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Harry Ten

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Apa itu ISO 13485? Gambaran Umum Standar ISO 13485

by Harry Ten
written by Harry Ten

ISO 13485 adalah standar internasional sistem manajemen mutu (SMM) yang banyak digunakan pada industri peralatan medis. Dikeluarkan oleh International Organization for Standardization (ISO), standar ISO 13485 merupakan solusi efektif untuk memenuhi persyaratan komprehensif sistem manajemen mutu pada industri peralatan medis.

Apa tujuan ISO 13485?

Dimulai dengan dukungan manajemen dan identifikasi persyaratan pelanggan untuk sistem manajemen mutu, Anda juga harus membuat persyaratan dokumentasi yang mencakup Kebijakan Mutu, Sasaran Mutu, dan Pedoman Mutu. Ketiga dokumentasi tersebut menentukan cakupan keseluruhan dan implementasi Sistem Manajemen Mutu. Selain itu, Anda juga harus membuat proses dan prosedur wajib dan tambahan yang dibutuhkan untuk organisasi Anda agar dapat memproduksi dan mendistribusikan produk atau layanan Anda dengan sebaik-baiknya.

Sebuah survei terhadap perusahaan yang bersertifikasi ISO 13485 terkait jumlah perusahaan yang mengimplementasikan Sistem Manajemen Mutu ISO 13485 menunjukkan tren positif di seluruh dunia (penurunan pada tahun 2018 dikarenakan metodologi pengukuran yang berbeda).

Apa versi terbaru ISO 13485?

Revisi terbaru ISO 13485 untuk peralatan medis dilakukan pada Maret 2016. Penambahan pada versi ini, antara lain: fokus pada risiko, penjelasan tanggung jawab manajemen, penjelasan tanggung jawab pelatihan, peningkatan persyaratan fasilitas produksi dan distribusi, peningkatan desain dan persyaratan regulasi, peningkatan kontrol terhadap pemasok, persyaratan untuk prosedur penelusuran, peningkatan penanganan terhadap keluhan, peningkatan persyaratan kebersihan produk.

Standar ISO 13485:2016 sejalan dengan versi sebelumnya yaitu ISO 9001, ISO 9001:2008. ISO 9001 merupakan standar internasional yang dikeluarkan oleh ISO (International Organization for Standarization) untuk Sistem Manajemen Mutu (SMM). Persyaratan ISO 9001 diakui di seluruh dunia sebagai standar untuk implementasi Sistem Manajemen Mutu. Meskipun standar ISO 13485:2016 dikeluarkan setelah revisi ISO 9001:2015, Standar ISO 13485 tidak sejalan dengan revisi terbaru ISO 9001. Sebaliknya, perubahan terbaru pada ISO 9001:2015 tidak lagi diperlukan pada industri peralatan medis.

Apa persyaratan ISO 13485?

ISO 13485:2016 menetapkan persyaratan Sistem Manajemen Mutu pada produksi peralatan medis dan layanan terkait agar sesuai dengan harapan pelanggan dan persyaratan yang berlaku. Persyaratan ISO 13485:2016 dapat diterapkan pada semua skala dan tipe organisasi, kecuali yang telah disebutkan secara eksplisit. Apabila persyaratannya diterapkan pada peralatan medis, persyaratan tersebut juga berlaku untuk layanan terkait yang disediakan oleh organisasi tersebut.

Apakah ISO 13485 merupakan sebuah kewajiban?

Jawaban singkatnya adalah tidak, ISO 13485 bukan sebuah kewajiban. Anda dapat membuat SIstem Manajemen Mutu yang sesuai dengan kebutuhan organisasi Anda, namun proses Sistem Manajemen Mutu tersebut harus memenuhi persyaratan hukum dan peraturan untuk peralatan medis yang akan Anda produksi dan distribusikan. ISO 13485 merupakan standar yang lebih dari cukup untuk memenuhi persyaratan hukum; ISO 13485 mencakup seluruh sistem yang dikhususkan untuk membantu Anda agar sistem manajemen mutu Anda lebih baik.

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Business

Finding Halal Foods in America

by Harry Ten
written by Harry Ten

Being able to find halal food is a joy for Muslims in the United States, especially in America. Because not a lot of halal food is sold in this area.

One of the famous halal foods in the DMV area is Ravi Kabob, a restaurant that has halal certification USA located at 305 North Glebe Road, Arlington, Virginia. This restaurant, which serves Pakistani food, has been around since 1997.

