Conflict Minerals Compliance: A Complete Guide 

Conflict Minerals Compliance: A Complete Guide 

Conflict Minerals Compliance: A Complete Guide
 

  • How does the regulation affect people? 
  • To what extent does the legislation seek to address risk? 
  • Are there any conflict-affected or high-risk countries? 
  • Do companies outside the EU have similar regulations? 
  • Why is Conflict Minerals Compliance important? 
  • How Does A Supply Chain Assessment Benefit Your Organization? 
  • Conflict Minerals Compliance: 5 Key Steps 
  • Plan, schedule, and execute compliance assessments for various regulatory requirements in a more streamlined way 
As defined by US legislation, a conflict mineral is a metal derived from one of four minerals: tantalum, tin, tungsten, or gold. 

Today, a small fraction of all tin, tantalum, tungsten, and gold metals are sourced from the Democratic Republic of Congo (DRC). Armed groups use these precious metals to finance the ongoing conflict in neighboring countries. Products in the electronics industry can contain some of these minerals in their supply chains. 

No matter where a metal hails from or whether the mining has financed armed groups, tin, tantalum, tungsten, and gold are always conflict minerals. 

How does the regulation affect people?

 
Tin, tantalum, tungsten, and gold importers operating within the European Union must comply with the Conflict Minerals Regulation so that their minerals are sourced responsibly and that their supply chains do not contribute to armed conflicts or other illegal activities. 

These minerals must be imported into the EU following the following requirements: 

  • Build a robust management system for your company
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  • Assess the risk associated with their supply chains
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  • Prepare a strategy for responding to identified risks
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  • Conduct a due diligence audit of the supply chain by an independent third party
  • The due diligence report on the supply chain needs to be submitted every year.
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Approximately 500 smelters and refiners worldwide will also be impacted indirectly due to the requirement that EU-based importers identify and check these firms’ due diligence practices. In addition, EU importers will have to manage and report when the patterns of smelters and refiners are inadequate or associated with risks. 

A company that uses these minerals in its product (i.e., one that is not an importer, such as a manufacturer) is not subject to the rules. Their due diligence activities, however, are encouraged to be published. 

To what extent does the legislation seek to address risk?

 

Due to their frequent links to armed conflicts and human rights abuses, EU legislation focuses mainly on the four 3TG minerals. However, money flow can occur at different points in the supply chain – including extraction, refining, and transportation. 

New regulations require importers to provide additional information about the mines and processing plants used and taxes, fees, and royalties paid when minerals are obtained from conflict-affected and high-risk areas. 

With these obligations, the Commission hopes money won’t reach armed groups or criminals and that the local mining community will be able to prosper instead of being exploited and abused. 

Are there any conflict-affected or high-risk countries?

 
The European Commission maintains an expert-developed list of conflict-affected and high-risk countries. These countries typically have highly demanded minerals, poor governance, and systematic violations of international law, including human rights and armed conflicts, such as civil wars. 

Currently, this list features 27 countries, including Afghanistan, the Central African Republic, the Democratic Republic of Congo, Sudan, South Sudan, Libya, Somalia, and Yemen. 

Several other countries on the list also indicate high risks for forced labor in the mining and quarrying industry. 

Do companies outside the EU have similar regulations?

 

As part of the Dodd-Frank Act Section 15002 passed in 2010, the US passed legislation known as the Dodd-Frank Act. As a result, US stock markets require companies to conduct due diligence on minerals sourced from Congo and its neighbors. 

Supply chain checks are now required in several African countries, including the Democratic Republic of Congo and Rwanda. 

According to Chinese Due Diligence Guidelines for Responsible Mineral Supply Chains released by the China Chamber of Commerce for Metals, Minerals & Chemicals Importers & Exporters in 2015, responsible mineral supply chains should include these guidelines. 

Why is Conflict Minerals Compliance important? 

The process of conflict minerals compliance involves performing mandatory due diligence on smelters and refiners in a supply chain to identify the source of conflict minerals. Companies, suppliers, importers, etc., must comply with their respective laws to sell conflict minerals in the United States or the European Union. Ensure conflict-free minerals are sourced globally through conflict minerals compliance. 

Conflict minerals regulations require supply chain transparency. It will be easier for organizations to adapt to future regulatory requirements if they prepare for this regulation. By having a compliant supply chain, you can also improve your compliance program and process to effectively meet changing compliance requirements. 

How Does A Supply Chain Assessment Benefit Your Organization?

 
Conflict minerals are commonly used in manufacturing telecom parts and components, as they are present in all electronic products and contain many different metals. However, the amounts and concentrations of each metal vary. 

It should be an enterprise goal that the tantalum, tin, tungsten, and gold metals that feature in their products will never, directly or indirectly, contribute to or benefit armed groups in the Democratic Republic of Congo or neighboring countries as part of our commitment to responsible sourcing, human rights, and sustainability. 

Dodd-Frank Act also regulates this in part. In 2010, Congress passed legislation requiring public companies to have a responsible raw material supply chain. In addition, a conflict mineral sourcing policy ensures that DRC conflict minerals are not sourced from the conflict zone. To adhere to this regulation, every company must file an annual disclosure of conflict minerals’ origin. 

Conflict Minerals Compliance: 5 Key Steps

 
Managing conflict mineral compliance is challenging. However, the best-practices and the right tools can make the entire process simpler for you. To begin with, we are sharing the 5 key steps to conflict mineral compliance so you can align your processes better. 

The five steps to conflict mineral compliance can be summarized as follows. 

  1. Product Filter: Identify products that fall under the scope of the investigation. 
  2. The Reasonable Country of Origin Investigation (RCOI): Identify sources of conflict minerals in a company’s products, such as the DRC or recycled materials. 
  3. Due Diligence: After completing the RCOI, a company engages in due diligence to gather information about potential risks so they can be assessed and managed appropriately if it becomes aware or has reason to believe conflict minerals originating in the DRC do not come from recycled or scrap sources. 
  4. Data Analysis: There must be a lot of caution when using information from the supply chain. A company must assess the completeness and accuracy of provided data. 
  5. Report: Provide SEC with Conflict Minerals Reports and Special Disclosure forms as necessary. 

Plan, schedule, and execute compliance assessments for various regulatory requirements in a more streamlined way

 
Several regulations, such as Conflict Minerals, Reach, and RoHS, require companies to evaluate their supply chains during due diligence. In addition, periodic reviews are necessary for response to changes in smelters and customer inquiries. In many cases, companies will remove the supply chain of high-risk smelters. The choice to remove or retain the smelter depends on the company’s policies and position regarding using conflict minerals. 

The entire process, however, is labor-intensive and time-consuming. Therefore, the most innovative solution for enterprises is to use next-generation software like Qualityze to manage material compliance, periodic reviews of suppliers’ smelters, documents, and reporting. 

Our next-generation Material Compliance Management software is designed to comply with Dodd-Frank Act Section 1502 and EU Conflict Minerals Regulation due diligence requirements. With the customizable and technology-driven platform, you can gather data about the origin of 3TG in your supply chain by configuring Conflict Minerals Reporting Templates (CMRTs) for your suppliers. A concise, visual report allows you to analyze supplier data and track supplier responses. 

As regulations and standards change rapidly, companies need to establish a compliance management strategy that considers the nature and design of rules and their risks. Companies can respond more effectively to changing regulatory demands by adopting the user-friendly and efficient Qualityze Material Compliance Management solution. Moreover, the solution gives stakeholders real-time access to compliance across all supply chain tiers and an understanding of how risk impacts their objectives. 

Is this relevant to you? An effortless way to comply. The supply chain transparency our solution provides can help make it simple for you to comply with conflict mineral regulations. Let us show you how our Conflict Minerals compliance software can make a difference in your business. Request a demo today. 

Qualityze will make your conflict minerals compliance journey easier! 


If you want to learn more about the product functionalities, please contact our customer success team at info@qualityze.com or call us at 1-877-207-8616, and we will be right there for you at the earliest. 

Regulatory Reporting of Adverse Events: Things You Should Know 

Regulatory Reporting of Adverse Events: Things You Should Know 

Managing Adverse Events with Post Market Surveillance
  • What is an Adverse Event?
  • When to Report an Adverse Event?
    • Death
    • Potentially fatal
    • Inpatient or outpatient hospitalization
    • A permanent injury or disability
    • Defects at birth/congenital anomalies
    • Prevention of Permanent Impairment or Damage (Devices)
    • Other Important Medical Events
  • Adverse Event Reporting: 4 Benefits
    1. A better workplace and a safer patient environment
    2. Understand what contributes to system failures
    3. Transparency & Trust within Facilities
    4. A heightened sense of security & peace of mind
  • Post market surveillance: keeping adverse events to a minimum
  • Adverse Events: Best Practices to Manage Them
  • Adverse Events: Reporting and Managing Them Made Simple
  • The Bottom Line
Businesses must prioritize customer safety at all times. Even though adverse event data is valuable for improving quality systems and processes, it can be challenging without standardized reporting standards. However, Quality professionals can minimize adverse events through proper planning and react appropriately if they do happen to prevent the situation from spiraling out of control.

