Context of the Organisation
Good day
With regards to section 4.1, 4.2, 4.3, 4.4 in ISO 22000:2019, what type of documents are required to fulfill these clauses, ie Policies or Procedures?
thanks
Hope you meant "ISO9001:2015" not "2019."
Our Quality Manual addresses them in the body as text, with visuals (matrix/chart) and closes with a "for more information, see Policy X, and Procedure 123."
I had no hand in drafting our Q Manual, but it is laid out to mirror the ISO9001:2015 standard, same heading and paragraph numbers... which makes it very easy to use in an audit.
Short of that, you could merely define your context of the org in a policy letter...
Attached Files
We use what we think is the minimum possible to pass the audit, but our ISO 9001 auditor has given it the stamp of approval.
1. A formal, documented management meeting near the start of the calendar year, for the purposes of (a) discussing the Context etc. of the organisation and (b) the Business Objectives for the coming year.
2. A section in our Quality Manual where we have two tables literally stating (respectively) (a) the Context of the company and (b) the Needs and Expectations of Interested Parties.
3. A Quality Policy that arises from and references the above.
Also for section 9, you would need evidence that the Context, Needs, Expectations etc. are being discussed in management meetings, e.g. in MRMs.
Good reminder! Management review is where you can shore up much of your QMS... "fill in the blanks" so to speak. Document it in slides, or meeting minutes and it will help you in the audit!
Good day
With regards to section 4.1, 4.2, 4.3, 4.4 in ISO 22000:2019, what type of documents are required to fulfill these clauses, ie Policies or Procedures?
thanks
Sorry I meant ISO 22000:2018
Hi,
For context of the Organization as such there is no specific document required however a SWOT analysis or Risk assessment based on the nature of business will suffice, this can be part of your FSMS Manual or Management Review but in both cases it shall address the threat/ risk associated with your business and what are the protective/Safeguard measures organization is addressing.
For example if you are a Meat processor then one of the risk can be Salmonella contamination. which can impact the business. This is just one example of external issues
Internal issue can be untrained staff who can have an impact on the food safety etc.
4.2. Interested Parties can be your Customers, suppliers, legal or statutory bodies, employees etc.
Ex. If you are adding an ingredient which can be an allergen then it will have an impact on your customers (Interested parties) so how you are going to address it? most common way is communication through labeling etc.
4.3. Is the scope that is the limits of your FSMS like which products, processes and locations are covered under it.
Hope clarified.
Regards
Nazahath