What is the importance of introducing a quality management system in dental practice in Singapore?

What is the Quality Management System?

The Quality Management System, which is often mentioned as QMS, is a collection of policies, processes, documented procedures and records. This collection of documentation describes the set of internal rules that will govern how your organization creates and delivers your product or service to your customers. The QMS must be tailored to the necessities of your organization and the product or service you provide, but the ISO 9001 standard provides a set of guidelines to help ensure that you don't miss any important elements that a QMS needs to be successful.

What is ISO 9001:2015?

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations utilize the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the main standard in the series to which organizations can certify. ISO 9001:2015 was the current version released in September 2015.

What are the benefits of ISO 9001:2015 certification in Singapore?

Both private and public healthcare facilities are showing an increased interest in ISO 9001 quality system certification since it guides to constant improvement in patient-oriented activities and a guarantee of well-being when cutting-edge first-class therapies and treatments are known as into play.

Together with doctors, dentists aspire to reach a standard of care that enables them to offer their patients a service that complies with internationally recognized technological and hygiene requirements. Doctors and dental practitioners have no legal obligation to put a quality system in place, however there can be no doubt about how significant is to have one to improve patient satisfaction and elevate the overall prestige of the dental practice.

Professional Recognition:

One of the principle reasons that prompt dental clinicians to request for a certification is the requirement for recognition of their professional qualifications and of the status of their clinic. ISO 9001:2015 certification in Singaporeis indeed an official acknowledgement of a clinician’s commitment to stay up-to-date with new strategies and techniques, and raising the standards of care.

Social Benefits:

Apart from enabling dental practitioners to benefit from the accreditations and agreements accessible with private and state healthcare insurance institutions, having a ISO 9001 certification in Singapore also allows them an edge on the market while putting their practice head and shoulders over the others, elevating its reputation and expanding its visibility.

Improvise Organization:

Another significant advantage lies in the improvements in terms of the organization and management of the practice. A quality certification requires a practice to have a specific organizational system in place. This is likely to enable it eliminate on financial losses caused by a poor utilization of resources and guide it towards operational procedures, routine practices and skill sets which boost efficiency levels and performance standards.

How to obtain a quality system certification?

General Process, which are required to establish for Dental Clinic are Dental General Treatment is administered on First Come First Serve basis, while Dental Special treatment is given on Appointment basis and Appointment Diary is kept for each Doctor, Work is carried out as per Work Instructions, Room wise equipment checklist is kept updated ,Material used in treatment is recorded for each room, Records of Lab work are kept, Equipment maintenance records are kept, Sterilization of equipment is carried out in Autoclave and records are kept, Patient Feedback is taken for improving the services, Work Instruction for Dental Staff.

Three main steps are necessary in order to acquire a quality system certification:

1. Choosing a consulting agency and drawing up a project plan identifying the objectives to be achieved;
2. Quality improvement in terms of structure, organization, equipment and technological systems, materials, know-how and skills;
3. Identifying an ISO 9001 Certification body in Singapore to audit quality levels and issue the ISO 9001 certification in Singapore.

STEP-1:

The initial step requires you to define the primary goals and a suitable time frame for the project, pick out a reference figure for the practice and define suitable guidelines to be followed. Still reference figure (in other word, the Quality Manager) is concerned, in a small practice there is no reason why this responsibility shouldn't lie with the owner. As for the guidelines, they should prioritize the objectives to be achieved; for instance, more technological equipment, a better association, more efficient in-house supervision and a stronger focus on client relations.

STEP-2:

Step two requires you to conduct an in-depth analysis of present situation, and to appropriately reorganize and enhance all the areas involved, educating and preparing all relevant staff members. You can plot out this path in a series of meetings with the consulting agency (ISO 9001 Certification Services in Singapore) where you can deal with the most pressing issues. At this stage, the improvement procedure, which has been properly defined and documented, is disclosed and implemented in accordance with the strategy.

