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Everything You Need to Know About ISO 13485 Certification

Have you spent countless stressful hours preparing for ISO 13485 certification? You’re not alone. ISO 13485 is the internationally recognized quality management standard for medical device manufacturers.

Certification guarantees the trust of your regulators, stakeholders, and future customers while quickening your route to market. There’s no denying that it’s a complex process that needs to be done right. But with expert guidance and the right toolset, your company can release and bed-lasting ISO 13485 compliance.

This guide contains everything your team needs to kickstart and complete a successful ISO 13485 delegation trip and to get your medical device to market before your competitors. Let’s dive in.

What Does Iso 13485 Mean?

ISO 13485 is an internationally agreed-upon standard quality management system (QMS) requirement for any company involved in the design, product, installation, servicing, and manufacturing of medical devices.

ISO 13485 was first published in 1996 and revised in 2003 and 2016. The current interpretation, ISO 134852016, came into effect in March 2016. The end of these requirements is to ensure that medical devices and services constantly meet client prospects and relevant regulatory requirements.

Why Is Iso 13485 Certification Important?

The International Organization for Standardization (or ISO) is a transnational-governmental association of assiduity leaders who partake their knowledge and expertise to give results for global challenges.

ISO 13485 effectively covers ISO 9001 Certification with many fresh requirements. As a result, consumers and the life wisdom force chain have come to trust ISO and frequently refuse to buy medical device products from companies that lack ISO 13485 certification.

To gain CE marking, which indicates conformity with safety standards for products marketed in the European Economic Area — medical device manufacturers must either gain certification with a notified body or have a quality system.

Five Key Elements of Iso 13485

ISO 13485 includes requirements for design and development, risk management, and product and post-production processes for medical device companies. Below are five key requirements from ISO 13485 that are critical for companies seeking certification.

ISO 13485 Certification
  1. Quality Management System (QMS)

To be certified to ISO 13485, a company must apply and maintain a quality management system that meets the requirements set out in the standard. This section applies to general quality management system requirements and the attestation needed to apply and maintain an effective quality management system.

According to ISO, organizations need to Determine the processes the quality management system requires and what is needed to apply these processes throughout the association, taking into account the colourful places involved, apply a risk-based approach to the control of the relevant processes needed for the quality management system, and determine the sequence and commerce of these processes.

  1. Management Responsibility

This section outlines management’s unique places and responsibilities concerning quality management system implementation and conservation.

In short, management should substantiate its commitment to developing and conserving the quality management system and its effectiveness. To do that, Communicate the importance of meeting regulatory requirements, establish a value quality policy to ensure quality objects are established and Conduct management reviews to ensure the availability of quality management system resources.

  1. Resource Management

This phase outlines the resources life sciences organization should commit to applying the quality management system and maintain system effectiveness. In addition, it outlines the provisions needed to meet major regulatory and client requirements.

Resources outlined in this section include;

  • The Provision of Resources
  • Human Resources
  • Infrastructure
  • Work Terrain
  • Impurity Control
  1. Product Realization

In a rush to develop products as soon as possible, numerous organizations frequently need to pay more attention to the planning phase. Therefore, section 7.1 requires that you appropriately plan your realization efforts.

  • More Specifically, It States That You Should Establish the Quality Requirements for Your Product (S)
  • Define What Your Needed Processes Will Be and What Supporting Attestation Will Be Needed for Those Processes
  • Outline the Company Infrastructure That Will Need to Be Created and What the Work Terrain Should Be Like
  • Define Employee Qualification and Training Requirements
  • Establish Your Processes for Verification, Confirmation, Measurement, Monitoring, Employing, Examination, Storehouse, Distribution, and Traceability

Eventually, you must organize all that information to be easily accessed and understood.

  1. Measurement, Analysis, Improvement

According to ISO,” the association shall plan and apply the monitor, measurement, analysis, and improvement processes” related to the quality management system and products.

In this pursuit, organizations need to Demonstrate conformity to the product ensure conformity with the quality management system Maintain the effectiveness of the quality management system ISO 13485 clauses ISO 13485 contains eight clauses as part of its requirements. They are;

  • Scope
  • Normative References
  • Terms and Definitions
  • General Requirements
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis, and Improvement

Let’s Compactly Review Each Clause

  1. Scope

The Scope sets out the intended issues of the modern medical device quality management system, including the importance of the process approach and continuous improvement.

  1. Normative References

Provides details of the reference standards or publications relevant to the particular standard, including ISO 90012015.

  1. Terms & Definitions

Details Terms and Definitions relevant to the standard, including Definitions of Active Implantable Medical Device, Active Medical Device, Advisory Notice, client Complaint, Implantable Medical Device, Labelling, Medical Device, and Sterile Medical Device.

  1. General Requirements

Lays out the broad requirements for a duly documented ISO 13485 QMS, including;

  • Quality primer with clear QMS Scope
  • Attestation control procedures
  • Needed forms, records, and bribes
  1. Management Responsibility

Enterprises the part of ‘top management,’ the group of people who direct and control your association at the highest position. client and patient satisfaction and safety should be overseen and maintained by top management with Clear responsibilities Frequent management reviews A clear quality policy with objects.

