Third-Party Audit Services of Your Supplier's QMS

Aims Management Consultants can let you know whether your suppliers are meeting their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/or other testing laboratories.
No matter where your suppliers are located, we can most likely provide these services at less travel expenses. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located.

REGISTRATION PROCEDURES FOR ISO 17025

• Begin the project by preparing your organizational strategy with your top management
• On your route to registration, help is a simple phone call away. Call SARA Registrar. We will consider your business requirements, then arrange the services that best suit your needs.
• After assessing your needs, we will give you a formal quotation so that you know how much your registration will cost. An application form will be sent with your quotation, enabling you to apply for registration.
• On return of your application form and registration fee, we will assign you a Lead Assessor
  The Lead Assessor will be your principal contact with SARA Registrar throughout the registration process and beyond. They will have knowledge concerning the nature of your business, the local business environment and will offer support while you develop your systems.
• Together, you and your Lead Assessor, will review your documentation. This will ensure that all documented procedures cover the requirements of ISO 17025 relating to the scope of registration you require.
• Together with your Lead Assessor, you will determine the best timetable for your registration and agree on a date for initial assessment (your top management will need to be available to participate on this date). Many organizations benefit from our pre-assessment 'dry run' of the formal assessment - and you too could find this helpful.

ISO 17025 - Calibration & Test Lab Standard

ISO 17025 (formerly ISO guide 25) presents additional quality system requirements for accrediting laboratories who conduct calibration and/or testing. Oxebridge is pleased to offer implementation of ISO 17025 systems under the same methods as our other implementation services.
The ISO 17025 standard requires certain activities and confirmations which are dependent on third parties, such as round-robin proficiency testing. As a result, a “Rapid” implementation program is not possible for this standard. However, Oxebridge still attempts to conduct its portion of the implementation as quickly as possible, reducing your overall implementation time.

Corrective and Preventive Actions

The Z540-1 contains a general statement about procedures for corrective actions regarding measurement discrepancies or departures from documented procedures. The statement is contained in a list of 21 items that are to be contained in the quality manual. The 17025 excludes this list but outlines corrective action procedures. Cause analysis, implementation, monitoring, and additional audits are specifically discussed. The 17025 also requires procedures for preventive actions regarding the quality system or technical issues, whereas the Z540-1 does not address preventive actions.

TRACEABILITY OF MEASUREMENT

The results produced, within the scope of work of the laboratory, must be based on a recognized system of measurement that derives from accepted, known quantities (SI system) or other intrinsic or well-characterized devices or quantities.
The chain of comparison of measurement between these accepted, known quantities or intrinsic devices or quantities, and the device providing objective results, must be unbroken for the competent transfer of measurement characteristics, including uncertainty, for the whole of the measurement chain.

Relationship between L-A-B and Laboratory

The laboratory must accommodate L-A-B during the accreditation process to assure that they are provided with the necessary materials, and appropriately arrange access to all areas of the laboratory necessary to assess the compliance of the laboratory. These accommodations extend to surveillance, reassessments and for purposes of resolving complaints against the laboratory.
An accredited laboratory shall:
1. At all times comply with the provisions of the accreditation program, as defined in the Accreditation Program Documentation.
2. Claim that it is accredited only for those services for which it has been granted accreditation and which are carried out in accordance with these conditions.
3. Pay fees assessed by L-A-B.
4. Not use its accreditation in a way that brings the accreditation body into disrepute, and not make any statement relevant to its accreditation that the accreditation body may consider misleading or unauthorized.
5. If the accreditation is suspended or withdrawn, the laboratory shall discontinue the use of all advertising materials that contain any reference to L-A-B, and return any certificate of accreditation to L-A-B.
6. Not use its laboratory accreditation to imply product approval by L-A-B.
7. Endeavor to ensure that no certificate or report, nor any part thereof is used in a misleading manner.

How Aims Management Consultants can help with you ISO 17025 Implementation?

• Executive Overview Training for ISO 17025
• Project Planning, Scheduling, & Management
• Worker Training
• Generic Templates for Policies, Procedures, Process Maps, and Documentation Systems
• Statistical Data Analysis of 7 Characteristics of a Metrology System
  Repeatability
  Reproducibility
  Linearity
  Bias
  Hysteresis
  Accuracy
  Granularity
• Calibration Models
• Inter-Lab Calibrations
• Reducing measurement system sensitivity to Operator, Environmental, Common cause, and Special Causes
• Developing Customized tests and measurement criteria.

ISO/IEC 17025:2005 Internal Quality Audit

The requirement for testing and calibration laboratories to conduct Internal Quality Audits is inherent in the ISO/IEC 17025 Standard. Be equipped with the knowledge of internal quality auditing to systematically conduct internal quality audits as required by the standard.
Course Content

• Purposes & benefits of internal audit
• An overview of the ISO/IEC 17025:2005 Standard
• Roles & Responsibilities of Auditors
• Planning Audit schedule
• Audit Preparation
• The audit process & findings
• Audit checklists & questionnaire
• Listening & communication skills
• Workshop: Simulation audit.

Features of ISO /IEC 17025.

• contains a quality manual, procedures and quality records
• written in standard Microsoft Word
• covers all sections and subsections of the ISO 17025 standard
• document titles and numbers exactly match the standard
• defines a baseline system that satisfies the requirements
• provides model of a quality system that is natural simple and free from excessive paperwork
• will save much time in typing alone

Agenda of ISO/IEC 17025.

• Audit applications of key concepts of compliance contained in the standard
• Planning the audit-preparation, performance, reporting and closure phases
• Performing the audit--recognizing the audit trail
• Concluding the audit
• Application activities so that auditors can integrate their audit actions with their new auditing knowledge.

ISO 17025 for Laboratory certification:

ISO 17025, which replaces the previous Guide 25 accreditation, is a document prescribing the "General requirements for the competence of a calibration and testing laboratories".
It's aims are to:
a. Provide a basis for use by accreditation bodies in assessing competence of laboratories
b. Establish general requirements for demonstrating laboratory compliance to carry out specific calibrations or test; and
c. Assist in the development and implementation of a laboratory's quality system.

