What are the Safety and Quality Standards in QMS

Every industry wants fewer errors and better outcomes—and it begins with Safety and Quality Standards in QMS.  

With today's fast-changing, highly regulated business environment, producing consistent quality and ensuring safety in operations is not only a requirement—it's a competitive edge. Quality Management Systems (QMS) no longer merely check compliance boxes—they have become all-encompassing systems that help organizations embed a culture of excellence, risk avoidance, and ongoing improvement. 

Safety and Quality Standards within QMS are the basis upon which this culture is established. These standards offer the framework, metrics, and tools necessary to reduce risks, simplify operations, and ensure products and services are compliant with both customer requirements and regulations. Sectors such as healthcare, manufacturing, and pharmaceuticals use these standards heavily in order to provide outputs which are not only efficient but safe and reliable. 

Through the deployment of a strong QMS model that integrates globally accepted safety and quality standards, organizations are able to build confidence with stakeholders, save money on non-compliance costs, and enhance their competitiveness in the marketplace. 

Having established that as the basis, let's delve into what these safety and quality standards actually are within the context of QMS. 

What is QMS Safety & Quality Standards?  

Safety and Quality Standards in QMS are documented procedures and procedural frameworks that aim at leading an organization to reliable, high-quality, and safe results. The standards ensure that all processes, products, and services comply with regulatory requirements and customer requirements. 

Whether it's lowering the risk of job-related accidents or verifying a product has met high quality standards, these standards are integrated into a QMS to make compliance proactive instead of reactive. This is not an exhaustive list but includes:  

• ISO 9001: It addresses quality management principles such as customer focus, process approach, and continual improvement. 

• ISO 45001: Regulates occupational health and safety management. 

• ISO 13485: Applies to medical device quality systems. 

• FDA 21 CFR Part 820: Refers to U.S. regulatory requirements for medical devices.

All of these standards focus on systematic control of processes, thorough documentation, and performance-based testing. An effective QMS incorporates these standards into day-to-day operations organically, making compliance a value-added business initiative.

Knowing what these standards are is necessary—but knowing why they are necessary is even more important.

Why are Safety and Quality Standards necessary in QMS? 

Safety and quality aren't compliance checkboxes—they're business imperatives. Safety and Quality Standards in QMS are the foundation of secure product delivery and workplace safety.

Here's why these standards are so important: 

• Proactive Risk Management: Organizations can identify and solve issues before they grow into crises. 

• Customer Satisfaction: Safe and quality products tend to produce increased customer loyalty. 

• Regulatory Compliance: Minimizes legal liabilities and increases audit readiness. 

• Operational Efficiency: Standardized processes minimize variation and maximize process stability. 

• Cultural Alignment: Creates a collective accountability among all staff to uphold safety and quality.

Example: For the automotive sector, the use of IATF 16949 (a combined safety and quality standard) has led to the quantifiable reduction in recalls and defects.

Trivia! Unsafe healthcare practice costs more than $42 billion in lost productivity worldwide per year, according to the World Health Organization.

Let's discuss how these principles come to life in a high-stakes setting such as healthcare.

Evaluation of Healthcare Safety and Quality Standards in QMS

Healthcare is among the most regulated and sensitive areas as far as quality and safety are concerned. A strong QMS ensures that hospitals and medical manufacturers are able to satisfy clinical, regulatory, and operational excellence.

Key Healthcare Standards Include: 

• ISO 13485: Addresses design, manufacturing, and distribution of medical devices. 

• FDA 21 CFR Part 820: Requires robust documentation and validation principles. 

• GxP Guidelines (GMP, GCP, GLP): Provide good practices in manufacturing, clinical, and laboratory operations.

Real-World Impact: One European hospital rolled out ISO 9001 and ISO 13485 together. It achieved a 25% increase in patient outcomes and a 40% decrease in medication errors within 18 months.

Healthcare QMS tools not only decrease clinical mistakes but also enhance patient satisfaction, decrease readmissions, and establish long-term reputational trust.

Fact check! Empirical evidence indicates that the use of ISO 13485 enhances compliance rates and patient safety outcomes for hospitals and medical device companies.

Having discussed industry-specific standards, let us now examine the relationship between safety and quality in QMS.

Relationship Between Quality and Safety Standards in QMS? 

Quality and safety within a QMS are dependent upon each other. To achieve one but not the other is not only unproductive—it's hazardous. A product that is on spec but unsafe is a compliance failure.

Synergistic Objectives:  

Quality is about conformance to product and process specifications. 

• Safety is about reducing risk of injury to users or workers. 

