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ISO 17025:2005

Introduction to ISO 17025

QMS Corp. is one of the leading consultant in USA, Middle East, Mexico & India. We provide quick, result oriented and easy to implement IT Consulting, Business Consulting, ISO Consulting , Training, Implementation & Certification Services.

We have been associated with organizations across the world for their ISO 17025 accreditation project. Whether yours is a small organization or a multinational corporation, our proven consultation solutions will ensure that you implement ISO 17025 standard in the most effective manner with timely project completion.

ISO 17025 quality standard implementation, with the consultants and experts of QMS Corp. not only assures 100% successful ISO 17025 accreditation but also improves process performance and business operations.

Consultants of our organization assist your company in your quality management initiative through ISO 17025 accreditation to get your company ISO 17025 accreditated quickly, with ease of implementation, and in the most cost-effective manner. We make sure that ISO 17025 standard implementation does not remain just a documented activity, but prevails as a way of life for the organization, laying a foundation for Total Quality Management and a quality-conscious organizational culture.

We offer onsite consultation solutions and online consultation solutions for ISO 17025 accreditation. Our customers have been utilizing our services not only for initial accreditation consultation, but also for post-accreditation consultation to ensure that our consultants regularly add value to the process & quality standardization initiatives and business processes of our customers.

Our ISO 17025 certificate consultation services include awareness training, quality policy, objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats, etc., implementation assistance & training, internal auditor training, lead auditor training, assistance in conducting internal audit, pre-assessment audit, and everything else required to ensure a 100% successful ISO 17025 accreditation audit within scheduled project completion time-period.

The biggest benefit an organization gets out of ISO 17025 standard is an improved control over business process through process standardization. No matter what benefits you are looking from ISO 17025 accreditation, we will make sure that your organization benefits from ISO 17025 implementation and accreditation.

What is ISO/IEC 17025?

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 requirements similar to ISO 9001. Technical requirements address the competence of staff; testing methodology; equipment and quality; and reporting of test and calibration results.

IMPLEMENTATION OF ISO 17025

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

Main Benefits of Correctly Implemented ISO/IEC 17025:

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

Analytical testing laboratories seeking ISO/IEC 17025 will be affected 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.’

The overall impact of accreditation on an analytical laboratory can be best illustrated by looking at the whole sample/data workflow. Figure 1 shows a typical laboratory workflow of samples and test data, together with ISO/IEC 17025 requirements.

Requirements Overview

Requirements along the analytical workflow

Some requirements impact greater than one workflow step:

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

Key Steps towards Accreditation:

There are eight key steps towards laboratory accreditation:

  1. Management defines a project owner.
  2. The project owner studies details of the standard, supporting literature, and other relevant information
  3. The project owner defines the preliminary scope of accreditation, and works with laboratory professionals to prepare a list with requirements.
  4. 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.
  5. 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.
  6. Estimated costs are presented to management, along with incremental opportunities.
  7. Management decides to proceed with accreditation.
  8. The project owner leads implementation steps.

ISO/IEC 17025 – Laboratory Quality System

Laboratories play an important role in company quality systems. The ISO/IEC 17025 (1) can be used as a standard to develop and establish a quality system for a laboratory, and also for assessment by laboratory clients or third parties. The standard can also be used as a criterion for laboratory accreditation. Working according to global standards is especially important for laboratories to ensure validity and global comparability of test & calibration results. One of the goals of using global standards is to reduce the number of tests required in national and international trading.

The first edition of the “International Standard General Requirements for the Competence of Testing and Calibration Laboratories” was produced as a result of extensive experience in implementing ISO/IEC Guide 25 and EN 45001; it replaced these earlier standards in 1999. This new standard contains all the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.

Management requirements in the first edition refer to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an update of ISO/IEC 17025 necessary. In the second edition of ISO/IEC 17025, released in 2005, clauses were amended or added only when considered necessary in the light of ISO 9001:2000.

Testing and calibration laboratories that comply with ISO/IEC 17025 will, therefore, also operate in accordance with ISO 9001.

Accreditation bodies that recognize the competence of testing and calibration laboratories use ISO/IEC 17025 as the basis for their accreditation.

ISO/IEC 17025 is divided into five clauses, two annexes, and one bibliography section:

Management Requirements

Management requirements pertain to the operation and effectiveness of the quality management system within the laboratory. The requirements are similar to ISO 9001. This clause is divided into fifteen chapters, described below.

Organization

This chapter ensures that the roles and responsibilities of the laboratory, the management, and the key personnel are defined.

Key points:

Management System

This chapter describes how to ensure that a management system is implemented, maintained, and continually improved.

Key points:

Document Control

Individual paragraphs in this chapter describe how to ensure that all documents related to the management system are uniquely identified and created, approved, issued and changed, following the documented procedures.

Key points:

Review of Requests, Tenders, and Contracts

This chapter describes how to ensure that requirements of requests, tenders and contracts are well defined, reviewed, understood and documented.

Key points:

Subcontracting of Tests and Calibrations.

This chapter describes how to ensure that tests and calibrations subcontracted to third parties are performed according to the same quality standards as if they were done in the subcontracting laboratory.

