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ISO 9001 auditing and inspection guidelines

Unfortunately, we do not have any guidelines about good auditing practices concentrated in a single document.

What we have is distributed among courses, books, webinars  and articles. For example:

• Article - Surveillance visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
• Article - ISO 9001 internal auditor training: Is it for me? - https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/
• Webinar - Free webinar on demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
• Course - Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
• Course - Free online training ISO 9001:2015 Lead Auditor Training Course - https://advisera.com/training/iso-9001-lead-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/
   

Implication of EU MDR Deadline on 26th May 2021

You have to check that with Notify's body. Basically, certification under MDD is possible until May 2021, but Notify bodies to have their own dates until it is possible to certify the medical devices under the MDD.

CE Certificate that will be issued before May 2021 under the MDD is valid until 26/05/2024. 

However, be aware that periodic audits that will be performed after May 2021 – therefore period audits that will be performed under the MDR – will require certain documentation to be ready according to the MDR requirements. First of all, this refers to the Post-market surveillance system. This process needs to be in place in accordance with the MDR requirements on the first periodic audit. It means the following for example: if you receive an MDD audit in April 2021, your first-period audit will be in April 2022. On that periodic audit, your post-market surveillance system must be in place according to the MDR requirements.  

Required process documentation for certification

What process documentation from across the company is required for certification?

Inventory management

There is no direct requirement in the ISO 13485:2016 that cover inventory management. In requirement 5.1 Management commitment is stated that management must ensure the availability of resources. Furthermore, in 6.1 Provision of resources is stated that top management must determine and provide resources needed to implement the quality management system and to meet applicable regulatory and customer requirements.

Inventory management usually considering to determine the vital stock levels. Following steps can be used to control your stock levels: establishing levels of operating stocks based on consumption/rate of usage; maintain periodically stock usage reports of each item kept in the store; establishing quantity, lead time, and availability of each item supplied on the market; keeping a record of all non-stock items received from suppliers, returned to suppliers and issued out to users.

Of course, as inventory management important is to have under control shelf life of both raw and packaging material and final goods; to follow the FIFO (first in first out) or FEFO (first expire first out) principle, which you find most useful for your type of production. 

The following article can be helpful:

• How to use the ISO 9001 standard to improve stock efficiency and increase profit https://advisera.com/9001academy/blog/2016/11/08/how-to-use-the-iso-9001-standard-to-improve-stock-efficiency-and-increase-profit/

You can see how we describe this process in our procedure for warehousing in our ISO 13485:2016 documentation toolkit:

• Warehousing Procedure https://advisera.com/13485academy/documentation/warehousing-procedure-iso-13485-2016/
• Procedure for wholesale and retail operation https://advisera.com/9001academy/documentation/procedure-for-wholesale-and-retail-operations/
• ISO 13485:2016 documentation toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/

• ISO 14001 cost and benefits

  About advantages, please check these articles - 6 Key Benefits of ISO 14001 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/6-key-benefits-of-iso-14001/ and - ISO 14001: The benefits for customers - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/

  About costs, it is difficult to answer because ISO 14001:2015 imposes nothing that the legislation does not impose. Thus, the costs incurred to comply with the legislation are not imposed by ISO 14001: 2015. Other costs are implementation and maintenance costs for the management system. For example, I’m currently working with a manufacturing company where costs of waste disposal are going to be reduced because of introducing waste segregation and recycling and by avoiding landfill.

  You can find more information about ISO 14001 below:

  • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
  • Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

• Necessary facility requirements to build medical devices

  This really depends on the type of medical device that you produce. Facility requirements are not the same for example, for the software or sterile gauze products. 

  If you have a sterile medical device then it is necessary to monitor the cleanliness of the production premises. Usually, medical devices that need to be sterilized are produced in a cleanroom. Requirements necessary for the cleanroom are stated in the ISO 14644 family of standards. 

  Depending on the type of sterilization, each method has its own facility requirements.

  Storage place is also important if there is a strict requirement for the storage temperature and humidity. 

  For more information, please see the following article:

  • Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/