Annex SL is the single biggest change to the ISO 9001:2015 document. Other topics that are new to ISO 9001 include:
a] organisational context (clause 4),
b] knowledge (clause 7),
c] the control of externally provided products and services (outsourcing, clause 8) and
d] the formal introduction of a risk based approach (several clauses), among others.
Amongst the areas of the standard that have been revised or now contain more specific information, organisations should pay attention to:
a] increased emphasis on top management engagement with ISO 9001 (clause 5)
b] managing change (clause 6)
c] performance and evaluation (clause 9)
d] management review (clause 9) and
e] repeat references to the process approach (several clauses).