STEP-3:

The third and last step requires you to choose anISO 9001 Certification body in Singapore: this is an independent choose which represents a wide range of stakeholders (suppliers, public and private clients and associations) that is accredited by a specific company and tasked with supervisory activities. Once a contract has been drawn up with the certification body(which providing ISO 9001 Certification Services in Singapore), the audit will take place: first of all, all documents will be explored to ensure that they comply with legislative necessities, and secondly, an on-site verification will occur to ensure that the system has been implemented both properly and effectively.

AUDIT PROCESS: CLICK HERE

CERTIFICATION

When the audit is finished, the dental practice will get its quality certification, which is valid for three years but subject to surveillance audits. Should any non-compliance emerge during the audits, they might be scheduled with a greater frequency. There is a risk of the certificate being temporarily suspended or even withdrawn (although this latter circumstance is highly unlikely).

IAS, ISO Certification Body in Singapore provides ISO accreditation necessitates that the organization occasionally reviews its quality procedures.

The importance of ISO certification for patients

The importance of having a quality system isn't merely confined to the benefits for the dental practice. This is because elevating overall standards means also enhancing the level of healthcare services provided, therefore patients feel more protected and their fulfillments are significantly higher. Customers will enjoy a better quality of service and more up-to-date treatments, with a reliable assurance on hygiene, health safety and the professional skills of the dental practitioner.

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ISO standards and systems for manufactures of Medical equipment and devices in Singapore

Medical Device Standards Supported By IAS

Several management standards are applicable to manufacturing of Medical equipments and devices. A brief overview of the most relevant, also information about the role IAS (ISO 13485 Certification provider in Singapore) can play in getting your organization certified.

What are the common medical device manufacturing standards?

The most common medical device manufacturing standards include:

·         ISO 9001:

This is the general standard for quality management. It isn't industry-specific and as such can be effectively adopted by any organization that wishes to implement a more rigorous system based on a continuous improvement cycle. For Medical equipments and devices manufacturers, ISO 9001 engages management in the quality control process, helping make organization-wide changes that keep costs down, improve accountability, facilitate growth in a more responsible way and simplify regulatory compliance. The most recent version of ISO 9001, published in 2015, is based on the high-level Annex SL directive, utilizing a common vocabulary and structure that makes it simpler to attain compliance with other, more specific standards.

·         ISO 13485:

This is the quality management system specifically designed for Medical equipments and devices manufacturers. It expands on and refines the framework established by ISO 9001, with the aim of harmonizing regulatory requirements. Compliance with ISO 13485 Certification assists with overall quality control, traceability, process validation and risk management. Manufacturers that attain ISO Certification for Medical Devices in Singapore compliance will have an easier time carrying their products to global markets. Compliance can also streamline your processes and ultimately help you to run a progressively efficient, beneficial and risk-averse operation. There are many ISO 13485 Certification Services in Singapore who can help you to achieve ISO Certification for Medical equipment in Singapore.

·         ISO 14001:

Sustainability is an important concern for all manufacturers trying to run a leaner business. Implementing an environmental management system compliant with ISO 14001 standards can help medical device manufacturers cut down on waste, conserve energy and reduce their overall carbon footprint — important benefits when working with complex global supply chains. Like ISO 9001:2015, the latest version of ISO 14001 is based on the Annex SL structure. As an outcome, if you already have a certified quality management system in place, adopting ISO 14001 can be relatively straightforward. When your environmental, health and safety, and other protocols share necessities, your business is better positioned to succeed in the competitive medical device industry.

·         ISO 50001:

This standard complements ISO 14001 by offering a particular standardized system for energy management. With it, Medical equipment and device manufacturers can reduce their operating expenses and improve their overall energy efficiency, which can subsequently enhance their reputation and facilitate regulatory compliance.

·         OHSAS 18001 / ISO 45001:

Pharmaceutical and medical device manufacturing often presents specific occupational risks, especially when working with the advanced technology found in imaging equipment and other products. While ensuring the safety of your team is essential, it shouldn't come at the expense of productivity. OHSAS 18001 / ISO 45001 outlines requirements for occupational health and safety management systems that can be utilized in the medical device industry to reduce risk and improve accountability while positioning your organization for sustainable growth. Use it to diminish accident rates and related liability issues on an ongoing basis.