What to Expect

When visiting Ravi Kabob for the first time, visitors will be surprised by the atmosphere in the restaurant which is often full of customers. The chairs provided were entirely occupied by dinner connoisseurs.

The queue of buyers and those waiting for orders became one. As a result, many wait their turn for empty seats, so they can enjoy the food at the restaurant directly.

A number of the staff seem to have trouble serving customers, the majority of whom are Middle Eastern citizens who live in the United States. Meanwhile, other staff seemed busy cleaning up chairs and tables that had been used so they could be reused by new customers.

Before ordering, you can see a number of foods from the glass display case. Seen a row of typical Pakistani food served. You just have to order from the clerk, then the officer will immediately take the food from the window.

Pictures of the food menu are also displayed at the top, so that potential buyers can clearly see the food menu provided. Some menus are cooked suddenly so customers have to wait patiently.

Not only that, a row of food menu names is also listed in the menu book. Starting from the appetizer menu, the main menu to the dessert menu and drinks.

The Specialties

We recommend that you order the famous Chicken Karahi menu at this restaurant. When the staff came to bring the ordered food, Chicken Karahi was served in a large bowl in a puff of smoke. The aroma of spices typical of the Middle East immediately smelled.

When you first tasted it, it seemed familiar to the Indonesian tongue. The chicken is tender and wrapped in a rich yellow spice that smells good of spices. It feels so good. Suitable for Indonesian tongue. One large portion of Chicken Karahi can be enjoyed by 3 to 4 people.

In addition, you can also order the Lamb Chop Tandoori. This is a menu of mutton cooked with a mixture of spices and then grilled. The goat meat is soft and doesn’t smell at all. It’s even more delicious when dipped in chutney sauce and fragrant biryani rice.

Another menu we highly recommend is Beef Kabob. This is minced beef that is shaped into an elongated round and grilled served nice and warm. The beef is tender and goes well with sauces and salads. You can also enjoy each dish with biryani rice or tandoori bread.

While enjoying the food served, you can see the walls of the restaurant which are full of pictures of mosques that stand in Pakistan.

Pricing

The price for a serving of Chicken Karahi is $28.99, while the Lamb Chop Tandoori is $20.99 and Beef Kabob is priced at $14.99. The price is in line with the good taste; no wonder this restaurant is visited by many visitors every day.

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DezignNewsPrint

Types of Graphic Design. Now and Then

by Harry Ten
written by Harry Ten

If the think about it, graphic design is evolving in such a speed rate, that we all should follow the pace thoroughly to know all the new elements, innovations and software that is launching to understand it fully.

Of course, for all of us who are just in love with graphic design and stick to one area of it, there’s no need to be an absolute professional in most cases. You just have to understand the basics and exceed at your own pace.

Here are some types and methods that take a huge part of our lives, whether we realize it or not.

Graphic design has a broad range. It offers opportunities for individuals from all walks of life.

  • Motion graphics design – or in on other words “animation”.  It can bring multiple elements to life with specialized software and skills. It is used in TV Shows, video games, movies, advertising, etc.
  • Website design – in the last decade one of the most talked-about topics is website design. It takes a big part of website building, more intuitive pages, loading speed, media representation, text and search engines love when the sites are well-optimized for user experience (UX).
  • User Experience – as we said it above, UX is a top-ranking factor for websites, but it is pivotal in web applications, mobile and smart devices as well. Everybody loves a service or product that is user-friendly, can’t we agree all?

Now graphic designers are advancing in drawing directly on their digital tablets and can create so much easier.  Devices and technology, in general, are pretty well-optimized.

In the past, even 30 years ago it was way more difficult. And we are not only talking that computers were more basic, but their parts and components were weaker than current years.

Before that, people in the 50’s, the ’60s and 70s were drawing all their icons, typography letters and images on paper and they were using way more sophisticate technology to print them and get the design ready for whatever.

Some of the graphic designs were black and white, others were coloured, which was way more difficult in the past, due to the lack of technology. Even the remarkable black and white movies from the past have colourful posters because people were making an actual representation of the real thing.

Whether if graphic design is moving in the right direction, there is no second guess about that. Nowadays is easier than ever to start and give unlimited sources of information to express your creative genius.

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DezignPrint

5 Beautiful Card Stock Alternatives for Invitation Card Printing

by Harry Ten
written by Harry Ten

There are a lot of different types of invitation card printing in Singapore. They are used for different things. But one thing that’s the same for all of these invitation cards is that they all need to look appealing and, well, inviting. It is important to create a great first impression on your event’s guests, and a great looking invitation card is the best way you can do it. 

