ISO/FDIS 9001:2015 QMS requires an organization to determine and control legal and regulatory requirements for company products and services. It is the responsibility of the organization to demonstrate compliance with its quality management system. When reviewing this ISO/FDIS 9001:2015 QMS standard, we note in the introductory part of the standard that this standard can be used by internal and external parties. Therefore, it is essential that the organization is aware of the general and specific legal and regulatory requirements that apply to the product and services as part of the quality management system. In this context, it is recommended to have a working group team with legal knowledge. The team must determine the applicable legal and regulatory requirements regarding the organization`s products and services. The responsibility of staff and functions in compliance with those requirements should be defined and implemented. Team members can also study industry best practices to get ideas for the smooth implementation of these requirements. The difference between legal and regulatory requirements is subtle. In general, a legal requirement is an established rule, such as copyright, trademark protection, Sarbanes-Oxley Act (SOX).
A regulatory requirement is established by government agencies. As a method of demonstrating senior management leadership and commitment, legal and regulatory requirements must be identified, understood and met. In sections 8.2.2 and 8.2.3.1 when defining and reviewing requirements for goods and services. No less than thirteen times the term “legal and regulatory requirements” has been used in the ISO/FDIS 9001:2015 QMS standard, including the introduction and Annex A. This article is an attempt to understand the meaning of the term and how the organization should comply with it. Regulatory requirements stem from regulations issued by government agencies. When a law is written, we make sure that it has no other meaning, because when different cases are brought before the courts, these laws should not be interpretable. The term “legal and regulatory requirements” has been used in 0.1 General of this standard, which states: “The potential benefits to an organization in implementing the quality management system based on this international standard are (i) the ability to consistently provide products and services that meet the customer and applicable legal and regulatory requirements. Legal and regulatory requirements should be taken into account when defining design and development inputs in section 8.3.3. In Section 1 – Scope of the Standard, it has been used three times to emphasize the importance of compliance and compliance with applicable legal and regulatory requirements. Through these methods, the quality management system can demonstrate compliance with the legal and regulatory requirements of products and services.
Clause 8.5.5 requires that legal and regulatory requirements be taken into account when determining the scope of the required post-delivery activities. The term “legal and regulatory requirements” may be expressed as legal requirements; as explained in note 2 of section 1.1 (General) of ISO/FDIS 9001:2015 – QMS standard. The team must ensure that established legal and regulatory requirements are communicated to affected employees or functions with a copy to senior management. However, the question here is, “What is the difference between legal and regulatory requirements?” – Regulatory requirements are enforced by regulators such as OSHA or the EPA. Statutory is a term that refers to something that comes from Parliament or a legislative body. This term is used with laws, and therefore the term “legal laws” is derived. The following will help you distinguish between the two: The internal audit process can support compliance and evidence by assessing “legal and regulatory requirements.” It is advisable for the auditor to obtain relevant information from internal and external sources regarding the legal and regulatory requirements applicable to products and services during the preparation phase of the audit. The term “legal and regulatory requirements” appears 12 times in ISO 9001:2015. Together, these two requirements are also called legal requirements. Legal requirements are often supported by criminal sanctions for non-compliance, while regulatory requirements do not provide for such penalties.
If the law is not successfully passed, only a few amendments can be made to it and then passed again in Parliament. Legal laws are adopted throughout the country. It does not matter whether a region has these laws or not. If the law is written into law, it must still be respected. From a cybersecurity and data protection perspective, legal compliance requirements include: Legal requirements are applicable requirements due to government laws.