Connect with us

Health Care

How ISO 13485 can help reduce operating costs

Published

on

How ISO 13485 can help reduce operating costs

Dollar rate decrease icon vector illustration. Money symbol with down arrow. Decrease profits, salary, income, cost, price, economy and income. Business concept icon.

Quality management system standards are a great tool for organizations that want to plan an effective and efficient quality management system.

ISO 13485, the ISO standard for medical device quality management systems, can help manufacturers streamline quality assurance processes, improving their efficiency and potentially reducing costs.

Key benefits of the ISO 13485 standard

The ISO 13485 standard establishes a standard for implementing a QMS, adopting a risk management approach to product development, validating quality management processes and establishing methods to manage traceability and product recalls.

The most significant benefit of implementing ISO 13485 will be the improvement of QMS processes. The standard establishes a process to design, implement, validate and review these systems, which helps streamline every step of the QMS design and implementation process.

The 13485 standard requires that a company’s QMS be data-driven. This means that quality assurance and validation processes will be based on existing product information, such as the frequency of certain quality defects or the potential impact of complications if a product fails in a certain way.

A more effective QMS will also have notable benefits. Fewer errors from a simplified process often means faster cycle times and less waste.

Creating processes for traceability and recall can also be extremely valuable in the event of a manufacturing error.

If a lot needs to be recalled, traceability processes generally help narrow the scope of the recall – knowing exactly when and where each product was produced and how it was shipped generally provides the information needed to identify the products affected or relevant to the recall.

In the event of a recall, this can save a significant amount of money and generally reduce the impact of the recall itself.

The expanded market access and enhanced business credibility offered by the standard alone or a third-party certification can also lead to additional sales, helping to further increase profit margins.

A manufacturer can access these benefits without even fully committing to adopting ISO 13485. While there are additional benefits to fully implementing the standard or obtaining ISO 13485 certification, the guidelines alone may be sufficient to help establish a Effective QMS for medical devices.

Simple steps to implement ISO 13485

All businesses want to implement ISO 13485 you must follow the same steps. How they are implemented will vary depending on the product you produce and the quality management processes you already have in place.

For this reason, most companies start with a gap analysis that compares existing QMS processes with the ISO standard. The companies will then develop an implementation plan that will align the QMS processes with that standard. At the same time, the company will also create documentation for its QMS processes.

Once these steps have been completed, the company can provide employee training and conduct an internal audit, reviewing the effectiveness of the documentation and processes in practice.

Once the internal audit is completed, the company is ready for the external audit process. This involves a stage one audit that reviews internal documentation and training practices, and a stage two audit that reviews the role of the QMS in practice.

To begin this process, your company will need to choose a certifier to work with.

ISO does not directly certify companies. Instead, the organization relies on a network of external certifiers, called registrars or certification bodies (“CBs”), who adhere to certain ISO standards on how they should operate.

The current Conformity assessment standard ISO 17021: 2015 establishes the ISO requirements for these bodies and describes how these certification bodies should operate. Before an audit, it may be worth reviewing these standards to understand how POs work.

After the audit, your company will also need a regular review of its CMS to stay certified. Typically, this review will take the form of an annual performance or monitoring audit.

Using ISO 13485 to optimize quality management operations

Implementing this standard can be an effective way to reduce operating costs by optimizing a company’s QMS. With a standardized QMS, companies can reduce waste, shorten cycle times, and potentially limit the impact of recalls.

Preparing for an audit will also help a company review its processes and learn more about how ISO certification works in practice.

Advertisement
Advertisement

Lifestyle

LifeStyle19 hours ago

5 Tips To Write Your Essays Before the Deadline

Deadlines are not easy to deal with. When there is an approaching deadline, one tends to get overwhelmed at the...

LifeStyle2 weeks ago

How to Prioritize Self Care as a New Parent

A bundle of joy has joined you in your life and you couldn’t be happier. But, at the same time,...

LifeStyle2 weeks ago

5 Reasons Why You Can’t Stay Asleep

You have likely heard it most of your life: getting a good night’s sleep is important for your overall health....

LifeStyle2 weeks ago

4 Ways to Spread Joy This Fall

Traditionally, many people strive to spread as much joy as they can in the weeks leading up to Christmas. But...

LifeStyle1 month ago

Tips to Boost Your Energy and Ensure Life Longevity with NMN Supplements

Australia’s median age limit increased by two years recently. Higher NAD+ can improve your metabolism rates and prolong natural aging....

LifeStyle2 months ago

5 Tips on Writing APA Research Paper

When students reach college education, they understand that it won’t all be flowers and sunshine. There are different courses with...

Support group for businesses to overcome challenges Support group for businesses to overcome challenges
LifeStyle3 months ago

Support group for businesses to overcome challenges

All-day brunch and soup kitchen Cafe Coco suffered as walk-ins dwindled significantly. It’s a tourist-dependent cafe that’s nestled in the...

