You are required to determine external and internal issues affecting your understanding of the organisation and its context.

External issues could be considered a macro review – whats going on in the economy eg BREXIT whats going on by way of technological changes, is your industry moving from product based to service based? Are any changes in the legal environment going to affect you eg patent roll-off, or perhaps is the government going to add, or take away any subsidy for the marketplace you operate in eg Farming, Solar, Energy

Internal issues is a much fluffier idea to get your head around. Why are we here, what do we do, what are our values, mission statement possibly – do you want to review this at every management review meeting? Probably not, but you need to demonstrate that you consider it to your auditors and that it fits within the operation of you business. We suspect most auditors will only be interested in a cursory glance at this item, unless it is a big deal for you. Equally these issues could be combined with the risk assessment you conduct as part of Planning  section 6.1 and these collated within the same record / plan. This would typically be reviewed at a management review meeting see here

In order to be a better company, the ISO 9001:2015 standard is wanting you to think not only before you sell to customers, but think before you even begin your processes. There could be an argument that would suggest it would make the organisation less reactive to customer requirements, but lets revisit that in section 8.2 requirements for products and services

We invite you to leave your comments below this post and any other post, we then either update to the post to reflect your comments or reply directly to you. Obviously if you want an answer that is specific to your organisation, you are better off contacting us for a better and discreet discussion.


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