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US FDA Certification
The US FDA certification fee is estimated to be around $3,500 USD but can vary depending on the type of product. This US FDA certification cost covers all of your items and labels. In exchange, you will obtain US FDA certification from IAS certifying that your products are consistent with FDA labeling regulations for health and nutrition claims.
ISO 14001
Organizations that achieve ISO 14001 certification have demonstrated that they have implemented an effective environmental management system, and are compliant with the requirements of the ISO 14001 standard. Certified organizations are more likely to meet or exceed environmental regulations. Certification can increase an organization’s credibility with environmental regulators, customers, and suppliers.
ISO – International Organization for Standardization è un’Organizzazione indipendente che definisce gli standard per il business in termini di Qualità, Sicurezza e Ambiente del Sistema di gestione. certificazione ISO
ISO 13485 Certification Requirements and Structure
Are you aiming to understand the ins and outs of ISO 13485 Certification? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 Certification requirements and structure.
The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.
Clause 4 – Quality Management System (“Intersection”)
Clause 4 targets two very specific aspects of a Quality Management System: General Requirements and Documentation Requirements.
General Requirements. In evaluation of any ISO standard, there are a few systematic requirements that are the driving force for establishment and implementation of a Quality Management System.
The requirements specific to ISO 13485 Certification include the following:
Adhere to the standard.
Document what needs to be documented.
Maintain what is required of you.
Have written procedures in place and ensure the effectiveness of the system that you implement.
Consider the risk factors in all activities.
Introduce steps to minimize the risks identified and aim to not cause catastrophic events.
Identify how things should be done to generate your medical device and stick to those processes.
Determine ways to track your activities, correct any process failures or oversights, and generate records to show all the activities are being done.
Determine the requirements that you are legally bound to, and follow them!
Even when outsourcing work, ensure you maintain responsibility for that work.
Any systems used in your manufacturing processes should be confirmed to ensure they work as intended and don’t negatively affect your processes.
Documentation Requirements. Most quality systems require a key component, a Quality Manual. Beyond the Quality Manual, an organization should determine the promise that they will make to ensure an environment and culture that can be consistent with putting quality first in all activities. This commitment can be captured with a policy or objective statement.
The standard includes very specific requirements for both procedures and records, each of which must be fulfilled:
Medical device creation should be accompanied by a file that includes product specifics and guidance on intended use.
Plan for controlling documents.
Plan for controlling records.
Clause 5 – Management Responsibility (“Highway”)
Management must demonstrate their commitment by showing they can be held accountable for the operations within their organization. They have to ensure that their focus does not deter from the needs of the end user, and that all laws are followed in the manufacturing process. Management has an absolute responsibility to support the quality policy, confirm its alignment with the laws of the country of work, and communicate the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also responsible for a periodic review of operations and improvement within the organization, known as the Management Review.
Clause 6 – Resource Management (“Roadway”)
Top management has a responsibility to ensure that the Quality Management System is compliant with ISO 13485:2016 Certification and adheres to local regulatory requirements. As a requirement within ISO 13485:2016 Certification for Medical Devices, top management must ensure that adequate resources are available to perform the work promised by the organization. Providing resources can refer to personnel, infrastructure, consumables, equipment, succession planning, and risk aversion. This can be as specific as controlling the daily workflow to prevent contaminants or ensuring that operations are seamless in years to come with an awareness of looming retirements. This commitment from management, although it may seem minimal, is critical to the organization’s success in medical device manufacturing and is required according to Clause 6.
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis and Improvement
Clause 7 – Product Realization (“Overpass”)
An organization must plan for the journey from conceptualization to implementation. This can include developing a process for documenting how thoughts are initiated, concepts are verified, and products are designed and developed, as well as how to verify and validate to fulfill the requirements for ISO 13485 Certification, Clause 7. Communication is critical for the design and development of the device.
The key is to follow the process from planning to inputs, outputs to review, onward to verification, followed by confirmation through validation. Transferring ideas, controlling the design, documenting any required changes, and retaining any and all files included in the process is critical in product realization. Defining and tracking supplies, retaining critical information associated with each product, and determining how to verify these products should be clearly documented within a procedure.