While it is important to pay attention to the content, typography, colors, and other design embellishments, it is also important to remember to choose a proper type of card stock for invitation card printing. 

Many people dismiss the importance of a high-quality card and settle for a cheap one while in fact, the quality of the card stock can really affect the overall look of the invitation card. 

So that you don’t make the same mistake, here are some of the card stock types worth considering for your invitation card. 

1. Cotton Card Stock 

The cotton card stock is smooth to touch, and it is highly adsorbent. It is one of the best choices for laser printing. With this type of card stock, you can make wedding invitations that look elegant, clean, and modern. Moreover, the cotton card stock is photo safe, meaning that it can last a long time in scrapbook and wedding albums for years. There are three colors you can choose for this type of card stock, which are white, ivory, and grey. 

2. Linen Card Stock 

The linen card stock is another favourite. It looks like linen fabric with a delicate texture. The finish is matte looking and appears like woven linen. Compared to the cotton card stock, there are more color options. However, it is still considerably limited. 

3. Canvas Card Stock 

This type of card stock for invitation card printing is also textured. The texture on a canvas card stock is more noticeable compared to linen card stock. Don’t worry, this card stock is not thick. In fact, this one is still thin enough to go through even home printers. 

4. Parchment Card Stock 

The parchment card stock is a semi-translucent paper. With this card stock, your invitation card will have a slightly marbled look with a soft and subtle feel. It isn’t thick, but it can be layered with vellum or cotton card stock if you need more depth for your invitation card. It is great for wedding invitation card as it will create a unique look. 

5. Felt Card Stock 

If you want a thick card stock, this one is for you. It is less thin than canvas, but thicker than cotton. It feels smooth yet coarse and can even be printed with home printers. Don’t worry, it is still quite affordable especially considering the quality it offers you. 

So, have you made up your mind regarding which type of card stock will you choose for your invitation card? Take your time in deciding and make sure you get the most suitable one for your event. 

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FeaturedMarketing

Set Up a Business in Singapore for your Startup

by Harry Ten
written by Harry Ten

When it comes to knowing about building your business, you can get to know about how to meet a customer with their needs. Here in Singapore, many opportunities offer you to make your business success and allow you to lead a great success and you able to register via A1 company registration Singapore agency.

Satisfying the customer is the key to successful business development. In that way, Singapore helps people with different offers to make them be a great successful person in the future. The high point of customer satisfaction is a fundamental business goal for every brand and the key to success. So if you understand this article right now, it means you probably agree with this article. In that way, they set up some goals for you to help and achieve you to reach the top.  

Being responsible for customers

Listening to your customers and meeting their needs is essential and can be beneficial for your business. But listening is not enough if you don’t respond to your customers. It is to gather and process customer feedback to realize the requested changes and develop your business. So being responsible for what you do to them is much vital thing to satisfy them. Some of them are expecting that, so before it, they need to fulfill their thoughts. While answering your customers’ questions or solving their problems, try to show some human face instead of using boring templates.

Unique to your customers

Being Unique is the essential one for any kind of business that the people are going to do. You will have a lot of business ideas like the accountant, Information technology, eCommerce, digital marketing, and many others. All these kinds of businesses will need a transparent entity. So if you are the person searching for the best body to start the market, then you have to choose whether your budget limit and the sole company is reasonable or simply pick the partnership business. Even in the partnership, some of the entities like the limited liability will be available. In it, the debts or losses are not subject to the shareholders apart from their share. It will give them more tax benefits and other offers to satisfy the customer moods and needs.

Satisfying customer’s requirements

if you are hiring in Singapore, then you no need to worry further process. It is because here, only less tax amounts charged for the business peoples. If you compare with other countries, then sure, you can know the worth of these tax benefits. It is also very much helpful in your savings. For each month, you can save a lot here. In case you are going to run the small business, then surely these tax benefits are effectively useful for you. Make use of the double taxation agreements, and hence you can gain the top-notch process in an extraordinary process. So these make them satisfy and help your customers to reach you more and more.

So by knowing all this importance, you can choose Singapore for your business and can satisfy more customers by building up your own company.

