Where to include Scope and Context...

Hello everyone,
I am currently implementing the ISO 9001:2015 in our cosmetics production company from scratch.

Since the current version of ISO 9001 does not require the creation of a Quality Manual, I cannot find a way to include the Scope and Context of the Organization sections in our documents.

Where do you think this documented information should be included? How extensive does it have to be? How can you explain everything that is included in our QMS?

Thanks in advance.

 

Good day @CarlosNS , and welcome to the site...

"Where" you document any of this information is certainly up to you and your organization. Without seeing/being aware of your companies documentation/system structure I do not see how "we" can possibly give you direction on this.

I would counsel, however...
- Keep documentation to a minimum
- Keep documentation simple and direct (remember the audience the documentation SHOULD be those within the organization and not the auditor, etc...
- Organize documentation in a simple/visual structure so all relevant associates can easily locate/access.
- Do not duplicate documentation content (this creates a nightmare when it comes to maintaining common/current/consistent revisions and information).

Hope this helps.
Be well.

 

Thanks for the answer.
It is very true that the informations should be suitable for the organization and I am trying to work with that in mind (i.e. I focus on working with many short specific instructions rather than large documents involving a whole process).

So far, I have mentioned the scope parties and the context of the organization in the Quality Assurance procedure.

May a flowchart help on reviewing all this information?

Thanks

 

Thank you for the answer Andy.
I may be wrong, but I have created this QA process - and its associated documents - in order to ensure the correct implementation of the QMS throughout the company.

This procedure includes the ways to collect the indicators (KPI's) that are useful to later show the management the benefits of working on (and improving) a QMS.

So, all the documented information that I have decided to include in this document, in your opinion, what would be the best way to make it reach the different people who work in the company? For example.... KPI's, outsourced processes, self-inspections (not audits), traceability, market withdrawal process, cosmetovigilance,...

I do not see the use of creating a process for every one of these sections and since they are all dependent on having a QMS, I have decided to include this process to encompass all this information (and their respective records).

Thanks in advance.

 

I could send you by PM a sanitized version, but it is in spanish and still under construction... I'll see what I can do...

In order for you to understand, I will paste the "Purpose" of the procedure: "The purpose of this procedure is to define the scope of the Quality Assurance System, ensuring its correct application and functionality in COMPANY processes, identifying the requirements that meet the needs and expectations of the interested parties."

As you said, in the Managemen Review Process I have included the annual meetings for reviewing the data of all the processes (among other things), but not its calculation.

Probably by tomorrow I could hace a "clean" version of what I am working on. I would be greatfull if you send me your feedback on what you think can be improved.

Thank you.

 

Sorry but I have explained myself wrong.

There is a process for Management Review that sets out management responsibilities (among other things) with respect to company and quality objectives. These objectives are reviewed biannually by the Quality Committee and annually together with management. (This has been created following the guidelines of point 5 of the ISO 9001 standard).

However, this does not mean that the QMS is not reviewed daily. We have records and indicators that indicate how improvable each of the defined processes is, and this information is reviewed daily.

When you talk about check in with you what I understand from the meetings in section 4 (Context, interested parties, scope, ...), an initial meeting was held with the company's management to define the reasons why it was decided to implement a QMS and maintain it. They are fully involved, management is one of those responsible for reviewing and approving all the documentation generated.

What I am trying to understand, and it is not really clear for me, is where to include all the information in section 4 as documented information.

I hope I have clarified any doubts about these issues, since it is difficult for me to expose some of these in our documents.

Excuse the long text, but what you say is interesting and I want to do my job as well as possible.
Thank you.

 

Ok, now I understand what you mean. Thanks. I will think about include the context + scope + interested parties in our Management Review process.

 

Clauses 4.1 and 4.2 do not require documents. Both require organizations to "monitor and review information". Annex A.6 of the standard clarified this by stating:

Where this International Standard refers to “information” rather than “documented information” (e.g. in
4.1: “The organization shall monitor and review the information about these external and internal issues”),
there is no requirement that this information is to be documented. In such situations, the organization
can decide whether or not it is necessary or appropriate to maintain documented information.​

Monitoring/reviewing of internal and external issues (clause 4.1) can be done through:

• management and operational meetings;
• national and international press;
• websites and social media accounts;
• radio, TV, print, internet news;
• publications from government agencies;
• professional and technical publications;
• subscription to advocacy group publications;
• conferences with relevant agencies, professional associations;
• performance evaluations of the system, processes, employees and external providers

Monitoring/reviewing of needs and expectations of interested parties (clause 4.2) can be done through:

• reviewing orders received;
• monitoring compliance with statutory and regulatory requirements;
• handling customer feedback, including complaints;
• conducting customer or user surveys;
• monitoring customer satisfaction;
• holding focus group discussions;
• consultations with stakeholders;
• participating in relevant associations;
• market surveillance;
• benchmarking;
• reviewing supply chain relationships

 

We have Quality Objectives and Management Objectives. We do not have (yet) a bussines plan documented though.

 

Most of them are shared. Many of the Quality Objectives are included in the Management Objectives but not all of these Management Objectives (which can be compared to the Business Plan that Jennifer Kirley comments, for understanding).

The Management Objectives are usually focused on the activity throughout the year, while the Quality Objectives are short-medium term objectives and are carried out with the final results in mind. For us, it helps to check the status of our QMS during periodic meetings.

Do you think this can be approached in another way that will help us improve?

 

Hi all, sorry if my question is posted in the wrong forum section, but my question is the following : why is there no guide line in the ISO standard what should be included in the quality manual and what and/or which chapters should be kept as documented information in ISO 9001:2015. For me it's obvious that work instructions, related forms etc. need to be in the manual but what with the procedures ?
It's sometimes already hard to make the difference between a procedure and an instruction/SOP. If you follow and describe the 10 chapters from the standard what is left for the quality manual ? Or can you just include all information in the quality manual ? Not clear to me.

 

Good day @quality fan and welcome to the site.
ISO 9001:2015 requires no quality manual and no procedures.

Do what is best for your organization.

Hope this helps.
Be well.