Monitoring each part of the process involves ensuring cleanliness, monitoring installment, performing the necessary service, and fulfilling the requirements specific to medical devices. Effectively monitoring and maintaining equipment, as well as ensuring that identification requirements are met for the device itself, are also components of product realization. Lastly, monitoring the effectiveness of the product as it relates to traceability, managing customer property, and ensuring preservation of product will help achieve compliance with ISO 13485 Certification.
Clause 8 – Measurement, Analysis and Improvement (“Bridge”)
Now that your product has been manufactured and has been released for general use, you kind of have a responsibility to ensure that the people have what they want. So, how do you accomplish that? It’s simple: you seek feedback. According to Clause 8, development of a procedure for effectively monitoring and measuring product success must include:
handling complaints
reporting events to regulatory authorities
undergoing internal evaluations through auditing
continual process and product evaluation internally
identifying and controlling products that don’t meet the original design requirement (nonconforming product)
analyzing data generated and continually improving the process.
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what is the CE marking (CE mark)? do your products need CE marking?
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
General principles of the CE Marking Certification Services
The CE marking shall be affixed only by the manufacturer or his authorized representative.
The CE marking Certification shall be affixed only to products to which it's affixing is provided for by specific Community harmonization legislation, and shall not be affixed to any other product.
By affixing or having appendant the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the merchandise with all applicable necessities started within the relevant
Community harmonization legislation providing for its affixing.
The CE marking shall be the only marking that attests to the conformity of the merchandise with the applicable requirements of the relevant Community harmonization legislation providing for its affixing.
The affixing to a product of markings, signs or inscriptions that square measure doubtless to mislead third parties regarding the meaning or type of the CE marking shall be prohibited.
Any other marking may be affixed to the merchandise provided that the visibility, legibility, and which means of the CE marking Certification don't seem to be thereby impaired.
Member States shall make sure the correct implementation of the regime governing the CE marking and take applicable action within the event of improper use of the marking. The Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offense and constitute an effective deterrent against improper use.
The European Economic Area (EEA):
The EEA includes EU countries and also Iceland, Liechtenstein, and Norway. It allows them to be part of the EEA single market.
Switzerland is a member of EFTA, however neither Associate in Nursing EU nor EEA member.
It, however, remains a part of the one market
Along with additional directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market.
However, several non-EU exporters are still unaware of or unsure regarding this fact and its impact on their business.
Comparison of correct/real and misuse/fake CE Conformity Marking
DO YOUR PRODUCTS NEED CE MARKING?
Unfortunately, the method of determining whether the CE marking applies to a product is quite advanced.
The European legislator doesn't give product lists or nomenclatures that indicate the appropriate CE marking directives.
The CE marking Certification applies to merchandise placed within the market or put into service in the European Economic space, and only for certain product groups or product aspects.
Thus to answer the question of whether a product has to be CE certified, one has to determine first in which countries the merchandise is going to be
placed within the market or used. Secondly, for every single directive, it must be determined whether the products or some of its aspects, fall within its scope.
CE Certification
certification ISO 14001
L’obtention de la certification ISO 14001 permet à une entreprise d’évaluer, de surveiller, de mesurer et d’atténuer efficacement les conséquences environnementales négatives. La certification ISO 14001 permet aux entreprises de se conformer aux lois, règles et autres obligations environnementales applicables tout en améliorant la responsabilisation de leurs systèmes de gestion.
ISO 9001:2015 Certification
iso 9001 certificering kosten History of ISO 9001 Certification ISO 9000 Certification was first distributed in 1987, in spite of the fact that its underlying foundations return to the MIL-Q-9858 US Branch of Guard standard that was distributed in 1959. ISO 9000 Certification depends on the models set forth by the English Gauges Establishment that were exhibited to the ISO board of trustees in 1979. MIL-Q-985 was updated into a NATO AQAP standard in 1969, which were then amended into the BS 5179 standard in 1974, which were by and by reconsidered to turn into the BS 5750 standard submitted to ISO to progress toward becoming ISO 9000.
Requirements ISO 9001:2015 Certification ISO 9001:2015 Certification specifies requirements for a quality management system when an organization: 1. Required to expose its capability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and 2.focus to increase customer fullfillment through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Requirements of ISO 9001:2015 Certification are collective and are planned to be applicable to any organization, mindless of its type or size ratio, or the products and assistance it provides.
