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  • Statement of Applicability

    When going for the certification audit, you should have most of your controls implemented, and make sure that controls that mitigate the biggest risks are fully implemented, or the certification auditor can consider that the ISMS is not ready for certification yet.

    In other words, you can leave only a smaller number of less significant controls to be implemented after the certification. In your case, you have to ask risk owners to accept the residual risks related to this control still "in progress".

    This article will provide you a further explanation about certification:

    This material will also help you regarding certification:

  • Implementing ISO 9001 when ISO 22000 is already in place

    While ISO 9001 has as its purpose meeting and improving customer satisfaction. ISO 22000 has as its purpose food safety.

    I can understand that an organization applies to both certifications since they have different purposes and can signalize different messages to interested parties.

    The following material will provide you more information about ISO 9001:2015:

  • Are intermediate checks required for calibration laboratories?

    A calibration includes evaluation of measurement uncertainty and provides metrological traceability to SI units. The purpose of intermediate checks is to maintain confidence in the calibration status of measuring and test equipment in-between calibrations. This, for some applications may be daily, and others before use. An example is the verification of the performance of a calibrated balance by using calibrated mass pieces in the working range for the measurement. Where results are favourable, intermediate checks can provide justification for the extension of calibration intervals.

    All laboratories, both testing and calibration must have a procedure to perform intermediate checks when necessary to maintain this confidence in the performance of equipment. “When necessary” will depend on the nature of the equipment and the purpose of the measurement. When a calibrator (reference standard or certified reference material) is used every time before a measurement, a calibration is being performed – no need for any “intermediate” checks.  

    For more information on associated calibration intervals, refer to ILAC G24:2007 Guidelines for the determination of calibration intervals of measuring instruments (note currently under revision) available for download at https://ilac.org/?ddownload=818 
    and the ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

  • ISO 9001 benefits

    ISO 9001:2015 can benefit an organization through:

    • a better definition and standardization of processes;
    • a common and explicit set of priorities around a strategic orientation translated into a set of objectives;
    • a focus on customer and other interested parties’ satisfaction;
    • developing a basis for evidence decision making;
    • an improvement of credibility and image.
       

    The following material will provide you more information:

  • Technical Records

    This is a good question. It is an example of the need to take a risk-based approach to creating records. I can’t tell from your question if the temperature monitoring relates to a piece of equipment (e.g. an incubator oven or water bath); or environmental conditions (e.g. room temperature). Either way, you need to look at the risks of not recording something of importance, and equally risk of recording something like "n/a" and having to justify during review or audits, that in fact it was not applicable. It is therefore advisable to avoid using n/a on a technical record. 

    To resolve  this issue, consider the purpose of the record and therefore it’s design. There are three questions here – why the data / information needs to be recorded, what must be recordered and when ?  If the purpose relates to a manual operation, e.g. to verify a temperature specification was met for glassware used for the preparation of samples; then the recorded temperature must cover the duration of the activity. If the need, as in this example, always excludes recording data outside of operational hours, then an option could be to redesign the form so that there is no need to record over weekedends, thus avoiding using "n/a". You would document in a procedure or test method, why and when the particular temperature record needs to be supplied.  Generally, you could state for equipment, the need to manually record temperature “before use”; while  general environmental conditions like room temperature and humidity are recorded “at the beginning and end of each shift”.

    Don’t forget if there are specific risks, such as temperature fluctuations which could affect the validity of the results; then the temperature should be recorded at the time, not just at the beginning of shift. If the activity affected by temperature extends outside of operational hours, then the use of a min and max recording may be required, or even live temperature loggers. Consider, for example, the risk of a refrigerator housing valuable reference bacterial cultures or sample, failing on a saturday morning and only being discovered on a monday morning.

    For more information, see the ISO 17025 toolkit document templates:  Facilities and Environmental Condition Procedure  and Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/facilities-and-environmental-condition-procedure/ and https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure// as well as 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/

    Some additional information is available in the ISO 17025 Expert Community question regarding Environmental conditions for testing and calibration laboratories, available  at https://community.advisera.com/topic/environmental-conditions-for-testing-and-calibration-laboratories/

  • ISO 13485 Servicing vs FDA refurbishment of medical devices

    This means that service activities can be provided by your supplier, and service activities can be outsourced to some other company. Then, of course, with this outsourcing, the company must be managed as described in 4.1.5.

  • Is 5S Methodology shall requirement of IATF 16949?

    5S is not a requirement of the IATF 16949: 2016 standard. 5S is a customer-specific requirement from Toyota. If TOYOTA is your customer, you have to comply with 5S requirements. 

    However, in the article 7.1.4.1 of the IATF standard, "The organization will maintain its facilities in case of an order compatible with the product and production process needs, in case of cleaning and repair".  Even if it is not specified as 5S in the IATF 16949:2016 standard; nevertheless, cleanliness, order, standardization is a very important issue for automotive expectations.

    These issues, as you know, are the main foundations of 5S and must be complied with as an IATF 16949:2016 standard requirement.

  • Procedure for correcting the wrong report

    IATF 16949: 2016 standard states as follows in its article 10.2.6. 

    ‘’The organization shall perform analysis on customer complaints and field failures, including any returned parts, and shall initiate problem-solving and corrective action to prevent a recurrence.  Where requested by the customer, this shall include analysis of the interaction of embedded software of the organization's product within the system of the final customers' product  The organization shall communicate the results of testing/analysis to the customer and also within the organization.’’

    Therefore, it is always necessary to send the correct analysis report.

    If it is seen in the IATF 16949:2016 audits that you have submitted the wrong report, this issue must be handled as non-conformity. As you realize, you can apologize to your customer and send the correct report.

  • Are Data Protection Laws extra territorial?

    Are Data Protection Laws extra territorial?

    GDPR has an extra-territorial effect. According to Article 3 GDPR, it applies to all processing of personal data in the EU and to all processing of EU individuals all around the world. Therefore, UE companies and companies processing EU personal data need to comply with GDPR.

    GDPR allows EU Member State to develop some internal regulation in certain fields and these internal rules have a territorial effect in the Member State.

    Do Data Protection Regulators in various countries communicate with each other?

    Yes, they all belong to the European Data Protection Board (EDPB) where they can cooperate and develop some guidelines to help internal interpretation.

    You can find more information here:

    You may also consider enrolling in this online EU GDPR Foundations Course:

    • EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

    • Requirements for Medical Gown Production under ISO 13485

      There are no strict requirements regarding environmental criteria for the manufacturing of medical gowns. According to the ISO 13485:2016, requirement 6.4.1 Work environment, the organization must document requirements for the work environment needed to ensure that the final product is in conformance with the requirements and specifications. If the medical device is sterile, the manufacturer must document requirements for control of contamination with microorganisms. It means that it is up to the manufacturer to decide which cleanroom classification he will use and how will he control that medical device is sterile. Usually, manufacturers of medical gowns have a cleanroom class ISO 7 according to the ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. 

      A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity, and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 microns and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used. Cleanrooms are classified by how clean the air is and according to the number and size of particles permitted per volume of air.  

      For more information about the cleanliness of medical device production, please see the following articles:

      You can also see in our ISO 13495:2016 Documentation toolkit how Procedure for Infrastructure and work environment look like on the following link: https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/
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