·         ISO 27001:

As medical devices become progressively sophisticated, cyber security is an expanding concern. The developing market for smartphone based health monitoring apps, as well as connected devices in the diagnostic room and operating theatre, requires proactive information security standards. Add to that the danger of your valuable intellectual property being compromised in a data breach, and it is clear to see why ISO 27001 has turned into a critical standard for health care and medical device manufacturers. ISO 27001 contains tools that can help you assess and manage cyber security risks in your organization. It is based on a set of globally recognized best practices that aren't specific to any one platform or software package. Becoming ISO 27001 certified will position you to adapt accordingly as the threats against your enterprise change and to maintain continuity in the event of a cyber-security incident.

ISO 13485 Quality Management System certification

Evolving in the Medical Device field calls for a level of understanding of the regulatory environment and what it suggests for duties and obligations.

Countries are increasingly developing their local regulations based on the GHTF (Global Harmonization Task Force, now the International Medical Device Regulator’s Forum - IMDRF) model.

Already-existing regulatory schemes tend to be assessed by Health Authorities controls and/or Certification Bodies.

The majority of these regulations have as common base the Quality Management System (QMS) and Risk management principles. ISO 13485, in its recent evolution affirms that the regulatory requirements are intended to be a key consideration in the future of Quality Management Systems.

What is the ISO 13485 standard?

ISO 13485, Medical devices - Quality Management Systems necessities for regulatory purposes, is an globally recognized standard for organizations engaged with the medical device industry. Companies are utilizing compliance to this standard to get the certification of their Quality Management System. The main purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems. The survey conducted by the International Organization for Standardization (ISO) shows that in 2015, the quantity of ISO 13485 certificates issued worldwide was 26255. ISO 13485 Certification Services in Singapore provide ISO accreditation necessitates that the organization occasionally reviews its quality procedures.

Who can be ISO 13485 certified?

The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations engaged in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc.,.

Note that ISO 13485:2016 expands the profile of companies and organizations to which the standard can apply:  Organizations engaged in one or several stages of a Medical Device Lifecycle or a Supplier or other External Parties providing such organizations with products for example.

AUDIT PROCESS: CLICK HERE

Organizations involved in one or more phases of the medical device life cycle

• Design and Development
• Production
• Storage
• Distribution
• Installation
• Servicing

Suppliers or External Parties who provide products to such Organizations

• Raw materials
• Components
• Sub-assemblies
• Medical devices
• Sterilization services
• Calibration services
• Distribution services
• Maintenance services

In addition, the ISO 13485 standard requires that the organization recognizes its roles in connection with the regulatory requirements (e.g. Manufacturer, Representative, Importer and / or Distributor), and determines the applicable regulatory requirements depending on the role(s), then integrates the regulatory requirements in the QMS.

A Quality Management System is neither intended to be a frozen in time nor is the company. The QMS is defined to help streamline and reinforce internal processes and procedures while carrying on with the changes and evolutions affecting the market.

How is ISO 13485 recognized worldwide?

ISO 13485 focuses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory necessities. It isn't surprising to see that many jurisdictions recognize or even require that Medical Device manufacturers obtain ISO Certification for Medical equipment in Singapore in order to access their market. Various regulatory authorities have adopted the ISO Certification for Medical Devices in Singapore standard as part of their own requirements to enable the sale of Medical Devices on their territory. The Medical Device Single Audit Program commonly referred to as MDSAP went a step advance: it is built on the ISO 13485 principles and incorporates those principles as feature of the audit criteria.

Why should I get ISO 13485 certified?

Voluntarily conforming to ISO 13485 is the best approach that companies have to prepare for an international market access. Being ISO 13485 certified provides stakeholders and business partners with the confidence that the organization has put all the efforts to conform to the standard.

Frequently asked questions: Click here

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Is ISO Certification beneficial to Medical Device Industries in Singapore… Methods and Procedure.

WHAT IS THE PROCEDURE TO GET ISO CERTIFICATION FOR MEDICAL DEVICE INDUSTRIES IN SINGAPORE?

