are eight key steps as bellow that helps laboratories while effective accreditation as per requirements of ISO/IEC 17025:2005.
- Management defines a project manager.
- The project manager studies details of the standard, supporting documentation, and other relevant information.
- The project manager defines the preliminary scope of accreditation and works with laboratory professionals to prepare a list with requirements.
- The project manager and laboratory professionals perform a gap analysis to determine the difference between needs and what is being implemented in the laboratory.
- Based on the results of the gap analysis, the project manager, laboratory professionals, financing and documentation professionals, and external consultants estimate the costs for accreditation.
- The estimated costs are presented to management, as well as additional possibilities.
- Management decides to proceed with accreditation.
- The project manager leads implementation steps.
ISO/IEC 17025 Procedures 