Why do you Need ISO 9001:2015 Certification Meet Client Requirements Many companies want ISO 9001 certification from a ISO Certification Body just to satisfy one customer requirement. The client wants only do Buisness with vendors who are Certified as ISO 9001 Compliant, so to get (or keep) the business they need that certification. The complication with these organization is that they’re looking for a short-term payment. They see nothing but that one profit— we need money — and ignore the long-term profit, like “if we keep the client well satisfied, they will want to come back again and again”. Get More Income and Business from New Clients You can advertise your quality certification Once you Acquire your ISO Certification for Quality Management and respond to requests for quotes (RFQ) from organization that make ISO 9001 certification a “must-have”. ISO Certification for Quality Management can open up new markets you were essentially unable to do business with before your certification.
Describe, Understand, and Communicate Your Company Processes The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better administer and control your business processes. Quality objectives form the center of your system. Your system’s performance are used to understand and communicate through metrics related to your quality objectives. If you make an honest attempt to conform to the requirements of getting ISO 9001 certification, you’ll learn more about your business.
Develop a Professional Culture and Better Employee Morale Implementing an ISO 9001 Quality Management System can empower employees. Your QMS will provide them with clear expectations (quality objectives and job descriptions), the tools to do their job (procedures and work instructions), and prompt, actionable feedback on their performance (process metrics). The result? An improved company culture and a more professional staff!
Improve the Consistency of Your Operations What is consistency? Well, one way to think of it is “decreased variation”. Reducing the variation in your processes is the definition of consistency. Is your customer better served by you supplying them with a consistent product — same dimensions, same weight, same tolerances, same output every time — or by your products being unpredictable and “all over the place”? (I hope you’re not thinking too hard on this.)
Of course, they won’t accept variation, and neither should you! And how do you decrease variation? Increase control of your processes! Control comes from having a clear target to shoot for (objective), collecting data on the process (metrics), and understanding how to adjust the process (procedures and work instructions) to maintain the target output. If your ISO 9001 QMS is working, you should beincreasing operational…and product…consistency. Check out these some frequently asked Questions.
After reading that you have a question in Mind that how to get ISO Certification for that there are many ISO certification Body to fulfill that. ISO 9001 Certification provider helps to check out the ISO procedure. Benefits of ISO 9001:2015 Certification ISO 9001:2015 Certification carries huge advantages to your association. Some of significant points are listed below :- 1: Boost staff performance and overall productivity. Employees are motivated to implement processes that are put in place to ensure that problems are quickly identified and resolved in a timely manner. Your QMS, is a formalized system containing procedures, documents, responsibilities, and processes for quality processes and objectives. It may be summarized as a set of requirements for success and satisfaction. 2: Flesh Out Your Company’s Processes. A key component of ISO 9001 is having thorough business processes, and the ability to define responsibilities for quality control, as well as relaying those specifications to employees. Your QMS needs to provide valuable metrics such as on-time delivery to commit, throughput, and overall equipment effectiveness to accurately reflect your system’s performance. This will help you make better decisions to improve growth and profitability. 3: Reduce Waste and Improve Efficiency. Rather than focusing on mistakes after the fact, an effective QMS hones in on preventive measures, so wasteful problems can be avoided altogether for the future. The certification enforces a continuous improvement strategy, so you’re always, by design, seeking ways to reduce waste and improve efficiency. 4: Provide an improved customer experience. The ISO process improves customer service for a variety of reasons. It identifies key areas that are most important and a priority to your customers. It then outlines the process on how you can implement it based on their expectations and needs. After all, delivering a product that reduces waste and cost means you can bring more value to your customer, which will reinforce their loyalty to you.
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ISO 50001 is a globally recognized standard that provides control measures to reduce the consumption of energy, increase energy efficiency, and cost savings. iso 50001 certification
How to get ISO certification online?
In this digital world, there are so many exciting facilities that have developed for communication. Regardless of the place there are in, people can communicate easily with each other with today’s improvements in information technology.
Digitalization is creating major changes in our society and as well as in day-to-day human activities. This also developed a great impact in our business process that is the way we are communicating with our clients. Nowadays, most of the business meetings are happening online and the companies also mostly prefer to conduct in this innovative format!
Achieving ISO certification also becomes an effortless task with this latest technology. This topic covers how can an organization obtain ISO certification online, the certification process, and as well as the benefits and drawbacks in acquiring ISO certification online.
