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Requirements for the certification-process

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Guest user Created:   Sep 23, 2019 Last commented:   Sep 24, 2019

Requirements for the certification-process

I was reading that in the 2015 version of ISO 9001 some requirements for the certification-process were reduced for (very) small-companies. Can you tell me which requirements were reduced?

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Sep 24, 2019

ISO 9001:2015 has no certification requirements. ISO 9001:2015 reduced the amount of mandatory documented requirements. The standard gives a lot of freedom to decide what kind of documented procedures or work instructions are needed, if any (see clause 4.4.2). Clauses 4.1 and 4.2 can be treated without any mandatory records, something that can be particularly useful for SME.

The following material will provide you with more information about the transition to ISO 9001:2015:

- Article - How to make the transition from ISO 9001:2008 revision to the 2015 revision – https://advisera.com/9001academy/blog/2015/10/06/how-to-make-the-transition-from-iso-90012008-revision-to-the-2015-revision/

- List of mandatory documents required by ISO 9001:2015 – https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

- Enroll for free course - ISO 9001:2015 Foundations Course – https://training.advisera.com/course/iso-9001-foundations-course/

- Book - Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Markus Sep 24, 2019

The main-goal of my question is to find out if i need all documents in my case:  i have a one-man company without any production-process and a VERY tiny storage. So I only buy and sell. So which documents would be mandatory in my case?

I am asking because I want to know if i need to buy the complete Toolkit, or if - maybe in my case - ~20 Documents would be enough, which i also can buy one-by-one as i saw.
(For example do i need a internal audit, if i do not have any employees / beside myself ?)

What is your advice in my case and why?


Thank you very much!


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Carlos Pereira da Cruz Sep 24, 2019

In the article List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ you can find that small list of mandatory documents, they are the minimum.

Now, for a one-person organization I would use clause 4.4.2 suggestion to the fullest. You draw your map of processes (see an example in this free webinar - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ ) and then you can think like this: Is there a process or set of activities that is/are too complex, or not performed regularly and that may give rise to doubts or forgetfulness? If that is the case(s), the existence of a work instruction or procedure may be helpful. For example, yesterday I visited a company where instead of work instructions they have flyers like those of supermarket promotions to help you remember how to act, for example, when you need to order a special transport service with police escort, something done 2 or 3 times a year.

Once your organization is a one-person organization, I would write my own procedures very simply. Perhaps just a flowchart can do the job.

If you don’t have enough experience with ISO 9001, and/or is in a hurry to get certification, I would recommend buying just those documents that are more about the quality system like:

  • Management review 
  • Corrective actions 
  • Internal audits 
  • Documents control 
  • Maybe context, internal parties and managing risks.
     
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Markus Sep 24, 2019

Hello,

Thank you for your answer!

So if i buy ONLY those around ~15 documents, i will be ready/able to be certificated based on that documents?
I have nearly zero knowledge about the topic, and i am a bit scared that it maybe could not be enough and the audit fails.

So i am kind of hoping for a statement like buy: A. D. E. W. X fill in the data and you are ready to go?

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Carlos Pereira da Cruz Sep 24, 2019

I cannot fool you and write that. Certification is not just the output of a paper filling operation. So, before buying any document I invite you to enroll for free in our ISO 9001:2015 Foundations Course, that way you will plunge into the standard and get an idea about what is and what is needed. And you will not lose your time because you will learn the basics to interact with certification auditors in the future. Implementing a quality management system according to ISO 9001:2015 is about following some rules, satisfying customers, and meeting important objectives.

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