ISO 9001 and 17025 Certification

What is ISO 9001 and what are the benefits to your company?

The International Organization developed the ISO 9000 series of standards for Standardization (ISO). The ISO's primary function is to develop guidelines for effective management systems, which in turn can serve as a framework for continuous improvement.

The ISO 9000 family represents a consensus on good management practices, which is an accepted business standard in more than 164 countries. ISO 9001:2000 is among the most comprehensive and difficult certificates to obtain, requiring careful documentation of all quality management procedures and evidence of a consistent system in conformance with international standards. ISO 9001:2000 specifies audits by third-party registrars for initial registration and continued compliance.

This quality assurance standard also deals with quality management, but it’s much broader than ISO/IEC 17025. The scope of ISO 9001 is “intended to be applicable to all organizations, regardless of type, size, and product provided” (ISO 9001). This standard is used for any organization that “needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction through the effective application of the system” (ISO 9001).

ISO 9001 promotes the use of a process approach when organizations create or improve upon their quality management systems. The goal of the standard and the quality management system is to enhance customer satisfaction by meeting quality control requirements.

Every effective organization must manage multiple linked activities. Any activity that involves transforming inputs into outputs with the use of resources is a process. Processes are often linked, with one output becoming the input for the next process.

The “process approach” is an organization’s use of a system of processes, along with identifying the processes and how they interact. It also includes the management of production of the desired outcome.

By using the process approach, an organization can have continual control over how the individual processes are linked together within the overall processes system. It allows the organization to control how the processes combine and interact.

Because the ISO 9001 standard is so generalized, carefully interpret the parts when applying to a certain organization. All organizations and businesses are different, but because the ISO 9001 contains general business management guidelines, it can be applied to any organization. Many diverse governments and administrations around the globe have successfully implemented ISO 9001.

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What is ISO/IEC 17025 and what are the benefits to your company?

ISO 17025 is the equivalent of ISO 9000 for calibration and testing laboratories. It applies to any organization that wants to assure its customers of precision, accuracy and repeatability of results. This includes in-house laboratories for which assurance of results is at a premium. Accredited services offer the highest degree of confidence that calibration measurements are trustworthy.

QS 9000, the Automotive Quality Management System, and its successor, TS16949, have stipulated that first tier suppliers of calibration and test services be ISO 17025 certified, and that suppliers upstream of them be compliant.

Simply put, this standard contains the general requirements for the competence of testing and calibration laboratories. “The scope of the standard includes all organizations performing tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods” (ISO/IEC 17025, p. 1). Most major labs are required to be accredited in this standard to be accepted as competent. ISO/IEC 17025 contains very specific requirements for competence. The standard does not include “compliance with regulatory and safety requirements on the operation of laboratories” (ISO/IEC 17025, p. 1).

This quality assurance standard shares some requirements with the ISO 9000 standard, but ISO/IEC 17025 is more specific. The standard was originally released in 1999, but a second release came out in 2005, which aligned its quality system words more closely with the 2000 version of ISO 9001. Most of the changes included placing greater emphasis on the responsibilities of senior management. The standard now explicitly states that the management system must continually improve itself and improve customer service, quality control, and communication. For example, our thread plug gages are all ISO 17025 certified.

The ISO/IEC 17025 standard is made up of five elements:

•    Scope
•    Normative References
•    Terms and Definitions
•    Management Requirements
•    Technical Requirements

Management and Technical Requirements of ISO 17025 Accreditation

While every section of the standard contains key information, the two largest sections are Management Requirements and Technical Requirements. The management section contains requirements for how the company operates, specifically how the management maintains quality and consistency within the lab. This section deals with the quality management system (QMS) and the predictability of results, as well as sustainability. It also includes requirements for customer confidentiality and training for new employees. The laboratory’s quality policy statement should be recorded in a quality manual, which should establish the overall objectives.

The technical requirements section deals with the precision and correctness of the equipment used in the laboratory. This section is important in maintaining standardization in calibration and test results throughout the industry. This section also deals with the following factors that affect result validity: human factors, accommodation and environmental conditions, test and calibration methods and method validation, equipment, measurement traceability, sampling, and the handling of test and calibration items.

Because the extent of the contributing factors varies depending on the types of tests and calibrations, the laboratory will take the differences into account when developing methods and procedures, training personnel, and selecting equipment. The technical requirements section covers training personnel more specifically than the management system. It stipulates that personnel who operate specific equipment must be considered competent and qualified, based on training, education, experience, or demonstrated skill. In some cases, personnel may be required to be certified to perform the task.

The environmental conditions of the laboratory also fall under the technical requirements part of the standard. The laboratory facilities must be inspected for energy sources, lighting, and other conditions that could affect the test results. This includes dust, electromagnetic disturbances, radiation, humidity, temperature, sound levels, and others. Many other requirements specific to the type and method of testing are contained in the technical portion of the standard.

ISO/IEC 17025 is used by laboratories to structure a quality management system that will allow them to achieve consistent and valid results. An accreditation body will use the standard as the base for granting accreditation. Accreditation is granted as a formal recognition of demonstrated competence. Every accredited laboratory must have a documented quality management system before receiving accreditation. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.