Introduction to ISO certification
ISO (International Organization for Standardization) is an independent, non-governmental organization that stands strong with the membership of 164 national standard bodies. With experts’ knowledge and guidance, ISO develops international standards to support the growth of the organizations. ISO does not provide certifications! ISO develops and publishes ISO standards but it does not involve in the conformity assessment or in the certification process.
· ISO Certified companies are globally recognized companies that conform to ISO standards and have a strong impression among consumers and shareholders.
· This ISO Certification ensures the manufacturing process, services, documentation procedure as well as the management system has all the requirements for standardization and quality assurance.
· ISO Certification is not a legal requirement for most organizations. But, for some companies, ISO certification may be required by law or contractually.
· Whatever the case, obtaining ISO certification will surely bring lots of benefits to your organization. This certification helps you have the products, processes, services, and systems with standardized improvements.
What is a remote audit?
Remote audit - an amazing hand-in-solution to get certified to ISO!
Sometimes, for some reason, the certification audit could not be conducted in person. Remote audit is a perfect replacement for these kinds of situations.
Remote audit is a virtual audit which is performed online through video conference by using digital platforms such as Google Meet, Zoom, Skype, etc. Through this remote audit, a certification body evaluates the organization process, system and collects the audit evidence remotely. This type of audit helps especially the organizations which are located in isolated areas.
During this Covid-19 pandemic period, Remote audit is the preferable choice for most of the organizations across the globe. Also, it creates an incredible opportunity of obtaining the IOS certification from the place you are. It avoids the need of travelling from one place to another.
ISO Certification process online
Here are the simple steps of IAS to get ISO certification online
Contact IAS:
Visit our website! Fill out the ISO certification application form specific to your organization’s management system and email it to us. Also, attach the required documents mentioned in that application form. You can also drop a mail if you’re not sure of which ISO certification helps represents the effective improvement of your organization. Our management team will help you get detailed information. Or you can contact us and have a free discussion about the certification and auditing process.
Remote audit by IAS:
After receiving the application form, IAS will initiate the procedure for conducting the remote audit. While conducting a remote audit, make sure there will be no interruptions in the internet connection. Proper communication helps the auditors to perform the audit with the flow. Also, it reduces audit duration and saves time.
Issue of certification:
The audit report will be sent to the registered mail address. If there are any deviations, our auditing team will send the audit report with a deviation report. The organizations need to implement the requirements within the specified time given by IAS.
After the effective implementation, our auditing will again conduct another remote audit to make sure your organizations meet the required ISO criteria specific to the scope you’re applied for. Finally, IAS will issue the certification. The soft copy of the certificate will be sent to your mail address.
Certification validity:
The initial certification provided by IAS is valid for 3 years. IAS also conducts surveillance audits in the gap of every 12 months. It ensures the continual improvement in your organization’s process, services, and system.
What are the advantages of certifying to ISO?
By achieving the ISO Certification, the organization can gain the following benefits.
· Global recognition
· Improved reputation
· New business opportunities
· Better internal management
· Enhanced customer confidence
· Better relationship with stakeholders
· Increased productivity as well as profitability
How to choose the best certification body?
It is also important to choose the right ISO certification body. Before you contact them, make sure they are providing the certification for the standard you have implemented. Verify whether they are an accredited platform and trustable organization. Some of the facts you need to check before you select the right ISO certification body are:
· Accreditation – this tells the certification body is certified to provide the standardized certifications.
· Reputation and credibility – this helps you gain the confidence of stakeholders/clients
· Experience – look for the certification body’s experience in providing the services in the specific ISO standard
· Professional auditors - Ensure the auditors have versatile knowledge about your organization’s process and system
· Language – it may be the last point, but it’s also important to choose the certification body that speaks your language. This helps you communicate with the auditors comfortably.
Advantages of obtaining ISO certification online
· Time and cost-effective method
By acquiring the ISO certification online, you can reduce the time required for conducting the audit.
· No travel or accommodation fee
In on-site audit, sometimes the organization needs to take care of the auditors travel and accommodation expenses. This is eliminated in remote audits.
· High-level performance
Remote audit is a convenient method for both the auditors and auditee. It helps auditors to conduct the audit at the comfort of their office and perform the audit more effectively.