Now Medical Device Industries are thinking about implementing a QMS (Quality Management System). They getting certified against ISO 9001:2015 Certification in Singapore, ISO 45001 Certification in Singapore, ISO 13485 Certification in Singapore, you may be wondering about where – and how – to get started. This list of the 13 steps you need to take so that you don’t miss anything as you work through your implementation and get ready for certification through ISO 13485 Certification Services in Singapore.

WHAT IS THE STEPS TO GET ISO 13485Certification in Singapore?

1) Get management support.

This step is number one for a reason: without management support, your ISO 13485 implementation project is doomed to failure (if it gets started at all). You’ll need to craft a well-though-out presentation outlining the benefits your company can realize through ISO 13485 implementation and get your management team on board right from the start.

2) Identify requirements.

The next critical step toward a successful implementation is making sure that you ascertain all the requirements you need to satisfy with your QMS which is similar to ISO 9001:2015 Certification in Singapore. Such requirements usually include legal and regulatory requirements, customer requirements, and other requirements depending on your company’s needs and culture.

3) Define the scope.

You want to avoid applying the QMS to areas of your business that don’t pertain to quality, but you don’t want to make the scope so narrow that the company sees no benefit. When you define your QMS scope, you will have a better idea of what needs to be done, and the boundaries of your implementation. Your best tools to help you with scope definition are the quality policy and quality manual, so these need to be the first documents you develop for your QMS.

4) Define processes and procedures.

The ISO 13485 standard defines certain required procedures that must be part of your QMS, however you will also need to determine what processes and procedures within your company must be defined in order to ensure adequate and consistent quality. The first thing to do is to define all of your company’s processes, and then see how they interact with each other. These interactions are often where problems become evident.

5) Implement processes and procedures.

For most companies, all that needs to happen is the documentation of existing processes and procedures to ensure consistent quality that meets requirements. You don’t have to document every process, but you do need to decide which processes need a documented procedure in order to guarantee consistency in the quality of products and services.

6) Deploy training and awareness programs.

It is vital to the success of your Quality Management System that every employee in your organization understands how the QMS works, and where they fit into the mix. ISO 13485 Certification Body provides ISO 13485 accreditation necessitates that the organization occasionally reviews its quality procedures. All employees need to be trained on the basics of ISO 13485, so they get an idea of the purpose of implementation; in addition, they need to be aware of any changes to be made in the processes they are a part of.

7) Choose a certification body.

The right certification body can make all the difference, because this is the organization that comes in after your implementation to audit your Quality Management System, and determine whether or not it conforms to ISO 13485 requirements. In addition, they will also decide how effective your QMS is, and whether it indicates continual improvement.

8) Operate the QMS / Measure the system.

 When you will collect the records that will be required in audits to show that your processes meet the requirements set out for them that they are effective, and that improvements are being made in your QMS as needed. Certification bodies need this to happen over a certain length of time, which they will identify, in order to ensure that the system is mature enough to show compliance.

9) Conduct internal audits.

After you have operated the QMS for the prescribed length of time, but before the certification body conducts their audit, you will need to perform an internal audit of each process. This will tell you whether or not the processes are performing as planned, and if not, you’ll have the opportunity to take corrective action to resolve any issues you find.

10) Conduct management review.

Not only must management be supportive of the company’s ISO 13485 implementation – it is imperative that they stay involved in the ongoing maintenance of the Quality Management System. During the management review, they will examine data from the QMS activities to make sure that all processes have the resources they need to continue to be effective, and to improve over time.

11) Take corrective action.

 

Here is where you look for the root cause of the problems discovered during internal audits, measurements, and management review, and take the necessary action to correct the problems at the source. This is a crucial step in the continual improvement of the Quality Management System, which is a key aim of ISO 13485 and ISO 45001 Certification in Singapore.

 THE STAGES OF CERTIFICATION AUDIT BY ISO 13485 CERTIFICATION SERVICES IN SINGAPORE

12) Perform the stage 1 certification audit.

