"We are planning to implement ISO 9001 to our organization. Our organization is an IT firm where we develop web applications for customers. Our business is more than 5 years old. We are in the process of completing gap analysis checklist. We are not sure with few concepts. Can you please advice us, in general, how many documents or information we need on hand to show it to the audit firm? Also, how does organization's scope works with products and services along with international standard?”
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: