ISO9001 Help

I don't have all the answers but I hope I can help you in answering your questions:

Since you have already started your gap analysis, you should complete it. Attending a course in understanding the requirements of ISO 9001:2015 will help you in completing your gap analysis. Once you have listed down all the gaps, you may ask help here to close the gaps or, better, call Andy.

The 3rd paragraph of Clause 8.5.3 Property belonging to customer or external providers says "When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred."

You don't need to purchase a software for your document control. It's appropriate that the owner of the process is the one who writes his/her procedure or work instructions. You can make use of the templates available in the internet to develop your own format. Typically, original or master copies of the documented procedures/instructions are kept by an assigned Document Controller. Reproduction of the master copies are controlled (hardcopies are suitably marked while softcopies are read-only). The objective is to make sure that only the current versions are available at points of use. The assigned Document Controller usually maintains a register (MS Excel or, if you're comfortable with databases, MS Access) to identify the latest revision level including the list of people with the hardcopies. A distribution list is usually needed so the Document Controller will know where to collect hardcopies once they are superseded.

What you have described above is sufficient to satisfy the standard. Clause 5.3 of the standard only says "Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization."

There is no requirement to document a procedure, as long as you can satisfy the requirements under Clause 8.3 Design and development of products and services. Though, you will need to retain documented information related to the Clauses on:

• 8.3.3 "The organization shall retain documented information on design and development inputs."
• 8.3.4f "The organization shall apply controls to the design and development process to ensure that documented information of these activities is retained."
• 8.3.5 "The organization shall retain documented information on design and development outputs."
• 8.3.6a "The organization shall retain documented information on design and development changes;"
• 8.3.6b "The organization shall retain documented information on the results of reviews;"
• 8.3.6c "The organization shall retain documented information on the authorization of the changes;"
• 8.3.6d "The organization shall retain documented information on the actions taken to prevent adverse impacts."

Consider the requirements under Clause 8.3.2 Design and development planning in developing your Product Launch Milestones.

By all means.

 

Andy and Tony thank you so much for your replies.

Andy - I am getting my thoughts together and will be giving you a phone call in the next few days.

Tony - I have completed the gap analysis, after re-reading my post I saw that I didn't really state that very clearly. I have completed it and we are working on closing the gaps!

Thanks again, I'm sure I'll be reaching out with more questions soon! (And P.S. - This forum is seriously the best thing since sliced bread!!!)

 

Personally, when I was setting up our present system, I actually found that a "Process Sequence and Interaction" flowchart was really useful - particularly as a training tool. I found that many people benefited from a visual overview of the system and its component processes. A with a flowchart it can be simple for people to recognize the specific inputs and outputs of their process, and how these are important to the overall system.

Otherwise, I'd say your current approach sounds great! Best of luck!

 

Thanks Mark, I agree! The "Process Sequence and Interaction" flowchart really is quite similar to how Mike Micklewright displays his Process Diagram in his 2 page quality manual; which is very useful. It is a good training tool - especially for new employees and that is exactly how we use it. I plan to implement our Process Sequence and Interactions chart into our Quality Manual to serve this purpose.

 

This is wild, this is the exact same scenario that I'm in. Bar the fact I've had my salary cut because 'I didn't have the skills that they needed' which is crazy because I've been hired for three months and hired at entry level!

I'm so stressed out the entire QMS system is on my head- being paid peanuts for a manager level role.

 

This is great thankyou