Supply Chain Management

Supply Chain Management recognizes that competition is now across supply chains, not individual companies. A supply chain is the network of companies linked together in supplier to customer relationships across a product life cycle from raw material to final consumption. Supply Chain Management integrates every aspect of product development and design, producing competitive advantages throughout the product life cycle.
Supply Chain Management optimizes and synchronizes material, process, information and cash flow from raw material to final consumption, while driving out excess inventory and unnecessary costs. The right product gets delivered to the right place, at the right time and at the right price.
Any organization in the supply chain network can initiate a supply chain program and realize benefits. However, the closer a company is to the final customer, the better it is positioned to lead a Supply Chain Management program.

General Philosophy of the Standard

The standard is split into two basic areas—management requirements and technical requirements. The management requirements are very similar to the requirements found in ISO 9001:2000. The technical requirements are what separate “17025” from “9001.”
Since the First Edition of 17025 referenced the predecessors of ISO 9001:2000—namely ISO 9001:1994 – Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicing and ISO 9002:1994 - Quality Systems – Model for Quality Assurance in Production, Installation, and Servicing—it was evident that the Second Edition of 17025 would have to reflect the more modern version of ISO 9001.
It should be noted that ISO 9001:2000 was a MAJOR change to the ISO 9000 series of standards in that it replaced the second edition of ISO 9001:1994, and it incorporated both ISO 9002:1994 and ISO 9003:1994 – Quality Systems – Model for Quality Assurance in Final Inspection and Test into the comprehensive document.

What is laboratory accreditation?

The international standard for competence in laboratories is ISO 17025.
Accreditation to this standard allows for mutual recognition of data generated by laboratories worldwide. For such a holistic approach to work, all laboratories must operate within the same set of guidelines.
ISO 17025 is written in such a way as to allow this to happen without undue proscription on business practice within the organizations to which the individual laboratories belong. It is, in essence, an over-arching statement of intent implemented by documented processes through validated methodology supported by record-keeping and audit.

What the differences between ISO 17025 and ISO 9000?

Aims Management Consultants Services has focused on the quality assurance and quality control of our services and is proud to have successfully accredited by the National Accreditation Board of Laboratories (NABL) against the ISO / IEC 17025 standard “General Requirements for the Competence of Testing and Calibration Laboratories.
ISO/IEC 17025 includes the quality system requirements of ISO 9001 and additional requirements to demonstrate that the laboratory is technically competent and able to produce technically valid data and results.
It is important to distinguish between a laboratory-specific accreditation like ISO 17025, and a general systems certification like the ISO 9000 series. ISO 17025 is based on the systems requirements of ISO 9000, but goes much further into the operations of a laboratory that are critical to its performance of tests. There are some very important differences in critical areas. Examples of these differences are highlighted in areas such as staff competence, test traceability, equipment calibration, audits and presentation of reports. ISO 17025 has extremely specific requirements in these areas whereas in ISO 9000 they are either not addressed or are presented in vague or general terms.
Therefore ISO 17025 accreditation provides the customer with a high level of confidence in the laboratory’s impartiality, technical competence and the technical validity of its results, as opposed to ISO 9000 which is purely a systems certification. Aims Management Consultants Services is a Bureau of Indian Standards and NABL accredited laboratory. NABL approval is from Department of Science and Technology, Government of India. NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO 17025.

Standard operating procedures

Standard operating procedures (SOPs) should be documented for all routine methods and for individual items of equipment to ensure that data are collected consistently and accurately. When there is more than one approved technique for any given procedure, all should be covered by SOPs.
SOPs should be written in simple language, readily accessible, and ideally in a standardised format. They should be updated as necessary, and only the current version should be available. Standard written protocols should also be available covering the process of seeking informed consent from patients or volunteers, to ensure clarity and consistency. Written protocols are likewise essential for ensuring strict adherance to regulations/licences, for example in research involving animals.

ISO 17025/IEC 17025: 1999

International Organization for Standardization (ISO) 17025 (more specifically ISO/IEC International Electromechanical Commission 17025:1999) is an international standard for calibration and testing labs “General Requirements for the competence of testing and Calibration Laboratories”2.
It requires labs to demonstrate that they:

• Operate a quality system covering processes, documentation and management.
• Generate technically valid results taking account of the equipment, procedures, and personnel.

This standard is an evolution of the former ISO Guide 25. It replaces EN45001 in Europe and has been adopted in the US as an ANSI standard that provides a migration path to international standards from the older Z540-19994.

All national accreditation bodies have adopted ISO 17025 as a way to ensure standardization. Several industries or countries have incorporated it into their industry-specific or application-specific regulations.

Why is Accreditation Important?

Accreditation provides an increased level of confidence in the data and information produced by a lab. This status allows the FSD laboratories the opportunity to collaborate with other recognized facilities on an equal basis. Stakeholders such as Health Canada, the Canadian Food Inspection Agency, and Alberta Health and Wellness can enter into joint projects with FSD knowing that they can expect high standards of excellence. Consumers are increasingly demanding that all sectors of the food production chain meet stringent safety and quality criteria. The agriculture and food producers of Alberta must meet these demands in order to compete in the global marketplace. If the FSD is to guide and encourage Alberta producers in this endeavour, it must be able to meet recognized quality standards itself. By achieving an accredited Quality System, the FSD has made significant progress towards this goal.