  1. Resource Management

Requirements for how resources are managed and applied to meet your quality objectives, including Personnel, equipment, and training.

  1. Product Realization

Charts out requirements for the end-to-end medical device product realization process, including;

  • Product and manufacture
  • Capturing and actioning feedback
  • Planning
  • Design
  • Purchasing
  • Traceability
  1. Measurement, Analysis, and Improvement

It breaks down how to cover and dissect your processes with a view to continuous refinement and improvement. Core considerations include;

  • Auditing
  • CAPAs
  • Non-Conformance Control
  • Measuring and Maximizing Client Satisfaction and Patient/ Product Safety
ISO 13485 Certification

ISO 13485 VS ISO 9001

ISO 9001 quality management system that can be applied no matter what assiduity you’re in or your product, service, or company size. First, however, you’ll need to seek ISO 13485 certification,

If your company intends to manufacture medical devices. ISO 13485 certification has new requirements not set up in ISO 9001 that are specific to medical device manufacturers. Let’s look at the parallels and differences between ISO 9001 and ISO 13485, so you can better understand where you need to raise the bar on quality as a medical device manufacturer.

  • Parallels Between ISO 13485 and ISO 9001 certification
  • Each Standard Helps the Organization Achieve a Quality Management System
  • Both Place a Focus on Risk Mitigation and Assessment
  • Both Use the Deming Cycle, Also Known as Plan Do Check Act
  • They Each Place a Focus on Faculty and Infrastructure for Quality
  • Both Emphasize Understanding the Client for the Realization of Quality Products
  • Fresh Requirements for Iso 13485:2016
  • Device Master Record Explicitly Defining Qms Requirements
  • Feedback and Review System for Conformance Detection 18
  • Product Quality Control (Monitoring and Measuring) Throughout the Production Process
  • Set Quality Requirements Must Be Met Before Product Release and Delivery
  • Advisory Notices, Rework Exertion, and Release of the Non-Conforming Product (Which Still Meets Regulatory Requirements) Must Be Documented
  • Personnel Require Access to Procedures, Requirements, and Reference Accoutrements at the Point of Work
  • Unique and Specific Records for Every Up-Documented and Vindicated Device Batch
  • Installation and Verification Device Requirements
  • Maintained Records of Device Installation, Verification, and Servicing Conditioning and Procedures

QMS contains product specification documents and quality policy, with a framework for reviews and updates controlled by the management team management must corroborate QMS goals and compliance documented procedures for shelf life, quality data collection/ analysis/ retention, conservation exertion, risk/ terrain management, adverse event flagging, product conformity, identification, returns, conservation, labelling, and packaging.

Tips to Prepare for ISO 13485 Certification

Now that we understand the key factors and clauses of ISO 13485 and the differences with ISO 9001, it’s time to look at medication for certification. This process can be simple and inviting. Follow these nine tips to help you get your certification briskly.

Familiarize Yourself with the Guidelines

Review the guidelines and ensure you understand what you need to become certified. You can then view an exercise and buy the complete document on ISO 13485 from ISO’s website.

Meet CAPA Standards

To ensure your company meets CAPA standards, relate to the FDA’s examination guidelines, ISO 134858.5.3 (forestalment) and ISO 134858.5.2 (correction). Failure to meet CAPA standards is the number one detector for FDA citations in medical device assiduity.

Apply Complaint Procedures

Establish complaint procedures following the guidelines in FDA CFR820.198 and ISO 134858.2.2. A lack of standard procedures for employing complaints or failure to substantiate that they followed procedures is the most common reason the organization entered a 483 observation.

Produce a written procedure for force chain management to reduce the risk of resistance or supplier pitfalls that could compromise your device quality.

Develop MDR (Medical Device Reporting) Procedures

MDR (Medical Device Reporting) should include events and periodic reports as detailed under FDA CFR803.17 and ISO 134852016. Nine ways to prepare for ISO 13485 certification 16 Written procedures and systems are critical for compliance with record-keeping guidelines for MDR.

Benefits of ISO 134852016 Delegation

While ISO 90012015 covers a broad range of businesses and diligence, ISO 134852016 has a narrower focus on medical device assiduity. By clinging to the guidelines set out in ISO 134852016, your association can enjoy several benefits, including;

  • Bringing Quality and Nonstop Improvement into the Heart of Your Medical Device Association
  • Advanced Patient/ Client Satisfaction – by Constantly Furnishing Safe Medical Devices That Meet Client Requirements
  • Enhanced Character and Credibility – by Being ISO 134852016 Accredited, You Can Demonstrate to Customers, Suppliers, and Other Stakeholders That Your Association Is Serious About Quality.

Greater Effectiveness: ISO 134852016 can help streamline your processes, making your association more effective overall.

