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  • ISO 17025 queries

    You asked:

    1. What is the difference between certification and accreditation? 

    Certification is the process where an independent body provides formal written confirmation (assurance) via a certificate that a management system, service, person or product, meets specific requirements. 

    When a laboratory formally demonstrates to an independent third party assessment body, the consistent operation of a management system according to ISO 17025 and technical competency for a defined scope of work; the body formally declares the laboratory competent by awarding a Certificate of Accreditation. The laboratory is known as a conformity assessment body and is referred to as accredited, not certified. The third party assessment body, known as the accreditation body themselves need to be accredited to ISO 17011:2017 (Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies) to accredit laboratories.

    Organisations that demonstrate they meet the requirement of a Management system standard such as ISO 9001:2015 also undergo a conformity assessment by an independent certification body, but it does not include assessment of competency. 

    You also Asked

    2. I do not understand the concept of measurement uncertainty. 
    Can you help me with it? 

    Measurements by principle involve an experimental process to determine the true value of something of interest, for example amount of chromium in drinking water. The result is often obtained after a number of steps where each is influenced by possible systematic and random errors. A single result is therefore an estimate of the true value of what is being measured. Imagine repeating the test a number of times, under various conditions, over a long period. Each of these conditions, for example different personnel, reference materials, equipment performance would impact on the quality of the result by influencing the pattern and width of dispersion of results.  Measurement uncertainty  (MU) is the parameter which defines the interval around the measured value, within which the true value lies with some statistical probability. A simple example of this parameter is standard deviation. Bear in mind MU is made up of many components. The probability distributions of some components can be evaluated over repeated measurements (e.g from quality control charts). Others will typically be evaluated from information such as calibration or reference material certificates or assumed probability distributions based on experience of the technique.

    The importance of MU is the risk of a false accept or false reject of a result when making conformity statements. Consider if the upper tolerance threshold for chromium in water was 50 µg/L and a laboratory reports a result of 48 µg/L. This appears as a pass if MU is not taken into account. If the uncertainty MU for the test was 10 µg/L, statistically the range the result could have actually fallen (equally probability) is the from the measured value minus 10 µg/L up to measured value plus 10 µg/L, meaning  between 38 and 58 µg/L. This means there is a chance of a false pass if the MU is not considered – result could be as high as 58 µg/L.  This is why decision rules (ISO 17025 clause 7.8.6 Reporting statements of conformity) are reuired in certain cases.


    You asked

    3. I do not understand clause 6.5 Metrological traceability. 

    What do they mean by the measurement uncertainty of each calibration must be available?"

    Metrological traceability means there is confidence in the validity of the result as each step that could influence the measurement has a calibration traceable to the International System of Units. What “measurement uncertainty of each calibration must be available” means is that any equipment, such as balances, are calibrated by a calibration laboratory that conforms to ISO 17025 and the certificates state the measurement uncertainty of the calibration. Likewise the certificates supplied with weight pieces used for verification, certified reference materials, volumetric equipment and other items must be supplied with reported measurement uncertainty. In practice, the MU of, for example, the weighing step in preparing a sample cannot be smaller than the MU of the balance in that range of operation.

    The following may be useful to you:

  • Framing Standard Process Conditions (SPC) and specifications

    Many thanks for your replies. Now I have some idea what is to be done.

  • Team training in Good Manufacturing Practices - is it essential?

    It is essential to educate employees that are directly involved in manufacturing the medical device - workers in the production, workers in the warehouse, workers in the quality control, cleaning staff. Also, some management staff also need to be educated to know how premises have to be organized (eg. to avoid cross-contamination), what resources it is necessary for the smooth implementation of GMP, what knowledge it is necessary to ensure for smooth conduction of GMP.

  • Legal requirements related to 27001 in the UK

    We are not legal experts, so our recommended approach is indeed for organizations to hire local expert advice to identify legal requirements that must be fulfilled to be compliant with the ISO 27001 in your country. An online search can help at the beginning of your work (for an overview), but local expert advice is highly recommended.

