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ISO 17025:2017

1.Introduction What is ISO/IEC 17025:2017-Laboratory Quality Management System-NABL Accreditation:

National Accreditation Board for Testing and Calibration Laboratories (NABL) is a Constituent Board of Quality Council of India. NABL has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories.

In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025:2017 for testing laboratories.

2.What is ISO 17025: 2017- Laboratory Quality Management System

ISO/IEC 17025 is an international standard for testing and calibration laboratories. It was established with the aim of offering quality and improving the processes within laboratories.  ISO/IEC 17025 has two key clauses; Management Requirements which are associated with the performance and efficiency of the Quality Management System inside the laboratory, and Technical Requirements which focus on the competencies of employees, testing methodology, equipment, and the test and calibration results.

3.Why ISO 17025: 2017-Laboratory Management System?

  • Demonstrates your commitment to implement the requirements of this standard;
  • Enable to become technically proficient and produce accurate test and calibration data;
  • Able to increase your job opportunities because there are many large laboratory companies which will value your comprehensive knowledge as a professional in this field;
  • Win contracts as certified professionals and laboratories, as the majority of customers prefer to receive services from certified labs;
  • Enabling to maximize your earning potential.

What benefits of ISO/IEC 17025 Laboratory Management System brings to business:

  • Improve your reputation
  • Create new business connections
  • Gain competitive advantage
  • Increase laboratory effectiveness
  • Gain access to more contracts for testing and calibration
  • Offer proficiency on improving work processes
  • Offer more reliable and efficient lab testing and results
  • Achieve customer reliability

Applicable to:

Testing Laboratories in the following disciplines: Chemical, Biological, Mechanical, Electrical, Electronics, Fluid Flow, Forensic, Non-Destructive (NDT), Photometry, Radiological,  Diagnostic Radiology QA Testing, Software & IT System

ISO 9001 Certification

ISO 9001:2015-Quality Management System.

Most organizations face challenges when developing a quality management system. These challenges are potentially greater due to:
  • Availability of resources;

  • Costs involved in setting up and maintaining a quality management system;

  • Difficulty in understanding and applying a quality management system, especially concepts such as organizational context, organizational knowledge, process approach and risk-based thinking.

1.What is a quality management system?

A quality management system (QMS) is the way an organization directs and controls its activities that are related to achieving its intended results.

Broadly, it consists of organization’s structure together with the planning, processes, resources and documented information that is used to achieve quality objectives (such as for meeting customers’ and relevant interested parties’ requirements, to improve quality management system, or to improve products and services).

Every organization will already have a management structure and on that basis its quality management system is built. Organization might be fulfilling many of its requirements included in ISO 9001, but has simply not yet organized its activities into a formal quality management system.

2.Why have one?

The adoption of a QMS is a strategic decision that helps an organization to improve its overall performance and to provide a sound basis for its sustainable development initiatives.

Many organizations implement a formal quality management system after finding that their customers want assurance that the products and services they are looking to purchase or obtain will meet their requirements for quality. Those customers are looking for the confidence that can be provided by an organization offering products and services produced under an effective quality management system, such as one conforming to ISO 9001.

A quality management system, on its own, will not necessarily lead to an improvement of work processes or to improvements of products and services. It will not solve all industry problems. It is a means for organizations to take a more systematic approach to fulfilling the organization’s objectives, which in turn should achieve such improvements.

3.What is ISO 9001:2015

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).

4.What benefits we can assure through the implementation:  

  • Ensure that customers get consistent, good quality of products and services, which can bring the business benefits;
  • Assess the overall context of organization to define who is affected by its work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.
  • Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to more repeat custom, new clients and increased business for your organization.
  • Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.
  • Meet the necessary statutory and regulatory requirements.
  • Expand into new markets, as some sectors and clients require ISO 9001 before doing business.
  • Identify and address the risks associated with your organization.

5.This standard is applicable to:

Any legal dealing with sectors like, Pharma, Chemicals, Food Processing, Iron and Steel, Construction, Automotive, Aerospace, Granite, and Service organizations like Trading Houses, Banks, Hospitals, Diagnostic Centres, Insurance, Educational Institutions, Government Agencies, NGOs, etc. are eligible to implement and get certified.

6.Our Consulting approach:

  • Gap Analysis:  Assessment of existing management system practices against the selected standard requirements.
  • Project Plan: Prepare a implementation project plan based on the time lines looking for; 
  • Orientation Training:  Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
  • Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;       
  • System Implementation: Implementation of the selected management system as per the developed documentation;
  • Company-wide Training: Training on detailed clause wise requirements and relating them to their  departments, 5-S implementation, and Internal audit.
  • Internal Audits: Periodic assessment of system implementation and corrective actions.
  • Pre assessment:  Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification.
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