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  • Environment microbial limits

    You should be guided by you sector and any regulations, standards or specifications applicable to your scope of work and tests being performed. For example, the requirements for Food and Agriculture differ from Health and medicine. The intention is that conditions should not adversely affect the validity of your results. Look to guidance documents for your specific sector, e.g. from the FDA, USP or EU on microbial controls. There are also a number of ISO Standards, for Example ISO 14160:2020 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices.

    There is a clear need to perform a risk assessment for each test or calibration method and associated activities in the laboratory’s scope of work. Then you can determine what facilities and environmental conditions are suitable and what controls (measures) are required to provide the consistent conditions.

    For more information, see the ISO 17025 toolkit Facilities and Environmental Condition Procedure at https://advisera.com/17025academy/documentation/facilities-and-environmental-condition-procedure/

    The following articles may assist further:

    What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

    Five-step laboratory risk management according to ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps and the webinar How to manage risks in laboratories according to ISO 17025 at https://advisera.com/17025academy/webinar/iso-17025-risk-management-how-to-manage-it-free-webinar-on-demand/

  • Is it necessary having third party come to certify accuracy of my equipment periodically

    You asked

    do I have to have a third party come in a certify the accuracy of my equipment periodically?  

    The requirement is to ensure the correct capability and performance of you equipment and to document the calibrations for all equipment that contribute to the overall measurement uncertainty of test or calibration results .This means having a linked unbroken calibration chain and known measurement uncertainty (MU). Then on an ongoing basis maintain confidence  (clause 6.4.10) by either performing your own intermediate checks or perhaps own calibrations. Whether you can do you own calibrations all depends on the type of equipment, knowledge of standards and specifications required, and the purpose. If you require measurement uncertainty (MU) values to use in you uncertainty calculation then an external ISO 17025 accredited laboratory can provide that, giving you the required metrological traceability, the MU and a suitable ISO 17025 calibration report. Also consider requirements from your accreditation body as they will typically have a policy on the options or approach required. 

    You also asked

    If so how often?"

    The calibration period must be determined by you, based on accreditation body requirements, risk or best practices. Refer to ILAC (international organisation for accreditation bodies) for policies and guidelines.

    Consider, for example, that the annual calibration of a weight set that is used for routine analytical balance verification may be excessive, if the personnel are trained to handle the weights properly, and they suitably stored. For your sensors and gauges, you should refer to recommendations from suppliers and best practices.

    The article: What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

    The ISO 17025 toolkit document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure/

    Also refer to  ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results and ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments, available from https://ilac.org/publications-and-resources/

  • ISO 14001 requirements for emergency planning

    Unfortunately, I cannot give you a specific answer. I can only give general answers. I would start with looking for legislation and regulation concerning large-scale and high-risk manufacturing. In many countries these economic activities have to follow some preventive rules that must be taken in consideration while developing an emergency plan.

    An organization has to determine potential emergency situations, evaluate them and for the most critical develop preventive actions. In some cases, may be a retention basin to contain leaks and spills, in another may be changing procedures or equipment. However, even with prevention measures emergency situations may occur. For those situations the organization must develop a response. How to act, who must act, where to find help. ISO 14001:2015 also mentions training the response measures and learning with simulations and with the follow-up of any emergency situation.

    You can find more information below:

  • Risk and opportunity register

    A risk and opportunity register is not a mandatory document required by ISO 9001:2015. So, organizations are free to include whatever they find useful.

    You want to list risks and opportunities. For each one you can record where they occur or their source, and an evaluation of its importance or significance. You can also include a column to include actions to be taken to handle significant risks and opportunities.

    You can find more information below.

  • Privacy policy and GDPR docs

    Yes, you need a privacy notice on the website because you are collecting email addresses, IP, cookies from your visitors, which are personal data. You need to inform your visitors in a transparent manner on the purposes of data processing (for marketing reason or subscribing to a newsletter), on data retention period (how long will you keep their email addresses), how to contact the data controller and how they can exercise their rights.

    We developed a mini toolkit for websites with templates that help organizations to set up easily all the documents:GDPR Mini Toolkit for Websites https://advisera.com/eugdpracademy/eu-gdpr-mini-toolkit-for-websites/ 

    Here you can find more information:

    If you want to know more about GDPR compliance you can consider enrolling in this EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course// 

  • Level of competence

    You asked

    if an individual who has 20 years plus of experience with both methods and hands on experience and is really knowledgeable on the subject, it that sufficient to provide responsible sign off of product even although the individual is not a doctor or a professional body member etc. 

    ISO 17025 requires personnel competency, however laboratory management must define the competency requirements for this activity. You need to base this on your sector, applicable legislation, and requirements from the accreditation body. For many sectors, highly skilled an competent personnel are not necessary member of a professional body. In other sectors it is mandatory. 

    What is required by ISO 17025 is that personnel must have assigned, communicated and well understood responsibilities an authorities. 

    Typically a laboratory will appoint a competent “signatory” who takes responsibility for the technical validity of results, and they sign the report. Bear in mind that depending on the size of the laboratory, other personnesl, such as a quality controller may be responsible for the quality control of a particular batch and may “sign off” the batch analysis as valid as the QC passed. The laboratory’ s quality assurance process should specify this, meaning what objective checks and responsibility does a  “sign  off” versus report “signature” indicate. Often the laboratory manager will co-sign a test report, taking overall responsibility for the approval of a report to go to a customer

    You also asked

    Is there a document that would define the requirements to sign off on testing and results etc.