Now is the time for the auditors from your chosen certification body to review your documentation and verify that – at least on paper – all of the ISO 13485 requirements have been addressed in your QMS. You’ll receive an audit report detailing the areas in which you are compliant, as well as those in which you have problems. You will be given an opportunity to implement the necessary corrective actions to resolve the problems. This is often done during the same timeframe given for the initial operation of the Quality Management System.

 AUDIT PROCESS: CLICK HERE

13) Stage 2 certification audit.

During this audit, the ISO certification body in Singapore which provide the ISO 13485 Certification Services in Singapore will send auditors to have a look at the records you have collected through the operation of QMS processes. These records will include those from management review, internal audits, and corrective actions. When the review is completed, which often takes a few days, the auditors will provide you with an audit report that outlines their findings, including their determination as to whether or not your QMS appears to be effective, and if it complies with requirements of the ISO 13485 standard. If they find that your QMS meets all of the requirements set out for it, the auditors will recommend you for certification. If they have found any major nonconformance, you will have an opportunity to implement corrective action to make sure the problems are resolved, and that you are ready for certification.

The Certification procedure: CLICK HERE

What are the benefits of being ISO 13485 certified?

Whether you are hoping to operate internationally or develop locally, ISO 13485 Certification in Singapore can enable you improve overall performance, abolish uncertainty, and broaden market opportunities. Organizations with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with ISO certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut expenses and monitor supply chain performance
• Demonstrate that you produce secure and more effective medical devices
• Meet regulatory requirements and customer desires.

Frequently asked questions: CLICK HERE

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INTEGRATED ASSESSMENT SERVICES PTE LTD,

Mail: info@iasiso.com
Website: www.ias-singapore.com

ISO LEAD AUDITOR TRAINING WITH LOWEST COST IN SINGAPORE

What is the position of Lead auditor in ISO?

The ISO (International Organization for Standardization) develops voluntary international standards in a range of industries, from the food industry right across to business services. International Organization for standardization specifies ISO standard is a set of standards necessary for the implementation and operation of quality standards for business in different fields from manufactured products and technology to food safety, agriculture and healthcare. An ISO certification ensures that an organization's internal operations meet ISO criteria. The ISO auditor checks that the ISO management system is working. Audits can be conducted by a certified auditor or a team of auditors managed by a lead auditor.

Internal Auditor:

An internal auditor is an auditor who is appointed by the management of the company in order to carry out the internal audit function. Generally an employee of the company acts as an internal auditor, whereas some companies appoint an external expert as an internal auditor.

Lead Auditor: 

A lead auditor is the one who responsible for leading the audit team in an organization. He or she prepares the audit plan, delivers meetings and submits audit report at the end of quarter or year. Conducting audits is the main responsibility of a lead auditor and that needs to be done on a daily basis.

STEPS TO BEING A LEAD AUDITOR

1. Firstly you have to attend and clear the ISO Lead Auditor course in Singapore offered by certified organization. e. EAS, IAS etc.
2. If you want to be independent auditor you need to apply for the same with IRCA and pass their requirements.
3.  For applying with IRCA you must have some defined year of experience in same field.
4.  Also, you need to decide first which sector you want to proceed for.
5. Last but not least brush up your auditing skills as much as you can. This will make you more eligible to qualify.

What is CQI?

The Chartered Quality Institute (CQI), formerly known as The Institute of Quality Assurance (IQA), is the chartered body for quality professionals. It improves the performance of organizations by developing their capability in quality management. As a registered charity, the CQI exists to advance education in, knowledge of and the practice of quality in the industry, the public sector and the voluntary sectors.

What is IRCA?

Formed in 1984, the International Register of Certificated Auditors (IRCA) is the world's original and largest international certification body for auditors of management systems. 

IRCA provides auditors, business and industry with two main services:

1. Certification of auditors of management systems.
2. Approval of training organizations and certification of their auditor training courses.

Why EAS is the best choice for lead auditor course in Singapore?

Empowering Assurance Systems Pvt ltd., is a leading third party Conformity Assessment Body (CAB) with vast experience in assessment and certification of businesses for various management systems against International Standards like ISO 9001, ISO/IEC 27001, ISO 22000 etc.