• A successful QMS must combine both aspects through: 

• Risk-based thinking 

• Detailed documentation 

• Employee training and competency

Integrated Systems: Standards such as ISO 9001 and ISO 45001 encourage harmonization between safety and quality due to their common requirements for leadership commitment, risk management, and performance evaluation.

Did you know? Businesses which approach safety and quality as a single initiative experience a 65% increase in audit scores and customer satisfaction.

Let's consider a step-by-step process to integrating these standards in your QMS.

How to Adopt Safety and Quality Standards in Your QMS?

Adopting Safety and Quality Standards in QMS is a strategic process that needs to be carried out step by step. This is how organizations can proceed:

Implementation Steps:

1. Perform a Gap Assessment: Find out what the present compliance level is compared to the desired standards. 
2. Prioritize Risk Areas: Target risk-prone departments or procedures. 
3. Standardize Documentation: Follow ISO-compliant formats. 
4. Create SOPs and Training Plans: Make sure all the stakeholders know their role. 
5. Invest in EQMS Tools: Automate document control, audits, CAPA, and risk assessments.

Success Tips: 

• Use cross-functional teams for increased buy-in. 

• Track KPIs monthly on both safety and quality measures. 

• Implement feedback loops for ongoing improvement.

Did you know? Organizations that adhere to ISO 9001 implementation schedules and undertake staff training have a 50% better compliance rate when audited for certification. 

Source

Next, let's highlight the main standards you need to put first within your QMS.

Key Safety & Quality Standards in QMS?

Your QMS has to be designed with internationally accepted standards in order to be effective as well as audit-ready. The following are the key frameworks which every quality-focused organization should adopt:

Quality Standards: 

• ISO 9001: Emphasis on customer satisfaction, leadership, and decision making supported by evidence. 

• ISO 13485: Specialized for manufacturers of medical devices. 

• IATF 16949: Automotive sector QMS standard.

Safety Standards: 

• ISO 45001: Provides guidelines for occupational safety and health. 

• OHSAS 18001: The predecessor to ISO 45001 that is used in some geographies. 

• FDA 21 CFR Part 820: U.S. medical product developers cannot do without it.

All of these standards contribute to: 

• Less variability in results 

• Improved alignment with business objectives 

• Quicker market access

One now knows the standards; now one needs to apply them successfully. Let us consider best practices.

Fact file! ISO 45001 directly addresses Occupational Health and Safety (OHS) within QMS frameworks. 

Safety and Quality Standards Best Practices? 

Utilizing Safety and Quality Standards in QMS effectively involves integrating them into daily practices and leadership principles. 

Best Practices Include: 

• Routine Audits: Internal and external audit to monitor progress. 

• Employee Engagement: Transparency of communication and routine training. 

• Feedback Mechanisms: Having anonymous reporting systems for near misses. 

• Use of Technology: Using digital dashboards for real-time visibility. 

• Alignment with Business KPIs: Map safety and quality objectives to revenue and growth.

Next, let's see how Qualityze supports embedding and sustaining these practices.

Did you know? Organizations with integrated safety and quality systems see up to 30% fewer compliance violations.

Ensure and Maintain Safety and Quality Standards with Qualityze EQMS Software 

Qualityze EQMS is a cutting-edge cloud-based software tool based on Salesforce architecture, assisting businesses to bring safety and quality into every function and process.

Features Include: 

- Real-time collaboration between functions 

- Automated audit, CAPA, document control workflows 

- Audit trail, analytics dashboards for intelligent decision-making 

- Compliance-ready with ISO 9001, ISO 13485, ISO 45001, FDA, 21 CFR Part 820 

Customer Impact: One of the top 5 medical device manufacturers reported 60% faster audit readiness and a 35% improvement in supplier quality metrics after using Qualityze.

Integration: Qualityze supports integrations with ERP, MES, LIMS, and HR systems, creating a connected compliance ecosystem.

Let's conclude with key takeaways and how you may begin.

Conclusion 

Adding Safety and Quality Standards to QMS is not only a regulatory requirement—it's a strategic investment in excellence. From reducing risk to optimizing operational effectiveness, the payoffs of embracing these standards are both quantifiable and revolutionary.

Key Takeaways from today’s blog: 

Safety and quality need to be addressed together for lasting success. 

A standards-based QMS fosters trust, compliance, and performance. 

Implementation is made easy and scalable by EQMS solutions such as Qualityze.

Why Qualityze for QMS? 

If you want to simplify compliance, bolster safety statistics, and enhance product quality—Qualityze is your ally in progress. Our solutions are designed to address your unique industry requirements, be it healthcare, manufacturing, or life sciences.