Scope of the Lesson

The lesson will cover the requirements of the standard, how it is applied to calibration and test laboratories, and what a technician who works for an accredited lab needs to know. On completion, you will understand these topics and will understand what behavior and activities are required of you in order for your work to be conformant to the standard.
• Intro to documentary standards
• Quality systems and standards
• Prescriptive and non-prescriptive standards
• Accreditation, registration, and certification
• ISO/IEC 17025 and ISO/IEC Guide 58
• Accreditation bodies and ISO/IEC 17025
• Mutual agreement and mutual recognition Conformance and conformity assessment
• Requirements of the standard(s)
• Shalls, should, and notes
• Normative references
• Additional requirements from accreditation bodies
• The assessment process

Advantages to using Quality Systems Services:

By signing a contract with Anova Quality Systems Services, you will gain the services of a professional Quality System Specialist who is committed to the success of your Quality System. As an external facilitator, we can more easily effect the changes required in your company to ensure quality. By drawing on our experience, we will reduce the overall cost of implementing and maintaining your quality system through:

• Developing and reinforcing your staff's commitment to the quality system.
• Performing a professional, unbiased, initial assessment of your operations, to ensure.
• Your quality system is started on the right track. Reducing the workload placed on your staff.
• Providing indoctrination and training tailored to meet the specific needs of your staff.
• Reducing mistakes made by trial and error.
• Reducing the cost of registration audits.
• And shorten the learning curve

Meeting ISO 17025 Requirements for Complex Electronic Test Equipment

Hardly anything seems to be as confusing as interpreting ISO/IEC 17025 compliance forcomplex electronic test equipment (M&TE). The difficulty of the measurement uncertaintyanalysis for modern M&TE adds an additional impediment to the task of comparing themanufacturer's specifications to evaluation of available calibration services. This is essential to meeting the "Challenge of Measurement Interoperability." Calculating measurement uncertainties for a single parameter such as DC voltage is relatively straight forward, but to do so for a complex microwave spectrum analyzer that relies on digital signal processing is another matter. Accreditation was originally intended to provide a common denominator to compare quality of calibration services between one laboratory and another. Yet, the implementation of accreditation prevents a simple yes or no answer to the question: "does the instrument meet manufacturer's specifications?" Rather, the purchaser of accredited calibration services must evaluate a laboratory's scope of accreditation against the manufacturer's product specifications, which is not a simple matter for some derived parameters. This paper will explore the ways in which one equipment manufacturer, Agilent Technologies, is approaching in pragmatic and cost effective ways the balance between a metro logically correct ISO 17025 calibration and the needs of the equipment end user.

Differing Purposes of the Standards.

The primary aim of the ISO 9000 standards is defined in the "Scope" section of ISO 9001:". . . specifies quality-system requirements for use where a supplier's capability to design and supply conforming product needs to be demonstrated."
The standards' primary purpose is, therefore, to provide a management model suitable for the supply of a conforming product or service between two parties -- a supplier and his customer. However, the focus on the use of the ISO 9000 standards as two-party models has shifted greatly as more and more use is made of them for third-party certification purposes. In today's complex world, there are limited opportunities for all customers to have direct relationships with their suppliers, so third-party certification bodies are, in effect, taking on the roles of representatives of multiple second parties (all the customers which rely on independent certification for their reassurance about a supplier). It is important, therefore, that users of third-party certification understand what form of reassurance is provided when an organization is certified against a quality system standard.
Since the ISO 9000 standards are generic, it is often a significant challenge to interpret their use in different industry sectors, or in organizations of different sizes or technical complexities. Quality system certification does not, however, certify the quality of a particular product or service for compliance with specific technical specifications, but only the management system's compliance with a defined model (ISO 9001, 9002, or 9003).

CEBEC expertise in ISO IEC 17025

Test- and investigation-procedures are performed by an modern and independent laboratory by experienced engineers and technicians.
Test- and investigation-procedures are performed by an modern and independent laboratory by experienced engineers and technicians.
CEBEC is able to test and certify newly developed products in various ways:

• In their own labs, or in CEBEC-connected labs.
• TMP: Testing at Manufacturer’s Premises. Product tests are carried out on the manufacturers' premises
• SMT: Supervised Manufacturer's Testing. In this case, CEBEC
• supervises tests implemented by the manufacturers themselves

Essential Skills and Knowledge

• Act as Technical Officer during implementation of ISO 17025 / Guide 34 in Chemistry division of Company;
• Help maintain ISO 17025 Accreditation once it has been obtained and work on accreditation for additional methods;
• Maintain Proficiency Testing Program;
• Perform Internal Technical Audits in the laboratories (Chemistry);
• Validate and approve any new or modified methods;
• Maintain MAT and pEcheck certifications;
• Maintain calibration and ensure preventive maintenance of all laboratory equipment;
• Coordinate stability testing and management of retained samples;
• Investigate of customer concerns related to chemistry;

How long are my Certificates of Calibration retained?

ISO/IEC 17025:2005 requirements dictate that we retain customer calibration records for a period of 5 years. We surpass that requirement. Additionally, any calibration which was performed on or after 11.01.2007 will have the calibration certificate and related documentation retained indefinitely!

When will I receive my Certificates of Calibration?

Per ISO/IEC 17025:2005 requirements, all Certificates of Calibration must be reviewed and approved by management prior to being issued. For that reason, if your equipment was calibrated onsite, your Certificates of Calibration will follow in the mail a few days later (or be viewable online). If your equipment was calibrated in one of our labs, your Certificates will in most cases be returned to you along with your equipment.
If you require your Certificates immediately after an onsite or in-lab calibration, please contact our quality department so they can immediately fax or email the Certificates to you.

2nd Level - ISO 17025:2005

• Certifies that quality-oriented tests are performed correctly. These tests establish that the product is indeed a quality product.
• All aspects of quotations and contracts, the Research and Design operation, and Manufacturing and Quality Control activities are examined by this standard. The qualification, education, and training of all associates are scrutinized against their job responsibilities. Even the qualifications of vendors and collaborators are checked, as well as every Quality Critical specification and purity requirement.

Aims management consultants Awarded ISO 17025 Accreditation

Aims management consultants, a leading Solutions Provider and Distributor received accreditation under ISO Standard 17025 for its calibration laboratory facility in Singapore, effective 3 December 2007.
The accreditation is awarded by the Singapore Accreditation Scheme (SAC-SINGLAS) and is internationally recognized. It certifies that Aims management consultants calibration laboratory meets or exceeds the international ISO 17025 standards and guidelines for test and measurement.ISO 17025 is an international standard that assesses the technical competency of calibration laboratories and helps to ensure accurate data generation, controlled test methods and procedures, and properly trained personnel. ISO 17025 covers every aspect of laboratory management, including analytical testing proficiency, report generation and record keeping. Laboratories which comply with the ISO 17025 international standard also operate in accordance with ISO 9001."In today’s business climate, companies are constantly on the lookout for value added suppliers that can provide affordable products at superior quality levels.