Reduced costs: ISO 134852016 can lead to reduced waste, rework, and other inefficiencies, thereby reducing your association’s overall costs and bettered risk management – by having a robust quality management system in place, you can more effectively identify and manage pitfalls associated with your medical devices.

A Stronger Foundation for Growth: ISO 134852016 can give a solid foundation for your association to grow and expand its management into new markets.

Enforcing a quality management system can only cure an association led by quality-driven management. Successfully shifting to a quality-driven culture requires full support from the leadership team and a commitment to change.

Quality management software offers a different range of business benefits. For example, when you apply a robust eQMS for your life sciences company, you’re one step closer to obtaining and keeping ISO 13485 certification.

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The importance of Lifting Equipment Inspection and how it can Perfect Safety

The Importance of Lifting Equipment Inspection and how it can Perfect Safety

Providing safety is a precedence for a lot of people. Whether it be those working in the construction assiduity – a dangerous place to work – or those working in an office, the idea of staying safe is always at the front line of peoples’ minds. But what can you do to ensure that you’re safe and not putting yourself in trouble?

Inspect for broken chains, rasped rope, or chains with any signs of rusting or corrosion. However, strain them up as soon as possible so they don’t get lost and beget unborn damage to the machine’s functions If there are any loose bolts or nuts.

Whether you’re working as a welder or apparel director, this blog will walk you through the way of safe processes in Lifting Equipment Inspection Pakistan.

Look for in the Lifting Equipment Inspection

The coming step is to inspect the equipment looking for damage similar to a long deep cut and cuts in straps, lines, or chains; attrition on hooks, hurdles, or other elements; wear on ropes or line ropes; and any other signs of damage.

Next, you need to look for signs of overfilling including excessive the result of long and hard use or distortion on any parts of the equipment, stretching or deformation in lines or chains, ropes showing signs of deterioration similar to heat damage, broken cables in line ropes and welded connections showing signs of cracking.

Inspect that no elements are missing and that there are no loose parts. Pay particular attention to hurdles.

Lifting Equipment Inspection Regulations and the Law

The Lifting Operations and Lifting Equipment Regulations 1998 (LOLER) claim employers to ensure that all lifting equipment is completely examined by a competent person at least formerly every six months.

The purpose of these inspections is to ascertain whether the lifting equipment is safe to use and remains fit for purpose. The thorough inspection report must be made available to whoever uses the equipment as well as the applicable Health & Safety Executive (HSE).

The Machinery of Labour in PAKISTAN has a strong commitment to icing the safety of workers. This includes icing that the lifting equipment used by workers is safe and of high quality.

Lifting equipment comes in numerous forms, including pallet exchanges, cranes, hoists, forklifts, and slings. The inspection and testing procedures for each piece of lifting equipment are different. still, there are some general rules which all must follow if they’re to meet the conditions of the PAKISTAN Machinery of Labour.

For example, winches and rolls used in fishing must be inspected according to this schedule as they’re subject to harsh rainfall conditions

What can be if you don’t do it?

We all know that lifting operations can be dangerous – but with proper preventives in place, there’s no reason why they need to be fatal.

also, there’s the financial risk roughly 30 of all worker’s compensation claims involve some kind of manual running incident. The average payout per claim is heavy, which adds up snappily for a business operating at scale.

Lifting Equipment Inspection

Importance of Ongoing Conservation and Record-keeping

Regular inspections similar to Lifting and Crane Equipment Inspection Pakistan are essential to ensure that all equipment is safe for use. However, it could beget an accident which could injure or even kill the people using it, If a piece of equipment has come damaged.

What are the Parts of a Crane?

  • Blast
  • Sling
  • Shackle
  • Anti-Two Block Device
  • External Rigger
  • Supplementary Hoist
  • Pulley
  • Web Sling
  • LMI (Cargo Movement Indicator).

Lifting Equipment Includes any Equipment that’s used at work for Lifting or Lowering Loads or People. This can Include;

  • Lifting Accessories (E.g., Slings, Eye Bolts, and Hurdle)
  • Lifting Gear (E.g., Jacks and Trolleys)
  • Lifting Machines (E.g., Cranes, Hoists, and Forklift Exchanges)

Reducing the Risk Factor

Lifting Equipment Inspection will help you to identify any damage or the result of long and hard use before putting them into use. This will help to forestall accidents at workplaces when a damaged machine can snap causing injuries or even death.

  • Safe Work Place

The frequency of inspection for lifting equipment varies depending on their operation and the nature of their operation. A safe plant is one where there are no pitfalls in terms of machinery and terrain.

When you inspect your machinery regularly, you can make necessary repairs or reserves before they beget any cause to the workers or affect the productivity of your business.

  • Improved Safety Norms

Safety norms are important as they help to keep workers safe while they’re working on a specific design. These norms also include using proper safety measures similar to using particular protection equipment (PPE) when handling heavy machinery like lifting equipment.

  • Builds Client Trust Ability

This is the most important benefit that a company gets from doing regular inspections on its lifting equipment. guests will trust your company and won’t doubt your sincerity. When you inspect your equipment regularly, you show them that you watch for their safety and comfort. This makes them feel secure and comfortable when they’re working at your plant.