In this post, we will go through all the essential elements of adverse event reporting so you can manage them more efficiently and effectively than ever.

What is an Adverse Event?

In medical terminology, an “adverse event” is harm associated with medical treatment rather than disease-causing damage. An adverse event can be classified into several subcategories, including:

  • An adverse event that could have been prevented: one caused by an error or the failure to follow a prevention strategy.
  • “Ameliorable adverse events” refers to events that could have been avoided if care had been different, though they cannot be prevented.
  • Negligence-related adverse events occur because clinicians in the community do not meet clinical standards.

Another term that defines hazards to patients without causing harm is:

  • Near Miss: A near miss happens when there is no difference between the outcome of an unsafe situation and a preventable adverse event. As a result of either luck or early detection, a patient does not suffer harm from a hazardous condition.
  • Error: negligence that exposes patients to potentially dangerous situations by committing an error or omitting to do so.

When to Report an Adverse Event?

It is considered a severe event and must be reported to FDA when the patient outcomes are:

  • Death

    You should report any death that may have been caused by an adverse event, including the date if you know it.

  • Potentially fatal

    It is important to report if it is deemed likely that the patient is at substantial risk of death at the adverse event or if the product or device may have led to the patient’s death.

  • Inpatient or outpatient hospitalization

    Adverse events may result in hospital admission or prolongation of hospitalization.

    A patient visiting the emergency room should be evaluated for other serious outcomes without being admitted to the hospital.

  • A permanent injury or disability

    When an adverse event substantially disrupts a person’s everyday life function, such as when the adverse event alters, impairs, damages, or disrupts the patient’s body function/structure, physical activities, and quality of life in a significant, persistent, or permanent manner.

  • Defects at birth/congenital anomalies

    It is important to report if you suspect your child may have experienced an adverse outcome due to exposure to a medical product before conception or during pregnancy.

  • Prevention of Permanent Impairment or Damage (Devices)

    If you suspect a medical product damaged a body structure or impaired a body function permanently, you should notify the FDA.

  • Other Important Medical Events

    You need to report a medical or surgical intervention (treatment) if the event doesn’t fit every outcome but is likely to jeopardize the patient and require medical or surgical intervention.

Adverse Event Reporting: 4 Benefits

Reporting systems are essential to understanding adverse events and implementing preventative measures. Reporting adverse events consistently and uniformly has four key benefits:

  • A better workplace and a safer patient environment

Consistent reporting is essential when it comes to increasing patient safety. This is especially important given the troubling surgical safety statistics.

Approximately one in ten hospital patients suffer an injury while receiving care, and 25 percent of surgical procedures are unsafe. The majority of adverse events during surgery occur in hospitalized patients. Positively, half of the adverse surgical incidents are preventable.

Health and safety legislation is based on consistent and comprehensive data. It is difficult to improve the safety of patients and workers when adverse events are not reported or underreported, thus distorting results.

Many non-fatal and non-harmful medical events go unreported within the healthcare sector. As a result, surgical facilities cannot identify hazards and develop interventions to lower the incidence of future risk by reporting these incidents.

A consistent reporting system provides risk managers with the information they need to optimize worker and patient safety policies and practices.

  • Understand what contributes to system failures

Adverse events and near misses should be reported rigorously, following best practices. With this information, a surgical facility can better identify safety protocol breakdowns or system failures.

Analyzing individual cases of adverse patient events can help identify areas for system improvement. For example, what interventions can we implement to stop these events from happening in future surgeries?

To improve systems, a data-focused approach naturally shifts away from blaming individuals. In this environment, employees at all levels will feel comfortable and empowered to do what is best for patients and the company.

  • Transparency & Trust within Facilities

The Bureau of Labor Statistics (BLS) says there are several reasons why adverse events are still underreported. For example, workers generally resent reporting adverse events for fear of losing their jobs, incentive programs discourage reporting, and barriers within OSHA recordkeeping regulations affect the collection of comprehensive data sets in the healthcare sector.

Is there anything healthcare systems can do about this? First, all employees must be encouraged to report all incidents to create a fair working environment. In addition, emphasize, mitigate risks, and assess system failures instead of individual mistakes. Reporting becomes more transparent and consistent as a result.

  • A heightened sense of security & peace of mind

It’s not just about patient safety when reporting adverse events. It also protects healthcare organizations from costly liability claims by reducing reimbursements for preventable hospital-acquired conditions.

A healthcare facility should report an adverse event immediately if it is responsible for it in any way. Then, when a case goes to court, rapid action can be taken to address patient needs and establish the grounds for demonstrating prompt resolution.

Healthcare facilities need a streamlined system like Qualityze Field Safety Action Management for adverse event reporting to keep pace with compliance requirements and safety standards.

Post market surveillance: keeping adverse events to a minimum

A post market surveillance program (PMS) is responsible for monitoring the safety of pharmaceutical drugs and medical devices after they are released on the market and is an essential part of pharmacovigilance.

FDA approvals are based on clinical trials, which involve relatively few people, which means they do not generally have other medical conditions that may exist in the population as a whole. Post market surveillance can confirm or deny a drug’s safety after it has been used in large numbers of people with a wide range of medical conditions.

The post market surveillance process monitors drug and device safety by using a number of approaches, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linking. A process known as data mining is used to review these data in order to identify potential safety concerns.

Adverse Events: Best Practices to Manage Them

• Set up a safe environment. First, the surgery center must create a nonjudgmental environment. Staff should feel comfortable reporting mistakes promptly if they occur. It’s not to blame anyone; the emphasis is on the system.

• Plan your strategy. It is essential for staff to know who to report adverse events, how to report them, and the expectations regarding timeliness when an adverse event occurs. For example, it is essential not to throw away trash or empty syringes if the adverse event is severe.

• Find someone good at communicating. It is best to speak to a patient about an adverse event with a person who is known as a good communicator by leaders. Ideally, this person would be a physician, nurse, director, or anyone who can build trust with others.

• Assess the need for malpractice insurance. Determining whether malpractice insurance carriers must be notified and involved in serious adverse events is crucial.

• Assess track records. Managing risk involves identifying near-misses and abnormal events. For example, a surgery leader could assess whether people with frequent mistakes are more likely to make errors and collect data about their track records.

• Monitor medication errors. Patients who react negatively to a drug may need a different medication to counteract the reaction.

• Simplify the system. You can always find a solution to any problem. The weakest approach is to educate the employee involved in the adverse event about how to prevent it from happening again.

Adverse Events: Reporting and Managing Them Made Simple

With the advent of cloud solutions, it has become simpler and better to manage and report adverse events timely. You just need one solution to standardize the workflow for adverse events from identification to documentation, evaluation to resolution, and regulatory reporting.

Yes, you heard it right!

Qualityze Field Safety Action Management Software is a cloud-based solution for the enterprises striving to achieve post market excellence. Qualityze provides reliable integration capabilities to ensure efficient management of post-market surveillance activities such as Field Safety Interventions, Recalls, Complaints Handling, and Adverse Events. This software solution helps standardize data fields so that you can consistently capture all required details regarding Field Safety Actions (FSA). This will result in improved decision-making. To ensure the safety of consumers, Qualityze Field Safety Action Management allows enterprises to continuously analyze and improve their field safety management processes.

You can enforce standardized processes using Qualityze Field Safety Action Management to:

  • Track, manage, and capture all the details of the FSA in one place.
  • Perform a health hazard analysis.
  • Monitor distribution data for affected lots and batches of products.
  • Communicate directly with your customers.
  • Report Product Issues/Recalls to the Regulatory Authorities.
  • Integrate with Enterprise Quality Systems for improved control over adverse events.

In addition to medical industry, Qualityze is suitable for Manufacturing, Food and Beverages, Oil and Gas, Electric Vehicles and much more. You can easily configure this cloud-based solution to your business and compliance needs.

The Bottom Line

Managing and reporting adverse events in time is crucial to limit the impact that the slightest error, defect, or deviation can make. In addition, having the right software to manage your post market surveillance activities can reduce the workload for you and your quality inspectors – no matter your industry.

Ace Your Audits Remotely with Cloud-Based Audit Management Solution 

Ace Your Audits Remotely with Cloud-Based Audit Management Solution 

Table of Contents
  • Remote audits: what are they?
  • Remote audits: what are the advantages?
  • Remote audits: 5 best practices to follow
    1. Conduct a review of internal controls
    2. Make sure your files are ready
    3. Take it as a regular audit
    4. It’s essential to maintain interaction even if you’re remote
    5. In some cases, it is best to call
  • Remote audits: 7 Key Requirements
  • Remote audits: Put A Cloud-Based Audit Management Software to Use
COVID-19 has changed the way we work for the rest of our lives. The possibility of remote work is available for an extended period to the entire staff in many organizations was never considered before the virus spread globally.

