What Are The Documentation Requirements Of ISO 9001?
An ISO certification enhances the reputation of your service or product. There are different types of ISO certifications your business can apply for such as ISO 9001, ISO 14001, ISO 5001, etc. Each one is unique in itself. Here, we will discuss ISO 9001. Interestingly, in many cases, customers state that they will do business with only those vendors who are ISO 9001 compliant. It is the quality management standard that organizations follow to provide goods & services. The ISO 9001 allows organizations the flexibility to choose their documentation procedure, enabling them to plan effectively and efficiently and to control and organize their processes. This also helps them stay organized and on top of all their activities. Here’s a look at everything you need to know regarding the documentation requirements of the ISO 9001.
Why was the ISO 9000 revised?
1. To help small, medium, and large types of organizations develop a simple set of standards
2. Standardize the amount and detail of documentation that is required
3. Help in organizing the documentation process of different organizations
What is documented information?
As per ISO 9000 clause 3.8., documented information helps in communicating messages and also to serve as evidence of what work has been completed. It helps organizations study what they had planned, and how much of that they were able to complete. It also serves as a channel for knowledge sharing. The type of documentation depends heavily on the organization’s nature, products, processes, and degree of formality. It also depends on the level of communication within the organization, and what its work culture is generally. Examples of documents include paper, magnetic forms, electronic media, optical computer disc, photographs, and master sample.
What are the main objectives of documented information?
Serves as a tool for information communication, transfer, and sharing
Evidence regarding work undertaken and completed
Disseminate knowledge within the organization
Used for technical specification
Useful when it comes to product design and development
What are the Documentation Requirements for ISO:9001?
Clause 4.4- Quality management systems, better known as QMS, must maintain documented information in order to support daily operations and processes and to ensure they are completed as planned.
Clause 7.5.1- This clause explains that QMS documentation must include:
1. a) Information required by International standard
2. b) Information organization requires for the effectiveness of the QMS
The extent of documented information differs as per:
Activities performed by the organization
Processes undertaken by the Organisation
Products and services offered by the organization
The complexity of processes undertaken
Competence of persons involved
Documentation Requirement for QMS
1. Clause 4.3- Scope of the QMS
2. Clause 8.4.1- Evaluation and selection of suppliers
3. Clause 5.2- Quality policy
4. Clause 6.2- Quality Objectives
Documentation Required for Communication
These are examples of documents which help in adding extra value to the QMS