ISO/IEC 17025-2005 AWARNESS

What is ISO 17025?

ISO 17025 is the measurement of quality and competency within an organization’s (testing/calibration labs) management system.
“Management system” refers to the structure and process of organizing services and objectives including satisfying the customer's quality requirements, complying with regulations, and meeting environmental objectives.

There are five basic elements that make up the review process for ISO 17025 certification:

1.     Scope: The area of the lab being evaluated that will represent the lab as a whole (i.e. mechanical equipment, environmental conditions)

2.     Normative References: Documents that give the most recent information about every area of the process and equipment standards.

3.     Terms and Definitions: The labeling of all equipment, instruments, work stations, employees, and defining instructions, protocol, procedure, and safety measures.

4.     Management Requirements: EX: document control, service to clients, contract reviews, preventative actions, internal audits, management reviews, etc.

5.     Technical Requirements: EX: Safe working conditions, functional equipment, proper calibration of devices, handling of tests and substances, result reporting etc.

A Brief History of ISO 17025

Prior to the current ISO 17025 standard, there were a number of similar management standards and systems such as UKAS M10 in the UK. These systems tended to be exceedingly specific and prescriptive, whereas ISO 17025 allows for labs to execute procedures their own way.
ISO 17025 now gives a global standard of what constitutes excellence in calibration lab management, yet gives labs the freedom to apply ISO methods of management to their specific organization, building, staff, and clients.

3 Reasons Why ISO 17025 Is Important

1.     ISO 17025 is not required. Calibration labs volunteer to be reviewed by a third-party accreditation body based on their adherence to ISO 17025 standards in an effort to prove their lab is among the highest ranking.

2.     ISO 17025 certifies that a lab has demonstrated an ability to produce accurate tests and/or calibration data and has displayed excellence in technical and management competence.

3.     ISO 17025 is a regular and extensive review of a calibration lab’s quality management system. ISO 17025 prevents laboratories from cutting corners and ensures that calibration labs are always audit-ready.

5 Steps Toward ISO 17025 Compliance

1.     Provide specific, documented procedures to explain your calibration lab’s process or methodology.

2.     Designate an internal enforcer of quality management who reviews and maintains the management system daily.

3.     Create names, terms, titles, instructions, records, and definitions for every aspect of the lab space (e.g., label equipment, give employees job titles (i.e. lab assistant, chemist), indicate what each work station is for, and use signs to make safety information visible to the entire lab staff and visitors).

4.     Keep thorough documentation of all clients, tests, employees, incidents/accidents, inventory, complaints, shipments, training, protocol, orders, etc. Organized records are essential for a quality ISO compliant management system.

5.     Maintain safe, working, clean, and new equipment. Make sure the lab space is an environment that promotes accuracy, employee health, and reliable equipment.

The Relationship Between ISO and IEC

ISO: International Organization for Standardization

·       Global standards for worldwide proprietary, commercial, and industry IEC: International Electrotechnical Commission

·       Global standards for electrical and electronic technologies

These two international standards often work side by side because their areas of standardization tend to overlap. The use of electrotechnical equipment is prevalent in many ISO areas of worldwide proprietary, commercial, and industrial work places. This often results in an interdependent relationship between the two organizations of standards.

1. What does Accreditation to ISO/IEC 17025 mean?

ISO/IEC 17025 is applicable to testing and calibration laboratories and covers the use of standard, non-standard and laboratory-developed methods.

Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements for which they hold accreditation.

The management requirements of the Standard were written to meet the systems requirements of ISO 9000:1994 series. However, accreditation against ISO/IEC 17025 cannot be interpreted to be the same as certification against the ISO 9000 series Standards.

2. What does Certification to ISO 9001 Mean?

From 15th December 2003, the ISO 9000:1994 series of Quality Management Standards becomes obsolescent and will be superseded by a single Standard known as ISO 9001:2000.