· No interruptions, happy employees
In the on-site audit, there may be chances to make changes in the employees' daily work schedule. But in remote audit, the auditors will interact with the respective person and collect the required evidence.
Obstacles in getting ISO certification online:
Obtaining the ISO certification online also has certain obstacles.
· Lack of internet facility
While performing the remote audit, there may be chances for a slow internet connection. This disturbs the commutation between the auditors and auditee.
· Duplicate evidence
The audit evidence can’t be evaluated physically. So, there may be chances of mismatching in the documents and organization’s process.
· Poor interaction
Sometimes, the auditors have poor knowledge about the remote audits. So he/she may fail to collect the required audit evidence.
· Be aware of fake ISO certification
There are so many spam websites available online. So, make sure you have chosen the right ISO certification body to guide you in the implementation process for the achievement of ISO certification.
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British Retail Consortium (BRC) is a UK trade organization, famous for developing food safety standards, called BRC standards. These standards specify control measures and guidelines to reduce the food safety hazards and improve the food safety management system performance of an organization. This internationally accepted standard is applicable to all food business organizations in the supply chain. BRC Certification in Jordan
La certification ISO 9001 est accordée aux organismes qui démontrent qu’ils disposent d’un système de gestion de la qualité efficace. Il fournit un cadre d’amélioration continue et aide les organisations à assurer la qualité de leurs produits et services.
Achieving the ISO 45001 certification not only ensures the employees’ safety but also give them job satisfaction that improves process efficiency of the organization. It reduces the operational risks and enhances the confidence of the stakeholders to trust in your business process. Also, the ISO 45001 Certification increases credibility and promotes the organizations’ reputation.
Are ISO Certifications transferrable?
Yes, the ISO certifications are transferrable. Most of the organizations did not aware that the ISO certifications are transferrable. But, it is true and acceptable. Whatever the stage you are in, you can transfer your ISO certification from one certification body to another. The choice is always yours!
Not all certification bodies provide high-quality customer services. So, every organization is looking to transfer their certification to a different certification body which meets all their needs. In this article, we will let you know how the transfer process work and what are the standards that can be transferred from one certification body to another.
What is ISO certification?
To say it in simple words, ISO certification is a declaration of an organization to the customers, clients or stakeholders that its management system follows the practices in compliance with international standard’s requirements.
ISO certification enhances customer confidence in your products, processes and services. It creates lots of new business opportunities by promoting the reputation of your business.
Eligibility criteria
You can transfer the ISO certification from one certification body to another. But to transfer the ISO certification, it should comply with the following requirements.
· The current certification must be obtained from the IAF accredited ISO certification body.
· If you have not achieved from accredited certification, then you can’t able to transfer your certification.
· You are not allowed to transfer if your certification is expired.
· Also, you cannot transfer the current certification; the accreditation of your certification body is expired. Within 6 months, you should transfer to a new registrar. Otherwise, you will be considered as a new client.
Why one should transfer the ISO certificate?
There may be several reasons for an organization to change its certification body.
· Lack of quality in services
· Poor technical support and guidance
· Poor knowledge of auditors
· Lack of experience in the process
· To get better services, etc.
What are the transferrable standards?
All ISO standards are transferrable including ISO 9001, ISO 14001, ISO 45001, ISO 27001, etc. But the standards should be approved by the accredited certification bodies. The standards AS9100, IATF 16949 are also transferrable.
Process to transfer ISO certification
No need to be worried! Transferring ISO certification from one certification body to another is a simple process. Here are the simple steps to transfer your certification to another certification body.
· Check the terms and conditions of your certification body whether they charge for the cancellation
· Send an application form to the new certification body
· If you have accepted their quotation, the process will start for transferring your certificate
· You need to submit the copy of your current certificate and latest audit reports for evaluation
· The new certification body will analyze your previous documents to verify whether there is any non-conformity.
· Finally, the new certificate will be issued by the new certification body.
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Why should banks have ISO 20000 Certification?
A bank is an organization that provides services to customers. In order to improve customer satisfaction, it is essential for banks to maintain and implement the quality of services. This can be achieved with the help of the ISO 20000 standard.
In this article, we will let you know more about ISO 20000, how this standard benefits the bank, and how to obtain the ISO 20000 certification.
