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  • Laboratory activity - where to draw the line

    You asked why a testing laboratory, who conforms to ISO 17025 requirements to verify and calibrate their own equipment, cannot offer calibration services and calibration certificates for clients.

    Although ISO 17025 is applicable to both testing and calibration laboratories, the application of the standard differs. From a laboratory point of view, there are specific laboratory activities for calibration and testing laboratories, involving different technical and performance capability of equipment, operational activities and risks. Reporting requirements are also different. For the required purpose of metrological traceability to international units, an unbroken chain of calibrations is required, linked to appropriate references. For each chain a measurement uncertainty must be calculated so that the overall uncertainty can be known. Only then can a testing lab determine if a method is adequate for use. Testing laboratories generally rely on competent calibration laboratories to meet these specific metrological needs.

    From an accreditation point of view, accreditation bodies are themselves accredited for specific scopes, where testing and calibration scopes are independent and programs are managed separately. This said, an organisation could, in principle, apply separately for accreditation as a Calibration laboratory and as a Testing laboratory, each with their different range of activities and scope of accreditation

    Have a look at another ISO 17025 answered question that all addressed this topic - Calibration of measurement equipment, available at https://community.advisera.com/topic/calibration-of-measurement-equipment//

  • New measurement system

    I assume that by “CMM” you are referring to coordinate-measuring machines.  I cannot tell if the question is in the context of a calibration laboratories service, a legal metrology verification laboratory, or generally as a product quality assurance and quality control tool for a workshop (machining and assembly) in a manufacturing sector. There are a number of standards for measuring the geometry of physical objects. The ISO publication list is available at https://www.iso.org/committee/54924/x/catalogue/ Which are relevant will depend on the application, country, sector and any other regulations.  It could be, for example, a recognised national standard or other (based on an international standard) to which a verification laboratory will be granted accreditation.

    If the context is metrology for calibration laboratory, the ISO 17025 standard will require method development and validation and the evaluation of measurement of uncertainty to prove the system to be appropriate for its defined use.  ISO 17025 requirements must be met to ensure competency to produce consistently reliable results. 

    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, along a Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. 

    Have a look at other ISO 17025 answered questions for further information which may be of interest.
    Procedures for validation and verification of methods at https://community.advisera.com/topic/procedures-for-validation-and-verification-of-methods/
    Methods verification at https://community.advisera.com/topic/methods-verification/

  • ISO 45001 vs OHSAS 18001

    Probably the biggest change from OHSAS 18001 to ISO 45001 is the introduction of the context of the organization. This requirement means that you need to understand the internal and external issues that affect your OHSMS, as well as who your interested parties are and what their needs are. This information is used later in the standard to identify risks that are not directly related to hazards, as well as plans for emergency response.

    We have a pre-recorded webinar that discusses the change which may help: ISO 45001:2018 vs. OHSAS 18001:2007 – The main changes, https://advisera.com/45001academy/webinar/iso-45001-2017-vs-ohsas-18001-2007-the-main-changes-on-demand/

  • Certify company in safe data destruction and recycling

    We need to certify our company in the secure erasure of data, either by software methods or by the destruction of disks and that we can demonstrate or certify that the data is irrecoverable for the machines unsubscribed by the client.

     It is possible to certify a secure erasure of data process against ISO 27001, certifying that the process follows the standard's requirements and that the data is irrecoverable from the media where it was stored.

    But please note that ISO 27001 does not provide technical guidance on how to perform data disposal. For technical guidance, you need to consider additional references, like NIST special publications.

    These articles will provide you a further explanation about ISO 27001, how it can be used for media disposal, and NIST practices:

    These materials will also help you regarding ISO 27001:

  • ISO 9001 consultant challenges

    Some of the challenges of being a consultant are:

    • Finding new customers;
    • Winning a bad project;
    • Customers expecting that consultants do customers’ work;
    • Meeting project delivery dates;
    • Meeting budget target;
    • Always being in a research and learning mode

    You can find more information below:

  • ISO 9001 and property belonging to customers/external providers

    Clause 8.5.3 about property belonging to customers or external providers (suppliers) may not be applicable to every organization.

    Simpler case – a customer bought a product and that product is returned for planned maintenance, or for correcting some defect, or for upgrading some part (last week I updated my computer battery, for example).

    Business to consumer – your company sold a washing machine to a consumer and one of your company’s teams is going to install it at the consumer’s kitchen. You expect that the team does not damage the consumer’s kitchen.

    Business to business case – consider a brand that outsources the manufacturing of its garments to a manufacturer. The manufacturer buys and applies all materials, but the brand supplies the high-profile brand labels. Those labels must be protected from theft or any kind of loss. For all purposes, those labels are like money.

    Intellectual property – a customer sends you, the manufacturer, the blueprints of its later high-tech gadget. Customers expect that the blueprints are protected from theft or leaking into the media.

    Molds – A customer has a mold and asks your organization to manufacture injection molding parts with it. The customer expects that you don’t start injection parts with that mold for your own use

    External providers – It is becoming more common that organizations don’t possess equipment, they rent it to an external provider. For example, in a construction company, the scaffolding structure used may belong to an external provider.

    You can find more information below:

  • Inventory of Assets template

    For the value on the "Impact" column in the Inventory of Assets template, you must copy the value identified in the "Consequence" column in the Risk Assessment Table template.

  • ISO 27001 implementation

    Yes, the templates take into account the integration with ISO 27001 with other ISO management systems.

    Since 2012 all ISO management systems have common requirements aligned (e.g., control of documents and records, internal audit, management review, etc.), so you can use part of the documents you already have for ISO 9001 and make only small adjustments for them to be also compliant with ISO 27001.

    These articles will provide you a further explanation about integrating management systems:

    These materials will also help you regarding ISO 27001 implementation:

  • Information Security Policy vs IT Security Policy

    Please note that these are different documents:

    • the Information Security Policy is located on folder 02 (General policies), as you mentioned
    • the IT Security Policy is located on folder 08 Annex A Security Controls, subfolder A.8 Asset Management

    The purpose of the Information Security Policy is to define high-level information about how information security is managed, while the purpose of the IT Security Policy is to provide details on how to use the information system and other information assets.

    In the List of Documents file included in your toolkit, you can identify where each document is located and which clauses and controls are covered by each of them.

    This article will provide you a further explanation about the information security policy:
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