EAS is accredited by Joint Accreditation Systems of Australia and New Zealand (JAS ANZ) which is a national accreditation body and member of International Accreditation Forum (IAF).

In 2016, EAS also became an Approved ISO Training Partner of CQI and IRCA, the leading professional body for quality and auditing, ensuring the highest standard of CQI and IRCA certified ISO training in Singapore that we deliver. We offer certified ISO lead auditor training course in Singapore for quality, information security, business continuity, environment, occupational health & safety and food safety management systems.

How IAS Provide Course in Lowest cost?

IAS-Singapore offers ISO auditor course in Singapore, in relationship with Empowering Assurance System (EAS) in India. We direct our QMS lead auditor training, ISO Training in Singapore.

Enrolling yourself in the ISO Lead Auditor Training in Singapore will enable you to get ensured as an auditor for conducting audits. The course will get you concentrated on getting quality principles in business forms which will help in both the advancement of self and the organization.

Our lead auditor training is conducted as a 40 hour course that is spread crosswise over five days. The QMS lead auditor Training conveyed by the most talented and experienced experts who for all intents and purposes take part in the evaluation, review and issuance of ISO Certification in Singapore on daily basis. With this, you will get the privilege and most recent data about the techniques and policies followed.

ULTIMATE GAINS THROUGH EAS, ISO TRAINING IN SINGAPORE

• Lowest price for all ISO auditor course in Singapore.
• After effective completion of the ISO lead auditor training course in Singapore, you can be a certified auditor for third-party auditing.
• You can be a part of the IRCA by registering yourself there.
• As a lead auditor, you are able to issue certificates to internal auditors.
• In addition, you don't need to continue renewing your certificate as an auditor by taking up an auditor training on a regular basis. You will be required to do it just when the standards are overhauled.

ISO Lead Auditor Training Course in Singapore

IAS conveys IRCA following system association with EAS and the courses are as following:

• ISO 9001:2015 QMS
• EMS ISO 14001:2015 
• ISO 22000:2018 FSMS
• BCMS ISO 22301:2012
• ISO 27001:2013 ISMS
• OHSMS ISO 45001:2018
• MIGRATION OHSMS ISO 45001:2018

Who can take this course?

• Individuals interested in conducting internal/external audits
• Management representatives
• Assurance Managers Quality
• Quality Control Managers
• Quality Auditors
• Technicians in Quality

WHAT IS THE REQUIREMENT FOR A LEAD AUDITOR?

Experience

A lead auditor must have experience in applying ISO standards, methods and procedures in the auditing of standard management system. They might have quality assurance certification in a specific industry. There is no prescribed minimum number of years necessary before an auditor can become a lead auditor.

Certification

The following thing a candidate needs to turn into a lead auditor is to pass the Certified ISO Lead Auditor test. The assessment body is the IRCA. The test covers domains of competence, including principles of quality, QMS, auditing concepts and the preparation, conduct, management and closing of an ISO audit of the specific standard. Candidates are in charge of their own preparation; there is no compulsory training class for the test. The test is in essay form and should be finished in three hours.

Auditing Skills

The lead auditor should get a top to bottom comprehension of the organization, its administration structure and how they identify with the standard management system. Furthermore, the lead auditor should talk with senior administration toward the begin and close of the audit, give them input on their standard management system and, as the ISO Auditing Practices Group puts it, "look for proof of their responsibility" to commit with ISO standards.

Management Skills

Because the lead auditor deals with a group of auditors, he or she should likewise have the management and leading abilities. He or she must know about the variety of experience and skills inside his group and separation the audit tasks respectively. For instance, junior auditors may be matched with a specialist counselor inside the group when taking a shot at progressively complex assignments. The lead auditor will be in-charge of the exhibition the board of his group.

RESPONSIBILITY

He or she will need to deal with the association's external ISO consultants on the off chance that they are available during the standard management system audit. The consultant is commonly a third party who advises the association on the implementation and activity of the standard management system. As per the ISO Auditing Practices Group, the lead auditor must guarantee that consultants don't compromise the audit itself.

Frequently asked questions: CLICK HERE

Contact the Best ISO Training Service in Singapore

Mail: info@iasiso.com

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