    This article can provide a start: https://advisera.com/27001academy/knowledgebase/laws-regulations-information-security-business-continuity/

    But please note that the list in this article is not fully up-to-date because it depends on voluntary contributions from our readers – therefore, it is likely that not all regulations for each country are listed (some even may have been withdrawn).

    This article will provide you a further explanation about the identification of requirements:

  • Implementation of ISO 27001

    Unless there is specific marketing-related information included in the ISMS scope (e.g., information related to new products), or one of the expected outcomes of the ISO 27001 implementation can be marketing-related (e.g., enter a new market), there is no specific expectation from a marketing role in an ISO 27001 implementation project.
     
    Regarding documents requiring marketing role's attention in implementation, it will depend on how marketing will be involved. In the previous examples (i.e., when marketing-related information is included in the ISMS scope, or when one of the expected ISMS outcomes can be marketing-related), documents to be evaluated by marketing role are the ISMS scope and the Information Security Policy. By understanding them and being involved in their elaboration, it can become clearer what is expected from them and what they need to do.

    Additionally, after implementation, other relevant documents will be those security documents that employees of the marketing department use in everyday work - e.g. Information classification, Backup policy, etc.

    For further information, see:

  • Perform an audit using ISO 17025 guidelines

    To succeed with effective internal audits, the purpose and ISO 17025 requirements of clause 8.8 (internal auditing) must be clearly understood and met. A good understanding of the ISO 17025:2017 standard is needed as the audit criteria will be ISO 17025 and the laboratory’s own requirements. Refer to the white paper Clause-by-clause explanation of ISO 17025:2017. Internal auditing in an ISO 17025 laboratory involves auditing both management and technical activities. Plan the technical and management audits separately.  Select Technical auditors who have a good technical working knowledge of the particular technical activity they are auditing. Base your approach on the general guidelines of the ISO 19011 standard, Guidelines For Auditing Management Systems. Techniques / tools that will assist include checklists, document reviews, questioning and listening during interviews, and witnessing of activities. Follow these steps as a guideline:

    1. Seek objective evidence against the audit criteria.
    2. Document observations, recording audit findings, documents and records supplied during the audit, including version.
    3. Justify confirmation of findings as compliant or noncompliant against the audit criteria.
    4. Discuss the noncompliant findings with the auditees and raise nonconformances (NC) using the process agreed to, either within the audit report or on a NC form.

    The following will provide more information:

  • Mandatory roles in ISO 9001

    ISO 9001 does not prescribe any particular role. ISO 9001 gives total freedom to organizations about the way they distribute responsibilities and authorities among their people.

    You can find more information below:

  • Record Retention

    AS9100 does not dictate where to identify the record retention for each of your records, so you can do so in either procedure that you choose. We often recommend that each procedure that has a record includes a listing of records that gives the detail of how long the record will be kept, but exactly how you do this is up to you. You should also not that not all processes in the QMS require a documented procedure to be written in order to meet the requirements.

    You can read more on the new requirements for procedures and records in AS9100 in the article: A new approach to document and record control in AS9100, https://advisera.com/9100academy/knowledgebase/new-approach-to-document-and-record-control-in-as9100/

  • Changes to consider in regulating data transfer between EU and US

    The Schrems II decision revoked the adequacy decision that the EU Commission made over Privacy Shield. Before this decision data transfer between the EU and the US was allowed, because Privacy Shield was considered to provide an adequate safeguard for data and rights of EU individuals. Now the US is not considered to provide adequate safe space for privacy and rights of individuals, so the GDPR requires that controller and processor adopt Standard Contractual Clauses (SCC) in order to implement rights and safeguards on behalf of data subjects.

    You need to consider that your US recipient of data transfer can offer you a standard of data protection which is compliant with GDPR and use in your legal undertaking the Standard Contractual Clauses.

    Here you can find our free template with Standard Contractual clauses: https://info.advisera.com/eugdpracademy/free-download/standard-contractual-clauses-annexes

    You can find some information about data transfer under GDPR here:

    You can also consider enrolling in this free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//
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