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  • Overview of complete links for whole company QMS

    Unfortunately, there is no straightforward way to review the company's QMS documentation according to                  IATF 16949: 2016 standard.

    Important issues for major QMS documentation are given below.

    • The company has a documented methods in front of each "documented process" statement written in the standard,
    • The existence of a risk assessment system for each place where "Risk" is mentioned in the standard,
      Documentation of the quality manual,
    • Documentation of all QMS processes and documentation of at least 12 months of KPI data.
    • Inclusion and evaluation of customer-specific requests in the QMS system.
    • Documentation of machine set-up, maintenance, usage instructions, measuring equipment instruction work instructions, etc.
    • Availability of all relevant records (PPAP, corrective action, FMEA, capability analysis, MSA results, production and product approvals, supplier assessment and evaluation results, internal audits, management review results, job descriptions, Quality Policy, training records, etc.) in the system.

  • IAFT 3rd party training for PPAP

    The IATF 16949: 2016 standard does not expect 3rd party PPAP certification. In addition, there is no expectation of 3rd party PPAP certification. However, internal auditors and person who is preparing PPAP documentation may need PPAP training.Since the competence of the person giving the training is important.

    The instructor of PPAP training can be a 3rd party IATF 16949: 2016 and/or VDA 6.3 auditor, etc. Or the instructor's CV should be competent and sufficient in the PPAP subject. 

  • Risk vs Impact

    They are different. Environmental impacts are about the changes to the environment resulting from an organization’s environmental impacts:


    https://www.screencast.com/users/ccruz5284/folders/Default/media/f22fed39-62e0-4338-b967-cab7e77ba9e6

    Risks are about the effect of uncertainty. Most of time there is no uncertainty about impacts, they are happening and predictable.
    The impact is about the consequences for the environment, while the risk is about processes, products or services.


    https://www.screencast.com/users/ccruz5284/folders/Default/media/be180b68-ea2f-4ca1-84a5-7cd4abf08150


    Some risks become higher when they are associated with an abnormal or emergency situation.


    You can find more information below:

  • Document control and compliance with ISO 9001

    In order to be in compliance with the ISO 9001:2015 standard, a company only need to have Document Control in place for documents and records relevant for the quality management system.

    You can find more information about documentation below:

  • Educating staff on risk management

    According to ISO 9001:2015 risks must be:

    • determined
    • evaluated
    • acted upon the most relevant

    About determination I would provide a set of examples about risks and opportunities in processes, products, services and from the context, and I would train people to determine risks and opportunities.

    About evaluation I would develop a simple matrix to reduce subjectivity in evaluating risk and opportunity relevance, and I would train people to evaluate risks and opportunities.

    About acting, I would ask people to help develop actions to minimize probability of occurrence and/or minimize consequences of occurrence. I would also ask people how to monitor the implementation and effectiveness of those actions.

    Show examples and invite them to be part of the approach.

    You can find more information below about risks.

  • How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs?

    Requirement 7.5.6 consider the validation of processes for production and service provision. Section 4.1.6 considers software validation. In small companies, always is a question of how to implement this requirement. You have to understand that you need to validate only software that can have an impact on the or quality of your management system or on the safety of the medical device. This means that you do not need to validate word processor or spreadsheet software. But if you have software for managing your warehouse and delivery process, that you need to be sure that in the case of a software update, your warehouse quantity of goods, lot numbers, invoice numbers, and delivery notes have not changed.

    If you have any software in the production, software that runs the machine, that software also needs to be validated. 

    However, these validations are not software type validations. With this validation, you need to prove that the software updates did not disrupt your database. 

    For example, for the number of the invoices and delivery notes, the easiest way is to check the is numbering in the expected sequence, for warehouse, does the quantity on the shelves corresponds to the number defined in the program. 

    You can see how the record for software validation looks like in our ISO 13485:2016 Documentation toolkit here:

    • Record of Software Validation https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/

    • The best approach for QMS

      Standard ISO 13485:2016 is a standard that covers a quality management system for a manufacturer of medical devices. According to the section 1 Scope, this standard is applicable even for your type of the product: In section 1 Scope of the ISO 13485:2016 is stated that this standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide a medical device and related service that meet customer requirements and applicable regulatory requirements.

      For a company to be certified against ISO 13485, it needs to be in the medical device industry (manufacturer, distributor, importer). There are specific requirements that are connected with the specialty of medical devices like sterilization, installation and service activities, traceability of the medical device production, special requirements for traceability of implantable medical devices, validation of software is software is a medical device, and so on. 

      The process of implementation is to create and document all of the processes required by the ISO 13485 standard, as well as customer and regulatory needs. Our ISO 13485:2016 toolkit combines documentation templates and checklists that demonstrate how to implement this standard through a step-by-step process. In addition, you can access help from our experts to keep you on the right path, ensuring a straight-forward journey to ISO 13485 certification. You can buy the whole toolkit, or you can buy separately documents that you considered that you need.

      It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like: number of the employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take 3-4 months, for the company with up to 50 employees, some 8-12 months. But, once again, this is just the estimation.

      For more information about ISO 13485:2016 please see the following articles:

      You can see how our ISO 13485:2016 Documentation toolkit is composed here:

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