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DezignFeaturedReviews

3 Important Aspects That Make a Name Card Look Stunning in Singapore

by Harry Ten
written by Harry Ten

Is a name card printing in Singapore still important? Yes, it is. Even with the rapidly advancing technology, a lot of professionals still deem a name card as a necessity when it comes to giving out contact information either to fellow people in the line of work or business, even to potential clients and customers.

A name card, however, can only be effective if it is designed properly. A lot of people do not really understand or even know the necessity of a well-designed name card and simply design their half-heartedly. Unfortunately, doing this will only most likely turn into a waste of money. It is important to design a name card properly and with enough effort so that you can get one that gives out information effectively as well as leave strong enough impression to get you remembered.

1. Legibility

Ensuring legibility is important. A name card’s content must be able to be read without too much effort. What you have to pay attention to when it comes to making sure that your name card is legible is the font. This includes the font style, font style, and even spacing between the lines as well as the font color.

There are a lot of options when it comes to choosing a font style for a name card, from simple ones to heavily stylized ones. For a name card, a simpler font style is a lot preferred because it is easier to be read. A simple font style does not straight up mean that it is boring. If you can combine it well with the other design elements, it can look nice. Next, the size. A font size of a name card shouldn’t be too big or too small either. You should also pay attention to which words or lines that need to be bigger or smaller than the others for a good emphasis and balance. As for the color, you have to try and make it in strong contrast with the background color. Meaning that if you choose a light color for the background, then the font color must be of a dark color so that it can stand out against the background and be read much easier.

2. Design for your audience

Try to think about your audience as you design your name card. Your name card needs to be able to provide the right information about you in a simple way toward the recipient. This means that you have to make sure that you put only the relevant information in your name card and design it in a way that they can associate your name card easily with you and your company. For example, if you are an accountant, try to find or design a name card theme that can represent yourself well. Don’t design your name card in an unrelated theme or include images that have no correlation to your position or line of work. If you have two different occupations, then you have to make a personalized name card for each and make sure you don’t mix them up as you hand them out to people.

3. Printing

This aspect of name card production is important. Not only good design is required, but also high-quality printing. Choose a printing shop or service that can produce high-quality printing. Usually, places like this also will be able to provide you with many finishes options that can help you enhance the look and quality of your name card.

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ReviewsTech

Why the Latest Technology is Important for Today Business

by Harry Ten
written by Harry Ten

Why the Latest Technology is Important for Today Business

Establish a business with the latest technology pattern is good for business owners to achieve success. Technology develops in the fast-paced today that effective for marketing. No matter what type of business you need to establish. It gives many benefits to the market and engages them to earn the right amount of money. You can gain better results as per the company’s needs and requirements. Business owners rely on using the latest technology trend, which useful for business growth. You can implement ideal technology for business purpose like

  • Artificial intelligence
  • Robotic process automation
  • Machine learning
  • Edge computing
  • Blockchain
  • Internet of things
  • Cybersecurity
  • Augmented reality and virtual reality

It ensures excellent efficiency, culture, and the relationship of customers in business. The latest technology brings you a unique chance to enhance the security of confidential information and trade benefits. It plays a significant role in any size of business in the present time. It is the best time to expand the capacity and growth of the company. You can make sure effective business operations that right for the organization. You can utilize the latest technological innovation and gain comprehensive benefits them. You can embrace the ideal advantage with the implementation of new technology in business.

Manage effective communication:

It is a significant aspect of many business owners these days. Communicate with the potential audience and business clients easily by using proper technology. In a busy business place today, it is essential for employees to speak with clients frequently and clearly about business. The website lets visitors find out the right information within a minute. Quick shipment option is ideal for business owners to move products to the desired geographical area quickly. The business gains immense benefits due to communication that keeps up the sharp public image. It is better for business owners while customers use proper technology to interact with them.

Ensure efficient business operation:

Technology aids business owners to know the flow of cash and protect resources like physical space and time. Warehouse inventory technology allows business owners to realize how great to maintain the cost for storage to hold an item. You can implement proper technology in the workplace and gain excellent outcomes quickly. In this way, you can save money and money by organizing a meeting over the internet rather than a corporate office. Technology is an essential tool for businesses to gain great success.

Keep up security:

In the modern era, most of the business wants to implement the best security solution to prevent threat and attacks. It is a better way to avoid financial loss in the company. You can securely protect the financial asset, manage business information, and others. You can keep up the ideas away from the competition. Business owners need to operate computers with excellent security solutions that better for the company. You can make sure the security and confidentiality of the information and able to do business activities quickly without any hassle.

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