Why use an ISO /EN 17025 accredited calibration facility?

Accredited calibrations to 17025 are your guarantee of confidence in the calibration results & uncertainties of measurement, through internationally recognized technical auditing of a laboratory’s competence.
The International Standard covering the “General requirements for the competence of testing and calibration laboratories (ISO/IEC: 17025:2005) is virtually now the only internationally Recognized Calibration Quality System.
Traceable Calibrations from Non ISO17025 Accredited Calibration Sources are now generally technically questioned.
“According to the CEN/CENLEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia. Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.”

The ISO 17025 certification emphasizes on:

Quality policy & objectives.

Detailing out the responsibilities of personnel.

Process for subcontracting of tests and calibration.

Purchasing, services and supplies.Service to customer.

Handling complaints.

Bringing control on non conforming testing or calibration work.

Improvements.Corrective action.

Preventive action.

Control of records.Internal audits.

Management review.

Technical requirements.

Environmental conditions and accommodation.

Test, calibration methods and method validation.

Validation of methods.

Brief Course Description

The course follows the format and content of ISO standard 17025. Its impact on all aspects of test and calibration laboratory operations is analyzed clause by clause. The relationship of ISO 9000 quality programs to ISO standard 17025 is discussed.
Management requirements are discussed in detail, including organizational requirements, the Quality system, Document Control, contracting issues and the handling of complaints, nonconforming work, corrective and preventive action.
In the section on technical requirements, consideration is given to personnel issues, including training and job descriptions. Physical surroundings, test/calibration method development and validation and equipment control are discussed next. Uncertainty, traceability, sampling and quality assurance are covered before a discussion on the reporting of results of testing or calibration activities. The course concludes with guidelines on developing specific applications.

ISO 17025 in more detail

The current edition of the standard is ISO/IEC 17025:2005 which was published by ISO on the 12th May 2005. This edition had several clauses amended or added in the light of ISO 9001:2000.
ISO 17025 has replaced documents M10 and M11 for the United Kingdom Accreditation Services (UKAS) and has been adopted as an ANSI standard in the United States of America.
Several Industries/Countries have incorporated ISO 17025 within their industry/Application- specific regulation such as QS-9000 & ISO/TS 16949 for the automotive industry and FCC Part 15 for the United States Government.
ISO 17025 Key points:

• ISO 17025 is the most important metrology standard for calibration services as it is accepted internationally.
• ISO 17025 is an International standard for verifying the technical competence of calibration and testing laboratories.
• ISO 17025 gives you the customer confidence in the calibration laboratory.

ISO Guide 17025 Templates

Our ISO Guide 17025 Template System is designed to be used by test and/or calibration labs seeking laboratory accreditation. Lab accreditation is strongly suggested by and will eventually be required by ISO TS-16949. The system is designed for ease of use-if you can use a word processor you can use this system! There is no "software package learning curve" to suffer through before you can begin to make significant progress developing your ISO system documentation.
Our Laboratory Policy Manual and procedure templates address all of the requirements of ISO Guide 17025. It differs from our ISO-9000 templates in its extensiveness and specificity. The library includes templates for such as Qualification of Laboratory Personnel, Formatting of Test Reports, and Developing a Measurement Uncertainty Budget (including self-interpreting Excel spreadsheet), among many others.

Upgrading to ISO/IEC 17025 Participants will be able to:

• Identify the necessary actions to satisfy SO/IEC 17025 (2005) General Requirement for the Competence of Testing and Calibration Laboratories
• Relate the specifies of these requirements to their organization’s laboratory management system
• Define impact on documentation requirements
• Out line steps for up grading to the revised standard for their organization.

Organization and Management.

This section of 17025 stresses the fact that "the lab can be held legally responsible." The lab must be organized so that it can carry out its work at permanent or temporary facilities. If the lab is part of a larger organization, the responsibilities must be carefully divided to avoid conflicts of interest.
The lab must have management and technical personnel with the authority and resources needed to do the EMC testing. The lab personnel must be free from any undue pressures that could adversely affect the work. The lab must have policies to protect the clients' confidential information and they must have an organizational chart that specifies the interrelationships of all personnel. The lab must also have a technical manager and a quality manager.

ISO 17025 Success Factors

Research into what makes a ISO 17025 implementation a success has revealed 11 Critical Success Factors. They are, in order of importance: -

• Top management leadership & commitment
• A simple, comprehensive implementation plan
• Training & support for everyone involved or affected by the implementation project
• Buy-in and voluntary support & commitment from a critical mass of people (>1 person, building to 25% of employees)
• Early successes that clearly prove that ISO 17025 will benefit customers, suppliers, management, and especially workers
• Adequate resources and time to achieve all that needs to be done
• Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done
• Expert, pre-experienced advise, coaching, cheerleading, pre-warnings, and technical expertise on ISO 17025 implementation.
• Auditing, training, and remedial assistance to achieve consistent compliance to minimum requirements.
• Dress-rehersal audit, final fixes, then formal Registration Audit by Accredited Registrar
• Continuous assessment, improvement, and re-registration of systems.
  

How can Aims management consultants Calibration Toolbox Help?

Aims management consultants Calibration Toolbox is widely used in ISO 17025 accredited laboratories. This is because this calibration management / quality assurance software is designed in a way that expressly encourages you to work in the manner required by the standard.
Here are just a few examples:

• Measurement traceability
• Calibration History
• Measurement Uncertainties
• Compliant calibration certificate design
• Test procedures
• Record Environmental conditions
• Document control, maintenance, storage and disposal

Important Information About Viscosity Standards

All Koehler certified viscosity standards are Newtonian fluids manufactured from high stability base oils and polybutenes. The standards have an expiration date on the label at least twelve months or longer from the date of purchase. With time, changes resulting from slow oxidation or loss of volatiles may occur. These changes can be minimized by storing the standard in the closed bottle at ambient laboratory temperatures and out of sunlight. The expiration date on the label is part of Koehler’s program of total quality control and is intended to ensure that the standard will be utilized while the certified viscosity data remains valid.