Organizations are re-engineering their approach to work, requiring auditors and compliance teams to work remotely. Your audit leadership challenges may include the following:

  • Performing inspections remotely.
  • Gathering evidence while your clients are swamped, distracted, or worse, sick.
  • Engaging clients and team members in stressful or stressful times.

Having to conduct audits or coach team members remotely can make you nervous. Keeping on track with audits and building rapport with your clients in a distributed work environment can take time and effort. This blog will share a few simple tips to help you, your team, and your clients succeed. Also, we will recommend you a top-rated tool to make your remote audits efficient and effective.

Both auditing and technology are evolving. Today, remote auditing techniques can replace on-site auditing.

Remote audits: what are they?

Unlike an on-site audit, a remote audit uses electronic methods to obtain audit evidence, such as video conferencing, email, and telephone, as though it were being conducted on-site.

To determine whether the audit criteria have been met, it is necessary to evaluate this evidence objectively.

You can share files and screens using remote auditing, hold video conferences, and analyze data live.

Auditor skills and techniques used during on-site audits, such as assertiveness, diplomacy, listening, and respect, can also be used during this type of audit.

Remote audits maximize two essential skills that are maximized during a remote audit – being versatile and collaborative – by auditing key and relevant questions related to the scope of the audit.

Remote audits: what are the advantages?

It is beneficial for auditors to receive and exchange data, review documents and processes, conduct interviews and make observations with auditees worldwide without traveling.

As a result of eliminating commute time, auditors can spend more time exploring audit trails and writing audit reports that clearly outline audit outcomes, including opportunities for improvement, and more time doing things that contribute to the company’s success.

Related Articles: AUDIT MANAGEMENT: Fundamentals That You Should Know!

Using technology to conduct audits remotely also saves money and time. Through a cloud portal, users can access their data from anywhere. Providing a set time for remote audit activities will also likely increase engagement with auditees. With fewer interruptions and sidetracks, they are less prone to be sidetracked by urgent work requests like answering emails, taking phone calls, and assisting colleagues with queries.

In the certification industry, ‘audit burnout’ is a common term, particularly for auditors who frequently perform one-day audits and travel to various sites. Using remote auditing may allow auditors and auditees to take a different approach and approach the audit process differently, adding value to both.

Remote audits: 5 best practices to follow

Here are five best practices to make the virtual audit process smoother.

  1. Conduct a review of internal controls
  2. In advance of the audit, it’s a good idea to review internal controls and ensure they are still accurate or offer the required level of checks and balances, management, and oversight. The use of electronic signatures and approvals, as well as remote working, makes this extremely important. In addition, make any necessary updates to the accounting policies and procedures manual.

    Virtual audits save organizations valuable time and resources by eliminating the need to host audit teams for days.

  3. Make sure your files are ready
  4. It is best to provide the trial balance, general ledger, and several other items to your auditors at least a week before the audit. As a result, the audit team can create sample requests and submit them to the client before the audit work begins, giving the client time to pull and scan the samples before the audit starts. The audit will become much more efficient this way.

  5. Take it as a regular audit
  6. If your auditors are onsite, those days should be dedicated to the audit just like they would be if they were conducting the audit themselves. An out-of-sight, out-of-mind approach to remote audits is easy to adopt in the early stages. However, the audit will take longer if documents are not provided promptly, unlike an in-person audit.

  7. It’s essential to maintain interaction even if you’re remote
  8. You and your auditor should still interact even though the audit is being done remotely. Ideally, the auditor and your organization should have one team call to introduce themselves and discuss the audit approach, your current financial and programmatic situation, and the timing of the draft financial statements. Your auditor also needs to send your team a daily status update email at the end of the day.

  9. In some cases, it is best to call
  10. Remote audits use a lot of electronic information, but sometimes translation could be more precise. If this happens, it is recommended to pick up the phone or set up a team’s call so we can share screens and communicate directly. There is almost always no need for multiple emails or instant messages because a telephone call or teams meeting will solve the issue or confusion in a fraction of the time.

    Using best practices, you and your audit team can benefit from a remote audit. First, you are less likely to be disrupted by the changes. You won’t have to host your audit team onsite for days as an organization by moving to a virtual audit.

    Moreover, because the audit team works from home, they can access all the tools they have at their disposal: multiple monitors, high-speed internet, scanners, etc. These tools can improve the efficiency of the financial reporting process, which results in a shorter turnaround time for your organization. Your organization will also save money by eliminating travel time.

    Therefore, utilize remote audits as an opportunity to improve and grow.

Remote audits: 7 Key Requirements

Here are seven requirements for an effective remote audit. In addition, remote auditing requires assistance in the following areas:

  • A commitment and involvement from the top: Leadership must ensure the remote audit is taken seriously and prepared as if it were a regular audit.
  • Analyzing the Complexity of Processes: For this, you need to consider the complexity of the business operations, organization size, number of locations, and number of employees.
  • Assessment of the Existing Controls: A gap analysis will help determine how successful health and safety are and what needs to be done.
  • Audit Preparation Requirements: Planning the audit will help it be more effective.
  • It is necessary to establish communication protocols.
  • Defining the Audit Process and Defining the Objectives of the Audit
  • Engage your employees by:
    • Assuring that all parties are aware of their roles
    • What are the inputs and outputs?
    • Identifying risks and opportunities
    • Goals of audit programs and audit auditing

Plan and scope remote audits just as you would for a physical audit. However, each element of the auditing process should be considered in greater detail to account for technical glitches. Clarifying the audit scope and expected outcomes requires a legal agreement. Screen shares, live streams, and other media transmitted remotely should be explicitly prohibited to ensure data privacy.

However, the success of your remote audits largely depends on the tools you are using. The right audit management tool can help your achieve success and excellence effortlessly by streamlining the audit workflows and driving a culture of continuous improvements.

Therefore, you must implement industry-proven best practices, right tools and technologies, and right people to make every remote audit a successful one.

Remote audits: Put A Cloud-Based Audit Management Software to Use

From planning an audit to implementing improvements, a cloud-based Audit Management Software assists businesses through the entire audit process. The highly integrated nature of the system makes it conducive to remote auditing, as it provides a complete picture of quality and safety-related data without compromising security requirements. It is easy for auditors to assess risk levels, identify root causes, and suggest corrective actions based on historical and real-time data and a risk-based approach enabled by the tool.

Additionally, the cloud-based audit management tool provides greater flexibility, traceability, and security organizations need for remote audits. You can leverage the unique functionalities, from configurable workflows to intuitive platform, to manage end-to-end audit cycles efficiently and effectively.

As long as the organization is committed to conducting the virtual tour honestly and openly, Qualityze EQMS Suite will help businesses meet their quality and safety commitments.

Check out the link below for more information about the smarter quality solution and how it can help you audit more effectively, in person or remotely. You can also contact our customer success team info@qualityze.com, or you can call us on 1-877-207-8616, and we will get back to you at the earliest.

Best Practices to Proactively Manage Workplace Incidents

Best Practices to Proactively Manage Workplace Incidents

Incident Management: Things You Should Know
  • So, what is an Incident Management Process?
  • Why Incident Management Process is Important?
  • Reporting Workplace Incidents: Why Is It Important?
  • Reporting Workplace Safety Incidents: What to Include?
  • Managing Workplace Incidents: A Quick Look at the Process Workflow
    1. Recording incidents
    2. Definition and Classification of Incidents
    3. Assessing the priority of an incident
    4. The investigation and analysis process
    5. Resolving and concluding incidents
  • Managing Workplace Incidents: Best-Practices to Prevent Them
  • Always put safety first
  • An effective training programs
  • Work with qualified individuals
  • Make sure you hire enough people
  • Ensure the proper use of safety gear in the organization
  • Maintain equipment on a regular basis
  • Inspect safety procedures
  • Make sure the environment is safe
  • Identify vulnerabilities
  • Encourage feedback from employee
Experiencing workplace incidents and its consequences is simply unpleasant. No one likes to face adverse events since they reflect that there is something wrong with the way we are handling things currently. This is where we need to be proactive.

As they say, “Setback is a setup for a Comeback.”

So, dig deeper into the incidents, learn from your mistakes, and improve your quality processes to prevent the similar incidents in the future.

The way you manage incidents also reflects your organization’s commitment to culture of quality and continuous improvements. So, make a holistic approach to manage incident-related risks ahead. You should also involve your workforce to participate in safety management initiatives. It instills more confidence toward work culture.

Before changing your approach to workplace safety incidents, you should know a few things about incident management. This blog will provide you with all the necessary insights. Read on to learn more.

