ISO 17025 Remarkable Corrective Actions Resolution

ISO 17025 Remarkable Corrective Actions Resolution

The International Standards Organization has outlined a series of qualifications that pertain to quality assurance of products and services. ISO 17025 deals specifically with Laboratory Management Systems. If a company is seeking ISO 17025 accreditation, they need to conform to the rules set forward by the ISO committee. Before a business can determine whether it should start on the path of accreditation or not, however, the structure of the ISO program should be evaluated.

Structure of ISO 17025

There are a series of headings to review for ISO 17025. Among these are:

  • Scope: This heading covers the requirements (both scientific and technical) that a lab must display to demonstrate that it operates at the quality standards set forth by accreditation.
  • Normative References: Outlines a non-ambiguous framework for discussion of ISO 17025.
  • Terminologies and Definitions: The specific phrases and words that will be used to discuss laboratory Management Systems.
  • General Requirements: Requirements that the management system must have that encompass standard operating procedures and interface.
  • Structural Requirements: Infrastructure necessary to attain ISO 17025 accreditation.
  • Resource Requirements: Resources that a laboratory seeking ISO 17025 accreditation should have access to.
  • Process Requirements: Internal lab procedures should follow the guidelines set forward in this section.
  • Management Requirements: The management and running of the lab should use this section as a general guideline.

In addition to these clauses, two Annexes are also attached, viz.:

  • Annex A: Metrological Traceability (Informative)
  • Annex B: Management System (Informative)

To ensure that results delivered are accurate and precise, testing and calibration labs work within strictly defined guidelines for these specific tasks:

  • Documentation of results into a readable format
  • Sample analysis
  • Sample testing
  • Sample labeling
  • Sample identification

ISO 17025 requires a continuous review of processes. This review happens both during the audit process as well as after accreditation. The ISO 17025 methodology comes with a clause that focuses on corrective and preventative actions. The clause in detail states:

Clause 8.7 “Corrective Action” 8.7.1: Procedure for implementing Corrective Action: Selection and implementation of Corrective Action Selection and implementation of the most suitable Corrective Action. Document and implement any changes as a result of Corrective Action 8.7.2: Effectively addressing Nonconformities, Cause Analysis – Investigation of the root cause 8.7.3: Recording and Monitoring, Monitoring of Corrective Action

Steps in Addressing Corrective Actions

When corrective actions are prescribed to a laboratory, implementation of these corrective actions is done as follows:

  • Root Cause Analysis: A problem can’t be solved unless the root cause of the issue is located. A cross-functional team is best suited to examining every aspect of the matter in detail to determine where the problem exists within the procedure.
  • Examination of non-conformity: Non-conformity is a precursor to a problem arising within a process. The Corrective Actions unit should address any non-conformity that has occurred or has the possibility of re-occurring.
  • Determining Corrective Actions and Implementation: The most suitable corrective actions that will ensure the quality of the process would be selected from the potential actions, under the supervision of management. The chosen works will then be implemented to bring about change.
  • Monitoring of Actions: The team is required to observe and record what happens after the measures have been applied. If the discrepancy re-occurs, the process must be redone.
  • Additional Auditing: Determine whether internal audits are higher in quantity, or create any further non-conformity.
  • Record-Keeping: Meticulous recording of problems and actions taken to alleviate them allows for analysis of the methods undertaken both quantitatively and qualitatively. A review of records will make it easier to determine whether suggested activities are likely to work or not based on previous implementations.
  • Evaluation of Corrective Actions: Quality assurance departments are required to revisit the activities performed periodically to determine their long-term success. Management teams can use these periodic reports in the future for both internal and external audits.

The Vital Role of Continuous Improvement

ISO 17025 is an iterative process seeking to ensure that a laboratory raises the quality of methods with each audit. Daily improvement is facilitated by embedding a continuous improvement cycle and using Six Sigma Quality Management within the institution. Additionally, the current level of the institution’s Quality Management Service can be referenced. Additional benefits of a continuous improvement cycle include:

  • Reduction in customer complaints due to a higher quality of service, which leads to better customer response times.
  • Making it easier to gain ISO accreditation or re-accreditation.
  • Reduction in non-conformities that impact the efficiency and effectiveness of the system.
  • Delivering continual betterment through corrective actions.
  • Overview and verification of how effective the implemented corrective actions have been in both the short and long term.
  • Examining other opportunities the business has for improvement.
  • Checks on the efficiency of the company’s QMS.
  • Be updated with the current advances and changes to the company’s processes to match those developments.

Are you interested in gaining ISO accreditation for your company? We’d be happy to answer any questions you may have regarding the process. Contact us today!

ISO 17025 Remarkable Corrective Actions Resolution

ISO 17025 Remarkable Corrective Actions Resolution

The International Standards Organization has outlined a series of qualifications that pertain to quality assurance of products and services. ISO 17025 deals specifically with Laboratory Management Systems. If a company is seeking ISO 17025 accreditation, they need to conform to the rules set forward by the ISO committee. Before a business can determine whether it should start on the path of accreditation or not, however, the structure of the ISO program should be evaluated.

