What are the Documentation Requirements for ISO 9001?

Last Updated at: Dec 23, 2020
ISO 9001
In June 2020, Odisha became the first Indian state to obtain ISO certification for hostels meant for tribal students. This is a part of the ‘Mission Suvidya’ project launched by the State ST&SC Welfare Department to provide all the tribal hostels in the state uniform standards of infrastructure, amenities, and human resources.


For organizations that don’t have full documentation, rigidly follow policies, or might have undiscovered shortcomings or vulnerabilities, there is an accepted way to identify and address these gaps.


Any company that leverages its services in manufacturing and services is required to have an ISO 9001 certification. It is a mark that signifies that the company adheres to international quality standards, thus assuring that the company is delivering quality products and services to its customers. Any customer, who purchases the company, can cross-check whether the company has ISO 9001 certification or not. Quality standards work as a decision-maker, and hence ISO 9001 certification becomes a must. Therefore, in this article, we will be unfolding different details related to ISO certification and documentation.

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Why is ISO 9001 Certification required?

Before you go ahead for ISO, it is important to note that there are different kinds of ISO registration like:

        • Quality Management                    – ISO 9001 2008
        • Environmental Management         – ISO 14001
        • Information security Management – ISO 27001
        • Food Safety Management             – ISO 22008

Moreover, for quality management, you would need an ISO 9001 certification. Therefore, in this article, we will be illustrating various documents required for the same.

When it comes to the documentation for ISO 9001, it will depend on the size of your organization. Besides, other factors impact the documents required that includes:

  1. Type of activities, products, and services offered by the organization
  2. The complexity of business processes
  3. Nature of activities
  4. Competence of persons

Also, know more about what is ISO 9001.

Why would you need to go for ISO 9001 certification?

ISO 9001 certification implies that the products and services provided by the company meet international standards and indeed are of good quality. This certification is mandatory because:

  • It acts as proof of activities done as per the protocol
  • Management of the company can review the current processes and look for scope of improvement to ensure quality policy and deliverables
  • To carry out the process in a controlled manner
  • Reduces and further minimizes the errors
  • Enable effective communication between different verticals
  • Creates a benchmark and reference for understanding, implementation, and maintenance of a system
  • Helps in achieving consistency in actions
  • Brings transparency in business processes

Get your business iso certified

What are the different types of documents required for ISO 9001 registration?

The entire process of documentation is divided into four different levels:

Level 1 – Quality Manual

Firstly, the very first document requirement for ISO 9001 is a quality manual that has all the details about the structure of the organization. These documents must also meet the relevant management systems, explaining how the goals will be achieved while maintaining the quality of a prima facie.

Level 2- Documented Procedures

Secondly, every organization needs to have a specific protocol of work and this must be the principal document that would work as a standard document. This document would entail all the procedures written in detail, along with the quality standard that they need to match.

Level 3-Work Instructions

A work instruction is a detailed document mentioning all the details of various activities carried on in an organization. Indeed it mentions even the smallest of steps that help in achieving the desired result.

Level 4- Records and Forms

These are the records of all the work done. The management can later use it for reviewing or gauging the scope of improvement. Moreover, it would contain labels, cards, worksheets, forms, tags, etc.

Check out this blog: How to check the ISO certification online?

The 5 Steps Of ISO Registration

ISO 9001 Requires the Following Forms:

  1. Customer property
  2. Design and development verification
  3. Purchasing process
  4. Management Reviews
  5. Identification and traceability
  6. Internal audit
  7. Monitoring and measurement of the product
  8. Control of production and service provision
  9. Design and development output
  10. Competence, awareness, and training
  11. Design and development inputs
  12. Design and development validation
  13. Planning of product realization
  14. Design and development changes
  15. Control of monitoring and measurement equipment
  16. Design and development review
  17. Design planning output
  18. Review of requirements
  19. Corrective action
  20. Validation of processes for production and service provision
  21. Control of nonconforming product
  22. Preventive action
  23. Analysis of data

As it is already mentioned that the number of documents may differ for different organizations based on its size, complexity of processes, and other factors, there are six procedures for ISO 9001. However, for quality processes, some organizations might add new sets of procedures. Hence, the basic six procedures defined by ISO are:

  • Control of Documents
  • Control of Records
  • Internal Audit
  • Control of Nonconforming Product
  • Corrective Action
  • Preventive Action

Wrapping it up

It becomes imperative for any organization to have all the documents well-maintained and updated; it not only helps in gaining the trust of the stakeholders investing in the company but at the same time, customers also gain trust in the organization. However, having well-written documents impacts the reputation of the organization. Besides, it also gives you an insight into how well the company follows the standard protocols, which eventually ensures quality process. In addition to it, the protocols help employees follow a standard procedure which can help in improving the overall efficiency of the organization.

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