ISO 20000:
It is one of the globally recognized standards for IT Service Management System (ITSMS). This international standard specifies requirements for organizations/service providers to continually improve an SMS. It also helps to drive betterment in the design, transition, and delivery of services. However, this voluntary standard also supports the service providers to fulfill agreed service requirements.
The requirements of ISO 20000 are proposed to be applicable to any service provider, regardless of the service it provides. Whether it is a small start-up company or large organization, the ISO 20000 certification is suitable for all.
For financial institutions like banks, implementation of ISO 20000 helps to gain customer loyalty, promote process efficiency, and as well as to meet regulatory compliance.
What is the responsibility of ITSMS in an organization?
The service management system of the organization is responsible for providing high-quality IT services to the customers/clients/stakeholders. It helps to monitor and ensure the level of compliance. Moreover, the objective of SMS is to meet customer requirements by implementing the quality of services.
How does a bank benefit by achieving the ISO 20000 Certification?
· Effective delivery of IT services
To meet customer requirements, the banking sectors have developed so many innovative features such as mobile banking, online banking, net banking, etc. implementing the specifications of ISO 20000 helps the financial institutions to provide the bust banking IT services to the customers.
· Continual improvement in the quality of services
ISO 20000 specifies a framework to plan, monitor, operate, review, maintain, and improve the quality of IT services.
· Customer satisfaction
The improvement in the quality of IT services enhances the credibility of your business. This helps customers to trust in your business process and service management system.
· Stakeholders confidence
The ISO 20000 certification establishes your organization’s involvement in delivering high-quality services to the customers as well as stakeholders.
· Enhanced reputation
Developing the ISO 20000 requirements not only ensures betterment in the quality services but also improves the reputation of your business.
· Increased competency
Achieving the ISO 20000 certification is not an easy job. It requires lots of effort and resources. But once you implement the service management system in compliance with ISO 20000, it enhances your competency and lets you stand alone from the competitors.
· International recognition
ISO is an International Organization for Standardization. It develops and publishes international standards for the organizations to follow the best practices in their management system process. So, promoting your management system with the help of ISO 20000 lets you achieve international market access.
How to obtain ISO 20000 certificate?
Acquiring the certification is not a requirement of the standard. But, it plays a major role in promoting the competency of your organization. So if you are planning to achieve the ISO 20000 certification, the following guidelines will help you reach the desired goals.
· Scope of the certification
To achieve the certification, the organization/service provider needs to prepare a scope of the certification that should describe the main process of your business, the number of people involved in this scope, etc. Preparing a clear scope helps the organizations to be confident about their process and the certification body to conduct the audit in an effectively.
· Contact the best ISO Certification body
Find the best ISO certification body that has proven experience in the same process you have applied for. If you’re providing services to international clients, it will be helpful if you choose the certification body that has international recognition. Here are some of the factors you should verify before selecting the certification body:
· Accreditation
· Global recognition
· Proven experience
· Professional auditors
· ISO certification cost
Contact the certification body by sending a proposal that tells the information about your company. Based on the scope submitted by your organization, the certification body comes with a plan to initiate the certification audit.
· ISO 20000 Certification audit
Basically, the ISO 20000 certification audit includes 2 stages. In stage 1 audit, the auditors will evaluate the documentation provided by the organization. The audit team will also analyze the operational methods, delivery of services, etc. They will provide an audit report with a deviation report (only if the system needs further implementation).
The final evaluation is carried out in the stage 2 audit. This is the main audit that determines whether the organization met the desired ISO criteria.
· Reward of ISO certificate
Finally, the certification body will issue the certificate based on the scope submitted by your organization.
· Surveillance audits
The surveillance audit does not have stage 1 and stage 2 audit. This initial certificate is valid for 3 years. During this period, the surveillance audits will be conducted by the certification body in the interval of 12 months.
· Recertification audit
After the validity of the initial certification is over, the certification body will perform a re-certification audit. This helps the organization to ensure the continual improvement of the management system and to maintain the certificate.
ISO 22000 Certification
ISO 9001 Certification
ISO 9001:2015 is a management system Standard, published by International organization for Standardization ISO, which addresses to deliver consistent quality products and services to its customers. ISO 9001 Certification
How to renew ISO certificate?
To maintain the quality performance, each ISO certified organization should undergo re-certification process. This helps the organization to ensure the continual improvement of its management system.