Management Requirements

-Organization
- Quality systems
- Document control
- Review of requests, tenders and contracts
-Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to client
- Complaints
- Control of nonconforming testing and/or calibration work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews

It contains the following 5 sections

1. Scope
2. Normative References
3. Terms and Definitions
4. Management Requirements
5. Technical Requirements

What’s in it for you?

First, since accreditation involves a third party assessment of a laboratory’s QA program and technical capabilities, it provides an impartial viewpoint of the competency of the laboratory. It also provides an unbiased assessment of the laboratory’s standards, procedures, personnel qualifications, and traceability to an appropriate national laboratory. In the United States, this means traceability of all standards to N.I.S.T. In short, accreditation offers a lab’s customers a high level of confidence in its quality and technical abilities.
Second, because ISO 9001:2000 includes calibration requirements, many companies include accreditation for calibration suppliers as a mandatory part of their QA system. Often, accredited suppliers need only remit a copy of their accreditation scope in order to become an approved vender. This eliminates the need for time-consuming, expensive audits and other supplier evaluation methods. Further, a customer’s own audits run smoother when accredited suppliers are used.
Third, accreditation has benefits, for international customers. All recognized accreditation bodies have adopted the ISO 17025:1999 as the basis for accreditation of calibration and testing laboratories, and will be transitioning to ISO/IEC 17025:2005. Because these accreditations tend to be based on the same standards, countries may enter into Mutual Recognition Agreements (MRAs) whereby an accreditation body in one country recognizes the accreditations done by a fellow MRA signatory in another country. This has the effect of easing some of the barriers that have historically hindered the flow of calibrated instruments across borders.

ISO 17025 Accreditation Links and 17025 Accredited Lab Information

Laboratory Accreditation provides a means of determining the competence of laboratories to perform specific types of testing, measurement and calibration. It enables people who want a product, material or instrument to be checked or calibrated to find a reliable testing or calibration service able to meet their needs. It also allows a laboratory to determine whether it is performing its work correctly and to appropriate standards. Manufacturing organizations may also use laboratory accreditation to ensure the testing of their products by their own in-house laboratories is being done correctly.
Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to access reliable testing and calibration services.

Aims management consultants Calibration Laboratories

Aims management consultant existing worldwide network of 28 calibration service centers follow ISO 17025 procedures for calibration laboratory operation. Of these, an unmatched 21 have also been accredited to ISO 17025.

SELECTING AN ISO 17025 A2LA ACCREDITED LABORATORY MEANS:

• Acceptable degrees of uncertainty have been established
• All methods are validated
• Results are repeatable and reproducible at each laboratory
• All tests are performed according to written work instructions
• Technicians must complete documented training on each test they perform
• Quality control samples are run frequently to ensure that every result is a quality result
• Proficiency testing is done on a regular basis
• Equipment is properly maintained and calibrated

Executive Summary of the ISO 17025 Quality Manual Template Package:

- quality manual, procedures and forms that comply with ISO17025 (written in Microsoft Word)
- two ISO 17025 training presentations for management and staff (Microsoft Powerpoint)
- user's guide for customizing the quality manual and implementing the quality management system
- covers all sections and subsections of the ISO 17025 standard
- improves audits as document titles and numbers match the standard
- defines a baseline system that satisfies the ISO 17025 requirements
- provides model of a management system that is easily understood by all employees
- will save hours of time in typing
- unlimited email technical service

Additional One Day Executive Overview Outcomes:

• Identify steps necessary for your organization to successfully implement ISO 17025
• Impact on Documents and Processes
• How ISO 17025 will be interpreted by your auditor

Internal Audits and Management Review

Prior to the initial assessment, the laboratory must complete at least one Internal Audit of its activities that covers their technical competence, compliance with ISO/IEC 17025, and one Management Review that is compliant with the requirements of ISO/IEC 17025

Standards Facts

• Specific industries, local regulations, or your customers may require 17025-compliant calibration on your test equipment.
• Local governmental regulations may add requirements beyond calibration standards.
• Calibration in an ISO 9001-compliant facility does not guarantee accreditation.

When will I receive my Certificates of Calibration?

Per ISO/IEC 17025:2005 requirements, all Certificates of Calibration must be reviewed and approved by management prior to being issued. For that reason, if your equipment was calibrated onsite, your Certificates of Calibration will follow in the mail a few days later (or be viewable online). If your equipment was calibrated in one of our labs, your Certificates will in most cases be returned to you along with your equipment.

How can Aims management consultants help?

Aims management consultants has a team of ISO / IEC 17025 experts who provides consulting, auditing, and training services to laboratories of all sizes and in all industries. We have assisted over 100 different laboratories to implement 17025 systems, and many of our consultants have worked with governmental laboratories, including the FDA, EPA, and Army, Navy and Marines. Our solutions help companies leverage their resources to provide value add throughout the company. Whether you are looking for a small amount of guidance, or a complete turnkey system, we can help. We measure our success by your improvement.

Significance of Compliance

ISO-accredited organizations—like Forensic Quality Services for instance—will evaluate a laboratory facility to determine if it is in compliance with ISO/IEC 17025 standards. If the lab is found to be in compliance, it is deemed a lab certified to comply with ISO/IEC 17025. Test results from such a lab are typically accepted internationally.

What is Method Validation?

Method validation is the process of proving and documenting that a given analytical method, when correctly applied, produces results that are fit for purpose. No matter how well a method performs elsewhere, analysts need to confirm that the method is valid when applied in their laboratory.

Varied approaches for reviewing the new standard

Confusion and frustration hampering a rapid transition to the new standard can also be attributed to users' backgrounds or perspectives. Accordingly, different action plans for reviewing the standard might be beneficial.

• User’s familiar with ISO 9001:2000 but not with ISO/IEC 17025:1999 might be confused initially by ISO/IEC 17025:2005's consolidation of most management system items under clause 4 and technical considerations under clause 5. This works quite well with a modular-model approach, once familiarity with the standard is established. However, because ISO/IEC 17025:2005 doesn't fully embrace the process-model approach (including the plan-do-check-act cycle, eight management principles or other concepts found in ISO 9001), it's a waste of time trying to find them. Users would be better served by simply studying ISO/IEC 17025:2005 and knowing that much of the terminology in clause 4, and all of it in clause 5, is based on ISO/IEC 17000 and the Vocabulary International--Metrology (VIM). Neither of these documents, however, is listed in the ISO/IEC 17025 bibliography, nor are versions cited.
• Users unfamiliar with ISO/IEC 17025:1999 or ISO 9001:2000 will make the most effective progress through a combination of the above-mentioned recommendations. Read the new document without trying to link it fully to ISO 9001:2000's concepts or structure, and review information from accreditors.

