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ISO 17025 Certification

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What is ISO 17025 Certification?

ISO 17025  is the internationally recognized standard developed specifically for testing and calibration laboratories. The current release was published in 2005. Broadly ISO 17025 Certification includes the testing and calibration done according to the global standard methods, non-standard methods, and laboratory-developed methods.

ISO 17025 Certification is one of the most significant accreditations for the laboratories. It is viable for all types of laboratories, universities, and research centers that work in testing and calibration. ISO 17025 Certification holds to claim the technical competency by management and technical requirements that enable a testing or calibration laboratory.  Accreditation of ISO/IEC 17025 Certification will help to showcase that your procedures are regulated by standardized protocols.

ISO 17025  efficiency and consistency to the organization. The certification is applicable for all the organizations dealing with testing irrespective of the size.

Laboratories can exhibit compliance with ISO/IEC 17025 Certification at assessment have demonstrated they continuously operate regulatory management practices and are technically are competent to perform specific tests, calibrations and/or measurements as well as at the same time are able to generate technically valid outcomes for which they acquire the accreditation.

To maintain the recognition of ISO 17025 Certification, thorough re-evaluation and assessment of the laboratories is conducted to keep a check on whether they are consistently adopting the procedures for producing quality products or not. Also the management system is evaluated for assessing the regulatory practices. During the regular reassessments, the organizations need to participate in testing programs which will demonstrate their strengths and weaknesses.

PDCA Cycle

  • Plan – to think that what do we need to achieve in our organization
  • Do – to execute a planned action which will help us achieve the required objective
  • Check – monitor against the standards) (policies, objectives, requirements)
  • Action – finally implementing what has been rechecked.

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ISO/IEC 17025 standard has the potential to bring a number of benefits to your organization.

  • Helps to boost up the self confidence after acquiring the globally recognized standard
  • Potential to increase the profitability
  • Enhances the consumer satisfaction
  • Opens door to international market
  • Helps to showcase that you produce reliable products
  • Builds a positive brand image
  • Improves the reputation in national as well as international market
  • Reduction in cost
  • Opportunity of acquiring globally recognized standard
  • Traceability
  • Increases reliability
  • Better corporate image

There are two basic requirements for accomplishment of ISO 17025 Certification in your organization which are management and technical requirements.

  • Management Requirement: The laboratories need to take utmost care of inculcating quality management in their functioning system. According to ISO 17025 Certification, the organizations grow consistently and improve themselves. The customers will rely on the organization which makes sure that their practices are safe. The management requirements also include building a keen relationship with customers, government, stakeholders and other laboratories. The reassessment will enhance the capabilities of the organization and assist to formulate procedures for improvement.
  • Technical Requirement: Technical requirements of ISO 10725 Certification address a number of issues, including:
  1. The competence of staff
  2. Sampling
  3. Testing methods you use
  4. Types of equipment you use

However ISO 17025 Standard mentions the following requirements in order for the organization to get certified :

  • Clause 4: Context of the association- the section covers the requirements for distinguishing external and internal issues. It also includes the need for the individuals to incorporate administrative requirements as per the requirement of the standard.
  • Clause 5: Leadership- The requirement for top administration to be instrumental in the operation of the regulation and norms of the standard.
  • Clause 6: Planning- By Failing to plan, you are planning to fail. The administrators should take decision and responsibility to practice and accumulate the continuous procedures of the Standards. Dangers and chances in the association should be evaluated, and quality targets for development should be distinguished to achieve the goals.
  • Clause 7: Support- in this section, the organizations need to incorporate prerequisites around capability, mindfulness, correspondence, and controlling reported data. Controlling the assets, including HR, structures and framework, workplace, observations and estimation of assets, and hierarchical information falls under this area.
  • Clause 8: Operation- This module manages all required arrangements and production of the item or service. It includes the prerequisites for arranging item necessities audit, structure, controlling the outside suppliers, making and discharging the item or administration, and supervising nonconforming procedure outputs.
  • Clause 9: Performance assessment– the observation and estimation of your procedures, surveying consumer loyalty, internal audits, and continuous administration audit.
  • Clause 10: Improvement- This last segment consolidates the necessities to refine the existing system after a certain period of time. Providing guidance to the need of survey process dissension and advising to take restorative activities for forms come under part.

Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.
  • Stage One (documentation review) – At this stage, the auditors from the certification body verifies that your documentation meets the requirements of ISO 17025.
  • Stage Two (main audit) – In this stage, the realities of your processes are matched with your statements in the documentation for their compliance to the requirements of ISO 17025 standard.

the certification process goes further. Click here to view the next steps to the ISO certification process

Make Sure

Quality manual procedures need to be preferably performed by the company, noncompliance of procedure can result in losing the certificate (quality manual is different form system procedure can be given to customer on demand)

Work instruction manual includes step by step carrying out of procedures, forms, quality records, specification, master lists, need to be properly maintained and if not it may become a major problem in ISO 17025 implementation

Quality management principles is a comprehensive and fundamental rule/belief, of leading grand operations of an organization, aimed at consciously improving performance over the long term by focusing on customer while addressing the needs of all other stakeholders

How can I get an ISO 17025 certificate?

Achieving ISO 17025 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 17025 Certified are listed below:
  • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
  • Secondly, you need to document all the relevant information about your business.
  • Thirdly, you have to implement all the documented information in your organization.
  • Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
  • Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

How much does it cost for ISO 17025 certification?

Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

How do I maintain ISO 17025 certification?

Just because you received an ISO 17025 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 17025 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

How can I apply for ISO/IEC 17025 for my company for quality?

  • First of all, you need to choose an internationally accredited certification body meeting all the requirements of IAS Accreditation such as SIS CERTIFICATIONS.
  • Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar.
  • After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization.
  • The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps.
  • Then, there will be initial certification audits which will be followed by:
  • Stage I – where the auditors will check the changes made in your organization according to requirements.
  • Stage II – where the auditor will do their final audit for the certification.
  • As the auditors will approve all your processes then they will make a report and send it to the registrar. They will then grant you the ISO/IEC 17025 certification.
ISO 17025 Benefits

ISO/IEC 17025 standard has the potential to bring a number of benefits to your organization.

  • Helps to boost up the self confidence after acquiring the globally recognized standard
  • Potential to increase the profitability
  • Enhances the consumer satisfaction
  • Opens door to international market
  • Helps to showcase that you produce reliable products
  • Builds a positive brand image
  • Improves the reputation in national as well as international market
  • Reduction in cost
  • Opportunity of acquiring globally recognized standard
  • Traceability
  • Increases reliability
  • Better corporate image
ISO 17025 Requirements

There are two basic requirements for accomplishment of ISO 17025 Certification in your organization which are management and technical requirements.

  • Management Requirement: The laboratories need to take utmost care of inculcating quality management in their functioning system. According to ISO 17025 Certification, the organizations grow consistently and improve themselves. The customers will rely on the organization which makes sure that their practices are safe. The management requirements also include building a keen relationship with customers, government, stakeholders and other laboratories. The reassessment will enhance the capabilities of the organization and assist to formulate procedures for improvement.
  • Technical Requirement: Technical requirements of ISO 10725 Certification address a number of issues, including:
  1. The competence of staff
  2. Sampling
  3. Testing methods you use
  4. Types of equipment you use

However ISO 17025 Standard mentions the following requirements in order for the organization to get certified :

  • Clause 4: Context of the association- the section covers the requirements for distinguishing external and internal issues. It also includes the need for the individuals to incorporate administrative requirements as per the requirement of the standard.
  • Clause 5: Leadership- The requirement for top administration to be instrumental in the operation of the regulation and norms of the standard.
  • Clause 6: Planning- By Failing to plan, you are planning to fail. The administrators should take decision and responsibility to practice and accumulate the continuous procedures of the Standards. Dangers and chances in the association should be evaluated, and quality targets for development should be distinguished to achieve the goals.
  • Clause 7: Support- in this section, the organizations need to incorporate prerequisites around capability, mindfulness, correspondence, and controlling reported data. Controlling the assets, including HR, structures and framework, workplace, observations and estimation of assets, and hierarchical information falls under this area.
  • Clause 8: Operation- This module manages all required arrangements and production of the item or service. It includes the prerequisites for arranging item necessities audit, structure, controlling the outside suppliers, making and discharging the item or administration, and supervising nonconforming procedure outputs.
  • Clause 9: Performance assessment– the observation and estimation of your procedures, surveying consumer loyalty, internal audits, and continuous administration audit.
  • Clause 10: Improvement- This last segment consolidates the necessities to refine the existing system after a certain period of time. Providing guidance to the need of survey process dissension and advising to take restorative activities for forms come under part.
ISO 17025 Process

Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.
  • Stage One (documentation review) – At this stage, the auditors from the certification body verifies that your documentation meets the requirements of ISO 17025.
  • Stage Two (main audit) – In this stage, the realities of your processes are matched with your statements in the documentation for their compliance to the requirements of ISO 17025 standard.

the certification process goes further. Click here to view the next steps to the ISO certification process

Make Sure

Quality manual procedures need to be preferably performed by the company, noncompliance of procedure can result in losing the certificate (quality manual is different form system procedure can be given to customer on demand)

Work instruction manual includes step by step carrying out of procedures, forms, quality records, specification, master lists, need to be properly maintained and if not it may become a major problem in ISO 17025 implementation

Quality management principles is a comprehensive and fundamental rule/belief, of leading grand operations of an organization, aimed at consciously improving performance over the long term by focusing on customer while addressing the needs of all other stakeholders

ISO 17025 FAQs

How can I get an ISO 17025 certificate?

Achieving ISO 17025 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 17025 Certified are listed below:
  • Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.)
  • Secondly, you need to document all the relevant information about your business.
  • Thirdly, you have to implement all the documented information in your organization.
  • Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after.
  • Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

How much does it cost for ISO 17025 certification?

Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

How do I maintain ISO 17025 certification?

Just because you received an ISO 17025 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 17025 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

How can I apply for ISO/IEC 17025 for my company for quality?

  • First of all, you need to choose an internationally accredited certification body meeting all the requirements of IAS Accreditation such as SIS CERTIFICATIONS.
  • Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar.
  • After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization.
  • The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps.
  • Then, there will be initial certification audits which will be followed by:
  • Stage I – where the auditors will check the changes made in your organization according to requirements.
  • Stage II – where the auditor will do their final audit for the certification.
  • As the auditors will approve all your processes then they will make a report and send it to the registrar. They will then grant you the ISO/IEC 17025 certification.

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