Don’t burden yourself! The re-certification audit is a simple process and it just needs your effort. In this article, we let you know the process to renew the ISO certificate.
Does ISO certificate need to be renewed?
The answer is, yes. The ISO certificate should be renewed once the validity of the initial certification is over. It helps you maintain the quality of products, processes, systems and services.
What is certification audit?
Before getting into the topic of the re-certification audit, let’s know about ISO certification audit.
· A certification audit is a conformity assessment of verifying an organization whether it met the requirements of desired ISO criteria. Basically, the certification audit includes 2 stages.
· In stage 1 audit, the auditors come with a plan to conduct an audit based on a scope submitted by your organization. The auditing process includes the verification of documents, records, files, etc. If there is any non-conformity, the auditing team will provide a deviation report with the audit report. The organization should address the non-conformity before the stage 2 audit.
· After completing the stage 1 audit, the auditors will schedule a date for the stage 2 audit. It assesses the effective implementation of your management system in compliance with the ISO standard. If the non-conformities are implemented, the certification body will release the ISO certificate.
Certification validity:
The initial certification provided by the certification body is valid for 3 years. This ISO certification enhances your customer confidence in your products, processes and services. It increases your organization’s credibility and helps achieve new business opportunities.
What are surveillance audits?
The validity of the initial certification is 3 years. During this period, the certification body will perform the surveillance audit at the interval of 12 months. This audit does not include stage 1 and stage 2. Also, it helps the organizations to maintain the performance of the management system and the quality of products and services.
When re-certification is performed?
Re-certification is initiated by the certification body once the three-year validity of the initial certification is over. The processes of re-certification are similar to the initial certification processes.
Process to renew the certificate
By evaluating the organization’s processes every 3 years supports you to provide quality services that consistently meet customer expectations. It enhances the competency of your organization and helps standalone from the competitors. It ensures your organization is in the right path of meeting the desired goals and objectives.
Re-certification audit plan
Before the initial certification’s expiration date is over, the organization needs to apply for re-certification. It gives time and helps you take the necessary actions for the re-certification audit.
Sometimes, the certification body itself will send a notice to the certified organization for the renewal of the initial certification. This advance notice supports the organization to be updated with the certification process. Make a note of previous reports and records to reduce the non-conformities in the re-certification audit.
Implementation and preparation
Ensure the operational processes, products and services are continuing in compliance with the guidelines of certified ISO criteria.
Assessment of previous records
In the re-certification audit, the auditors will also review the past records and documents related to internal audits, corrections, corrective actions, preventive actions, etc.
Reassessment process
The certification body will send an audit team to perform a re-certification audit. They will evaluate, review, and submit the audit report. If there is any area which needs further improvement, the auditors will provide non-conformities and guide you with the effective implementation process.
Make sure your organization is following the best practices and is up-to-date with the latest technologies by renewing your certificate every 3 years.
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How to get ISO certification online?
In this digital world, there are so many exciting facilities that have developed for communication. Regardless of the place there are in, people can communicate easily with each other with today’s improvements in information technology.
Digitalization is creating major changes in our society and as well as in day-to-day human activities. This also developed a great impact in our business process that is the way we are communicating with our clients. Nowadays, most of the business meetings are happening online and the companies also mostly prefer to conduct in this innovative format!
Achieving ISO certification also becomes an effortless task with this latest technology. This topic covers how can an organization obtain ISO certification online, the certification process, and as well as the benefits and drawbacks in acquiring ISO certification online.
Introduction to ISO certification
ISO (International Organization for Standardization) is an independent, non-governmental organization that stands strong with the membership of 164 national standard bodies. With experts’ knowledge and guidance, ISO develops international standards to support the growth of the organizations. ISO does not provide certifications! ISO develops and publishes ISO standards but it does not involve in the conformity assessment or in the certification process.
· ISO Certified companies are globally recognized companies that conform to ISO standards and have a strong impression among consumers and shareholders.
· This ISO Certification ensures the manufacturing process, services, documentation procedure as well as the management system has all the requirements for standardization and quality assurance.
· ISO Certification is not a legal requirement for most organizations. But, for some companies, ISO certification may be required by law or contractually.
· Whatever the case, obtaining ISO certification will surely bring lots of benefits to your organization. This certification helps you have the products, processes, services, and systems with standardized improvements.
