What are the ISO 9001 requirements?

What are the ISO 9001:2015 requirements? To become ISO certified, a company or organization must submit documents that report its internal processes, procedures and standards. These documents (or Quality Management System) determines that a company is able to provide quality products and services consistently.


Are you are thinking of becoming ISO certified? Looking to find the latest ISO 9001 requirements? Well, they have changed considerably since the last version of ISO 9001. Everything you need to know about the latest requirements — monitoring, documents and records is right here.

There are mandatory and non-mandatory requirements; to find out which of the requirements you should document, please see below.

ISO 9001

What is ISO 9001:2015?

Creating, implementing and maintaining your Quality Management Systems (QMS) is an important documentary requirement for any company. It formalizes the procedures and policies that promote the quality of products and services that a company provides.

One way to do this is to follow the ISO standard and gain ISO 9001:2015 certification.

The international standard that is known as the ISO 9001:2015 gives a list of requirements for a system that determines that a company is able to provide international-quality products and services consistently.

ISO 9001:2015

  • Newest edition published in 2015
  • International quality standard used world wide
  • Improves customer experience and satisfaction
  • Ten clauses of requirements

Through the implementation of the standard, ISO 9001:2015 aims to improve customer experience and satisfaction.

It also aims to improve the internal system of a company so that it is able to produce quality services and products while promoting a culture that is aimed towards growth and continuous improvement.

The ISO stipulates quality management principles, which, when complied with by certified companies, reassures clients that the company has established a proper Quality Management System.

To put it simply, ISO certification shows that your company can be trusted.

Moreover, it means that the products and services delivered by a company is of international-quality; aligned with different companies from countries all over the world.

ISO 9001 requirements folder

What are the ISO 9001 Requirements?

As with any standardization or regulatory organization that awards certifications, you can expect that there are a lot of requirements to comply with — especially since this is an international standard.

All the ISO 9001 requirements are set out by ISO in ten clauses.

Mandatory requirements need to be complied with, while non-mandatory requirements may be submitted for documentation purposes. To be certified compliant with ISO 9001:2015, the following documents must be submitted.

ISO 9001 Mandatory Requirements — Documents and Records

  1. Monitoring and measuring equipment calibration records
  2. Records of training, skills, experience and qualifications
  3. Product/service requirements review records
  4. Record about design and development outputs review
  5. Record about design and development inputs
  6. Records of design and development controls
  7. Records of design and development outputs
  8. Design and development changes records
  9. Characteristics of product to be produced and service to be provided
  10. Records about customer property
  11. Production/service provision change control records
  12. Record of conformity of product/service with acceptance criteria
  13. Record of nonconforming outputs
  14. Monitoring measurement results
  15. Internal audit program
  16. Results of internal audits
  17. Results of the management review
  18. Results of corrective actions

Non-Mandatory Requirements — But Often Included

  1. Procedure for determining context of the organization and interested parties
  2. Procedure for addressing risks and opportunities
  3. Procedure for competence, training and awareness
  4. Procedure of equipment maintenance and measuring equipment
  5. Procedure for document and record control
  6. Sales procedure
  7. Procedure for design and development
  8. Procedure for production and service provision
  9. Warehousing procedure
  10. Procedure for management of nonconformities and corrective actions
  11. Procedure for monitoring customer satisfaction
  12. Procedure for internal audit
  13. Procedure for management review

After reading through the lists above, you might be thinking that his must include a lot of paper work!

However, do note that because each company is unique and is run differently, having this certification lets other companies and people know that what your company does and produces passed an international standard of quality.

Not only does the ISO certificate benefit your consumers, it also benefits your company itself.

ISO 9001:2015 Quality Stamp

ISO Quality Management Systems (QMS)

A Quality Management System (QMS) refers to the sets of policies, procedures and other records that serves as a guide as to how a company delivers products and services.

In other words, it is a sort of internal manual of how quality is maintained within the company and with its output. The QMS is an entire system that is defined by documents that illustrate and report the policies and procedures that promote quality of a company’s product and/or service.

A company’s quality management system illustrates its systems for planning and executing its projects; this includes how to improve customer satisfaction.

In general, Quality Management Systems aim to set standards of practice within a company. By doing this, a company hopes to be able to formalize and document how they are able to produce their products and services. Beyond the outputs of the company, the QMS also details the training that is needed for the continuous growth and improvement of employees through trainings.

Employees play an integral role in the how an organization works, so it is important to ensure their professional growth within the organization.