    The specific technical requirement relates to technical quality assurance (control of the test method)., covered by ISO 17025 clause 7.7, Ensuring the validity of results. This should not be seen as the only requirement. It also requires knowledge and evidence that the overall Quality assurance of, for example suitable equipment, conditions, methods and metrological traceability is in place. Although these overall responsibilities may that of say a Quality Manager, the person approving the release of results should have evidence that the management system quality assurance is effective. 

    The following toolkit documents could assist you

    Quality Assurance Procedure at https://advisera.com/17025academy/documentation/quality-assurance-procedure/
    Competence, Training and Awareness Procedure and the four related appendices, available at https://advisera.com/17025academy/documentation/quality-assurance-procedure/
    Testing Report Procedure at https://advisera.com/17025academy/documentation/testing-report-procedure/
     

  • ISO 9001 Risk measuring

    First of all I recommend this free webinar on demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/ - where I develop the theme around managing risks.

    Standard reference in measuring Risks?

    Answer:

    As far as I understand your question there is no standard reference in measuring risk. Each person, each group of persons, each organization has its own standard for measuring risks. Even, what for some is a risk, for others is an opportunity.

    How it is measured? qualitative or quantitative?

    Normally, organizations develop quantitative methods to evaluate risk significance. They can use a matrix like this one:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/b88dee74-9e86-42bc-a11a-7740cf494b12

    To get results like this one:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/0a14e015-fc2a-4424-b3a4-96892a0a6630

    As a consultant, working with different organizations, normally I use that matrix approach, but I already used with some clients a more subjective and qualitative approach.

    How to identify risks?

    According to ISO 9001:2015 I recommend determining risks about:

    • The business context (clause 6.1, 41 and 4.2)
    • The products and services (clause 5.1.2 b))
    • The processes (clause 4.4.1 f))

    Think about expected results and what kind of uncertainties can deviate your organization from meeting them.

    Think about what can generate or promote undesirable results.

    Where to base your assessment? example manufacturing of foam industries.

    As far as I understand your question, start with my previous answer. What are your organizations main objectives and what in the business context can help or hinder in meeting them?

    The following material will provide you more information about risks and opportunities:

  • Addressing Improvement clause

    You asked

    1. How to address Improvement clause?

    The Quality Manual can be used to state the commitment and any policy addressing Improvements. Although a procedure is not mandatory, it is a commonly used non-mandatory procedure. This is because it is an important quality management system activity and you need to show evidence on how you consider, action and evaluate opportunities for improvement. This should be covered under the procedure Addressing Risks and Opportunities.

    See ISO 17025 document template: Addressing Risks and Opportunities Procedure, available at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/

    You also asked

    2. What data should be included in the context of Improvement data analysis

    For each potential opportunity, a benefit / risk evaluation should be performed. Inputs to the evaluation will be both subjective (knowledge of the system) and objective (for example client requests, contract requirements, strategic decisions).

    The record Registry of Key Risks and Opportunities, or similar, plus any other supportive records such as risk evaluation matrices should be used. The objective is to decide if the opportunity is worth the possible risk of change. Because the actions taken are required to be proportional to the potential impact, you can use a 3 x 3 risk and a 3 x 3 opportunities matrix for the evaluation to semi quantify the evaluation. Start with the benefit score. For example do a 3 x 3 opportunity evaluation where High = 3 points,  Med = 2 points and Low = 1 point. Consider Probability of successful implementation against Positive Impact. Multiple the probability and impact points to determine the Benefit points. Decide on a scale, for example if the Benefit points = 1 or 2 it is low, 3 or 4 is medium and 6 or 9 is high benefit.

    Then do the Risk Score. For example do a 3 x 3 Risk evaluation where Probability of Risk if you implemented the improvement change (High, Med, Low) against Severity, i.e. negative impact if implemented the improvement change (High, Med, Low) where again High = 3 points,  Med = 2 points and Low = 1 point. Multiple the points. Decide on a scale, for example if the Risk Score is 1 or 2 it is low, 3 or 4 is medium and 6 or 9 is high risk.

    Finally perform the overall Evaluation, which is a Benefit / Risk Ratio to guide your decision. State your approach, for example only implement if Low Risk and High or Medium Benefit; do not implement if benefit is Low or Medium and Risk is High; for all other cases evaluate further. Remember  this is not a policy to adhere to, but a guidance, to assist the laboratory decide (on a risk basis) which improvements to implement. Evaluating further will involve looking at how much resources will be needed, in terms of time and finances. These discussions could take place during management review.

    See the ISO 17025 document template: Registry of Key Risks and Opportunities available at https://advisera.com/17025academy/documentation/registry-of-key-risks-and-opportunities/ for more assistance

    The webinar How to manage risks in laboratories according to ISO 17025 will also assist, being available at https://advisera.com/17025academy/webinar/iso-17025-risk-management-how-to-manage-it-free-webinar-on-demand/

  • ISO 13485 implementation duration

    Small contract engineering firm, 10 employees. Decades of experience in product development but little in med devices. Starting from nothing, about how long should it take to achieve 13485 certification using the right consulting firm to assist?
Page 288-vs-13485 of 1128 pages

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