Updating ISO/IEC 17025

Protocol established by the International Organization for Standardization requires that all ISO documents be reviewed roughly every five years to ensure that documents maintain their usefulness. The review determines whether:

• The document should be cancelled and withdrawn because it has ceased to serve its intended purpose, or
• The document continues to serve a need, and no modification is required or justified before it's reissued, or
• A need continues to exist, but the document should be amended to better serve users and stakeholders before it's reissued.

How this ISO; 17025 document kit for test laboratory is useful to you?

• The user can modify the templates as per their working system and create own ISO 17025 documents for their laboratory.
• Ready made templates are available which can reduce your time in document preparation as well as training to staff.
• Procedures and formats provided in document kit can help in fine-tuning the processes and establish better control.
• Save much time and cost in document preparation. It gives value for money to customer and payback is very law.
• Take care for all the section and sub sections of ISO: 17025-2005 and give better confidence as well as improve a system.

Important Information about Viscosity Standards

All Koehler certified viscosity standards are Newtonian fluids manufactured from high stability base oils and polybutenes. The standards have an expiration date on the label at least twelve months or longer from the date of purchase. With time, changes resulting from slow oxidation or loss of volatiles may occur. These changes can be minimized by storing the standard in the closed bottle at ambient laboratory temperatures and out of sunlight. The expiration date on the label is part of Koehler’s program of total quality control and is intended to ensure that the standard will be utilized while the certified viscosity data remains valid.

ISO 17025 insures technical competence

Controlled documents

• All Calibrate, Inc. employees work from most current SOPs and QAPs ONLY.
• Eliminates “out of specification” work.
• Eliminates confusion and misunderstandings.
• Requires an organized system of communication, training, and record keeping, all of which are “hall marks” of a well run company.

Part and supplier control program

• All Calibrate, Inc. suppliers are accredited to ISO 9000. As part of our accreditation to ISO 17025 we can only use vendors that are accredited and all must be interviewed to determine that they meet the standard.
• Calibrate, Inc. follows a First In First Out program for all parts used in the repair and service of pipettes.
• Calibrate, Inc. uses Genuine Gilson Parts.
• The Calibrate, Inc. batch numbering system insures quality control.

Measurement and test equipment trace ability

• All measurement and test equipment undergoes installation qualification prior to use.
• All measurement and test equipment is calibrated by third party accredited vendors to insure SI through NIST traceability.
• Complete historical equipment logs are maintained for each item of measurement and test equipment.

Controlled data

• All data is reviewed for accuracy before release to the customer. This eliminates unnecessary concern, review and time on behalf of the customer.
• All data is secured through our three levels (minimal) of data storage: Level 1 is the reps home office, Level 2 is the main computer at the home office, and level 3 is the CD format each data file is copied to and stored in a locked and secured environment.

ISO 17025 consulting service capabilities

• Gap Analysis: Get a review of your operation with a report detailing your gaps to meeting ISO17025 requirements.
• Quality Manual Development: With our experience we can save you money and time!
• Training in ISO17025, Measurement Uncertainty Analysis, and Internal Auditing: Public or On-site Classes!
• Assistance in applying for ISO17025 Accreditation with guidance and support through the process.
• Complete Accreditation Project Management Available: Customized programs designed to fit your needs.

Feedback from Our 17025 Services

Feed Back from some of our ISO/IEC 17025 Clients:
"We are receiving many inquiries from companies that are looking for 17025 carts for their gages, which have in turn lead to several new customers.
Implementation was a lot of work at the time, but looking back on it, it does not seem to be as bad as we thought.
Many of our big customers that work with the auto industry required it and now we are finding even the smaller companies are requiring it.
Regarding the calibration of our lab equipment, we have a lot more confidence in them being right."

General requirements for the competence of testing and calibration laboratories

This international standard specifies the general requirements for the competence to carry out tests and /or calibration, including sampling. It covers testing and calibration performed using standard methods, non standard methods, and laboratory developed methods.
This international standard is applicable to all organizations performing tests and /or calibrations. These include, for example, first second and third party laboratories, and laboratories where testing and /or calibration forms part of inspection and product certification.
This international standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and /or calibration activities. When a laboratory does not undertake one on more of the activities covered by this international standard, such as sampling and the design/development of new methods, the requirements of those clauses do no apply.
The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form anintergral part of this international standard.
This international standard is for use by laboratories in developing their quality, administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.

Where are you on the path to Accreditation?

• Are you familiar with the requirements of ISO/IEC17025?
• Do you have an ISO/IEC17025 compliant Quality System?
• Have you computed all of your Measurement Uncertainties?
• Have you developed your Laboratory Scope of Capability?
• Have you had an ISO17025 Gap Analysis performed?
• Do you have qualified personnel to perform your Internal Audits?

Why choose an ISO 17025 Accredited Laboratory?

ISO 17025 Accredited labs have been independently assessed by a National Accreditation Body and have been deemed competent to carry out test and/or calibrations. All national accreditation bodies have adopted ISO 17025 as a way of ensuring standardization. This standard is also being incorporated into industry-specific regulations. The Automotive industry requires all of its Tier One suppliers to be QS 9000/TS 16949 registered. In fulfillment of this standard, their measuring and test equipment are required to be calibrated to the ISO 17025 standard.
You can be confident that ISOLAB possesses the technical competence to calibrate your instruments accurately and precisely. A calibration report from ISOLAB will ensure both National and International recognition that the calibration of your equipment is traceable to the International System of Units (SI) through the National Research Council of Canada.
With a higher confidence level in your equipment calibrations, you can, in turn, have superior confidence in your product quality.