So, what is an Incident Management Process?

Incidents are unexpected disruptions to services. It disrupts normal operations, negatively impacting end users’ productivity and health. Incidents may occur due to missed ill-functioning equipment, noncompliance with standard procedures, inappropriate training, and much more.

An organization’s incident management processes govern how it recovers from unplanned service interruptions.

Why Incident Management Process is Important?

Defining an incident management process that allows incidents to be resolved faster and at a lower cost is critical. You can maximize team efficiency if you have a straightforward incident management process that follows best practices. An incident management process can provide the following benefits:

  1. A shorter MTTR and faster resolution of incidents.
  2. A reduction in costs and a positive impact on revenue.
  3. Enhancing communication within and outside the incident management team.
  4. An ongoing process of improvement and learning.
  5. An improved customer experiences.

Reporting Workplace Incidents: Why Is It Important?

Several incidents at work require employers to report them by law. These circumstances are categorized as ‘notifiable incidents. Of course, preventing incidents from occurring in the first place is ideal, but they do happen regardless of how well the controls are in place. Reporting them in time help work health and safety regulators identify the causes of the incidents and prevent them from happening again.

It is required by the Work Health and Safety law that:

  • Notifiable incidents must be reported to regulators as soon as they are discovered
  • Upon request from a regulator, a written notice is provided within 48 hours
  • It is a policy to keep the incident site clean until an inspector visits unless otherwise directed.

Employers are liable for penalties if they fail to report a notifiable incident.

Quick Read: Workplace Productivity Depends on Employee’s Training and Development

Reporting Workplace Safety Incidents: What to Include?

You must include the following details in your incident report:

  1. What exactly happened?
  2. When did the incident occurred?
  3. Where did the incident occurred?
  4. Who were impacted by the incident? (Make sure to include all the details and the relationship with your business or organization)
  5. What all injuries the incident led to, and the initial treatment impacted person received?
  6. What action plans were implemented?
  7. Who is taking care of entire incident management process?

Managing Workplace Incidents: A Quick Look at the Process Workflow

Recording incidents

Identifying and reporting incidents is the first step in incident management. The end users themselves can do this, or an agent can. To speed up recovery, your team should use a form template to capture all incident information. End users must also have easy access to appropriate channels for reporting problems.

Definition and Classification of Incidents

Organize incidents into appropriate categories and sub-categories so that the right person and team can be easily identified. Save time by customizing incident forms with the correct fields and using automated rules for identifying, prioritizing, and assigning tickets. Accurate classification of incidents will result in faster report generation.

Assessing the priority of an incident

Choosing the proper priority for tickets influences SLA policy and getting critical business issues resolved on time. Establish a realistic Service Level Agreement (SLA) to meet customer demands.

The investigation and analysis process

IT team members conduct an initial analysis of an incident and send an appropriate resolution to the end user. Upon not finding a resolution, they escalate the incident to the tier II & tier III teams for further investigation. Identifying, analyzing, and containing an incident requires several components. The incident is also associated with the relevant CI to speed up the diagnosis.

Resolving and concluding incidents

Quality teams strive to resolve incidents as soon as possible, regardless of how they come about. To determine and close these tickets efficiently, communication is essential. Through the self-service portal, the user can complete the resolved tickets himself or themself automatically.

Managing Workplace Incidents: Best-Practices to Prevent Them

Serious workplace incidents can lead to catastrophic injuries, or even death. It is also possible for a workplace incident to cause:

  • Expenses related to medical treatment
  • Productivity Loss of Affected Workers
  • Forms and documents related to workers’ compensation
  • OSHA inspections
  • Reduced morale

Below are some tips for preventing workplace incidents and ensuring the safety of employees.

Always put safety first

Your company should always put safety first. Everyone at the workplace should understand that safety is a priority, from top management to the newest employee. Employee handbooks should include all safety protocols and procedures, and they should be posted throughout the workplace when appropriate.

It is important for companies to ensure that their employees sign documentation indicating their understanding of the company’s safety standards and their commitment to follow them at all times.

An effective training programs

Continuing education and training are also important to keep the workplace safe, as well as providing safety information and protocols in employee handbooks for new hires. All employees should receive training on all aspects of their employment, including how to operate all equipment and machinery properly.

Work with qualified individuals

When it comes to hiring employees, employers must take the time to select qualified candidates. An overall understanding of building safety can be greatly enhanced by obtaining safety-related certifications. It is important to carefully investigate an applicant’s certification and work history before hiring them if they boast they have a particular certification.

The conduct of pre-placement physicals can also verify that workers meet the qualifications for certain positions. Both new employees and other workers who would rely on that new employee can benefit from the screening process, which ensures that each worker is matched to tasks that are appropriate for their level of ability.

Make sure you hire enough people

Incidents often occur because employees are overworked and understaffed. Employee fatigue and stress can cause workplace incidents if companies fail to meet adequate staffing levels. Hiring part-time or seasonal employees can help reduce stress during busy periods.

Ensure the proper use of safety gear in the organization

To ensure safety and prevent accidents, every employee should always be provided with personal protective equipment (PPE). It is essential that every employee receives training on the PPE they will need for specific jobs, and it is also imperative that PPE is regularly maintained and tested to determine its efficiency and reliability.

Maintain equipment on a regular basis

The failure of equipment, vehicles, or machinery is often the cause of work accidents. Equipment and machinery used by employees should always be properly and appropriately maintained by employers.

It is imperative to repair or replace damaged or faulty machinery or equipment as soon as possible. Document all maintenance records and alert employees to faulty or defective equipment.

Inspect safety procedures

A regular, consistent hazard identification and assessment should also accompany routine maintenance of machinery and equipment. During these safety inspections, employees should feel free to speak out about any possible hazards at work. It is also important for employers to ensure that all existing safeguards at their company are effective and relevant.

Workers who meet or exceed safety standards can even receive rewards for their efforts.

Make sure the environment is safe

Work with your workers to maintain a safe work environment on a daily basis.

  • You Should Maintain Your Company’s Grounds
  • Maintain Equipment Regularly
  • Provide all employees with a wellness and safety plan
  • Maintain a clean pathway by removing debris
  • Clean Up Spills Immediately
  • Build An Organizational Culture of Safety

Working in a safe environment is just smart business.

Identify vulnerabilities

You should investigate near-misses or minor accidents at your workplace (or any past serious accidents) carefully if they occur. Create new safety strategies for the future to address these issues, if any preventable mistakes can be made.

Encourage feedback from employees

There is a fear that employees will be fired or retaliated against if they speak out about safety issues at their employers. To keep the workplace safe for employees and their coworkers, use a suggestion box or offer incentives to encourage employees to come up with innovative solutions.

Fortunately, you can organize all the prevention measures in a closed-loop workflow using a next-generation incident management software like Qualityze. Request a demo to see for yourself how Qualityze can streamline all your incident related processes while ensuring compliance.

To learn more about Qualityze Incident Management Software, please contact our customer success team at info@qualityze.com or call us at 1-877-207-8616, and we will be right there for you at the earliest.

Maintaining and Managing Quality Policy: How can EQMS software help?

Maintaining and Managing Quality Policy

Everything About Quality Policy
  • What is the Purpose of Quality Policy?
  • Defining Quality Policy: Things to Consider
  • Quality Policy: How to Establish One?
  • Quality Policy: Who Is Responsible to Manage It?
  • Quality Policy: How to Communicate It to Employees?
  • Quality Policy: Just A Statement or Strategic Direction
  • Quality Policy: Have You Examined the Business Foundations?
  • Quality Policy: An Example for Your Reference
  • Quality Policy: How to Implement One!
  • EQMS and Quality Policy: How Can They Work Together?
  • Managing Quality Policy using an EQMS: An Expert Assistance You May Need

What is the Purpose of Quality Policy?

Quality policies describe your company’s intentions, goals, and guidelines in relation to quality. You must create one to define your company’s policies that will benefit various stakeholders. Instead of just a written statement, make it more valuable and practical. For example, be sure to include a plan for continuous improvement. Moreover, top management’s responsibility is to exchange information with interested parties. Further, they intend to distribute and communicate the quality policy internally.

Ensure that your employees feel committed to your organization’s objectives by providing them with the conditions they need to succeed.

Your quality policy is essential to the functioning of your QMS and, consequently, to your business in general. This highest-level objective will guide every action and decision by your team for the system’s function. Having a thoughtful, intentional quality policy in place and communicating it across your entire team will help align your team to the same goal. It goes beyond importance — it’s an inevitable component of your QMS’s success.

Defining Quality Policy: Things to Consider

Please consider the following points as a guide for those of you who are considering how to structure your Quality Policy.