  • Reduce Costs

When an accident occurs, it’ll bring you, plutocrats. In addition to the damage caused by the accident, there may be time lost as well as possibly legal costs. inspection will help to keep accidents from passing and therefore reduce costs.

  • Improves the Quality of Goods

When your equipment is inspected regularly, any problems that could affect the quality of your work will be discovered snappily and addressed before they beget further issues. This will allow you to maintain the loftiest possible quality in your work.

TUV Austria Third Party Lifting Equipment Inspection

TUV Austria Bureau of Inspection & Certification is a company that offers Third-Party inspection in Pakistan. Our inspectors are good in agreement with ISO/ IEC 170202012 Conformity assessment Conditions for the operation of various types of bodies performing the inspection.

Lifting Equipment Inspection

Why Choose Us?

TUV Austria Bureau of Inspection and Certification has a long-standing reputation in Pakistan as the most dependable certification & inspection services provider. Our Company performs inspections under the guidelines of LEEA (Lifting Equipment Engineers Association). We hold a vast clientele list in Pakistan, including the oil & Gas sector, Power sector, Logistics & FMCG companies.

We’ve rich expertise in inspections of Lifting Equipment, cranes, and Accessories, including but not limited to. Having your equipment performing at peak performance is veritably Crane and lifting equipment inspection has a huge part to play in this.

Break the habit of using your lifting equipment for time without checking whether they’re in good shape or not.

At TUV Austria Bureau of Inspection and Certification, we give lifting equipment inspection services to help cover your means and protract their lifetime, while icing the safety of your workers.

  • Chopstick Lifts
  • Hill
  • Chain Blocks
  • Hoist
  • Harness/ Belts
  • Eye Bolts
  • Upstanding Platform
  • Hooks
  • hurdle
  • Hydraulic Jack & Pumps

Our people are well-trained and Endured.

  • Largely Complete Specialists
  • Specialized Reporting System
  • Unprejudiced & Independent Assessments
  • Familiarity with Original Regulatory Conditions


– What’s the difference between a regulation and a standard?

While conformity with principles is voluntary, regulations are required.

– Why do I need to be certified?

All industries partake in the responsibility to minimize risk and save a life, the yachting industry is no different. Although it’s only required for marketable vessels, it has become standard practice for confidentially possessed vessels too as the moral obligation to look after the boat’s crew remains.

– How do I know what needs certification? What’s the difference between lifting equipment, lifting accessories, and personal lifting equipment?

The items that need to be tested can be resolved into three orders;

  • Lifting equipment – A general term used to cover all lifting accessories and appliances. A more specific meaning covering lifting appliances, their harbors, and fixing.
  • Lifting Accessories – Any device similar to single-leg or multi-leg slings, eyebolt, spreader ray, etc. used to connect the cargo to a lifting appliance, but which isn’t itself part of the cargo or the appliance.

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Everything You Need to Know About HACCP Certifications

Everything You Need to Know About HACCP Certification

Food safety is essential to the success of any food business. The 7 principles of HACCP Certifications can help you take control of the food safety risk in your business and protect your customers (and yourself) from the consequences of a food safety incident.

Food businesses in Pakistan are needed to have a Food Safety Plan, which is a set of written procedures that help to exclude, help or reduce food safety hazards that can make your customer become ill or injured. Your Food Safety Plan also helps to protect your business from

  • The financial and legal consequences of causing food poisoning or a foodborne illness outbreak
  • The financial and legal consequences of causing a severe antipathetic response from improperly handling food allergens
  • Losing customers as a result of a character for unsafe food running or hygienic premises
  • Food Safety Plans are grounded on the seven principles of HACCP.

What’s HACCP?

‘HACCP’ which stands for Hazard Analysis Critical Control Points, is a systematic and preventive system developed in the 1960s and a group of food safety specialists. Considering that each astronaut on Apollo 11 the first manned charge to land on the moon — had only 73 cubic feet of space (roughly 4′ x 4′ x 4′) and no toilets, a system was needed to help the astronauts from contracting a foodborne illness while in route.

HACCP principles form the base of Food Safety Plans worldwide. HACCP Food Safety Management System is applied to processes throughout every stage of the food force chain, including product, preparation, packaging, and distribution, and is used to manage food safety across many types of food businesses.

HACCP Certifications

What are the Seven Principles of HACCP Certifications?

Think of HACCP principles as the way you need to take to manage and control food safety risks in your business.

The Seven Principles of HACCP Are;

  • Action a Hazard Analysis
  • Identify Critical Control Points
  • Establish Critical Limits
  • Researcher Critical Control Points
  • Establish Corrective Action
  • Establish Record Keeping Procedures
  • Establish Verification Procedures

1. Action a Hazard Analysis

The first step in any Food Safety Plan (or HACCP Plan) is to identify all possible food safety hazards that could do in your business. First, consider your processes. These might include

  • Receiving Goods
  • Cooking Food
  • Serving Food
  • Waste Disposal

Next, consider the food safety hazards that could do during each of these processes. A food safety hazard is anything that causes food to become contaminated (and thus dangerous or unsafe).

