What are the mandatory requirements of ISO 9001?

Don’t be disheartened by the large number of procedures in ISO 9001. As every organization is unique, most of them may not be relevant to you or your company. In the earlier version, there were only six mandatory procedures that a company needed to adhere to become certified. However, this status quo has changed. The latest standard version was updated in 2015 and now provides much more flexibility to organizations. This article will discuss the answer to “What are the mandatory requirements of ISO 9001?” for your organization to become certified.

How are requirements categorized in ISO 9001?

Before discussing ISO 9001 essential documents, to know ISO 9001 meaning, read the linked article on the Edara Systems website. ISO 9001 demands two types of documents to become ISO 9001 certified. These include documents and records, which include policies or objectives that your organization has set and can be amended later. Records, on the other hand, serve as evidence of all the results achieved by your organization. Records can never be altered, changed or revised as they serve as evidence/proof of an outcome.

The mandatory documents of ISO 9001 

Let’s discuss the answer to “What are the mandatory requirements of ISO 9001?”. ISO 9001 requires organisations to produce the following mandatory documents to become ISO 9001 certified. These include:

• Scope of the Quality Management System (QMS): As per clause 4.3, the scope statement should include the boundaries of the QMS, stakeholder participation, and other relevant details of interested parties so that, during an audit, the auditor knows the limit to which the QMS extends.
• Quality policy: As per clause 5.2.2, an organization’s quality policy is a set of defined criteria that the organization is attempting to achieve in relation to the design, functionality, and reliability of its products or services. Understanding the quality policy will help the auditor assess if the organization is succeeding or failing to achieve it.
• Quality objectives: As per clause 6.2, organizations not only have to produce the quality objectives but also have to outline how these objectives will be achieved. The purpose of presenting the quality objectives to the auditor is that it forms the foundation of all your operations.

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The mandatory records of ISO 9001 

The list of records is extensive, but remember, as each organization is different, this list will vary. For example, if you are a manufacturing company, you will need to present proof of how you are monitoring and measuring your equipment and its calibration; however, this does not apply to you if you are a service-based company. In such a case, the auditor will focus on service requirements review records. The mandatory records for ISO 9001 are:

• As per clause 7.1.5.1, organizations must submit their monitoring and measuring resources.
• As per clause 7.1.5.2, organizations must submit monitoring and measuring equipment calibration records.
• As per clause 7.2, records that evaluated staff competency must be presented.
• As per clause 8.2.3.2, the review records of your product/service requirements need to be presented.
• As per clause 8.3.3, your design and development input records need to be submitted.
• As per clause 8.3.4, the records of the current controls in the design and development operations have to be presented.
• As per clause 8.3.5, the records which have assessed the outputs created in your design and development operations need to be presented.
• As per clause 8.3.6, if any changes were made in the design and development operations, the record of the changes should be submitted.
• As per clause 8.4.1, you must present a list of the selection criteria you utilized to evaluate and shortlist your suppliers.
• As per clause 8.5.1, the specific characteristics of your service or your products need to be presented along with samples of the current batch.
• As per clause 8.5.2, records of identification and traceability systems need to be presented. 
• As per clause 8.5.3, records about customer property, including any modification, should be presented.
• Clause 8.5.6 states that control records dedicated to any changes in product or service provider should be presented.
• Clause 8.6 dictates that proof of the release of products and services should be presented.
• Clause 8.7.2 dictates that the control of non-confirming outputs should be included.
• Clause 9.1.1 dictates that monitoring and measuring results should also be presented.

These included the mandatory records that may vary from organization to organization. The following list contains the mandatory non-negotiable requirements that every organization, irrespective of the fact that they are a manufacturing or service-based company, has to present. This includes:

• Internal audit results, as per clause 9.2.2.
• Management review results, as per clause 9.3.3.
• Results and current status of corrective actions, including opportunities for improvement as per clause 10.2.2.

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Acquire ISO consultant help for the ISO 9001 requirements checklist 

While reading the above list, you must have realized why documentation is called the most challenging part of the certification process. It is always beneficial to acquire the help of an ISO 9001 consultant, as they are experts in analyzing your processes and understanding which documents should be presented to achieve compliance.

Edara Systems consultants help you with ISO obtaining procedures.

In this article, we have discussed the answer to the “What are the mandatory requirements of ISO 9001?” question. In conclusion, ISO 9001 requires many documents and records to be presented to achieve compliance. While the list of records is variable, you must present internal audit results, management review results, and results of corrective actions.

Similarly, when talking about mandatory documents, the scope of the QMS, quality policy, and quality objectives should be presented. If you need help getting your company ISO 9001 certified, visit edarasystems.com and contact the most professional ISO consultants in Australia.