NABL 17025,NABL 17025 Certification,NABL 17025 Certification Consultants,NABL Accreditation for Laboratory in Mumbai,India by Ikon Consultancy Services

ISO/IEC 17025 / NABL General Requirements for the competency of testing and calibration laboratories combines the applicable quality system aspects of ISO 9001 along with criteria for determining the ability of the laboratory to generate valid results. This is recognized as the standard that must be met for ensuring confidence in lab results.

Our ISO 17025 consulting services are to the point, practical in nature, result oriented and easy to implement.

We ensure that ISO 17025 consulting and implementation project resulting in accreditation to ISO 17025 becomes a time bound exercise with highest level of professional approach and process optimization.

ISO 17025 NABL accrediation consulting, certification, implementation and documentation for laboratories across the world in India, UAE, Dubai, Saudi Arabia, Europe, Africa, USA and Middle East.
ISO / IEC 17025 NABL Accreditation for test laboratories.
ISO / IEC 17025 NABL Accreditation for calibration laboratories.

ISO/IEC 17025 is the global quality standard for testing and calibration laboratories. It is the basis for accreditation from an accreditation body. The current release was published in 2005.

There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements address the competence of staff; testing methodology; equipment and quality; and reporting of test and calibration results.

Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs involved should be considered before proceeding.

Main Benefits of Correctly Implemented ISO/IEC 17025:

Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs involved should be considered before proceeding.

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides both laboratory and business benefits such as:

Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help to get more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations.
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.

Analytical testing laboratories seeking ISO/IEC 17025 will be impacted in multiple areas. The main difference between good analytical practices and formal accreditation is the amount of documentation to be developed. There is no doubt that any good analytical laboratory uses qualified analysts, checks the performance of equipment used for testing, and validates analytical methods. However, many times the outcome of the tests is not fully documented. ISO/IEC 17025 accreditation requires formal documented environment – ‘what is not documented is a rumor,’ and is viewed by assessors as ‘not being done.’

Requirements Overview

Requirements along the analytical workflow

Sampling should be performed according to a sampling plan, and all sample details should be documented
Samples should be uniquely identified and the sample integrity should be protected during transport and storage.
The quality of test results should be monitored.
Test reports should include test results as well as an estimation of the overall measurement uncertainty. The report should also include either detailed information about the sample and test conditions, or a link to a reference document.
Records should be properly maintained to ensure data integrity and availability.

Some requirements impact more than one workflow step:

All analytical methods and procedures should be validated. This includes methods and procedures for sampling, testing and data evaluation.
Equipment used for sampling and testing should be calibrated, tested, and well maintained. Material such as calibration standards should be qualified and traceable to System International (SI) units or to certified reference material.
Nonconforming test results should be documented and controlled.
People should be qualified for their assigned tasks through education, experience, or training.
Environmental conditions such as temperature, humidity, and electromagnetic interference should be monitored and controlled.
All routine tasks should be performed according to written procedures.

Some additional requirements impact not only sample analysis, but also the organization of the entire laboratory:

Specific documents should be developed and maintained, including individual policies and a quality plan.
Known existing problems should be corrected and an action plan should be developed to avoid recurrence of the same or similar problems.
All complaints from clients should be formally followed up.
A formal program should be used to manage suppliers, service providers, and subcontractors.
The organizational structure should be such that there are no conflicting interests that could impact quality.
Compliance with ISO/IEC 17025 and internal procedures should be assessed during regular internal audits.

Key Steps towards Accreditation

There are eight key steps towards laboratory accreditation:

Management defines a project owner
The project owner studies details of the standard, supporting literature, and other relevant information
The project owner defines the preliminary scope of accreditation and works with laboratory professionals to prepare a list with requirements
The project owner and laboratory professionals perform a gap analysis to determine the difference between the requirements and what is currently implemented in the laboratory.
Based on the outcome of the gap analysis, the project owner, laboratory professionals, financing and documentation professionals, and external consultants estimate the costs for accreditation
Estimated costs are presented to management, along with incremental opportunities.
Management decides to proceed with accreditation.
The project owner leads implementation steps.

Electromagnetic Compatibility (EMC Directive)

The design and construction of all electrical and electronic equipment to ensure that they do not cause, or are not unduly affected by electromagnetic interference.

Low Voltage Directive (LVD)

The design and construction of all electrical equipment to ensure that it does not jeopardise the safety of people, domestic animals and property.

Machinery Directive

Any necessary research of tests on components, fittings or the completed machinery or safety components to determine, whether by its design or construction, the machine is capable of being erected and put into service safely.

Manufacturers who need to comply with the Machinery Directive must also ensure that a technical file is stored at a location within the EU. Atlantic Management Consultant provides storage services for those clients outside of the EU, which ensure manufacturers can comply with the Directive.

If you are looking for NABL 17025 certification consultants in mumbai then please contact Ikon Consultancy Services.

NABL 17025:2017 Certification

NABL 17025:2017 Certification by Ikon Consultancy Services