  • Natural Contamination
  • Physical Contamination
  • Chemical Contamination

Once you have linked all the potential hazards in your business, classify them as natural, physical, or chemical.

2. Identify Critical Control Points (CCPs)

Now that you have linked all your food safety hazards, you need to identify critical control points (CCPs). CCPs are the way in your process where a control measure is applied and is essential to help, exclude or reduce a hazard or hazards to an acceptable position.

Relating CCPs will help you to reduce the risk of foodborne illness in your business by helping you to help the growth of dangerous bacteria and other microorganisms, as well as to help cross-contamination between different types of food, which can spark life-hanging antipathetic responses in some customers.

Some Examples of CCPs Could be;

  • The Sign-Off Step When Receiving Deliveries
  • Checking the Temperature of Food Before Serving
  • Cooking Food to a Specific Temperature

It’s important to remember that there’s no general template that can be used to identify the CCPs in your food business. many factors, similar to the physical layout of your business, your equipment, the ingredients you use, and your processes, make your business (and its food safety hazards) unique. Indeed, facilities that process or prepare similar foods will not inescapably identify the same hazards or CCPs.

3. Establish Critical Limits

A critical limit is a maximum or minimum value to which a food safety hazard (natural, chemical, or physical) must be controlled to help, exclude or reduce the hazard to an acceptable position. Each CCP must have one or further critical limits for each hazard.

Critical limits are generally concerned with parameters that are measurable with equipment or can be answered with a yes or no answer, similar as

  • Time
  • Temperature
  • Acidity
  • Stylish Before or After Expiry Dates

Critical limits must be assigned a factual value (e.g., high-risk foods must be cooked to a minimum internal temperature of 74 °C/ 165 °F*). Determining or assigning factual values to critical limits can be grueling, as there’s such a wide variety of hazards, each with different acceptable values.

In some cases, you may need to action tests or gain information from maximum sources (e.g., nonsupervisory guidelines, expert opinions) to get the information you need. However, make a judgment call — be sure to err on the side of caution, and keep your reasons for making the decision and any reference accouterments you used in your Food Safety Plan If information isn’t available.

4. Critical Control Points (CCPs)

Monitoring ways can be broken down into four different orders;

  • Observation Protecting
  • Chemical Protecting
  • Physical Monitoring
  • the Stylish Way to Make Sure (And Verify) That Monitoring Is Being Done Regularly Is by Using Rosters and Other Documentation to Record Results.

5. Establish Corrective Action

Corrective action is the action that must be taken if a divagation from an acceptable critical limit occurs. These are either immediate or Preventative.

Immediate corrective action is stopping a breach that’s happening now. For example

  • Throwing Out Contaminated Food
  • Rejecting a Food Delivery with Signs of Pest Infestation
  • Chilling Food to Keep It Out of the Temperature Danger Zone (4 °C – 60 °C/ 40 °F – 140 °F)

Preventive corrective action is stopping a breach from being in the future. For example

  • Performing Routine Maintenance on Equipment
  • Changing Work Procedures
  • Training Staff to Follow Food Safety Stylish Practices
  • If Corrective Action Must Be Taken, Remember to Record and Communicate It to the Appropriate Person (Or People) in the Business.

6. Establish Record-Keeping Procedures

Record keeping is essential to the effective operation of your Food Safety Plan and must include an over-to-date hazard analysis and details of any corrective action that has been taken in your food business. For example;

  • Delivery Rosters
  • Cleaning Schedules
  • Temperature Recordings
  • Pest Examination Results
  • Staff Training Records

All workers should know where the HACCP Food Safety Plan is located, what they’re responsible for doing (e.g., streamlining drawing schedules, filling out temperature logs), when they need to do it, and who to report issues to. It’s common for Health Inspectors to ask for these types of documentation during a health examination, so be sure to store them in a safe place.

7. Establish Verification Procedures

Developing your Food Safety Plan is only the first step toward food safety; consider your first draft (and each new interpretation) a design that requires real-world testing, adjusting, and tweaking. A Food Safety Plan is a “living document” — it’ll not and shouldn’t stay exactly the same.

Perform an audit of your Food Safety Plan at least once a time to verify that it’s working as anticipated, and to identify openings to improve it. Once you have linked these openings (and you will), acclimate your Food Safety Plan and apply the necessary changes.

There are several styles that food businesses use to seek out information, including

  • Internal Examinations
  • External Checkups
  • Hand Feedback

For each audit, ask yourself the following questions;

  • Have We Added Any New Product Dishes or Changed Any Fashions?
  • Have We Changed Any Processes or Food Preparation Ways?
  • Have There Been Any Changes to Food Safety Laws or Regulations That Will Impact Operations?
  • Are There Any Patterns in the Records That Point to an Occasion to Improve?

still, you need to update your Food Safety Plan, If you answered yes to any of these questions.

HACCP Certifications

The Benefits of the HACCP to the Industry

  • In conventional end-product testing, there’s a risk of losing the entire product batch if it fails to meet the product specifications norms.
  • Applying HACCP Certifications assures the product of safer and low business risk and compliance with regulations.
  • The staff is clear about food safety requirements with proper attestation, improving time operation.

Customer HACCP Benefits

The risk from food hazards is reduced for the consumers if they consume HACCP- certified foods, thereby adding consumer confidence in food.

Government HACCP Benefits

  • Applying HACCP certifications in the food Industry helps the government in further than one way.
  • It helps effective food control and reduces health care costs due to bettered public health.
  • Assured safe food budgets and eased better international food trade.

In Addition, to HACCP Audits, TUV Austria BIC. Also Offers a Range of Complimentary Services:

ISO 9001 Certification – Benefits for Startup Businesses

ISO 9001 Certification Benefits for Startup Businesses

If you have opened a new business, obtaining the ISO 9001 certification for quality management is one of the essential things to consider. It ensures customer satisfaction and performance, both in the short and long term, and provides many other benefits.

ISO 9001 Certification – Benefits for Startup Businesses

Certification helps a business demonstrate the quality of its process, products, and services. It can also demonstrate that your new business is committed to continuously improving its quality performance for higher customer satisfaction and making a path for growth.

Benefits that ISO 9001 offers to a New Business

Know the potential benefits that the ISO 9001 quality management certification can offer to a new small business.

1). Performance Excellence

A robust quality management system (QMS) must be implemented in the business. It helps in consistently improving performance. It streamlines all processes, maintains a consistent workflow, and reduces errors and waste. This results in the timely delivery of services or products.

2). Increase in Sales

The certification can help you increase sales immediately by providing excellent quality services without any delays.

3). Opens Up Market Opportunities

When you are new in the market, it is hard to catch the attention of suppliers, distributors, or investors. However, achieving the internationally known ISO 9001certification helps gain that attention in the market, despite beginning a new entrant, and opens up opportunities for business contracts.

4). Saves Costs in Your Business

Implementing a standardized QMS for ISO certification helps in saving many unnecessary costs. It saves the cost by helping to create more efficient processes, reducing waste, preventing defects or errors in products/services, reducing complaints or recalls, and so on.

Key Takeaway

For any Startup Business or a small business, the ISO 9001 certification can prove to be a remarkable improvement tool that can assure their growth along with an expanding customer base. In addition, it can help to drive their process efficiency, increase client satisfaction, boost stakeholder confidence, and provide ample business opportunities.


Checklist to Ensure Conformity – ISO 14001 Standard

Checklist to Ensure Conformity – ISO 14001 Standard

The globally known ISO 14001 Certification is for Environmental Management Systems (EMS). Achieving it helps organizations set standard practices and measures for handling their environmental concerns.

ISO 14001 Checklist

The framework of the EMS under ISO 14001 provides organizations with a definite approach to managing their impacts, promoting environmental policies and objectives, involving stakeholders’ participation, and continually improving their environmental performance.

We have provided a simple checklist to help you achieve the environmental certification. Tickling off each fact can help your organization conform to the standard.

Checklist to Ensure Conformity of Your EMS with ISO 14001

These are the top requirements your organization should meet to achieve conformance with the ISO 14001 standard and get certified.

  1. Document the environmental procedure in detail.
  2. Setting up a definite environmental policy and communicating it to everyone in the business.
  3. Checking or periodic auditing of business processes to ensure environmental impacts are eventually reduced.
  4. Recording all the environmental aspects and impacts, from mild to severe ones.
  5. Setting up targets or objectives of environmental management after analyzing the impacts.
  6. Performing management reviews of the implemented environmental procedures to ensure their effectiveness in delivering the targets.
  7. Gathering Customers/Stakeholders’ complaints about environmental issues and deciding actions to resolve them.
  8. Implement a register from compliance where all relevant environmental legislation and obligations of your organization must be noted.
  9. Providing necessary training to employees about the document environmental management procedures and reviewing their performance.
  10. Performing audits by external agencies to ensure compliance with ISO 14001 requirements and implement corrective actions for non-conformity.

Key Takeaway

Many organizations face challenges while implementing the EMS and achieving the ISO 14001 certification. The certification is instituted as a part of your management strategy, which encompasses all business areas and helps to check the environmental impacts.

As a result, meeting the compliance of the EMS with all requirements of the ISO 14001 might leave you confused. Therefore, you need to follow this checklist of 10 steps to prevent any failure in your EMS and assure conformity to the ISO 14001 standard.

Related: ISO 14001:2015 Environmental Management System

ISO 27001 Certification in Pakistan

ISO 27001 Certification in Pakistan

The ISO 27001 Certification in Pakistan demonstrates an organization’s commitment to continuously improving, developing, and protecting information asset/sensitive data by implementing appropriate risk assessments, policies, and controls.