  • In the first step, please write down the organization’s information, followed by the names of the people who wrote and approved it.
  • Next, give an overview of your Quality Management System and your company’s mission.
  • Next, make sure the QMS applies to the following departments, facilities, branches, or affiliates.
  • The final step is to consider the organizational structure.

Quality Policy: How to Establish One?

What are the steps involved in establishing a quality policy?

To continually improve your company results, your quality policy must include a commitment to fulfilling all company and stakeholder requirements. A quality policy should be created after verifying the organization’s context, identifying specific processes, and clearly defining its goals to support the company’s strategic direction.

In addition to providing a reference system for setting objectives, the document’s description should reflect a commitment from management.

A company’s quality policy will provide an overview of how quality is thought about and practiced day-to-day for all stakeholders, such as customers, suppliers, employees, and shareholders.

The policy is frequently consulted and tested to ensure that objectives, targets, and critical analysis align with the policy as stated during quality audits. The text must be clear, easy to understand, and without excessive formality or confusion.

It is essential to consider your company’s strategies and specificities when drafting this document. Using examples and templates from the internet may not reflect your organization’s strategic direction and objectives, resulting in nonconformities in audits and problems with your management system.

Quality Policy: Who Is Responsible to Manage It?

It comes under the responsibility of top management to establish, document, and communicate the quality policy and to make it available to interested parties. The quality policy is typically documented in a company’s quality manual, communicated to employees during a training session, and displayed throughout the facility as a reminder.

Quality Policy: How to Communicate It to Employees?

An organization must ensure that all employees understand, implement, and adhere to the quality policy. Different places have different methods of making policies public. Here are some examples of how companies have raised awareness about the policy by exposing it to the public:

  • Banner at the entrance of the establishment;
  • Through town-hall style meetings;
  • Active email communication;
  • Described on employee ID badges;
  • Cell phones and computers with company wallpaper;
  • Providing copies at places where employees are heavily trafficked;
  • An explanation on the company’s website;

The organization must conduct periodic assessments of how this knowledge is seeded within employees and hold continual training to explain how company policies are measured and controlled throughout the organization. You should also inform everyone who works for and on behalf of your organization, including subcontractors, temporary workers, and remote workers. Each of them must know their roles and responsibilities regarding the policy.

Quality Policy: Just A Statement or Strategic Direction

It takes more than just writing a slogan to create a quality management policy statement that is both purposeful and meaningful. In the company’s quality declaration, it is imperative to define the importance of these fundamental subjects clearly. Organizations must also be held accountable for meeting stated expectations. Under ISO quality policy, the company’s goals and direction must be derived from the knowledge and experience of top management and be written, documented, communicated, and enforced.

ISO standards require you to meet several further requirements. For a policy to be considered compliant with ISO, it must first complete the ISO goals. Then, it must actively and adequately serve your organization’s business purpose as defined by the context and meaning of your organization.


Quality management policies should also clearly support the business’s strategic direction and serve as a basis for determining quality objectives. You must evaluate objectives that work toward achieving the policy’s overarching goal. Ensure your company’s commitment to continuous improvement of its quality management system and meeting all applicable requirements is included.

Related Article: A Guide to Quality Objectives

All interested parties must access a current version of the quality policy’s documentation. In addition, all employees must understand and apply the quality policy, so easy access is essential.

Quality Policy: Have You Examined the Business Foundations?

Identify three key functions of your business by examining its roots:

  • Purpose: The reason for the existence of an organization
  • Context: that which affects the company from both an internal and external perspective, and the parties involved in the process
  • Strategic Direction: Organizational progress toward the desired outcome

Your quality policy statement will combine these functions to bring them all together, aiming them at quality, and stating your intention, commitment, and goals.

There is a good chance that any number of plans you have already developed state this information – your company’s purpose, context, and strategic direction. Growth and development plans, financial goal setting, and forecasting all play a crucial role in keeping the entire organization on the same page.

Make sure you pin down your executive leadership team to determine these three critical definers if these foundational building blocks do not exist in your organization – whether you are a small business, a start-up, or simply focus more on getting stuff done than writing stuff down. The mission and growth of your organization should be driven by the overarching purpose, context, and strategic direction of your organization.

A quality policy is a statement that focuses on your quality goals and commitments. As you write it with your QMS implementation team, you will weave together your purpose, context, and strategic direction. The policy will fall into place once the deep work is completed. To maximize your business’s quality performance, your ISO quality policy statement should be specific to your company, establishing the quality benchmarks that will make the biggest difference.

Quality Policy: An Example for Your Reference

While organizations need not adhere to any specific quality policy format, they should ensure that their statement addresses their purpose, context, and strategic direction.

Let’s take a look at a sample quality policy statement.

All Services, Inc.

  • Purpose: Responsible for managing and supporting telecommunication services.
  • Context: Competitors, a high-cost industry, higher customer expectations and constantly changing technology are all challenges the company faces.
  • Strategic direction: Maintain and expand client relationships by offering superior services to gain an edge over the competition.

Quality management is based on these fundamentals.

“All Services, Inc. strives to provide excellent telecommunications services and provide excellent customer service without compromising quality. By providing advanced networking solutions at the lowest costs possible, we will assist our customers to experience operational excellence. Our services are continuously improved, and we adhere to ISO requirements for excellence. Our goal is to meet or exceed our customers’ expectations while meeting applicable standards such as ISO – 33.040 – Telecommunication systems.”

There is no doubt about whose responsibility it is to maintain quality management starting with the company’s fundamentals.

Quality Policy: How to Implement One!

The quality assurance statement you develop and approve will be used by your organization as a guide for developing all quality objectives. The quality policy can be used to direct customer interactions while keeping the company’s overarching goals at the forefront.

A quality objective is what is desired, measurable, and achievable by a process in terms of quality. The quality of your deliverable can be influenced by any number of specific facets of your company. Taking policy steps down into your operation, they facilitate the delivery of high-quality products and services for your clients.

For example, All Services, Inc.’s policy clearly states its aim to deliver excellent telecommunication services for its customers. Creating an objective to measure the time it takes to respond to customer complaints is one way they can actively demonstrate this part of their quality management policy. It can be written as “address all the customer complaints regarding poor service within 12 hours.” and “keep your customers informed if it takes longer than 12 hours to resolve the issue.”

EQMS and Quality Policy: How Can They Work Together?

As you plan and implement the ISO standard, you’ll spend most of your time working on your quality policy. But you can’t just finish it and call it a day. It will become a working piece of your quality management system after your quality policy has been released as a controlled document. Your company’s baseline should be reviewed yearly during a management meeting to ensure that it remains appropriate. Every organization has to deal with changing business conditions and a changing strategic direction. If those changes occur, you will probably need to change your quality policy and related objectives.

Unfortunately, paper-based systems for managing quality processes and policies are not as efficient as they once were. As an alternative, you can implement a cloud-based enterprise quality management solution. An EQMS helps establish closed-loop workflows of industry proven best-practices, building a culture of quality within organization. In addition, the software makes the change process error-free and efficient.


The next-generation EQMS solutions like Qualityze EQMS Suite are robust, reliable, and secure. Moreover, they provide greater flexibility to manage end-to-end quality across the globe.

Managing Quality Policy using an EQMS: An Expert Assistance You May Need

ISO 9001 policies can be complex to implement owing to several factors. However, we are ready to assist you at Qualityze Inc. and will help you transform your QMS into Quality Decision Making Engine.

For more information, please get in touch with our customer success team at info@qualityze.com, or you can give us a call at 1-877-207-8616, and we will get back to you as soon as possible.

A Quick Look at Different Dimensions of Quality

A Quick Look at Different Dimensions of Quality

Table of Contents
  • Different Dimensions of Quality
    1. Performance
    2. Features
    3. Reliability
    4. Conformance
    5. Durability
    6. Serviceability
    7. Aesthetics
    8. Perceived Quality
  • In what ways does quality contribute to the success of your business?
    1. Improved profitability
    2. Increased efficiency and consistency of products
    3. Increased customer satisfaction
    4. Your brand’s protection and risk reduction
    5. Lower Costs
    6. Conforming to or exceeding compliance requirements
    7. Cutting down on waste
    8. Motivated employees
  • Quality Management – Whose responsibility is it?
  • Quality Management – The right tool to choose?
  • Conclusion
To be successful, your business needs to maintain quality at all levels. Managing an organization is about quality – how good is the product, service, process, action, or decision, and how can it be improved?

An organization’s success depends heavily on quality management. Also, it provides a superior customer experience in the competition for customer relationships. Therefore, companies shall establish best practices to ensure products meet the highest quality standards. Ultimately, the goal is to increase customer satisfaction and drive business growth.

The quality of your products isn’t just about the finished products; it includes all your processes, systems, and people. Managing quality means constantly striving to achieve excellence – keeping your organization on track to achieve its goals and stay on top of its competitors.

