No less than thirteen times the term „legal and regulatory requirements“ has been specified in ISO/FDIS 9001:2015 QMS, 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. Why is compliance with legal and regulatory requirements important? Clause 4.2 uses legal and regulatory requirements while understanding the needs and expectations of interested parties. Failure to comply with legal compliance requirements can open risks beyond fines. The term „legal and regulatory requirements“ has been used in section 0.1 General of this standard, which states: „The potential benefits to an organization of the implementation of the quality management system based on this International Standard are (i) the ability to consistently deliver products and services that meet the customer`s applicable legal and regulatory requirements. Meeting applicable legal and regulatory requirements in addition to customer requirements is the first step towards customer centricity for any business. If there are legal and regulatory requirements that do not affect the organization`s services or products if they are not met, only these requirements can be excluded with reasonable justification. Legal requirements are the requirements that are applicable under the law enacted by the government. These are promulgated by the adoption of the law by the legislative assembly or parliament.
A regulatory requirement may be called administrative legislation that establishes or limits rights and assigns responsibilities. It is somewhat different from legal legislation and there may be the following types of regulations applicable to an organization: Companies that do not adhere to mandatory compliance practices face many potential impacts, such as being forced to participate in remedial programs that include compliance audits and on-site inspections by the appropriate regulator. Non-compliant organizations are generally subject to fines and penalties. Brand reputation can also be tarnished by companies that experience repeated – or particularly egregious – compliance violations. Senior management must demonstrate leadership and commitment in ensuring compliance. The QMS ISO/FDIS 9001:2015 standard requires an organization to determine and monitor the legal and regulatory requirements for the organization`s products and services. It is the responsibility of the organization to demonstrate compliance with its quality management system. Looking through this ISO/FDIS 9001:2015 QMS standard, we see in the introductory part of the standard that this standard can be used by both 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. If the policy is written to address specific compliance issues, your training should reinforce that behavior and ensure employees understand what they need to do. The term „legal and regulatory requirements“ appears 12 times in ISO 9001:2015.
Together, these two requirements are also referred to as legal requirements. -Legal requirements derive from laws promulgated by law. Regulatory compliance is compliance with laws, regulations, guidelines, and specifications applicable to their business processes. Legal compliance violations often result in legal penalties, including federal penalties. Now that you understand the critical importance of regulatory compliance (and the challenges you may face), you can use the guidelines above as a course of action. Through these methods, the quality management system can demonstrate compliance with legal and regulatory requirements for products and services. The implementation of applicable legal and regulatory requirements, as well as better management control and improved efficiency of processes/products/services, is one of the main benefits of the ISO quality management system. Learn more about the general benefits of ISO 13485:2016.
Privacy-specific regulatory compliance requirements, such as the GDPR and CCPA, have become more common as companies handle consumers` personal data have been reviewed. As the number of rules has increased since the turn of the century, regulatory compliance management has become more important in various organizations. This development has led to the creation of the positions of Chief Corporate Compliance Officer, Chief Regulatory Compliance Officer and Compliance Manager. One of the main roles of these roles is to hire employees whose sole purpose is to ensure that the organization complies with strict and complex legal regulations and applicable laws. When a customer purchases a product or service from an organization, they are looking for a lasting relationship and a long-term connection with the organization. If for any reason regulatory requirements are not met, it will result in the loss of existing customers as well as potential customers. The company`s brand image is damaged, the company`s credibility is at stake, and the value of its stock is falling. This is especially important when it comes to other related standards such as medical and environmental safety standards, etc. Some customers require their suppliers to act ethically and protect the environment in all their businesses. Such regulatory violations distract the company from the focus it places on customer satisfaction.
The team should ensure that the legal and regulatory requirements established for the personnel/functions involved are copied to senior management. Your first step towards regulatory compliance begins with a comprehensive audit to identify a compliance baseline and identify areas of concern. The most important thing to remember about legal and regulatory requirements is that it is your responsibility to identify them and ensure that they are maintained and included in your QMS, where applicable. By incorporating these requirements into your QMS documentation and practice, you can better ensure that these important requirements are met and maintained so that you can continue to legally provide your products and services by complying with all applicable requirements. The inclusion of these requirements means that they are not easily forgotten. Once you know the requirements you need to meet, you need to find a way to incorporate them into your QMS. It doesn`t make sense to try to have a separate method of controlling the activities your employees must perform to comply with legal and regulatory requirements, so it`s wise to include these requirements in the processes, procedures, and documented information your employees follow. For example, some standards for the food industry focus on the entire supply chain to ensure product safety. These would be different from the requirements of the financial services industry, some of which focus on the handling of sensitive data and cybersecurity. There are basically two main types of legal and regulatory requirements to consider in your QMS: Follow these guidelines to set up a regulatory compliance program: The term „legal and regulatory requirements“ may express legal requirements; as explained in Note 2 of Section 1.1 (General) of ISO/FDIS 9001:2015 – QMS. In this context, it is proposed to establish a task force with legal knowledge. The team must determine the applicable legal and regulatory requirements regarding the organization`s products and services.
Komentari su zatvoreni.