ISO 27001 Certification in Pakistan

A company that is ISO 27001 certified is a sign to trust. They have an Information Security Management System (ISMS) in place. ISO 27001 is acknowledged by clients, suppliers, stakeholders, and others.

Pakistan’s ISO 27001 Certification is a competitive advantage, and It shows other businesses that can trust you to manage valuable intellectual property and third-party data assets. This certification opens up new opportunities and protects your company against risk.

Steps Involved in Obtaining the ISO 27001 Certification in Pakistan

1). Create a Team

First, appoint an ISMS lead to achieve ISO 27001 certification. They should have solid Information Security knowledge and be able to direct or give orders to other managers.

2). Make the Implementation Plan

The project team will use the mandate of the implementation group to create a more detailed outline for their information security objectives, plan and risk register. It also includes creating high-level policies that ensure ISMSs are:

  • Roles and Responsibilities
  • These Rules are for its Continual Improvement
  • Increase Awareness Through Internal & External Communication

3). Get Started with ISMS

After establishing the plan, you can choose which continuous improvement method to use.

4). Definition of ISMS Scope

You will next need to gain a better understanding of the ISMS framework. It is essential to determine your ISMS’s size and reach in daily operations. It means you must know all about your Organization to ensure that your ISMS meets your requirements. It is the most crucial step of the process. It includes identifying the location of information.

5). Identify Your Security Foundation

A security baseline is a minimum activity required to operate securely. You can establish your security baseline using the information you have gathered from your ISO 27001 Risk Assessment.

6). Develop a Process to Manage Risk

Your prioritized threats influence nearly all aspects of your security system. Therefore, risk management is essential for any organization that implements ISO 27001 Standard. This Standard gives organizations the ability to create their risk management processes. Common approaches focus on assessing the risks to assets and identifying specific dangers in particular scenarios.

7). Make a Plan to Manage Risk

The creation of Security Controls is necessary to protect your Organization’s information assets. It will be required to allow staff to use and interact with them. You should ensure that they are aware of and comply with information security requirements. You will also need to establish a process to determine, review, and maintain the competencies required to achieve your ISMS goals.

8). Measurement, Monitoring, and Review

Risk Monitoring should be performed at least once a year. First, a review identifies criteria that align with the objectives set out in the project directive. Next, quantitative analysis refers to a standard method that assigns numbers to things you measure.

9). Certificate Your Organization

After the ISMS has been established, you might want to apply for ISO 27001 certification. In this case, You will need to prepare to undergo an external audit. Two stages are required for certification audits.

An initial audit will determine if the ISMS was developed following ISO 27001 requirements. If the auditor is satisfied with the results, they will investigate deeper. After the audit is complete, the Organization is awarded an ISO 27001 certificate.

Related: ISO 27001:2018 Information Security Management System

Individual Business Traders – ISO 9001 Certification

Individual Business Traders – ISO 9001 Certification

ISO 9001 is the top International Standard Known for the Quality Management System (QMS), and it was developed to help businesses continually improve the quality of their products and services. The ISO 9001 Certification validates their QMS and ensures consistency in their quality management practices. Therefore, achieving the certification ensures that a business satisfies its customers and improves its processes.

Individual Business Traders - ISO 9001 Certification

ISO 9001 would benefit a sole trader in the same way it benefits a large business enterprise. However, there are some unique ways that it can help individual business traders.

Benefits of ISO 9001 for an Individual Trader

If you are a sole trader operating a small-scale enterprise or a shop, you can still achieve the ISO 9001 certification and realize these benefits:

  • You can gain a solid overview of your solo venture. ISO 9001 requires you to identify strengths, weaknesses, possible risks, and improvement opportunities.
  • You can improve your business performance over time. First, to achieve the certification, you need to identify the errors or nonconformities in your processes. Then, implementing corrective actions to cover them improves your business performance.
  • The ISO 9001 certification helps boost your customers’ confidence, retain them as regular customers, and attain new customers based on positive recommendations.
  • You get entry to new markets when you have the ISO 9001 certification. It is a mark of quality, and many distributors or suppliers only want to get products from ISO-certified providers.
  • You can escalate sales and aim for higher growth. An internationally acclaimed certification ensures your persistent commitment to quality and leads your path to continual business growth and value addition.

Key Takeaway

The ISO certification for your solo business venture prepares you to grow your business and face tough competition. Providing ideal requirements for your QMS strengthens it and prepares it for the growing challenges of your business.

A certified QMS supports your growth as a sole trader while ensuring consistency in your products/services quality and maximizing customers’ satisfaction.


ISO 50001 Standard – Why You Need It?

ISO 50001 Standard – Why You Need It?

With the world’s energy resources and reserves being used excessively, ISO (International Organization for Standardization) came forth with the ISO 50001 energy management system, which helps organizations to manage their energy resources, reduce their uses, and save on costs.

Need of ISO 50001

The ISO 50001 standard acts as a framework or set of guidelines for organizations to implement an effective energy management system (EnMS).

This standard applies to any organization, regardless of its size or type of business, and provides them with an opportunity to save energy costs and drive sustainability.

