Thursday, 28 November 2019

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.

Frequently asked questions: CLICK HERE


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INTEGRATED ASSESSMENT SERVICES PTE LTD,


Mail:
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Website: www.ias-singapore.com

Wednesday, 27 November 2019

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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