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.

Contents

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

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.

Structure

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

From clause four with its sub-clauses, the requirements would be as follows;

  • Clause 4 — Context of the company/organization
  • Clause 5 — Leadership
  • Clause 6 — Planning
  • Clause 7 — Support
  • Clause 8 — Operations
  • Clause 9 — Performance Evaluation
  • Clause 10 — Improvement

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.

Documentation

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

>> Review a Checklist of the 21 Records Required by ISO 9001

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, having this certification lets other companies and people know that using a process approach and continual improvement, your company passes 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. 

PDCA quality management

ISO 9001 Clauses - PLAN

ISO 9001 Clauses - DO

ISO 9001 Clauses - CHECK

ISO 9001 Clauses - ACT

Updated: 21st October 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 Checklist

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 Procedures