ISO/IEC 17025:2017: Documentation Requirements

ISO/IEC 17025:2017 Requirements

The requirements of the ISO/IEC 17025:2017standardsare organized in five sections or “Clauses”

Section 4: General requirements

Section 5: Structural requirements

Section 6: Resource requirements

Section 7: Process requirements

Section 8: Management system requirements

Today as “We Go for ISO/IEC 17025” we are going to look at the requirements in

Feel Free to Consult - ISO 17025 consultant , Cal Lab Access is leading services provider for

Clause 4: General requirements and Clause 5: Structural requirements.

 

 

The reason we are startingwith Clause # 4 is because the first three clauses do not have actual requirements; they are more of an introduction to the standard. The requirements are outlined in clause 4 through clause 8.

Clause 4: General Requirements

This first clause introduces two sub-clauses as general requirements.

First is impartiality, where laboratory activities are undertaken and managed in a structured manner in order to safeguard impartiality and provide presence of objectivity.

Second is confidentiality, where the responsible management of information obtained or created during the operations of a laboratory is considered and treated as confidential.

CLA have developed a very strong and audit ready document that covers all the requirements of this clause with risk identification and level of risk associated with each laboratory activity.

Clause 5: Structural requirements

This clause looks at our laboratory as a legal entity where overall responsibilities

and activities are identified in order to meet all requirements and ensure valid and accurate results. This section also asks the laboratory management to ensure that the organizational roles, responsibilities, and authorities for relevant functions are assigned, communicated, and understood.

The range of our laboratory activities will determine the scope of the LQMS, and includes the various services associated with laboratory tests, calibrations, and sampling.

“Very important aspect of this clause is defining your Scope of Accreditation”

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You will need to ensure that you have the ability to consistently operate yourlab business while taking actions to address risks and opportunitiesandmeeting legal obligations.

Documented information will support the operation of the processes andprovide confidence that they are carried out as planned.

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Each laboratory processand activity are looked at to make sure that it meets the requirements of the standard. Relevant documented information is provided to make sure that the process is well planned and that everyone does the process in the same and correct way.

Procedures are used to train employees on using the approved methods,so that youcan improve lab performance.

Our procedure on Impartiality and Management Responsibilityaddresses both clause 4 and clause 5.

Our documents and procedures have been through many audits by A2LA, PJLA, ANAB, etc., with no findings. We look forward to assisting you with your ISO/IEC 17025 project.

Contact Details: info@callabaccess.com

Is your company required ISO 17025 Training ?

ISO 17025 Training Courses

An accredited Laboratory means that the best quality standards are at place and the Laboratory is compliant to the standards set by the ISO 17025 for managing and administrating the technical processes and tests. As the best ISO Accreditation consultants, we provide a range of ISO 17025 Training Courses that allow Laboratories to maintain high quality standards and demonstrate to your customers, regulatory authorities and the accreditation bodies that the Laboratory is fully compliant to the ISO/IEC 17025 requirements. 

Benefits of ISO 17025 Training Courses:

Understanding the Laboratory Accreditation system and developing and auditing your own system to maintain compliance by undergoing ISO 17025 training courses, brings you a lot of benefits, including:

·         A definite management system that assist in managing and maintaining quality, administrative and technical operations.

·         ISO 17025 Accreditation is also used by the Laboratory customers, regulatory authorities and accreditation bodies to evaluate the competence of the laboratories.

·         Boosts efficiency and ensure that you deliver more accurate and user-friendly results and findings.

Why do you need qualified ISO 17025 Consultants?

Hiring a reliable ISO 17025 Consultant is important for implementing an efficient laboratory management system. At [COMPANY NAME], we are a team of qualified and experienced ISO 17025 certified consultants dedicated to make your laboratory systems compliant with the standards set by the ISO 17025 and gain the accreditation. 

Why ISO 17025 Accreditation?

·         Well, first, ISO 17025 Accreditation is important to work as a competent business carrying out tests and calibrations. Secondly, an ISO 17025 Accredited business is considered more quality oriented and reliable by the clients. In order to procure the ISO 17025 Accreditation, a business has to show its competence to abide by the industry and government imposed rules and regulations and also show their competence to implement an efficient laboratory management system. The clients thus remains assured that the laboratory that they are using for tests and calibrations maintains international quality standards.

Real Life Laboratory Experience and ISO 17025 consultancy

Who We Are?

CAL LAB ACCESS, LLCis an organization founded in the year 1995. CLA is a global team of quality and technical professionals with a combined world experience of more than 25 years. We (CLA) are in business to help calibration laboratories to improve business, customer relations, expand calibration capabilities, lean process, quality management system and training documentation (technical & quality) based on national & international standards. Please visit our newly designed website (www.callabaccess.com).

Feel Free to Consult Real life laboratory experience

ISO/IEC 17025 Highlights:

Three other important things that you will be hearing about as you move forward with this project….

1. Process Approach –

Application of a system of Processes and their Interactions

Laboratory Quality Management System (LQMS) will incorporate the process approach where consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes.

ISO/IEC 17025uses a process approach where a process is an action that turns inputs into outputs, like turning ice to water by heating it.So,as we (CLA) look at your business as a series of interacting processes, we (CLA)can try to improve them for better resultsno matter what the process is in your laboratory.

Identifying, understanding and managing interrelated processes as a 

system helps your company effectively and efficiently achieve yourlaboratory objectives. 

                             

 

2. Plan-Do-Check-Act –A Cycle for Continual Improvement

The Plan-Do-Check-Act approach requires that we (CLA) create and implement a plan to achieve the desired results. This is true for any type of management system and it is simply good business practice. ISO standards use this PDCA approach in all their Management Systems because it is really just a way to get things done and continually improve.

                                                          

Cal Lab access offers best ISO 17025 consultancy for Laboratories.

3. Risk-Based-Thinking

A proactive approach aimed at preventing undesirable outcomes

We (CLA)will make use of your organizational knowledge, lessons learned and experience withyour activities and the processes to determine the opportunities and risk that need to be addressed.

This way, we (CLA) will have assurance that we can achieve the intended objectives of producing accurate and valid results and eliminating errors.