ISO 9001:2000 is a generic standard for quality management systems (QMS) applicable to all organisations including laboratories. Its purpose is to specify a QMS that will allow an organisation to demonstrate its ability to provide products or services that meet customer and applicable regulatory requirements.

The “new” Standard has several differences in terms of requirements for documentation, customer focus, quality objectives, and continual improvement.

However the main difference is the change to an outcome driven, process approach, for quality management.

Certification of a laboratory against ISO 9001:2000 cannot be interpreted to mean that it demonstrates the technical competence to produce valid data and results.

3. What are the key differences between accreditation and certification?

Certification:

• Means compliance with a standard or specification (e.g. systems or product standards).

• Is assessed by management systems auditors who are certified by an independent body as meeting internationally agreed criteria.

• Can cover more than the sections or tests that have been accredited through laboratory accreditation.

• May be general in the scope of recognition.

• Considers the total business including strategy and planning.

Accreditation:

• Is the recognition of a specific technical competence?

• The scope of accreditation is normally highly specific.

• Evaluates people skills and knowledge.

• Is formal recognition that t attesting laboratory is competent to carry out specific tests or specific types of tests.

• Uses technical assessors who are recognised experts in their field.

• Also evaluates management systems compliance.

Both accreditation and certification use publicly available criteria and can provide public reassurance because both use independent, qualified assessors and an ongoing surveillance program.

4. Why would a laboratory that is accredited to ISO/IEC 17025 want to take up

or keep certification to ISO 9001:2000?

There are several reasons why dual recognition may be important.

• The laboratory’s customers may specify that the laboratory gains or retains ISO 9001 certification.

• ISO 9001 certification is seen by an increasing number of businesses as a way of underpinning continuous improvement.

• It depends on where the laboratory fits within an organisation e.g. if the laboratory is only a part of a larger organisation, which has ISO 9001 certification, the laboratory may need to retain it. If the laboratory is a complete business itself, i.e. a testing laboratory, and certification is not required by its clients, then ISO 9001 certification may not be required.

• Many laboratory-based organisations undertake activities additional to the generation of test, measurement and calibration data. Laboratory accreditation does not address these ancillary activities of a laboratory. If an organisation’s quality system covers non-testing functions such as production, accounting, marketing, information services, training etc, it may be necessary or desirable to seek to have such activities recognised through ISO 9001 certification.

5. Will the ISO/IEC 17025 laboratory assessment take into account ISO9001 certification and reduce the time of the assessment?

If a laboratory holds current ISO 9001 certification, and the NATA assessment team have access to recent ISO 900 audit reports and any associated follow-up and corrective action data, then it is possible that the assessment time could be reduced.

However, this will depend on the level of confidence derived from the audit reports and a sample of management system processes and records.

6. Can my ISO 9001 auditor conduct the ISO/IEC 1025 assessment?

No. Management systems auditors are usually only qualified to perform assessments against a management system standard. ISO/IEC 17025 is both a technical and management systems standard and requires technical experts in the assessment team who are able to make judgements of the specific technical competence of the laboratory.

7. Can the ISO/IEC 17025 assessment team also audit the ISO 9001 management system to save time and cost?

No. A laboratory accreditation assessment by NATA against ISO/IEC 17025 only includes assessment against the requirements of the ISO 9000:1994 series of quality management standards.

Certification assessments, or periodic surveillance audits, against the ISO 9001:2000 standard can only be performed by an assessor from a certification body meeting the accreditation requirements.

However, it is certainly possible, and in some cases desirable, to conduct the two assessments simultaneously. This can reduce overall time and possibly offer benefits in terms of integrated findings.

8. Which standard is the more appropriate for laboratories?

There are differences between the purpose, criteria and emphasis of the ISO 9001 quality system standard, and those of the accreditation standard ISO/IEC 17025. For laboratories concerned with demonstrating technical competence underpinned by sound quality system elements, ISO/IEC 17025 is the appropriate standard.

However, if the laboratory is seeking a more holistic, quality management recognition that demonstrates customer focus and continual improvement, it may decide to alsomaintain a certified ISO 9001 management system