Structure of ISO 17025

There are a series of headings to review for ISO 17025. Among these are:

  • Scope: This heading covers the requirements (both scientific and technical) that a lab must display to demonstrate that it operates at the quality standards set forth by accreditation.
  • Normative References: Outlines a non-ambiguous framework for discussion of ISO 17025.
  • Terminologies and Definitions: The specific phrases and words that will be used to discuss laboratory Management Systems.
  • General Requirements: Requirements that the management system must have that encompass standard operating procedures and interface.
  • Structural Requirements: Infrastructure necessary to attain ISO 17025 accreditation.
  • Resource Requirements: Resources that a laboratory seeking ISO 17025 accreditation should have access to.
  • Process Requirements: Internal lab procedures should follow the guidelines set forward in this section.
  • Management Requirements: The management and running of the lab should use this section as a general guideline.

In addition to these clauses, two Annexes are also attached, viz.:

  • Annex A: Metro-logical Traceability (Informative)
  • Annex B: Management System (Informative)

To ensure that results delivered are accurate and precise, testing and calibration labs work within strictly defined guidelines for these specific tasks:

  • Documentation of results into a readable format
  • Sample analysis
  • Sample testing
  • Sample labeling
  • Sample identification

ISO 17025 requires a continuous review of processes. This review happens both during the audit process as well as after accreditation. The ISO 17025 methodology comes with a clause that focuses on corrective and preventative actions. The clause in detail states:

Clause 8.7 “Corrective Action”
8.7.1: Procedure for implementing Corrective Action: Selection and implementation of Corrective Action Selection and implementation of the most suitable Corrective Action. Document and implement any changes as a result of Corrective Action
8.7.2: Effectively addressing Nonconformities, Cause Analysis – Investigation of the root cause
8.7.3: Recording and Monitoring, Monitoring of Corrective Action

Steps in Addressing Corrective Actions

When corrective actions are prescribed to a laboratory, implementation of these corrective actions is done as follows:

  • Root Cause Analysis: A problem can’t be solved unless the root cause of the issue is located. A cross-functional team is best suited to examining every aspect of the matter in detail to determine where the problem exists within the procedure.
  • Examination of non-conformity: Non-conformity is a precursor to a problem arising within a process. The Corrective Actions unit should address any non-conformity that has occurred or has the possibility of re-occurring.
  • Determining Corrective Actions and Implementation: The most suitable corrective actions that will ensure the quality of the process would be selected from the potential actions, under the supervision of management. The chosen works will then be implemented to bring about change.
  • Monitoring of Actions: The team is required to observe and record what happens after the measures have been applied. If the discrepancy re-occurs, the process must be redone.
  • Additional Auditing: Determine whether internal audits are higher in quantity, or create any further non-conformity.
  • Record-Keeping: Meticulous recording of problems and actions taken to alleviate them allows for analysis of the methods undertaken both quantitatively and qualitatively. A review of records will make it easier to determine whether suggested activities are likely to work or not based on previous implementations.
  • Evaluation of Corrective Actions: Quality assurance departments are required to revisit the activities performed periodically to determine their long-term success. Management teams can use these periodic reports in the future for both internal and external audits.

The Vital Role of Continuous Improvement

ISO 17025 is an iterative process seeking to ensure that a laboratory raises the quality of methods with each audit. Daily improvement is facilitated by embedding a continuous improvement cycle and using Six Sigma Quality Management within the institution. Additionally, the current level of the institution’s Quality Management Service can be referenced. Additional benefits of a continuous improvement cycle include:

  • Reduction in customer complaints due to a higher quality of service, which leads to better customer response times.
  • Making it easier to gain ISO accreditation or re accreditation.
  • Reduction in non-conformities that impact the efficiency and effectiveness of the system.
  • Delivering continual betterment through corrective actions.
  • Overview and verification of how effective the implemented corrective actions have been in both the short and long term.
  • Examining other opportunities the business has for improvement.
  • Checks on the efficiency of the company’s QMS.
  • Be updated with the current advances and changes to the company’s processes to match those developments.

Are you interested in gaining ISO accreditation for your company? We’d be happy to answer any questions you may have regarding the process. Contact us today!

How to get ISO Certified — 10 Step Guide

How to get ISO Certified — 10 Step Guide

 

When you get ISO certified you receive a document or certificate of proof. A certificate is a documented piece of paper that increases the credibility to the product or service of an organization/industry. This document demonstrates that the company is doing everything according to ISO standards. The company has implemented a reliable system of producing and delivering products and services.

The two-fold focus is involved in this ‘system’ to provide consistent products and services. Continual improvement in processes helps achieve better results. Certification is a contractual or legal requirement for most companies. ISO has over 2100 standards and each standard serves a different purpose.

ISO itself does not perform certification, it is an organization that set only international standards and provides general auditing terms and conditions. Certification is given by a third party. This third party gives certification after a thorough audit and according to the type of industry.

Now about the ISO certification process.