What is a remote audit?
Remote audit - an amazing hand-in-solution to get certified to ISO!
Sometimes, for some reason, the certification audit could not be conducted in person. Remote audit is a perfect replacement for these kinds of situations.
Remote audit is a virtual audit which is performed online through video conference by using digital platforms such as Google Meet, Zoom, Skype, etc. Through this remote audit, a certification body evaluates the organization process, system and collects the audit evidence remotely. This type of audit helps especially the organizations which are located in isolated areas.
During this Covid-19 pandemic period, Remote audit is the preferable choice for most of the organizations across the globe. Also, it creates an incredible opportunity of obtaining the IOS certification from the place you are. It avoids the need of travelling from one place to another.
ISO Certification process online
Here are the simple steps of IAS to get ISO certification online
Contact IAS:
Visit our website! Fill out the ISO certification application form specific to your organization’s management system and email it to us. Also, attach the required documents mentioned in that application form. You can also drop a mail if you’re not sure of which ISO certification helps represents the effective improvement of your organization. Our management team will help you get detailed information. Or you can contact us and have a free discussion about the certification and auditing process.
Remote audit by IAS:
After receiving the application form, IAS will initiate the procedure for conducting the remote audit. While conducting a remote audit, make sure there will be no interruptions in the internet connection. Proper communication helps the auditors to perform the audit with the flow. Also, it reduces audit duration and saves time.
Issue of certification:
The audit report will be sent to the registered mail address. If there are any deviations, our auditing team will send the audit report with a deviation report. The organizations need to implement the requirements within the specified time given by IAS.
After the effective implementation, our auditing will again conduct another remote audit to make sure your organizations meet the required ISO criteria specific to the scope you’re applied for. Finally, IAS will issue the certification. The soft copy of the certificate will be sent to your mail address.
Certification validity:
The initial certification provided by IAS is valid for 3 years. IAS also conducts surveillance audits in the gap of every 12 months. It ensures the continual improvement in your organization’s process, services, and system.
What are the advantages of certifying to ISO?
By achieving the ISO Certification, the organization can gain the following benefits.
· Global recognition
· Improved reputation
· New business opportunities
· Better internal management
· Enhanced customer confidence
· Better relationship with stakeholders
· Increased productivity as well as profitability
How to choose the best certification body?
It is also important to choose the right ISO certification body. Before you contact them, make sure they are providing the certification for the standard you have implemented. Verify whether they are an accredited platform and trustable organization. Some of the facts you need to check before you select the right ISO certification body are:
· Accreditation – this tells the certification body is certified to provide the standardized certifications.
· Reputation and credibility – this helps you gain the confidence of stakeholders/clients
· Experience – look for the certification body’s experience in providing the services in the specific ISO standard
· Professional auditors - Ensure the auditors have versatile knowledge about your organization’s process and system
· Language – it may be the last point, but it’s also important to choose the certification body that speaks your language. This helps you communicate with the auditors comfortably.
Advantages of obtaining ISO certification online
· Time and cost-effective method
By acquiring the ISO certification online, you can reduce the time required for conducting the audit.
· No travel or accommodation fee
In on-site audit, sometimes the organization needs to take care of the auditors travel and accommodation expenses. This is eliminated in remote audits.
· High-level performance
Remote audit is a convenient method for both the auditors and auditee. It helps auditors to conduct the audit at the comfort of their office and perform the audit more effectively.
· No interruptions, happy employees
In the on-site audit, there may be chances to make changes in the employees' daily work schedule. But in remote audit, the auditors will interact with the respective person and collect the required evidence.
Obstacles in getting ISO certification online:
Obtaining the ISO certification online also has certain obstacles.
· Lack of internet facility
While performing the remote audit, there may be chances for a slow internet connection. This disturbs the commutation between the auditors and auditee.
· Duplicate evidence
The audit evidence can’t be evaluated physically. So, there may be chances of mismatching in the documents and organization’s process.
· Poor interaction
Sometimes, the auditors have poor knowledge about the remote audits. So he/she may fail to collect the required audit evidence.
· Be aware of fake ISO certification
There are so many spam websites available online. So, make sure you have chosen the right ISO certification body to guide you in the implementation process for the achievement of ISO certification.