Here are some obvious persuasive reasons why you should embrace the ISO 50001 energy management standard for your business:

  • Finds the risk associated with energy supply and manage them
  • Measure and evaluate the use of different energy resources in your business across different processor areas and find ways to optimize the use.
  • Implements practices to raise the overall efficiency of your processes and reduce energy consumption and costs.
  • Measures areas where carbon emissions are high and adopt practices to reduce them, meeting government targets.
  • Demonstrates your credibility and environmental sustainability and earns potential tender opportunities in the international markets.
  • Continually seeks to improve your energy management practices or EnMS and leave a positive impact on the environment.
  • Strengthens your competitiveness in the industry and prevents any vulnerabilities that occur due to energy price fluctuations or the supply of energy sources.

Key Takeaway

Implementing the ISO 50001 energy management system helps organizations manage their energy uses and costs and confers credibility for their effective energy management practices. In other words, an additional value is placed on an organization certified with ISO 50001.

As they can demonstrate the sustainability of their energy resources to their present supplier partners, investors, or customers, it can open up a door for more contracts or opportunities from other local/informational businesses. There is a potential competitive advantage in the market for a company that gets certified with energy management standards.

Related: ISO 50001:2018 Energy Management System (EnMS)

ISO 14001 Certification – Why Businesses Should Consider It?

ISO 14001 Certification – Why Businesses Should Consider It?

With rising concerns about climate exhaustion of natural resources, different international authorities and public interest bodies emphasize the need for organizations to have an appropriate ISO 14001 Certification to minimize their environmental issues.

ISO 14001: 2015 Environment Management System

ISO 14001 certification is the specific certification issued by ISO for businesses to implement an EMS complying with best practices and regulations for environmental impact management. It helps them ensure that a greener approach is achieved in every sphere of their business and that there is an effective management system to improve their environmental protection services continually.

Need for Environmental Management

Societal expectations for sustainable development, transparency, and accountability have evolved;

  • With increasingly stringent legislation
  • Growing pressures on the environment from pollution
  • Inefficient use of resources
  • Improper waste management
  • Climate change
  • Degradation of ecosystems and 
  • loss of biodiversity

5 Business Related Advantages of the ISO 14001 Certification

Apart from addressing the worrisome environmental concerns of businesses, the ISO 14001 standard can provide some other remarkable benefits. These benefits can help to gain a competitive advantage. Here are a few to consider:

1). Reduced Costs

Having a proper environmental management approach means using renewable energy alternatives, ensuring less use of materials, and controlling the number of waste. All these contribute to cost savings.

2). Improved Corporate Image

In achieving compliance with an international standard, your organization is benchmarked for sustainability and environmental protection in the industry. This can attract more clients or business contracts because everyone is looking to partner with greener businesses.

3). Compliance with Legislation

The ISO 14001 standard incorporates all basic environmental regulations of national governments and local authorities. By achieving the certification, your organization can demonstrate its compliance with environmental legislation.

4). Reduction in Insurance Premiums

With an EMS, your organization has fewer risks of having environmental trouble or negligence and is liable to penalties.

5). Define CSR

Today, many businesses need CSR (Corporate Social Responsibility) to show their commitment to broader social and public concerns. Achieving ISO 14001 Standard helps them to cover a more general aspect of their CSR.

Key Takeaway

Achieving the ISO 14001 Certification helps organizations of all types and sizes to contribute towards environmental protection with specific practices and regulations implemented by an EMS.

Besides enabling them to have a consistent management system for handling environmental issues and achieving sustainability, it helps them have tremendous success with other achievements like cost efficiency, compliance with legislation, and improved reputation.

Related: ISO 14001:2015 Environmental Management System

5 Energy Advantages on Your Business – ISO 50001

5 Energy Advantages of Your Business – ISO 50001

ISO 50001 makes good business sense as energy costs are a significant portion of an organization’s budget. ISO 50001 is the International Standard for Energy Management Systems. ISO 50001 brings a variety of advantages to any organization. Therefore, a systematic focus on energy management is expected to reduce costs through optimum use of resources and waste reduction. It can also lead to increased production, Improved energy performance, higher profits, and reduced impacts due to rising energy prices.

Advantages of ISO 50001

The advantages of ISO 50001 are as follows:

1). Reduce Greenhouse Gases

Your company will be contributing to reducing greenhouse gases. Greenhouse gases cause global warming – a sudden rise in temperature that negatively affects the environment.

2). Carbon Reduction Commitment (CRC)

An ISO 50001 management system helps you comply with the CRC and more regulations!

3). Create Awareness of Roles in the Workplace

ISO 50001 allows every employee within your organization to be aware of their role in energy management.

4). Decrease Energy Bills

You shall reduce energy bills and increase company savings by managing your energy consumption.

5). Public Opinion

Implementing an ISO 50001 management system can improve your public image. Your business is more likely to be seen as sensible and responsible because you are energy efficient.

Related: ISO 50001:2018 Energy Management System (EnMS)