Documentation and scope

Answer:
1. About “how many documents” please keep in mind two phrases in ISO 9001: “keep documented information” and “maintain documented information”.

“keep documented information” means keeping records like an order from a customer, a validation checklist or a training session. Keep in mind that records can be in digital as well as in paper.

“maintain documented information” means keeping updated documents like the quality policy, or the scope of the system, or a procedure. ISO 9001:2015 does not include any requirement for mandatory p rocedures, it is up to each organization to decide what needs to maintain as a documented procedure. For example, an IT company can maintain procedures as digital checklists.

2.About the scope. For example, I work with an IT company that has three groups of customers to whom they develop software: manufacturing shoes companies; B2B commerce of fruits and vegetables and recycling companies. When developing their quality management system, they decided to just include under the certification scope the development, commercialization and service of software for the shoes manufacturing industry, because the other customers will not value working with a certified supplier.

The following material will provide you information about documented information and scope:

- ISO 9001 – List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
- How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/