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Compliance

Acquire and maintain regulatory compliance

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Luke is your partner to implement and sustain compliance systems

Why do you need regulatory compliance?

Unlike ISO certification, which despite its numerous benefits remains optional, compliance is not a choice. To operate within certain verticals, your business may be subject to various local and European regulations. Therefore, adhering to these laws and regulations is a crucial part of your operations.

Although this appears to be a straightforward process, achieving and maintaining compliance is not a one time thing. Maintaining compliance requires a proactive approach, which includes regular internal reviews and audits. It is only by continuously assessing the effectiveness of your systems and remaining vigilant that your organisation will truly maintain regulatory compliance.

Types of Compliance Regulations

Medical Device Regulation Compliance

Medical Device Compliance (MDR) refers to a set of regulations which regulate the production and distribution of medical devices. Compliance with this regulation is a legal requirement for medical device companies that wish to market or sell their products within the European Economic Area (EEA). Achieving compliance does not simply allow your company to get medical device approval from regulatory bodies, but also ensures that medical devices are safe to be used on patients.

In-Vitro Diagnostic Regulations Compliance

In-vitro diagnostics (IVDs) refers to reagents, instruments and systems used to collect, prepare and examine samples from the human body. These help diagnose diseases or other conditions for treatment purposes. Being IVD compliant shows that your products fall under the scope of 'in-vitro diagnostics' according to this specific legislation in the EU Market.

Good Distribution Practice Compliance

Good Distribution Practice (GDP) outlines the minimum standards that a wholesale distributor must follow to guarantee the quality and integrity of pharmaceutical products are maintained throughout the supply chain. This ensures that medicines within the medical supply chain are authorised in accordance with EU legislations and that storage and transportation are handled in a way that limits contamination by or of other products, amongst other advantages.

HACCP Compliance

Hazard Analysis Critical Control Point (HACCP) is a widely accepted practice used in the catering and food industry, as well as in the food processing industry. This set of regulations requires companies to recognise potential food safety issues and examine their entire food storage system and food handling processes. Therefore, when a company is HACCP compliant, it means that all aspects of food handling and storage are done in a safe and legal manner.

Good Manufacturing Practice Compliance

Good Manufacturing Practice (GMP) describes the minimum legal requirements that pharmaceutical manufacturers must comply with throughout their manufacturing processes. Outlining a system which ensures that products are consistently produced according to quality standards, complying with GMP regulations will also automatically prove your legal compliance and add to your company’s trustworthiness.

Medical Device Regulation Compliance

Medical Device Compliance (MDR) refers to a set of regulations which regulate the production and distribution of medical devices. Compliance with this regulation is a legal requirement for medical device companies that wish to market or sell their products within the European Economic Area (EEA). Achieving compliance does not simply allow your company to get medical device approval from regulatory bodies, but also ensures that medical devices are safe to be used on patients.

In-Vitro Diagnostic Regulations Compliance

In-vitro diagnostics (IVDs) refers to reagents, instruments and systems used to collect, prepare and examine samples from the human body. These help diagnose diseases or other conditions for treatment purposes. Being IVD compliant shows that your products fall under the scope of 'in-vitro diagnostics' according to this specific legislation in the EU Market.

Good Distribution Practice Compliance

Good Distribution Practice (GDP) outlines the minimum standards that a wholesale distributor must follow to guarantee the quality and integrity of pharmaceutical products are maintained throughout the supply chain. This ensures that medicines within the medical supply chain are authorised in accordance with EU legislations and that storage and transportation are handled in a way that limits contamination by or of other products, amongst other advantages.

HACCP Compliance

Hazard Analysis Critical Control Point (HACCP) is a widely accepted practice used in the catering and food industry, as well as in the food processing industry. This set of regulations requires companies to recognise potential food safety issues and examine their entire food storage system and food handling processes. Therefore, when a company is HACCP compliant, it means that all aspects of food handling and storage are done in a safe and legal manner.

Good Manufacturing Practice Compliance

Good Manufacturing Practice (GMP) describes the minimum legal requirements that pharmaceutical manufacturers must comply with throughout their manufacturing processes. Outlining a system which ensures that products are consistently produced according to quality standards, complying with GMP regulations will also automatically prove your legal compliance and add to your company’s trustworthiness.

DIGITAL OPERATIONAL RESILIENCE ACT (DORA)

In today’s world, cybersecurity is an important aspect of many institutions’ day-to-day operations. The Digital Operational Resilience Act, called DORA in short, looks at enhancing cybersecurity to make the digital landscape of agencies dealing with sensitive data safer.T he new set of regulations bundled with the Digital Operational Resilience Act DORA was launched on the 17th of January 2023 and will come into affect on the 17th of January 2025.

Receive funding for your journey toward regulatory compliance

As an approved Compliance Specialist in Malta, Luke can help his clients reap the full benefits of currently available funding. Applicable to any business based in Malta, the Government of Malta’s current funding schemes have never been better. The precise amount depending on your company’s size and ownership structure.