Each company may have a different QMS because of the nature of the business and how it is run.

While most (in not all) companies aim to produce quality products and services, the quality management system of each company may look different from another company’s quality management.

Applying for the ISO 9001:2015 certification “legitimizes” the procedures and practices stated in a company’s quality management system. A company that receives the ISO certification means that the company is compliant with the requirements. 

ISO 9001 certification

Benefits of Getting ISO Certification

Based on the list of mandatory and non-mandatory requirements for certification, it seems that the task is too daunting! However, data has shown that companies have greatly benefited from getting ISO certified.

  • Customer satisfaction – To satisfy a customer’s needs, the company must first identify their market and its needs. By having insight regarding the needs of their market, companies are able to continuously deliver products and services that fulfill the needs of their market.
  • Integration of internal policies and procedures – Collating all Quality Managements Systems (QMS) documents and having is certified as compliant by ISO aims to streamline the company’s processes and procedures.
  • Improved company image and reputation – getting or even attempting to get ISO 9001:2015 certification is no easy feat. As mentioned earlier, having this certification puts a company in the ranks of other companies from around the world that follow the same quality standards.
  • Company culture that is aimed towards continuous improvement – a company that complies with the ISO 9001:2015 have procedures that aim to improved products and services; it also aims to promote the professional development of its employees and the company culture.
  • Opportunities for partnerships – because getting ISO-certified impels that they meet international standards of practice, there are certain companies that make ISO certification as a requirement to become an accredited supplier in their organization.

To tie this up, the ISO 9001 outlines a set of quality standards that must be actively followed and maintained by any certified organization in order to ensure that everything coming in and out of the business is in tip-top shape for distribution.

While becoming certified with ISO 9001:2015 is not a legal requirement in order to run a company, it is highly recommended for the best possible business practices and results.

With all of the ISO 9001 ten clauses and requirements, there is very little room for mistakes within the daily operations of any type of business.

PDCA learn about ISO 9001

ISO 9001 Clauses - PLAN

ISO 9001 Clauses - DO

ISO 9001 Clauses - CHECK

ISO 9001 Clauses - ACT

Do All Companies Need To Apply For ISO 9001: 2015?

ISO 9001:2015 can be applied to all businesses and organizations. If you own or run an operation you wish to continuously improve, then it is highly recommended you go through the process and gain ISO 9001.

Why Is The 9001:2015 Certification Highly Sought-after?

ISO 9001:2015 is a highly sought-after certification. Although the task is challenging, it implies that a company has the necessary documentary requirements to comply with the international standard set by ISO and is a sure signal of quality.

What are the Requirements for Products and Services?

ISO 9001:2015 ISO 9001:2008 Summary of Changes
8.2 Determination Of Requirements For Products And Services 7.2 Customer-Related Processes Title only.
Customer Communication 7.2.3 Customer Communication Includes a new requirement for organizations to obtain ‘customer views and perceptions’ instead of ‘customer feedback’.
8.2.2 Determination Of Requirements Related To Products And Services 7.2.1 Determination Of Requirements Related To The Product This new requirement replaces ISO 9001:2008 Clause 7.2.1 - Determination of Requirements Related to Product Requirements. Organizations should implement a process to determine the requirements for the products and services that it intends to offer to customers.
8.2.3 Review Of Requirements Related To The Products And Services 7.2.2 Review Of Requirements Related To The Product This requirement is comparable to ISO 9001:2008 Clause 7.2.1 - Determination of Requirements Related to Product and Clause 7.2.2 - Review of Requirements Related to Product. The requirement states that organizations should now include a review of the requirements arising from any relevant interested parties.
8.2.4 Changes to Requirements for Products & Services N/A No ISO 9001:2008 Equivalent This is a new requirement for organizations to ensure that all relevant documented information; relating to changed product or service requirements, is amended and those relevant design personnel are made aware of the changed requirements.



Updated: 29th November 2021
Author: Richard Keen

Richard Keen

Richard Keen

Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard

ISO templates

Don’t Try to Manage It All Alone!


Our ISO Auditors and Quality Manager Trainers have been in this industry for years, and since 2002 we’ve been providing thousands of small businesses and large corporations with the tools they need to get certified.

Instead of trying to create everything you need to follow this process from scratch, use ours. We have procedures, templates, checklists, process maps, forms and gap analysis tools to help your documentation without missing a single input or output.

Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our templates.

Start with expert templates, then make them yours


ISO Checklists
ISO Quality Manuals
ISO Gap Analysis tools