Key points:

Purchasing Services and Supplies

This chapter describes how to ensure that services and supplies delivered by third parties do not adversely impact the quality and effectiveness of laboratory operations.

Key points:

Service to the Customer

This chapter describes how to ensure that the laboratory continually meets customer requirements.

Key points:

Complaints

This chapter describes how to ensure that any customer complaints are documented, evaluated, and adequately followed up.

Key points:

Complaints

This chapter describes how to ensure that any customer complaints are documented, evaluated, and adequately followed up.

Key points:

Control of Nonconforming Testing and/or Calibration Work

Tests, calibrations, and other laboratory operations should conform to previously defined specifications such as laboratory specifications or client-defined specifications. This chapter describes how to ensure that nonconforming test and calibration results are adequately followed up, and that corrections are initiated.

Key points:

Continuous Improvement

This chapter describes how to ensure that the effectiveness of the management system is continually improved.

Key points:

Corrective Action

This chapter describes how to ensure that the root cause of nonconforming work or deviations from laboratory and management procedures are identified, and that adequate corrective actions are selected, implemented, documented and monitored.

Key points:

Preventive Action

Preventive actions should be initiated when potential sources of nonconformities have been identified. Nonconformities may be technical or related to the management system. The objective is to reduce the likelihood of the occurrence of such potential nonconformities.

Key points:

Control of Records

This chapter describes how to ensure that all records in a laboratory are uniquely identified, readily available when needed, and protected against unauthorized access for viewing or changing.

Key points:

Internal Audits

Internal audits should verify that the laboratory complies with ISO/IEC 17025 and with internal technical and quality procedures. Internal audits are also an excellent preparation for external assessments, and can help to continually improve the quality system.

Key points:

Management Reviews

Requirements in this chapter describe how to ensure the continued suitability and effectiveness of the quality system, policies, and testing and calibration procedures.

Key points:

Technical Requirements

Technical requirements address the competence of staff, sampling and testing methodology, equipment, and the quality and reporting of test and calibration results.

This clause is divided into ten chapters.

General

The technical requirements clause starts with a general chapter. This chapter’s purpose is to make readers aware that the correctness and reliability of test and calibration results are determined by a variety of factors.

Key points:

General

The technical requirements clause starts with a general chapter. This chapter’s purpose is to make readers aware that the correctness and reliability of test and calibration results are determined by a variety of factors.

Key points:

Personnel

Personnel probably have the highest impact on the quality of test and calibration results. This chapter describes how to ensure that all laboratory personnel who can impact test and calibration results are adequately qualified.

Key points:

Accommodation and Environmental Conditions

This chapter has been included to ensure that the calibration and test area environment will not adversely affect the measurement accuracy. It includes five sections with information that is mostly common sense. One clause recommends having effective separation between neighboring areas when the activities therein are incompatible. An example would be to separate laboratories that analyze extremely low traces of a solvent from those which consume large quantities of the same solvent for liquid-liquid extraction.

Key points:

Test and Calibration Methods and Method Validation

Accurate test and calibration results can only be obtained with appropriate methods that are validated for the intended use. This chapter deals with the selection and validation of laboratory-developed, standard methods and measurement uncertainty, and control of data.

Key points for accurate test and calibration results:

Key points for measurement uncertainty:

Key points for control of data:

Equipment

Equipment that is performing well and properly maintained is a prerequisite for the ongoing accuracy of test and calibration results. This chapter deals with the capacity and quality of equipment. The whole idea is to make sure that the instrument is suitable for performing selected tests/calibrations and is well characterized, calibrated, and maintained.

Key points are:

Measurement Traceability

Traceability of equipment to the same standard is a prerequisite for comparability of test and calibration results. Ideally all measurements should be traceable to International System of Units (SI). While this is typically possible for physical measurements such as length (m) and weight (kg), this is more difficult in chemical measurements.

Key points for traceability of calibrations:

Sampling

This chapter has been added to describe how to ensure that statistically relevant representative samples are taken and that all information on the sample and the sampling procedure is recorded and documented.

Key points for sampling:

Handling Test and Calibration Items

This chapter describes how to ensure that sample integrity is maintained during transport, storage, and retention and that samples are disposed of safely.

Key points for handling test and calibration items are:

Assuring the Quality of Test and Calibration Results

This chapter describes how to ensure the quality of results on an ongoing basis through, for example, regular analysis of quality control samples or participation of proficiency-testing programs.

Key points are:

Reporting of Results

This chapter describes how test/calibration results should be reported. This is important for an easy comparison of tests performed in different laboratories. The chapter has some general requirements on test reports such as clarity and accuracy, but it also has very detailed requirements on the contents.

Test reports and calibration certificates should include:

What we offer for ISO 17025 Certification for your organization?

With a team of highly qualified consultants and trainers having vast industrial experience, QMS Corp. partners organizations across the world to implement and achieve ISO 17025 certification. Our consultation approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization.

We offer ISO 17025 training, implementation, consultation, gap analysis, documentation, internal audits, pre-assessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization get the best out of ISO 17025 quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 17025 QMS:
Contact us at info@qms-corp.com to get your organization ISO 17025 certified.