How Do You Get ISO Certified?

The first step to get ISO certified is a need assessment. This is accomplished by asking some questions and then trying to find the answers to those questions. Different gap analysis is performed and flaws in the existing system are determined.

  • What are the specific requirements of ISO?
  • How the requirements of the ISO are related to my company?
  • What requirements are applicable to my company?
  • Is there a need to implement the complex documentation process?
  • How long will this take?
  • What are the resources required to get the certification?
  • Will ISO be able to tackle or remove the flaws in the system and add value to the business?
  • How to ensure that ISO doesn’t merely become a documentation exercise only?
  • What are the other options to get this done?
  • Is the company in a position to adopt a change?

Get ISO Certification Readiness Review Report FREE, from one of our expert Consultants.

Effective Change Management

The next step to get ISO certified is effective change management. Workers and staff always oppose the change and they do not want to come out of their comfort zone and this is the very challenging stage. To overhead this, awareness sessions are conducted, in which workers and staff are told about the benefits of the new system and how will the new system help them and increase efficiency and productivity. Benefits may be related to ease in work, better environment, better health activities, and Pollution free environment.

Change implementation is a tough task because it involves a complete change of mind of working staff. That’s why effective change management is required to get the desired results.

Staff Allocation

Staff allocation is very important for getting ISO certified. Only those members of the staff are kept in the team who are responsible and can understand the nature of work. Clear instructions are given to them and they should be provided with their job descriptions and clearly state them what is company expecting of them and where their responsibilities lie.

It’s likely that a whole team of staff will be involved in getting the organization ready for certification.  Specific standard ISO Certified Requirements are breaking down into smaller parts and are fed in the intranet system available within the organization with some elaborations which help the staff navigate their way through the requirements and made the requirements available and accessible everywhere in the company.

Sharing of Information

Information sharing, communication, and coordination among the team members are the key factors responsible for the success and failure of a project. Modes of information sharing may be different and vary from company to company. The better way of doing it is to create some space in the intranet or any software available in the company so that every activity being performed must be approachable and accessible to every member of the team. Staff must be allowed to collaborate, share ideas and insights as well as the latest news and updates in the system.

Documentation Management

Management of documentation is fundamental to get ISO certified. Every process must be documented by the staff members whether an organization is certified or is starting, the key is to let the processes that are used to meet its goals determine documentation requirements. The standard has many instances where it calls for the specific evidence of conformity.

The Standard asks several times for the evidence of conformity which can only be dealt with by providing specific documented results. A documented procedure must be established to define the controls needed for records:

  • Identification of specific document when required
  • Storage of documents at allocated space
  • Protection of the documentation
  • Retrieval of documents when to ask for
  • Retention of documents as it could be asked any time
  • Keep every record legible, readily available, identifiable, and retrievable.

Documents can be kept in an updated version of the intranet system of the company so that the documents are available online and staff members can work simultaneously and can edit the same document in real-time.

Corrective and Preventive Actions

This is the practical stage and things will go wrong from time to time. When getting ISO certified the important thing is how you deal with problems and what type of countermeasures you would take to prevent them. The organization shall take actions to eliminate the causes of nonconformity in order to prevent recurrence (Corrective Actions) and the organization shall determine actions to eliminate the causes of potential non-conformity in order to prevent their occurrence (Preventive Actions). All these actions must be documented because these will help in the future for reality-based decision making.

Awareness and Training Sessions

To get ISO certified, training is necessary to check the capability of the members and their commitment in meeting the challenge. A proper and comprehensive training plan must be made which will include the step by step processes and procedures involved in achieving the certification. These training sessions will help the members to understand the complete framework for gaining the certification. Assessment of the training will help to measure the effectiveness of training sessions. In training sessions, those who are performing well must be rewarded and encouraged to keep it doing the same way.

Customer and Staff Involvement

An encouraging environment must be established so that staff members feel easy to share ideas and a mechanism for involving the customer must be established.

COMMON TERMS OF ISO STANDARDS

After performing the above tasks, some activities which are common in every ISO must be taken into account:

Context of Organization

It must be in a documented form that:

  1. What type of organization?
  2. Define the scope of the organization.
  3. What type of products or services is the company producing?
  4. Internal & External Issues

Internal and external issues must be defined and what type of competitors are a company in the competition.

Needs and Expectations of Interested parties

What are the needs and expectations of customers and suppliers and what is the company expecting from them?

Risk-Based thinking

Risk-based thinking is the main feature of every standard. In this risk analysis of every action is done and then control actions are advised to take.

Risks & Opportunity

After finding out the risks, actions are taken to counter the risks (Corrective actions), and also the actions are taken to prevent their re-occurrence (Preventive actions). With all this plan is established to avail every opportunity.

Policy

After doing all that upper management will design the policy. The policy includes a clear statement about what we do and what we achieve.

Audits

First initial audit (surveillance audit) is done which will give the idea about how much the system is in compliance with ISO standards. After that internal audit and external audits are done and if the system is found in compliance then certification is awarded.

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