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  • Internal Audit by Consultant

    Yes, that has been my practice for the past thirty years with no problems. Consultant and internal auditor. By the way, strangely, ISO 9000:2015 definition for auditor removed the requirement for “formal independence”. What is a requirement is that the auditor demonstrates objectivity and impartiality. I work on that by preparing my checklists and leaving audit reports that describe precisely what I found.

    You can find more information about audits:

  • Performing a successful audit

    Auditing in ISO 45001, as with the other ISO management system standards, follows a process audit methodology, where you compare what is happening in the process to the planned arrangements to ensure that what is planned is what is happening. When auditing it is important to remember that you want to audit both the ISO standard requirements, and the process as it has been implemented at the organization. I have found that this can be done best as a two step process. First, during audit preparation you want to compare the process that is implemented (including procedures where they exist) against the ISO 45001 standard to see if what is planned to happens meets the requirements.

    Once you know that the planned process meets the requirements, you can prepare questions to ask employees to confirm that what is actually happening meets the requirements of the process as implemented. Some of the best questions then include “Can you walk me through the process you use?”, “What happens when there is a nonconformity?”, etc. These are open ended and allow people to explain what they do which you can then compare to the process that is planned. Remember, you are auditing for conformity, not trying to hunt for mistakes. These questions and expected answers will be specific to your organization.

    You can learn more about the process audit using the ISO standard for auditing management systems in the article: How to perform an internal audit using ISO 19011, https://info.advisera.com/free-download/how-to-perform-an-internal-audit-using-iso-19011

  • Requirements for proficiency testing / ILC and repeatability & repeatability

    I assume from your question that you are referring to the initial formal assessment for a laboratory being assessed for accreditation for the first time. If you are referring to a requested voluntary pre-assessment by the accreditation body, prior to the initial assessment, the purpose is to identify gaps ahead of the initial assessment, so the same requirements must be met; however the purpose is to identify issues to address before the formal assessment (without formal nonconformances raised, that would have to be cleared in a specified time).

    To clarify, the route to ISO 17025 accreditation by an accreditation body starts with implementation of the processes, procedures and controls by the laboratory to meet the requirements and address risks. This includes knowing the requirements of the accreditation body, which should be a signatory member of ILAC (the international organisation for accreditation bodies). This means that their requirements must be in line with ILAC policies, requirements and guidelines. The policy document ILAC-P9:06/2014 ILAC Policy for Participation in Proficiency Testing Activities is applicable to your question.

    Implementation includes method validation for all the tests that the laboratory will be accredited for (will appear on the accreditation certificate) of which repeatability (precision) is one of the performance parameters. The method validations must be completed and submitted by the laboratory, typically on application. Furthermore, for each test to be accredited, laboratory processes must be in place to ensure the validity of results (clause 7.7) which includes monitoring and evaluating longer term internal quality control data (intermediate precision) for typically a few months; as well as enrolment and participation in a proficiency testing program where  a 4 to 5 year plan is usually required.

    I suggest your obtain the method validation, proficiency testing and other relevant policy and requirement documents from your selected accreditation body.

    The ILAC Policy documents are available at https://ilac.org/publications-and-resources/ilac-policy-series/

    Have a look at the response to a question on Procedures for validation and verification of methods at https://community.advisera.com/topic/procedures-for-validation-and-verification-of-methods/

    The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ includes the procedure for validation and verification of methods, named Test and Calibration Method Procedure and the Quality Assurance Procedure.  The procedures are also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/ and https://advisera.com/17025academy/documentation/quality-assurance-procedure/

  • External Risks

    Natural hazards or calamities may be external issues that can translate into risks or opportunities. For example, a manufacturing company located near a flooding area may lose the capability to operate normally for several weeks. A hurricane can weaken a competitor and create an opportunity to expand activity. Today, I read in a newspaper that the coronavirus pandemic lockdowns worked as a boon for software game companies. It is up to each organization to determine the relevant issues from its context.

    You can find more information in the following links:

  • ISO 13485 for Class 1 FDA medical device

    Within Class I, if a device is classified into a general category of exempted devices, then no Premarket Notification application or FDA clearance is needed before selling the device in the U.S. But, the supplier is mandated to register its institution and submit a list of generic products to the FDA. These Class I devices are under the fewest regulatory controls. Class I devices that are not listed as exempted devices undergo a Premarket Notification application with the FDA.

    The classification procedure and market approval processes are fully explained in the 21 CFR Part 860 (Code of Federal Regulations for Medical Device Classification Procedures). For the USA market, ISO 13485:2016 is not a regulation or law, however, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the United States. 

    For more detail on this topic, please see the following articles:

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