Suppliers do not determine the quality of their products; their customers decide what they want from them and how much they’re willing to pay. Incompetence, not hard work or cost, defines ‘quality’ products, not the difficulty of making them or the cost. It is only what customers find valuable and useful that they pay for. Therefore, quality is the only thing that matters.

Quick Read: A Guide to Measuring Effectiveness of Quality Management Processes

It would be best to ask your stakeholders what quality means for your organization. It is essential to understand who your stakeholders are, their needs, and how to meet (or even exceed) those needs today and tomorrow to deliver quality in your organization. By stakeholders, we mean customers, suppliers, employees, and the community in which your company operates who are interested in the success of what you do.

However, you and your stakeholders must consider different dimensions of quality before developing a quality policy and strategy.

That’s what makes it stand out and makes it valuable from its competitors. Now let’s look at each dimension.

Different Dimensions of Quality

  • Performance
  • A product’s performance characteristic describes what it does.

  • Features
  • The performance of a product is primarily determined by its features. It’s what makes products and services stand out. So, to make their essential functions even more useful, they add extra functionality.

    It can sometimes be difficult to distinguish between performance and feature dimensions.

  • Reliability
  • An item’s reliability is its ability to perform over time as expected.

  • Conformance
  • A product’s conformance is determined by how closely it follows its specifications.

  • Durability
  • Essentially, durability measures the life of a product. A product’s usage life determines how long it can be used before deteriorating.

  • Serviceability
  • The serviceability of a product refers to its ability to be repaired or fixed easily by the user. One way to measure this is how long it takes to repair and return to regular use of a faulty product.

  • Aesthetics
  • In aesthetics, we talk about how something looks. This includes the weight, color, size, texture, packaging, and other aspects of a product’s physical appearance.

  • Perceived Quality
  • The overall perception of quality is what customers think about a product. In addition, the brand’s name, price, salesperson, and marketing strategy are numerous factors.

In what ways does quality contribute to the success of your business?

Keeping up with the competition is crucial for businesses. Therefore, it is imperative to deliver superior products and services. Managing quality correctly begins with getting the correct information and following guidelines. Further, they maximize the efficiency of your business’s resources and reduce costs.

You can compete with your competitors in the long run by increasing your brand’s visibility. In addition, your business will benefit from them as they improve your products and operations.

Taking good care of your organization’s quality will enhance its brand and reputation, reduce its risks, improve its efficiency, increase profits, reduce waste, and position it for growth. As a result, staff members and customers are happier.

  1. Improved profitability
  2. Quality is strongly correlated with profitability. The higher the quality, the greater the return on investment (ROI).

  3. Increased efficiency and consistency of products
  4. Quality management ensures that products are reliable, durable, and perform well. A business can differentiate itself from its competitors by addressing these factors. Customer satisfaction and revenue increase when you consistently deliver quality goods to your customers.

  5. Increased customer satisfaction
  6. Consumers are becoming more demanding in today’s competitive market. Thanks to technological advances, consumers can access millions of brands and stores. Your revenue and brand will suffer if your products and services do not meet customer expectations.

  7. Your brand’s protection and risk reduction
  8. A company must consider the risks associated with its products after they leave the building. The customer experience can be adversely affected by recalls, for instance. Moreover, they may damage the brand’s reputation.

  9. Lower Costs
  10. Quality management systems and products are statistically linked to more customers and revenue. Great products are directly responsible for building a good reputation. You will gather referrals from happy customers who return for the same product or a different item.

  11. Conforming to or exceeding compliance requirements
  12. Some customers or laws may require adherence to a recognized quality standard. Several companies in the public sector require that their suppliers meet quality standards. Healthcare, food, and electrical products all fall under-regulated markets, where health and safety regulations are designed to protect consumers.

  13. Cutting down on waste
  14. If you cannot sell a product in your company, you must discard it. The more items that don’t meet the required standards, the more waste your business will produce over time. You will also waste a lot of things and money due to this.

  15. Motivated employees
  16. Additionally, quality management systems, such as ISO 9001, ensure that departments communicate clearly and have clear responsibilities. Thus, employee morale and performance are improved, and efficiency is increased.

Quality Management – Whose responsibility is it?

It is everyone’s responsibility to ensure quality in your organization. Quality is affected by different factors, including specifying requirements, meeting those requirements, or determining quality. Therefore, you must encourage your employees to maintain a culture of quality wherein everyone contributes equally.

Quality Management – The right tool to choose?

As customer demands and compliance requirements continue to grow, it has become necessary for enterprises to adopt more efficient ways of managing end-to-end quality.

The next-generation software solution like Qualityze EQMS Suite can help manage quality and all its dimensions efficiently. It eliminates the administrative workload while assisting the companies in meeting compliance.

Conclusion:

There is no universal definition of quality. Every individual has their own meaning of quality based on their experiences. Do we have a good explanation of quality? How to evaluate quality? A more objective definition of quality must take into account these eight dimensions.

You can also use it to set quality goals that can be aligned with the ongoing processes using the right Quality Management Software.

Please feel free to get in touch with us for any questions you may have about Qualityze capabilities via email at info@qualityze.com or on call at 1-877-207-8616.

A comparison of ISO 9001 and QMS

A comparison of ISO 9001 and QMS

What This Blog Is All About
  • ISO and QMS: An Enterprise’s Perspective
  • Defining ISO 9001:2015
  • Defining Quality Management System
  • ISO 9001 and QMS: How They Are Related?
  • ISO 9001 and QMS: Shared Goals
  • Right EQMS Is All You Need
  • Conclusion

ISO and QMS: An Enterprise’s Perspective

Businesses commonly standardize their processes. The standards in a particular field are highly distilled best practices developed by experts who understand the needs of their field. For example, a standard can describe how to create a product, manage a process, or deliver a service.

Historically, industry standards have been developed to enable organizations to align with external norms and provide their customers and suppliers with an understanding of their processes.

While several external bodies create standard systems, the ISO is the most commonly adopted. This is because it helps enterprises to make the most of their quality management system.

However, many enterprises consider both the terms the same. Here you will find out how ISO 9001 compares to quality management systems and how they differ.

Defining ISO 9001:2015

In ISO 9001, requirements are set forth for a quality management system (QMS) in an international standard. It demonstrates that a company can consistently provide products and services that meet client needs and regulatory requirements. Among the ISO 9000 standards, this is the most popular and the only one that can be certified.

Founded in 1987, ISO 9001 is an international standard developed by 160 national standards organizations from more than 160 countries. September 2015 marked the release of ISO 9001’s current version.

There is no industry or size restriction when it comes to ISO 9001:2015. The ISO 9001 standard is implemented in more than 160 countries by over a million organizations. ISO 9001 helps all types and sizes of organizations:

  • Streamline and standardize processes
  • Optimize processes to increase efficiency
  • Continuously improve

With ISO 9001, organizations can consistently provide high-quality products and services to their customers, leading to higher customer satisfaction, employee satisfaction, and management satisfaction.


Organizations use ISO 9001 because it specifies the requirements for an effective quality management system so they can:

  • Set up a quality management system
  • Satisfy customers, employees, and management
  • Continuously improve their processes
  • Reduce costs

With ISO 9001, you get a framework to set up quality goals and achieve them on time. It defines all the best practices an organization can adopt to build a quality and continuous improvement culture. It also helps manage change effectively and efficiently so that change is no more considered a challenge in the business environment. Instead, it should be regarded as an opportunity to improve the quality, safety, and reliability of the products and services offered.

Since ISO defines the QMS requirements, let’s dig deeper to understand the quality management system and the associated processes. Knowing the processes involved will help you implement best practices more effectively than ever.

Defining Quality Management System

Quality Management Systems outlines how a company intends to produce quality products and offer quality services in compliance with regulatory requirements. An integrated quality management system can cover the entire lifecycle of a product or service by putting in place several quality management activities:

  • Planning: ensuring all legal/regulatory requirements, as well as any customer requirements, are addressed.
  • Quality Control: Establishing processes for ensuring consistent product quality
  • Quality Assurance: Ensuring your product meets your customer’s expectations
  • Improvement: Implementing changes to your processes and reviewing your output to ensure your standards remain high and that your customers are satisfied

It is crucial to document a QMS but not at the same time confuse it with the Management System. You can train employees and ensure they know what is expected during Quality Control by documenting your policies and creating process maps during the planning phase. The document contributes to both Quality Assurance and Improvement efforts as it provides a benchmark for measuring and reviewing the quality of a product or service.

In a QMS, the risk is considered regardless of whether the risks affect the quality of products or services. This includes failures to identify customer needs, comply with legal requirements, and maintain customer security, as well as failures in the quality of the products or services. Although partners or suppliers may be at fault for these failures, a QMS will address them and manage these issues.

ISO 9001 and QMS: How They Are Related?

It is pretty evident from our discussion above that ISO 9001 and QMS are closely related. Therefore, you must implement an ISO 9001 compliant quality management system to deliver superior quality products while meeting compliance.

