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  • ISO 45001 documents for system control

    The ISO 45001:2018 standard does not define how you must create your documentation, or how it must look. In terms of procedures you can use whatever format works best for your organization, including flow charts, text documents, or even diagrammatic instructions if that is what works for your employees. As for records, again whatever format make sense to you for a particular record then that is what you can use. This is of course limited by any legal requirements that may exist for records and reports, such as a government form that needs to be submitted.

    The general flow for creating documentation should go like this: What information do we need to document? Is there a required format to use (such as legal or other requirement)? If not, what is the best, and simplest, way we can record this information so that it is usable for us?

    You can learn more about the new documentation requirements in the article: New approach to ISO 145001 documentation, https://advisera.com/45001academy/blog/2018/03/13/new-approach-to-iso-45001-documentation/

  • Evidence for clause 8.1.1 and 9.1.1

    thank you carlos.

  • ISO 9001 Internal audit tips

    That is an almost personal question. In my opinion, based on my experience, a good study of the audit criteria is of paramount importance to develop a sound checklist in order to audit with confidence, based on audit criteria and not on opinion.

    You can find more information below:

  • Clause 6.2.2

    You asked the meaning of “qualification ,experience", which relates to the personnel clause 6.2.2 in ISO 17025.

    It is mandatory that the requirements for each role are documented and records kept. It starts with identifying the personnel resource needs of the laboratory and defining them in terms of functional role, in terms of primary laboratory activities (refer to clause 5). Meaning that although the organisation may employ a person as say “Grade 4 laboratory staff”, their role is that of “technician”, “laboratory manager”, “lead analyst”, or “laboratory assistant”. For each of these functional roles, the laboratory must document requirements for education, qualification, training, technical knowledge, skills and experience.

    Qualifications are formal evidence of completing and meeting (passing) the required criteria of an institution which has a formal authority through for example a national qualification framework, or chartered institution of professionals. Example requirement for a function could be an Honours degree or higher from a recognised university plus a National Certificate in Quality Management Systems through an formally recognised institution. Note that qualification requirements can also be part (completed modules), for example “conducting audits”, a module of the diploma.

    Experience is knowledge and skills that a person gains over a period of time while participating in activities. For example, a requirement for a function a could be “Minimum  five 5 years’ experience working in an ISO 17025 accredited analytical chemistry testing laboratory conducting sample testing and quality assurance activities. At least two years  developing or reviewing management system documents and at least two years internal auditor experience”.

    The following toolkit document Competence, Training and Awareness Procedure may be of assistance, available. There are four related appendices, all part of the toolkit available at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

  • ISO 9001:2015 in mechanical engineering

    Design and implementing a quality management system (QMS) for a mechanical engineering firm implies being knowledgeable about ISO 9001:2015. Now the standard is less and less bureaucratic, it is up to each organization the task to design, develop and implement its QMS.

    Setup a project sponsor, a project manager and a project team. Determine the scope of the QMS, your organization may decide to include only certain lines of business. Ensure top management support, get training and as a first step perform a Gap analysis, to determine the amount of work to be done - comparing what your organization already has in place versus ISO 9001:2015 requirements. From that GAP Analysis you can develop your Project Plan, listing what needs to be done, by whom, until when.

    Then, an important step is to design a model of how your organization work as a set of interrelated processes. For example:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/682a30fb-ab44-4b94-9d5e-a5947da139a7

    Decide how to describe and monitor those processes.

    From there it is implementation in order to close the gaps found. Then, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.

    This is a very short description of the journey but below you can find more detailed information:

  • Clause 7.7 7.7.1

    You asked

    "The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to from (a to K) please can you explain b, c, d, h

    Option b involves an equivalence study, were you would compare for the same method;  the performance of new instrument or technology to previously validated one. An example would be changing the analysis part of a test method from Atomic absorption spectroscopy (AAS) to ICP-OES (Inductively coupled plasma - optical emission spectrometry).

    Option c, being functional checking involves evaluating the performance of the equipment. Depending on the equipment, this may be provided via software, for example checking analytical sensitivity before starting analysis.

    Option d simply involves running samples or standards that are not certified reference materials, but laboratory in house samples or standards. For example you prepare a sample in bulk, well homogenised and stable that you use for you validation, determine mean and standard deviation; establish a control chart with limits and then run the sample routinely comparing the result against previous results.

    Option h involves using professional knowledge of characteristics that have a known correlation. As a simple example there is, by principle of pH measurement;  a positive correlation between soil pH and extractable Ca and Mg.

    You also asked to explain

    Data from monitoring activities shall be analysed, used to control and, if applicable, improve the laboratory’s activities. If the results of the analysis of data from monitoring activities are found to be outside pre-defined criteria, appropriate action shall be taken to prevent incorrect results from being reported."

    The pre-defined criteria can include for example, allowed variance between replicates (acceptable %), that the control sample must fall within an acceptable limited range of results (between upper and lower limit); and over time, a random up and down pattern around the mean is observed for plotted results. The laboratory must state the criteria based on risk and purpose of the test.  When you monitor a test result using regular control charts, you firstly establish your mean and standard deviation using typically, at least 30 results over a period of time. You then establish the limits 2 or 3 standard deviations from the mean, depending on the level of confidence you require.  This means that that at 2 SD there is 95% confidence that the sample results should fall in the range. Note this also means at 95 % Confidence 5 out of 100 may will fall outside, but may not be statistically significant. You must consider the signifance. Simply what a laboratory is looking for is acceptable variation (deviation), realistic limits and if a deviation is observed, stop and consider the impact before releasing results. If trends are observed within the limits, for example consecutive points indicating a positive bias above the mean, consider the risks and opportunity to investigate and make improvements.

    The following ISO 17025 document template may assist further:
    Quality Assurance Procedure at hhttps://advisera.com/17025academy/documentation/quality-assurance-procedure/

  • Orthopedic device manufacturers

    So far, there is no such a unique list for Europe. However, each country in Europe has a national authority where all medical device manufacturers need to be register together with a complete list of medical devices.

    At USA market, such databse is on the FDA webpage, on the following link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/textsearch.cfm

  • Set time for internal training related to ISO 14001

    No, ISO 14001:2015 does not state any mandatory frequency for training, any kind of training.

    Please check clause 7.2 about competence. Competence is what is behind the need for training. If people are competent there is no need for training. For example, if an internal audit raises a non-conformity about errors on waste segregation, it may be a sign of a lack of competence that could be eliminated with training.
    If your management system has internal rules setting a frequency for training, your organization has to abide by those rules.

    The following articles might provide further guidance:

     

  • Prerequisites for ISO 27001 implementation

    There are no prerequisites for the implementation of ISO 27001 (i.e., an organization does not need to have any security control previously implemented before starting implementing ISO 27001), although the pre-existence of some good practices may help implement the standard faster or easier.

    To identify your situation regarding ISO 27001 you can use our ISO 27001 Gap Analysis Tool at this link: https://advisera.com/27001academy/free-iso-27001-gap-analysis-tool/

    These articles will provide you a further explanation about implementing ISO 27001:

    These materials will also help you regarding implementing ISO 27001:
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