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  • Converting from 17025:2015 to 17025:2017

    Transition is primarily about meeting the changed and new requirements. As a laboratory the transition means you need to identifying any gaps in your policies, objectives, processes, procedures and records, to meet ISO 17025:2017 scope of requirements (see clause 8.1.1 and 8.2). Revising and or establishing the necessary documents is part of the process, however there is no prescribed way to number your documents.

    Many laboratories that used the ISO 17025:2005 clause numbering have realigned the numbering with the new clauses. Others have not. What is important is link everything to the management system (clause 8.2.4), remove obsolete documents from use and make sure personnel have clear access to all the information necessary to comply with the new version.

    Decide what will work best for your laboratory, practically, considering opportunities and risks of different ways you could go about the changes to your documentation.

    The following may assist you:

  • Focus area on a surveillance visits

    Broadly speaking, you must focus to keep the documents up to date and to make sure everyone complies with all the documents.

    This approach ensures that all elements of your ISMS will be ready for the surveillance visit, regardless of the surveillance audit scope.

    This article will provide you a further explanation about surveillance audit:

  • Can contract manufacturer exclude validation from their scope?

    No, exclusion 7.3.7 Design and development validation is not possible since it is a strict requirement from the standard. They have to have documented validation plans and all other arrangments. However, this can be outsourced to some other company or laboratory, but then this should be explained as such.

  • Key positions in ISO 17025

    Typically in a small laboratory the key positions would be a single person as Laboratory combined Quality Manager and then technicians (or analysts) where technical responsibilities would be divided between them.

    Let’s look at the basic point that ISO 17025 requires the organisational and management structure to be defined. This means identifying personnel involved with operations and those who have management authority and overall responsibility for the laboratory (clause 5.2). Management can be one or more person. Their responsibility is to manage and communicate issues related to the management system; including impartiality, competence and consistent operation to meet the scope of ISO 17025.

    Note that one of the changes from the previous version is that there is no requirement for a specific Technical Manager and Quality Manager position.  To support any laboratory operation however; as a minimum, certain management, technical  and support service functions are needed. The  emphasis is on specifying the authority, responsibility, and interrelationship of all personnel. If the laboratory operations will benefit from a single person in the role of  “technical manager”, then this functional role could assigned to a person employed as, for example, a Senior Analyst.

    In terms of accreditation, there are two functional roles. You need at least one Authorised / Technical Signatory to take responsibility for the validity of results and sign the reports for your accredited tests. The Laboratory / Quality Manager would be the Representative who will liaise with the Accreditation body.

    Defining the Human resources is covered in the Advisera Toolkit ISO 17025 document template: Competence, Training and Awareness Procedure at https://advisera.com/17025academy/documentation/competence-training-and-awareness-procedure/

  • Internal auditor competencies

    Each organization has the authority to determine its competency requirements for its internal auditors. Normally, organizations consider that internal auditors should have knowledge of the audit criteria (ISO 14001:2015 in this case) and should have training in internal audits. You can even decide that an auditor has to study a book on audits or attend an online course and do an in-house exam. Internal auditor competence requirements can be established in a job description, for example.

    I would recommend training about ISO 14001:2015 and an internal audit course. As a plus I would recommend that you participate as auditor, making part of an audit team, in 2 or 3 internal audits.

    You can find practical information in the links below:

  • ISO 14001 benefits

    Recently, I've seen several organizations implement an environmental management system (EMS) and get its certification because that is becoming increasingly relevant to win B2B clients. I worked with an organization that implemented an EMS to improve the relationship with the neighborhood and local government, to reduce opposition to plant expansion. I worked with another organization that was able to reduce hazardous wastes due to better segregation of wastes. In this article, you can see a longer list of benefits - 6 Key Benefits of ISO 14001 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/6-key-benefits-of-iso-14001/

    Please check this information below with more detailed answers:

     

  • ISO 9001 benefits and certified assessor

    1. What benefits will be earned by an educational organization by implementing ISO 9001. 

    Answer:

    In this article - Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/ you can find a general list of benefits for all kinds of organizations. From my experience of working with educational organizations I think the most important benefit is process integration.

    2. Please advise me how to become a certified assessor of ISO 9001?

    Answer:

    If you want to become recognized as lead auditor, you have to evidence knowledge about ISO 9001 and evidence competence about being an auditor. You can, for example, enroll in our free ISO 9001:2015 Lead Auditor Training Course - https://advisera.com/training/iso-9001-lead-auditor-course/

    Then, you should start doing internal audits to gain experience. With time you can apply to audit for certification bodies.

     

  • Minimum number of audits per year requirement

    As stated in IATF 16949: 2016 standard 7.2.3 f) "Maintenance of and improvement in internal auditor competence shall be demonstrated through: f) executing a minimum number of audits per year, as defined by the organization". The minimum number of internal audits to be performed should be determined by the organization. The minimum number of audits could be 1 or 2, etc. Performing 1 audit annually can be a risk for the knowledge and practice of internal auditors.   

    If your internal auditors did not conduct any audit in the last year; my recommendation is that you can develop the relevant internal auditor with internal training and can conduct its first audit with an experienced auditor. You can define the internal training programs with IATF 16949:2016 and ISO 9001:2915  standard knowledge and internal auditor training. If you indicate these points that I recommend in your internal audit procedure, it will be effective for the system.

    This article may provide additional information:

     

  • Special training for employees to help in implementing ISO 17025

    Implementing and obtaining accreditation to ISO 17025:2017 requires you to meet general requirements for competence (of personnel and operations) and consistent operations (in terms of quality of the work and results). This means that all personnel must be sufficiently skilled, trained and deemed competent for the specific task they are responsible for. ISO 17025 has mandatory requirements for documenting the competency requirements and retaining records.

    The technicians should have suitable ISO 17025 awareness training, as they need to know how their role and actions can positively or negatively impact the consistent valid results of the laboratory. This could be inhouse, as long as the knowledge is gained and there is evidence of them understanding the scope and quality requirements of ISO 17025 as relates to their work and contribution to the laboratory accreditation.

    The Whitepaper Clause-by-clause explanation of ISO 17025:2017 could also assist you with ISO 17025 awareness. Available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/

    As personnel training and competency is a critical activity, the Advisera ISO 17025 toolkit includes the mandatory procedure as ISO 17025 document template: Competence, Training and Awareness Procedure along with 4 appendices: Training Program, Training Record and Performance Monitoring, Record of Attendance and Competence Approval and Authorization Record. You can preview the template at https://advisera.com/17025academy/documentation/competence-training-and-awareness-procedure/

    Also have a look at the Advisera Expert Advice Community question and answer in deeming someone competent for more information. Available at https://community.advisera.com/topic/how-training-should-someone-have-before-they-are-deemed-competent-for-a-specific-task/
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