However, an enterprise doesn’t need an ISO 9001:2015 certification to do business. It makes a more significant impact when they want to sell their products and services globally. So, if you want to start your quality journey, you can establish quality management processes in alignment with best practices without obtaining certification.

Once you are confident of the quality culture in your organization and want to scale your operations at a global level, you can apply for ISO 9001 certification.

ISO 9001 and QMS: Shared Goals

Although ISO 9001 and QMS are different yet closely related subjects, they share some common goals, such as:

  1. Ensuring quality, safety, and reliability of the products and services offered.
  2. Building a positive work environment.
  3. Ensuring customer and employee satisfaction.
  4. Establishing efficient processes for high-quality output.
  5. Improving brand reputation and market share.

Right EQMS Is All You Need

As stated above, ISO 9001 and QMS share some common goals. You can achieve them with the right approach, tools, and methodology. However, you might miss several opportunities if you are among businesses that still rely on paper-based systems or outdated technology.

It would be best to implement a next-generation, cloud-based enterprise quality management software like Qualityze. The software will help your teams to manage end-to-end quality processes on the cloud, enabling them to standardize best-practices workflows.

Highly configurable and intuitive, Qualityze EQMS Suite is delivered on the most powerful and secure platform, i.e., Salesforce.com. You can also leverage greater flexibility, security, scalability, and performance. It comes with a centralized database and many exceptional functionalities such as Digital Signature, Audit Trail, and Email Approval to ensure compliance.

Request a free demo today if you want to experience Qualityze difference in managing product and process quality.

To learn more about Qualityze products and their functionalities, feel free to contact our customer success team at info@qualityze.com or call us at 1-877-207-8616, and we will get back to you at the earliest.

Related Articles: Why Should You Invest in an Integrated EQMS Software?

Conclusion

ISO 9001 represents the set of QMS requirements, whereas a quality management system is a framework that binds all your quality processes together to produce high-quality goods. Aligning these together could be challenging with paper-based systems. Alternatively, it would be best if you use Enterprise Quality Management Software. It will help you achieve all your quality goals while meeting compliance and operational excellence.

Another benefit of the next-generation Quality Management Software is improved traceability since the cloud-based solutions provide a centralized database to securely manage all your quality records.

Would you like to experience the most simplified way of managing the quality process?

Achieving the Quality Goals: How Six Sigma Works?

Achieving the Quality Goals: How Six Sigma Works?

Table of Content
  • What is Six Sigma?
  • What is Lean Six Sigma?
  • How does Six Sigma Help in Process Improvement?
  • What are the Benefits of Six Sigma?
  • Six Sigma and Quality Management

Whether an organization succeeds or fails largely depends on the quality of its products and services. In the long run, you will not be able to survive if you ignore an important aspect like quality. Six Sigma aims to eliminate defects in processes and systems to ensure superior quality of products.

Organizations use six-sigma to identify, analyze, and remove the obstacles that hinder them from reaching perfection by analyzing and eliminating their processes and systems. In this post, we will learn more about the six-sigma methodology, its benefits for the organization, and its role in quality management.

What is Six Sigma?

In Six Sigma, errors or defects are analyzed statistically and based on data. It focuses on improving cycle times while reducing manufacturing defects.

The Six Sigma methodology is a data-driven approach to streamlining production and manufacturing. You can also leverage this most flexible project management and process improvement method for industries and businesses outside of manufacturing.

A business can use Six Sigma tools to eliminate defects and improve processes to boost profits. In the 1980s, a Motorola scientist developed it.

What is Lean Six Sigma?

A Lean Six Sigma approach focuses on eliminating waste and defects while improving work standardization to improve performance. Lean Enterprise combines Six Sigma methodologies and tools with lean manufacturing to reduce waste in manufacturing and organizational processes while ensuring quality. Using resources that do not create value for your customers is a waste of resources.

How does Six Sigma Help in Process Improvement?

Six-sigma defines five simple steps for process improvement wherein you need to;

  • Identify the problem. Defining the problem, the goal, the charter, the customer’s requirements, and the process map is essential.
  • Assess the current process. Gather performance and issue data. Reconfirm the data’s reliability, and update the charter as needed.
  • Investigate the causes of issues. Investigate and confirm what’s causing the problems, display the data, and continue to update project charters.
  • Streamline the process. Develop processes for new solutions to fix issues. Continue to measure improvements as you implement the latest fixes.
  • Take charge. Monitor the new process, refine it if possible, and use the findings elsewhere in the company.

Also Read: Explain the Five-Why Analysis to Determine Root Cause(s)

What are the Benefits of Six Sigma?

Six Sigma can drive multiple benefits:

  • There will be less waste

    Six Sigma aims to decrease your company’s total waste by optimizing processes. Your organization will save time, money, and resources by identifying and resolving waste within your organization.

  • The efficiency of your business will increase

    By leveraging Six Sigma, you are not only able to reduce waste but also improve your efficiency. In addition, having formal training will help you maximize the effectiveness of your current business processes.

  • There will be fewer errors

    Quality and process are equally important to Six Sigma. The best way to save money and time is to get your product right first!

  • The legal risk will be minimized

    As good as it sounds, the same process will save you money and prevent legal expenses. The Six Sigma methodology is dedicated to quality, making it an excellent choice for organizations trying to comply with international standards.

  • It can be applied to any industry

    Almost any industry can benefit from Six Sigma. No matter what industry you work in – healthcare, manufacturing, retail, higher education – it can help! Any company can reduce costs and increase profits by leveraging the skills and tools you gain from your training.

  • There will be a more significant profit for you

    Even though money can’t buy happiness, it can buy a nicer thing! You can save a lot on product recalls by identifying improvement opportunities with six-sigma.

Therefore, the six sigma methodology sounds like a win-win-win situation.

Six Sigma and Quality Management

Six Sigma strives for defects and waste elimination in all business processes, thereby enhancing quality and efficiency. The sigma rating measures how many products are defect-free. It is expected that 99.99966% of all production opportunities will be defect-free in a six-sigma process. Health care organizations use Six Sigma to ensure that delivering health care services is as reliable as possible. However, it was initially designed to increase manufacturing efficiency for General Electric in 1995.

Using Six Sigma, you can identify and eliminate defects (errors) in your processes and minimize inconsistencies. The new system uses quality management methods and creates a particular infrastructure within the organization of people who are experts in them (“Champions,” “Black Belts,” “Green Belts,” “Yellow Belts,” etc.).

Six Sigma emphasizes identifying and correcting the root causes of variations with statistical tools and analysis. In Six Sigma, DMAIC stands for Define, Measure, Analyze, Improve, Control as a framework for problem-solving and process improvement. Most companies use six-sigma as a part of their CAPA process to identify the root causes of the defects and nonconformances reported.

However, manually managing the entire process may present many challenges, especially in fast-paced business environments. Therefore, it would be best to use CAPA management software that gives you complete flexibility to choose the investigation tools based on your business and compliance requirements.

Qualityze CAPA Management enables enterprises to standardize CAPA workflow with necessary investigation tools. The software supports a variety of means, including – 5 whys, Six Sigma, Fishbone, and much more. In addition, it automatically stores CAPA records in a centralized database so you can quickly trace the details during inspections or audits.

Qualityze CAPA Management, built on Salesforce.com, has many exceptional in-built capabilities such as digital signature, audit trail, email approvals, and more. You can experience the Qualityze difference to improve quality by requesting a free demo.


For more queries, please get in touch with our customer success team at info@qualityze.com, or you can call us at 1-877-207-8616, and our team will get back to you as soon as possible.

Data Fidelity and Quality Management: What’s the Connection?

Data Fidelity and Quality Management

Table of Content
  • Defining Data Quality
  • Defining Data Fidelity
  • Data Fidelity and Quality Management: What’s the Connection?
  • The Conclusion

The most valuable asset to your organization is its data. First, however, you need to be sure that the data you use is reliable and trustworthy. Companies can make reckless recommendations when they work with untrustworthy data for any reason.

An individual’s data quality can be categorized into two categories: Data Fidelity and Data Quality. However, there are significant distinctions between these two terms. Both terms are used interchangeably. Companies making better business decisions need to understand the difference between their data’s accuracy, consistency, and context.

Defining Data Quality

Data quality is the degree to which data is reliable. Data quality is crucial to data integrity.

For data to be considered quality, it must be:

  • Complete: The amount of data available is a substantial portion of what is needed.
  • Unique: A unique dataset does not hold duplicate or unnecessary entries.
  • Valid: Data is as per business and compliance requirements.
  • Timely: The data is sufficiently current to be used for the intended purpose.
  • Consistent: This dataset is consistent in how the data is represented.

These criteria must all be met for quality data. The lack of just one element could compromise any data-driven initiative.

