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SOP for Control of Nonconforming Product/Proces

According to the ISO 13485:2016, there is a requirement for the SOP for the Control of nonconforming product (requirement 8.3.1 General).

Return merchandise authorization is covered in the requirement 8.3.3 Actions in the response to non-conforming product detected after delivery. Usually, this requirement is covered in the same SOP for the Control of non-conforming products. Organizations must take actions appropriate to the effect that non-conforming products can be issued.

For more details, please see the following article:

• ISO 13485:2016 nonconforming product – How to approach the post-delivery actions https://advisera.com/13485academy/blog/2017/04/11/iso-134852016-nonconforming-product-how-to-approach-the-post-delivery-actions/
• Understanding dispositions for ISO 9001 nonconforming product https://advisera.com/9001academy/blog/2014/11/18/understanding-dispositions-iso-9001-nonconforming-product/

On the following link you can see how our procedure and template for the non-conforming product look like in ISO 13485:2016 Documentation toolkit:

• Procedure for Control of Non-Conforming Products https://advisera.com/13485academy/documentation/procedure-for-control-of-non-conforming-products-iso-13485-2016/
• Non-Conforming Product Record https://advisera.com/13485academy/documentation/non-conforming-product-record-iso-13485-2016/

• Excluding clauses of ISO 9001 for a law firm

  Excluding clauses is not a technical decision, it is a management decision based on the scope of the quality management system. For example, are Law firms not innovative and do not develop new services? Is clause 8.3 automatically not applicable?

  Only after looking into the scope of the quality management system, one can say if a clause is applicable or not.

  The following material will provide you more information about exclusions:

  What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
  Free webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope -
  Enroll for the free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• Environmental risk assessment in a garments factory

  You can start looking at your environmental aspects and impacts and determine what can go wrong and provide undesirable consequences like emergency situations or breakdowns.

  Then look for interested parties and determine possible changes for the future and their potential impact in your organization. For example, customer requirements may demand more chemicals, environmental legislation may be more demanding.

  PESTLE analysis may be useful to frame thinking about risks related with policy, technology, economy and social movements. Although about ISO 9001, perhaps the technique that I use and present in this free webinar on demand - Context of the organization, interested parties, and scope - - may be useful for you to work with context and interested parties to determine risks.

  Please check this information below with more detailed answers:

  • ISO 14001 risks and opportunities vs. environmental aspects - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
  • ISO 14001 document template: Procedure for Identification and Evaluation of Environmental Aspects and Risks - https://advisera.com/14001academy/documentation/procedure-for-identification-and-evaluation-of-environmental-aspects/
  • Enroll for free in this course – ISO 14001:2015 Lead Auditor Course - https://advisera.com/training/iso-14001-lead-auditor-course/
  • Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

   

• ISO 9001 and supply chain control

  ISO 9001 is a generic standard applicable to all kinds of organizations. If an organization uses ISO 9001 to improve the business and to do more than just getting a certificate, we can look into clauses 4.2 and 6.1 of ISO 9001:2015 as a way of answering your concerns. For example, in this free webinar on-demand - Context of the organization, interested parties, and scope - - I show how a set of participants in a business ecosystem can be included. When working with organizations on this topic I recommend thinking in more than just the needs and expectations of the interested party – that means:
  

  About the fake/fraudulent components, it is a matter of thinking about risks and acting on those more significant. For example, I’m currently working with a manufacturing company on the implementation of a quality management system. One of the risks determined was about using raw materials during production with specifications changed by the supplier without warning. So, we determined a set of laboratory tests to be performed every x months. 

  You can find more information below about mitigating risks.

  • How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
  • How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
  • In this free webinar on-demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
  • Enroll for the free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ (I use a lot of examples based on the risk-based approach)

• Controlled vs Non-Controlled copy

  Who are these students?

  Are they future users of the SOP’s? If they are future users of the SOP’s, will they have access to them in the future through paper or through another medium, like digital? If they will have future access to SOP’s through paper perhaps the copies should be controlled.

  If they are not future users, or are future users with future access through digital, distributing non-controlled copies seems to be the best solution.

  Controlled copies are used to ensure that those that need to use them are on the loop to be informed of any change

  You can find more information about documentation below:

  • Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
  • Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
  • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

• Seperation of the ISO13485/MDR toolkit.

  Templates for the ISO 13485 can and are recommended to be in one folder. Considering MDR, my recommendation is that MDR folders should be organized for one medical device or group (family) of medical devices – it means that each medical device or family of medical devices will have one folder.

  A medical device family is a collection of medical devices that have the same or similar intended purpose, have the same risk classification, and have the same design and manufacturing process. Members of the medical device family can differ in the following (for example):

  • in the sizes (e.g. gauzes different sizes, syringes with different volumes, gowns different sizes)
  • strength (e.g. needle force)

  • 17025 accreditation

    Indeed, if you are referring to your organisation performing the testing, ISO 17025 accreditation will demonstrate that the method is valid, and your laboratory operates competently. This will provide confidence in your work internationally.  Standardising a method would involve engaging with other experts in testing laboratories and applying to your sector-specific standards body or national standards body. A technical committee is formed to coordinate /manage the process.

    For more information on ISO 17025 see the article What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/

  • When is there a need to open and handle a complaint?

    No, you do not need to initiate the complaint in the case that you have described. However, this situation is an input to your design and development process and also for the risk analysis. Responsible persons from these two processes (D&D and risk management) must be informed about the cause and a change process probably need to be initiate. 

    Following articles can be helpful:

    • How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
    • How to use ISO 14971 to manage risks for medical devices https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/