For more information, simply get in touch for a free consultation session! Luke will help you to make the most of the best available funding incentives applicable to your business.

Receive funding for your journey toward regulatory compliance

Luke’s approval as a Malta Enterprise approved advisor means that his clients can reap the full benefits of currently available funding schemes. Find out whether you are eligible for funding, by getting in touch with Luke for a 15-minute phone call.

The Process to obtain and retain regulatory compliance

Initial Consultation

Luke will meet with you to discuss your current business challenges and objectives in detail. This ensures there is a clear scope behind the consultancy approach and achieving legal compliance– including identifying which legal regulations your business needs to conform to.

Funding application and approval

All documentation to obtain funding from the relevant government scheme is prepared, and you will then await an approval letter. Receipt of the approval letter normally takes anywhere between 4 to 8 weeks.

Systems Mapping

Luke will map out your existing organisational processes, providing a birds eye view of all operational procedures. This is ideally executed with multiple stakeholders from your team, ensuring that Luke is able to understand the granular details of your operations.

Gap analysis

Based on your existing systems and your stakeholder input, Luke outlines the clear gaps within your existing structure, in order to plug such gaps.

Systems Implementation

The required systems, operational procedures, and quality checks are implemented across the business. This ensures that your business is conforming to legal regulations, whilst operating in the leanest, most efficient manner possible – maintaining quality across the bar.

Internal Audit

This stage examines the internal structures and practices that have been implemented. An internal audit and management review will be conducted to determine whether the new structures and practices are working well within the company, and what can be done to improve them. This helps to ensure that the changes made to company practices are viable and can be maintained.

Initial Consultation

Luke will meet with you to discuss your current business challenges and objectives in detail. This ensures there is a clear scope behind the consultancy approach and achieving legal compliance– including identifying which legal regulations your business needs to conform to.

Funding application and approval

All documentation to obtain funding from the relevant government scheme is prepared, and you will then await an approval letter. Receipt of the approval letter normally takes anywhere between 4 to 8 weeks.

Systems Mapping

Luke will map out your existing organisational processes, providing a birds eye view of all operational procedures. This is ideally executed with multiple stakeholders from your team, ensuring that Luke is able to understand the granular details of your operations.

Gap analysis

Based on your existing systems and your stakeholder input, Luke outlines the clear gaps within your existing structure, in order to plug such gaps.

Systems Implementation

The required systems, operational procedures, and quality checks are implemented across the business. This ensures that your business is conforming to legal regulations, whilst operating in the leanest, most efficient manner possible – maintaining quality across the bar.

Internal Audit

This stage examines the internal structures and practices that have been implemented. An internal audit and management review will be conducted to determine whether the new structures and practices are working well within the company, and what can be done to improve them. This helps to ensure that the changes made to company practices are viable and can be maintained.

External Audit

An external compliance audit is carried out to verify your company’s compliance with legal guidelines. During this regulatory audit, your organisation is assessed on the strength and thoroughness of its compliance preparations, security policies, user access controls and risk management procedures.

periodic Audits

At periodic intervals, your business will be re-audited by the relevant certification body to ensure all standards have been up-kept. In doing so, your regulatory compliance certificate will also be renewed for a further 12 months.

What is a certificate of compliance?

A Certificate of Compliance (CoC), also known as the Certificate of Conformity or Certificate of Conformance, is a contractual document given during the regulatory audit to formally verify that your company has successfully met the required legal criteria.

In fact, many countries require a certificate of compliance to ensure that imported products meet all international standards before exportation. Consignments that meet the required international standards are given a certificate of compliance and this is then presented upon reaching their destination, during customs clearance, so that the products may be cleared for importation.

Alternatively, when a company is not involved in product development or distribution, a certificate of compliance will indicate that a company’s services are also within legal regulations, implying a degree of quality and trustworthiness.

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ISO 9001 Clause 6.

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Taking a Closer Look at ISO 9001 Clause 6

certification bodies

January 8, 2024

Certification Bodies and What to Look Out for

Frequently Asked Questions

What is the meaning of compliance?

Compliance stands for following national and international laws and regulations.

What are the risks of non-compliance?

Non-compliance creates considerable risks to the growth and profitability of your business. From potential government sanctions to costly penalties, your company could easily lose money on fines and lawyer fees. Additionally, due to non compliance, your company might be barred from government programs, potentially decreasing annual sales and damaging your company’s reputation.

Who is Responsible for Medical Device Compliance in Malta?

The Medicines Authority.

What is the difference between ISO certification and compliance?

Whilst ISO standards are optional, compliance must be achieved or else risk breaking the law. Nevertheless, there are a few overlaps within their proposed management systems. The principles of ISO 9001 include compliance management systems, and in fact, after achieving ISO certification your company will certainly be better equipped to pass a regulatory audit for compliance.

download the free 7-point iso 9001 readiness checklist

Wondering how close to attaining ISO certification your business is? Download our free resources to carry out a quick 7-step self-assessment to identify your ISO readiness.

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