ISO 17025

ISO 17025 and IEC 17025 Laboratory Accreditation is the criteria for laboratories to demonstrate the technical competence to carry out specific test methods; generate valid calibration data, test results, and operate an effective quality system. ISO 17025 applies to any organization that wants to assure its customers of its precision, accuracy and repeatability of results.
ISO 17025 certified manufacturers demonstrate to their customers that the product quality laboratories optimally perform specified tests on the products supplied; laboratory personnel are trained and qualified to conduct these tests; instruments utilized are calibrated and serviced, results are properly reported, and that all of these processes have been confirmed by an independent auditor.
Analytical tests and associated data generated by accredited supplier laboratories are typically not reproduced by the clients that purchase the products. With measurement and measurement related operations estimated to account for 3% to 6% of industrialized countries’ GDP, accredited laboratories are able to command higher prices than their non-accredited competitors.

EHS offers comprehensive services that will help you achieve your ISO 17025 quality goals. We can

• Conduct an initial gap analysis
• Help you establish policies and objectives
• Identify documentation requirements
• Make assignments and prepare schedules
• Prepare documentation
• Coordinate document preparation, reviews, approvals, and production
• Prepare the following key documents: Quality Policy
• Quality Manual
• Administrative Procedures
• Master List of Documents
• Manage implementation schedules, training, follow-up actions
• Help you select a Registrar that has experience in your industry
• Prepare status reports and monitor progress

How does this fit in with a Quality Management System?

If I have ISO 9001 certification, what else do I need to do to achieve certification to this standard?
ISO/IEC 17025 is divided into two principal parts, i.e. Management requirements and Technical requirements. The management requirements are similar to the ISO 9001 Quality Management System. Hence, an organisation with prior ISO 9001 certification would fulfill this component and would only need to put in a bit more work on demonstrating that it is technically competent and able to generate valid results.

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