Related Article: Data Quality Management: Benefits of Electronic Document Management System Every Business Owner Should Know

Even high-quality data is not necessarily valuable for an organization. For example, even with a database of valid and correct customer names and addresses, without supporting metadata that explains the relationship between those customers and your company, that database is not as valuable as it could be. In this case, data fidelity is critical.

Defining Data Fidelity

In data fidelity, the characteristics of a source are quantified and embodied accurately. However, data fidelity is now used in cybersecurity to detect intrusions at the granular level using the granularity of event data captured. It is also possible to define fidelity in terms of granularity and accuracy of data detailed in a report.

To ensure fidelity, data must be;

  • Traceable: So, you can track it easily and quickly when needed.
  • Accurate: The data should be accurate to identify gaps and inconsistencies.
  • Secure: The data must be managed securely to ensure access for authorized users only.

Building, managing, and maintaining high-fidelity data architectures require more complex skills. Speed, volume, and variety of data have their respective effects, but these effects are influenced by technology drivers like asynchronous processing and improved I/O throughput mechanisms. Likewise, increasing fidelity and lowering latency requires more skill and engineering.

Data fidelity and finer granularity are important for EHR (Electronic Health Records) and CDS healthcare verticals.

It is essential to understand data fidelity and latency and how they relate to data complexity, architecture, and models to gain meaningful insights into the data. For data fidelity to be quantified within a domain like healthcare, it would require a scientific evaluation on a scale appropriate for an academic paper.

Similar to the efficacy of a vaccine, data fidelity and latency impact the data model. Data fidelity is an excellent way to quantify the success of any data-related project. As a rule of thumb, you can correlate data fidelity and latency to the different business scenarios and determine how well they worked.

Data Fidelity and Quality Management: What’s the Connection?

As already discussed above, data fidelity is an excellent way to quantify the success of any data-related project. Furthermore, it can play a crucial role in the success of your quality management system since the enterprises’ quality related decisions are data-driven.

In fact, data quality and fidelity – both are equally important for quality management.

So, how would you take care of both aspects while managing quality processes?

It just takes one simple solution to make things right. And the solution is Qualityze Forms Management System.

Qualityze Forms Management Software enables enterprises to manage form-related activities more effectively. It is easy to create, edit, share, and track all types of forms to capture valuable inputs from customers, employees, suppliers, and stakeholders. Data can be validated in real time with Qualityze Forms management. Validating your data when it is collected will improve the quality of your database. Furthermore, you can integrate it with existing quality systems to standardize data collection best-practices across the organization. You can effectively and efficiently manage forms with Qualityze Forms Management System by:

  • Centralizing forms and critical information in a database.
  • Monitoring the forms’ status whenever necessary.
  • Establishing standardized audit checklists, supplier questionnaires, customer feedback forms, and more.
  • Managing forms on a single site or across multiple sites.
  • Creating forms based on different business and regulatory standards.
  • Reducing the risk of compliance issues.
  • Controlling access to forms containing sensitive information.
  • Making better decisions by analyzing form inputs.

Building the right forms helps you gather the right data, which you can further analyze and make intelligent decisions. Qualityze Forms Management Solution standardizes the process and makes it simpler for you to create a quality data repository to assist you with critical decisions. It is a fully configurable and validated solution. Moreover, you need not stress about the forms’ data security since the solution has in-built security controls to keep all the data safe from unauthorized users.

You can see your product features and in-built capabilities by requesting a free demo today.

The Conclusion

An organization seeking data-driven decisions needs to ensure data quality and data integrity. Of course, it is important to start with data quality. Still, data integrity is the key to enhancing the usefulness of the data to an organization and ultimately driving better business decisions.

Data quality may be the first step toward data fidelity. In all their data-driven initiatives, companies that make proactive efforts to fix data quality issues see better results.

With Qualityze Forms Management Software, enterprises can significantly improve data accuracy, consistency, reliability, and safety. Furthermore, you can leverage the advanced integration capability to improve the data quality and fidelity across all the systems organization-wide.


If you have questions about Qualityze Forms Management Software, you can contact our customer success team. We can be reached at info@qualityze.com, or you can give us a call at 1-877-207-8616, and our team will reply as soon as possible.

7 Benefits of Organizing your Employees into Efficient Teams

7 Benefits of Organizing your Employees into Efficient Teams

Table of Content
  • Train your employees to become game changers!
  • Training Statistics: Change Your View of Employee Training
  • How to train your employees well to be more effective?
  • What are the benefits of organizing your employees into efficient teams?

Training plays a critical role in creating efficient teams that help you achieve operational excellence and business goals. The benefits of building efficient teams extend way beyond. You can build a more substantial brand reputation and significantly improve customer service. However, this requires a proactive approach. It can be achieved with the right management and powerful Training Management Software.

Train your employees to become game changers!

Whether you are running a small business or a part of a large enterprise, you need efficient teams in the workplace to achieve business goals. Having the right people with the right skills and competency can set you apart from your competitors. However, it would be best to train your employees to maintain their efficiency and productivity in the long term.

Yes, you heard that right.

Training your employees well can help build efficient teams that can adapt well to the growing business and compliance requirements. Here are a few statistical facts for your reference.

Training Statistics: Change Your View of Employee Training

A recent survey presented the following statistics on employee training. These statistics are likely to change enterprises’ perspectives about training and the associated benefits:

i. 68% of employees say that training and development opportunities are the most important policy of the organization.

ii. Investing in training increases profit margins by 24%.

iii. 87% of millennials value learning and training in their workplace.

iv. A thoughtfully designed training program improves employee retention by 30-50%.

v. About 12% of employees say they use training knowledge in the workplace.

vi. The cost of ineffective training per 1000 employees is $13.5 million.

vii. An investment in training would increase employee retention by 94%.

viii. 74% of employees believe they aren’t achieving their full potential because of a lack of development programs.

ix. 59% of employees say they have never been trained for their job.

x. 56% of HR managers say employee training is essential to their business.

xi. 70% of employees would switch to a company that invests in employee development if it were offered.

How to train your employees well to be more effective?

We have curated a step-by-step approach to train your employees to be more effective. However, to ensure you are making the best efforts in the right direction, you must:

  1. Educate your team on “why” before “how.” It will help them understand the value of training in their day-to-day operations. When employees know why they are learning something new or getting trained, they tend to apply their learning in their routine more effectively.
  2. Encourage your employees to practice things they have learned in the training programs. As the adage goes – “Practice makes you perfect.”
  3. Encourage your employees to share their expertise with other team members. It will serve multiple purposes:
    • Your employees will learn from each other and appreciate each other’s strengths, building a better work culture.
    • Your employees will be more motivated to speak about their interests than the other non-relevant topics.
    • Your employees will gain more confidence in public speaking.
    • Your employees will invest their time in the skills that matter for personal and professional development.
  4. Encourage your employees to attend conferences and seminars where they can interact and learn from people with similar expertise.
  5. Record the training sessions (internal or external) that your employees can refer to whenever they want to revisit any session or training topic.
  6. Provide your employees flexibility to complete their training, so it doesn’t harm their productivity. For example, you can use next-generation training management software. The software will help you manage many other activities associated with training – for example – you can conduct assessments once training is completed. One of the effective solutions is Qualityze Training Management Software. Request a demo to experience the difference.

Therefore, training helps you create efficient teams to accomplish business goals effectively.

What are the benefits of organizing your employees into efficient teams?

Managers must create efficient teams to help their employees perform at peak levels. It is easier for team members to share ideas and solve problems creatively when they develop positive relationships. This article describes the seven benefits of building efficient teams.

  1. Efficient teams will be more productive and creative at work, achieving their goals within a specified timeline. In addition, they will utilize best practices to manage data and process quality.
  2. Efficient teams communicate more often. This will improve employee engagement so they can share new ideas and opportunities without any hesitation.
  3. Efficient teams will collaboratively work towards achieving short-term and long-term goals.
  4. Efficient teams help create a positive work environment where every team member considers quality a responsibility rather than a specific department’s job.
  5. Efficient teams will help deliver better and faster customer responses. It will improve overall customer service and satisfaction.
  6. Efficient teams manage risks proactively since they understand the impact they can have on the business.
  7. Efficient teams learn new things quickly and adapt to changes more positively.
And the most significant benefit of all is lesser stress. Every employee will complete their tasks within the specified timeline, so there is no last-minute rush, leading to expensive errors and shipment delays.

So, ensure your teams are trained well to perform their tasks efficiently.

As we already discussed above, you need to invest in good training management software to build efficient teams.

Here’s a comprehensive blog on How to Choose the Best Training Management Software?

It will help you select the right software for your business and compliance requirements.


For more information and assistance, please get in touch with our customer success team at +1-877-207-8616 or email us at info@qualityze.com. We will get back to you as soon as possible with the best possible solution.