You will learn how to:

• Interpret and apply the requirements of ISO/IEC 17025
• Identify and implement the controls necessary for ensuring the QMS translates customer needs into satisfied customers
• Relate fiduciary concerns to the performance of the QMS
• Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
• Determine and communicate the resources necessary for the system to work as planned
• Communicate the roles and responsibilities within the QMS to the organization
• Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
• Relate the capabilities of the organization to the expectations of customers, top management and shareholders
• Use the QMS to work proactively and not reactively
• Explain to customers how the organization plans to fulfill its promises and show evidence that it has done so in the past

ISO/IEC 17025:2005 What the Standard Requires

• Quality system
• Subcontractor quality
• Equipment control
• Maintenance
• Training
• Calibration
• Traceability
• Test procedures
• Sample preparation
• Nonstandard samples
• Environmental conditions
• Reports
• Document control, maintenance, storage and disposal
• The auditing and accrediting process

What is it and Why is it Important?

ISO/IEC 17025 is a recently introduced standard from the International Organization for Standardization and the International Electrotechnical Commission. "ISO17025", as it has become known, replaces a number of older standards and guides including ISO/IEC Guide 25, EN45001 and ANSI/NCSL-Z540.
It is a global standard for the technical competence of calibration and testing laboratories. In addition to establishing quality system, documentation and personnel requirements, it directs calibration labs to:

• analyze the uncertainty of each measurement
• incorporate the uncertainty into the test procedure and/or test limits
• provide the uncertainties with the calibration certificate and results

Reporting the uncertainty qualifies the accuracy of the measurement and aids understanding when results from different labs are compared. The ratio of specification-to-calibration uncertainty is one way that equipment users gauge their confidence in a product's performance.
ISO17025 is the single most important metrology standard for test and measurement products. Nearly all national standards bodies and accreditation agencies around the world have adopted it. A growing number of companies require it and some industries have even incorporated it into sector-specific standards (for example, the automobile manufacturers' QS9000).

Standards of Compliance

"ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods."
For a DNA testing lab, this means that ISO/IEC 17025 is a set of standards that has been internationally established to ensure high-quality and technically acceptable laboratory and business practices. Specifically, a lab that is in compliance with ISO 17025 is a lab that produces reliable reports and is overseen by qualified and competent staff, meeting all international standards.

ISO/IEC 17025:2005 - An Innovative Standard for Laboratory Quality Systems

ISO/IEC 17025:2005 has been revised to align the ISO 17025:1999 version with ISO 9001:2000. Thus, ISO harmonized lab system accreditation by recognizing the ISO 9001:2000 standard as the basis for sound management of lab systems. This is now found in Clause 4 of ISO/IEC 17025. The technical part, in Clause 5 contains all of the requirements that testing and calibration labs have to meet if the wish to demonstrate that they operate a management system, are technically competent and are able to generate technically valid results.
ISO/IEC 17025:1999 replaced ISO/IEC Guide 25:1990 & EN 45001:1989 as the contemporary standard to be adhered to by all testing & calibration laboratories. It integrated the requirements of ISO 9001 & 9002(1994) & embodied the extensive experience gained over a time span of 10 years of lab systems implementation.
Provided the accreditation bodies of various countries negotiate mutual agreements, the acceptance of testing & calibration results among these nations will be the mutually beneficial outcome. The global nature of the present standard enables any laboratory to comply with it.

How this presentation kit is useful to you?

• Our key result areas and performance based appraisal system presentation is ideal for individual or for use by a facilitator with large groups.
• By using these slides, you can save a lot of your precious time while preparing the course materials for in house training.
• Providing you with the presentation material and hand out that you need for preparation of effective presentation on goal setting and KRA what it is, and what it requires and making effective performance appraisal system for your organization.
• Good tool to establish and implement goal setting and establish better work system with the help of KRA performance appraisal.
• Having a well proven process for strategic palnning and goal setting makes the effort more efficient and provide a frame that will shape an organization’s future.
• It helps in setting goal s you must achieve and having a goal achievement process for those goals.

ISO 17025 accreditation package overview

• A one hour audio presentation with Q&As: Understanding and Implementing ISO 17025: Requirements, Strategies and Tool Kits for Laboratory Accreditation(Train yourself and others on requirements and best practices)
• Quality Manual: ISO 17025, 57 pages
• ISO 17025: Step by Step Implementation
• Two checklists: ISO 17025 and Laboratory Audits
• 31 SOPs, e.g., for document control, complaint handling, corrective and preventive actions, management reviews, facilities and environmental conditions, sampling, sample handling, validation of software and computer systems, validation of methods, qualification of equipment, maintenance of laboratory equipment, training of laboratory personnel, auditing of laboratories, control of non-conforming tests and calibration
• 12 Forms/Templates
• 10 Reference papers related to laboratories
• 30+ most frequently asked question and answers related to laboratory quality systems
• Two years online support. Buyers can ask questions at any time.
• Guides from official organizations that help to implement ISO 17025

Initial Requirements of ISO 17025

The opening sections of 17025 are entitled Introduction, Scope, Normative References, and Terms/Definitions. The introduction is similar to the Guide 25 introduction in that it refers to ISO 9001 and 9002 and specifies that certification to those standards does not necessarily demonstrate technical competence. Of course, technical EMC competence is the key to producing technically valid testing results.
The section on scope is very similar to that of Guide 25. It specifies the general lab requirements and the organizations to which it is applicable, including first-, second-, and third-party laboratories. The normative references include ISO/IEC Guide 2, VIM, ISO 9001, and ISO 9002. The terms and definitions section includes best measurement capability as the only definable term, and it only applies to calibration labs.

Upgrading to ISO/IEC 17025 Participants will be able to:

• Identify the necessary actions to satisfy ISO/IEC 17025 (2005) General Requirements for the Competence of Testing and Calibration Laboratories
• Relate the specifics of these requirements to their organization’s laboratory management system
• Define Impact on documentation requirements
• Outline steps for upgrading to the revised standard for their organization

The ISO 17025 quality policy

Aims Management Consultant seeks to achieve and maintain the highest standards in all aspects of the provision of services to the Customer.
It is the intention of the Company to provide a Quality-assured service to our Customers that complies at all times with the requirements of the ISO 17025 Standard. We aim to operate a Management System that at all times ensures that the services we provide are of the highest Quality. All employees familiarise themselves with the content of this Quality Manual and comply with the policies and procedures laid down herein at all times. We aim to improve the effectiveness of ourISO 17025 Management System and the Quality of our services on a continual basis.

