What are the ISO 9001 requirements?

Written: 22nd May 2019
Author: Richard Keen

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.

What are the ISO 9001:2015 requirements? To become ISO certified, a company or organization must submit several 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.

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

What is ISO 9001:2015?

Creating, implementing and maintaining the 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 get the ISO 9009:2015 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:

  1. Newest edition published in 2015
  2. Improves customer experience and satisfaction
  3. List of requirements for consistent quality
  4. International quality standards used all over the world

 
Through the implementation of this system, the 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 consistent and continuous growth.

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

To put it simply, this certification shows that a certified company can be trusted. When a company gets certified, it means that they passed the standards of the ISO.

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

ISO 9001 requirements checklist

What are the 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.

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 Certification Mandatory Documents and Requirements

  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

ISO Certification Non-Mandatory Requirements

  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 the consumers, it also benefits the company itself. Each company has its own set of quality standards, but having it align with the ISO standards is important.

Through the compliance with the requirements set by ISO, companies are mandated to implement systems that focus on quality.

ISO 9001:2015 Quality Policy Stamp

Quality Management System (QMS)

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. 

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 benefitted from getting ISO certified.

Take a look at the list below to discover what some of the reported benefits, with a brief explanation of each one.

Reported Benefits of ISO Certification:

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 detailed clauses and individual requirements, there is very little room for mistakes within the daily operations of any type of business.

Related Questions

Do all companies need to apply for ISO 9001: 2015?

The ISO 9001:2015 applies to all businesses and organizations. If you own or run such operations, then it is highly recommended that you apply for the certification. This certification lets others know that the organization complies with the ISO standard of quality.

Why is the 9001:2015 certification highly sought-after?

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

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.
8.2.1
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.

Learn more about the requirements for products and services

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