Use promo code:
CTA20

Expert Advice Community

Guest

Questions on document management

  Quote
Guest
Guest user Created:   Dec 19, 2017 Last commented:   Dec 19, 2017

Questions on document management

1. If Quality Manual isn't mandatory, how to establish processes of QMS? Any alternative tools for this?
0 0

Assign topic to the user

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Strahinja Stojanovic Dec 19, 2017

To establish a process means to define how the process is conducted, what are the inputs, outputs, responsibilities and resources necessary within the process. It can be done in different ways depending on the complexity of the processes and risks of nonconformities emerging in the process. If you have complex processes where lot of things can go wrong, it is better to have documented procedure that explains in details how the process is carried out. If you have simple processes or your employees are very competent, you can define the process just with flowchart or quality plan.

2. Which documents exactly should be recorded or retained?

The standard has significantly decreased the amount of documents that are mandatory, basically only the scope, quality policy and the objectives are considered as a mandatory documents. The focus of the new version of the standard is more on providing evidence on whether something was done in ac cordance with requirements than how it was done.

For more information, see: List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

3. If an organization already has a number of documented procedures but with 2008 reference, how to dispose of them?

You should follow your current procedure for document control and apply rules for document disposal defined by this procedure. If you don't have such rules defined, I would suggest you to mark the documents as obsolete and keep them as a part of the archive.

4. How to determine the required types of mandatory or non-mandatory documents & records based on different types of industries?

The mandatory documents will be the same regardless of the type of industry, this will depend on which requirements of the standard are applicable to your organization. For example, if you exclude design and development, you don't need to have records required by the clause 8.3 design and development.

When it comes to non mandatory documents that will be part of your QMS, you need to make a decision on what documents should be included. Usually for more complex activities or processes you will have more documents simply to ensure they are carried out as planned.

These materials will also help you regarding the documentation:
- Book DISCOVER ISO 9001:2015 THROUGH PRACTICAL EXAMPLES https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Dec 19, 2017

Dec 19, 2017

Suggested Topics

Guest user Created:   Nov 11, 2019 ISO 9001
Replies: 1
0 0

SOP approval signature needed or not

Guest user Created:   Nov 08, 2021 ISO 9001
Replies: 1
0 0

Interviewing an auditee