Background on ISO/IEC 17025:1999

ISO/IEC 17025:1999 replaces ISO/IEC Guide 25:1990 & EN 45001:1989 as the contemporary standard to be adhered to by all testing & calibration laboratories. It integrates the requirements of ISO 9001 & 9002(1994) & embodies the extensive experience gained over a time span of 10 years of lab systems implementation. The new standard not only contains specifications for quality systems requirements but also those based on technical competency & the ability to generate technically valid results.As a rule, within an organization any process or technology should be subjected to calibration & testing and measured by a sampling scheme that ensues in data collection & analysis. It is then possible to gauge the effect of the activities or goods produced & plan appropriately for improvement.

Introducing the Four Faces of ISO 17025

There are four applications of ISO 17025 within a calibration environment, which we call 'The Four Faces of ISO 17025.' These ISO 17025 calibration applications include:

• ISO 17025-compliant laboratories. A calibration laboratory can follow ISO 17025 processes and claim to be ISO 17025 compliant without obtaining external validation. ISO 17025 compliance satisfies the needs of users who require a level of confidence in the lab's competency and want to be sure that it has good quality built into its processes.
• ISO 17025-conformant calibration services. A calibration laboratory following ISO 17025 processes can sell ISO 17025-conformant calibration services that include enhanced data reports showing measurement uncertainties. Services conforming to the ISO 17025 standard provide customers a higher degree of confidence that the calibration follows the procedures set out by the manufacturer. Agilent is one of a very few companies that are able to offer ISO 17025-conformant services, and is the only one publicly offering them for complex instruments on a worldwide basis.
• ISO 17025-accredited laboratories. A calibration laboratory following ISO 17025 processes can get external validation by becoming accredited to ISO 17025. ISO 17025-accredited laboratories are able to provide high-level accredited calibration services, which are necessary for some users. Accreditation also satisfies the needs of users who do not necessarily require an accredited service, but know that an independently accredited laboratory is likely to provide higher quality calibration than a non-accredited laboratory.
• ISO 17025-accredited calibration services. An accredited calibration laboratory can sell accredited calibration services. Accredited services offer the highest degree of confidence that calibration measurements are trustworthy. Companies most likely to require accredited services are those whose business depends on the measurements they make, such as calibration labs and EMC

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.

Who should implement ISO/IEC Standard 17025?

• Analytical testing laboratories of companies or organizations who are registered to an ISO 9000 based standard, if laboratory activities are subject to an audit.
• Testing laboratories which want to prove to their clients that the analyses are done within a well recognized quality system.
• Direct suppliers to organizations that require 17025 certification, such as TS 16949.
• Laboratories getting official accreditation status by an accreditation body, for example by A2LA
• All regulated laboratories can use ISO 17025 as a basis for their operations since the US FDA is implementing it in their labs, and recognize it when they conduct their FDA audits

What are Key Session Topics?

· Background and overview of the ISO/IEC 17025 requirements
· An introduction to auditing and implementing an audit system and the auditor's role in the process
· Management's role in reviewing the effectiveness of the overall quality system
· Planning and managing the audit: - resources and timing - use of checklists - selection of audit teams
· Conducting the audit - skills, techniques and auditor competence: - evaluating the significance of audit findings - communicating and presenting audit reports
· Developing and implementing corrective action programmes
· Nonconformities and quality improvement as a result of corrective actions
· Management of the third party assessment and certification process

What are the Benefits of Accreditation?

As with any well constructed standard, ISO 17025 is not to be considered as an unnecessary imposition on your time and efforts. It is designed to be help you improve, and then maintain, your quality and standards. By following the procedures and methods specified, everyone can be assured of the accuracy and integrity of your laboratory. However, you will have to continually monitor your quality processes to ensure that they continue to meet the guidelines of this standard. This is a good thing for everyone, remember: rigorous quality processes equate to fewer failures and errors.
It is also important to remember that as more calibration laboratories become accredited, correlation between these accredited laboratories’ measurements will improve, thereby improving the general quality of the measurement process everywhere.

How do I obtain accreditation to ISO/IEC 17025?

In the United Kindom all aspects of accreditation are the sole responsibility of UKAS, The United Kingdom Accreditation Service. In the U.S. there are two bodies that are mutually recognised to provide accreditation to ISO/IEC 17025. They are the National Voluntary Laboratory Accreditation Program (NVLAP) and the American Association for Laboratory Accreditation (A2LA). There are many other bodies in the US that provide accreditation to ISO/IEC 17025, but most do not have either bilateral or multilateral recognition arrangements with other recognised bodies.
A first step to obtaining accreditation is to contact one of the bodies mentioned above, or you own national accreditation organisation. They will be able to provide you with detailed information on how to prepare your management and other sytems, ready for the accreditation process to begin.

Following procedures are included in our ISO 17025 implementation package.

· Document control
· Contract review
· Purchasing
· Client complaints
· Control of non-conforming work
· Corrective actions
· Preventive actions
· Control of quality records
· Internal quality audits
· Management review
· Training
· Estimation of uncertainty
· Equipment
· Sampling
· Handling of test items

Who should attend?

• Individuals wishing to perform internal laboratory audits
• Laboratory Managers and Supervisors
• Companies seeking ISO/IEC 17025 accreditation
• Registrar/Accreditation body Auditors
• Existing (ISO/QS 9000) internal auditors who are looking to expand their skills in the area of laboratory practices
• Supplier Quality Auditors wishing to evaluate laboratory service suppliers, including calibration suppliers

What is ISO 17025?

Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives.
ISO 9001 is a generic management standard that can be applied to any business enterprise, public administration, or government department.
Growth in the use of management systems generally has increased the need to ensure that laboratories can operate to a quality management system that is seen as compliant with ISO 9001 as well as demonstrate technical competency. Therefore, ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.