The Advantages of ISO 17025 in Calibration

The ISO 17025 standard offers key advantages for both users and providers. Users of ISO 17025 calibration services benefit from enhanced data reporting that makes it possible to compare measurements from different laboratories -- even those from multiple countries. The enhancement and standardization of calibration data provides companies an increased level of confidence in their test instrument accuracy.

The ISO 17025 standard helps calibration service providers by reducing the need for customer audits. In the past, calibration laboratories could demonstrate their competency and adherence to standards by undergoing separate external audits from each of their major customers. These audits consume a considerable amount of time for both the calibration labs and their customers. With ISO 17025, labs can now schedule a single third-party audit and become accredited to a standardized set of requirements that are recognized by their customers.

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What is ISO Certification?

ISO certification lends credibility to a product or service. Customers can be assured that their expectations of quality will be met. Some industries are required by law to be officially certified to ISO standards. Certification means that an independent body has given a written form of assurance (or a certificate) that the system, product, or service meets specific requirements. ISO itself does not perform certifications; it only publishes the standards. A separate organization, or “certification body,” performs the actual certification.

However, ISO does have a committee called the Committee on Conformity Assessment (CASCO) that produces standards related to the certification process. CASCO standards outline the process of inspection, reporting, documenting, and general good practice. These standards are used by certification bodies. Certification bodies can be accredited, which means that they are formally recognized by a national accreditation body to operate according to international standards. Accreditation provides independent assurance of competence, but it’s not compulsory. Some non-accredited certification bodies may be very reputable.

What do ISO and IEC Stand For?

ISO is the International Organization for Standardization. The organization is not part of any government, and it is headquartered in Geneva, Switzerland. ISO is responsible for creating international proprietary, industrial, and commercial standards. Founded in 1947, the organization consists of volunteer members from 164 countries. Every member is a recognized authority on standards. Standards are developed through a rigorous process after a need in the market appears and representatives from an industry contact ISO requesting a new standard.

ISO forms technical committees with global experts from every sector: industry, academia, government, and non-profit. The committee meets together to review proposals and draft, approve, and publish the new standard. Every standard is based on a consensus from the committee. The long and precise process of creating a new standard ensures that it will promote quality and harmony across sectors.

IEC is the International Electrotechnical Commission. Like ISO, it is an international, non-governmental organization that creates standards. Unlike, ISO, IEC focuses specifically on standards for electrical technologies. IEC publishes standards on a wide variety of electrical technologies, including marine energy, nanotechnology, solar energy, batteries, fiber optics, semiconductors, and home and office equipment. Members of IEC are experts from industry, government, academia, and testing and lab work.

Each member country has a national committee, which represents the country’s electrotechnical interests in the public and private sectors. IEC currently has representatives from 82 countries, and the headquarters are located in Geneva, Switzerland, with regional centers in Asia, Latin America, and North America. Predating ISO, IEC was founded in 1906. IEC collaborates with ISO and ITU (International Telecommunication Union) and other major organizations. Standards developed jointly have both acronyms: ISO/IEC 26300. Both the ISO and IEC work with developing countries to improve technology and industry.

Benefits of International Standards

The benefits of International Standards impact technology, society, and the economy. International Standards harmonize service and product specifications, which improves the industry’s efficiency. Additionally, Universal technical specifications help remove barriers to international trade. Consumers can rest assured that all products are safe for the environment and were produced for efficient and safe use.

International Standards improve general quality of life. Consumers can be confident that all products are reliable and high quality. The ISO standards are broad and cover almost everything—from medical supplies to children’s toys. Conformity to the standards helps the world be a little bit safer for everyone. All standards are developed in a committee of experts, including representatives of consumers. Besides concern for the consumers’ safety and satisfaction, ISO promotes environmental responsibility, including standards on quality of air, water, and soil. ISO makes every effort to preserve the environment.

Businesses benefit economically from the International Standards, through using the guidelines to streamline their processes. Used as strategic tools, the standards can assist management as they make challenging decisions. The International Standards increase the efficiency of any organization, which increases productivity and improves the bottom line. ISO has published a free report of benefits to businesses, which contains statistics and case studies. This report outlines three key benefits that all businesses experienced:

1.    Streamlining internal operations--The study found that standards could be used to reduce the time needed to perform tasks. They were also used to reduce waste of materials and decreasing procurement costs, while boosting productivity.
2.    Innovating and scaling up operations--The International Standards promote innovating business processes. This could include expanding suppliers, or developing new products. In some case studies, the standards helped mitigate the risk of introducing a new product.
3.    Creating or entering new markets--Standards have been used to enter both domestic and export markets and develop new products. These new markets have supported the market uptake on products and created new markets.

Benefits of International Standards Extend Beyond Business and Society

Because the ISO develops standards with extensive research and experts from around the globe, it has been a government resource for decades when developing regulations. While ISO standards themselves are voluntary, some governments can require compliance. Governments benefit from expert opinions without having to form their own special committee. The standards also benefit world trade because the standards for import and export will be the same all over the world, which increases the ease of moving goods and technologies. In a global economy, people around the globe benefit from ISO standards of quality assurance.