S’pore startup Shiok Meats acquires clean red meat company Gaia Foods S’pore startup Shiok Meats acquires clean red meat company Gaia Foods
LifeStyle3 months ago

S’pore startup Shiok Meats acquires clean red meat company Gaia Foods

According to Technology in Asia, Shiok Meats has acquired a stake of more than 90% in Gaia Foods for an...

Marianna Hewitt’s home proves that neutral decor can be full of personality Marianna Hewitt’s home proves that neutral decor can be full of personality
LifeStyle3 months ago

Marianna Hewitt’s home proves that neutral decor can be full of personality

If anyone understands the importance of maintaining your brand, it is Marianna Hewitt. The trusted influencer and founder of the...

The 16 best stuffed pepper recipes for every occasion The 16 best stuffed pepper recipes for every occasion
LifeStyle3 months ago

The 16 best stuffed pepper recipes for every occasion

Something you may not know about me is that I absolutely adore a pepper. Raw, cooked, marinated, bathed: each and...

Advertisement

Sport

Sports2 months ago

5 Tips for Setting Up Your PC for Online Gaming

Due to advances in technology, online gamers can enjoy a gaming experience that was unthinkable even a decade ago. High-resolution...

Sports2 months ago

How to Succeed in Poker Tournaments

Perhaps your first big poker tournament is coming up, or you’ve been gathering skills ready to enter – no matter...

Sports2 months ago

Is The Olympics Still Relevant?

As the Tokyo Olympics has come to a close, competitors must move on from the excitement of experiencing an Olympic...

Fernández reflects on the game against Dart: ‘Honestly, I can’t think of anything positive’ Fernández reflects on the game against Dart: ‘Honestly, I can’t think of anything positive’
Sports3 months ago

Fernández reflects on the game against Dart: ‘Honestly, I can’t think of anything positive’

var adServerUrl = “”; var $ el = $ (“# video_container-985707”); var permalink = $ el.closest (‘. snet-single-article’). data (‘permalink’);...

Tammy Abraham to Roma – Mourinho is the perfect coach for the striker Tammy Abraham to Roma – Mourinho is the perfect coach for the striker
Sports3 months ago

Tammy Abraham to Roma – Mourinho is the perfect coach for the striker

It seems that not too long ago, a young English Target Man was a troubling prospect for most Premier League...

Explanation: Why Barcelona had to let Messi go Explanation: Why Barcelona had to let Messi go
Sports3 months ago

Explanation: Why Barcelona had to let Messi go

Barcelona’s Argentine forward Lionel Messi cries during a press conference at Barcelona’s Camp Nou stadium on August 8, 2021. –...

Are Arsenal and Spurs left out of the top 6 in dispute as the 2021/22 season approaches? Are Arsenal and Spurs left out of the top 6 in dispute as the 2021/22 season approaches?
Sports3 months ago

Are Arsenal and Spurs left out of the top 6 in dispute as the 2021/22 season approaches?

Manchester United, Manchester City, Liverpool, Chelsea, Spurs and Arsenal are the teams that are widely regarded as the top 6...

What should team Canada’s men’s hockey roster look like? What should team Canada’s men’s hockey roster look like?
Sports3 months ago

What should team Canada’s men’s hockey roster look like?

We have sent an email with instructions to create a new password. Your current password has not been changed. We...

Haaland, but staying in Dotmund, can BVB get the title on 21/22? Haaland, but staying in Dotmund, can BVB get the title on 21/22?
Sports3 months ago

Haaland, but staying in Dotmund, can BVB get the title on 21/22?

There are almost twenty days left in the transfer window. The window is in full swing as deals that would...

Knicks agree to deal with Dwayne Bacon: reports Knicks agree to deal with Dwayne Bacon: reports
Sports3 months ago

Knicks agree to deal with Dwayne Bacon: reports

Dwayne Bacon # 8 of the Orlando Magic shoots as John Collins # 20 of the Atlanta Hawks defends during...

Advertisement

Entertainment

Venice adds Doc ‘Ennio’;  Netflix Confirms Sanjay Leela Bhansali Series – News Block Venice adds Doc ‘Ennio’;  Netflix Confirms Sanjay Leela Bhansali Series – News Block
Entertainment3 months ago

Venice adds Doc ‘Ennio’; Netflix Confirms Sanjay Leela Bhansali Series – News Block

Venice adds Giuseppe Tornatore’s Ennio Morricone film The Venice Film Festival incorporates the Out of Competition screening of Ennio Morricone’s...

The Jeffrey Epstein Victims Fund has finished paying $ 121 million The Jeffrey Epstein Victims Fund has finished paying $ 121 million
Entertainment3 months ago

The Jeffrey Epstein Victims Fund has finished paying $ 121 million

After awarding more than $ 121 million to about 150 applicants, a compensation program for survivors of Jeffrey Epstein’s sexual...

Matt Roloff and Karyn Chandler move in together, discuss marriage Matt Roloff and Karyn Chandler move in together, discuss marriage
Entertainment3 months ago

Matt Roloff and Karyn Chandler move in together, discuss marriage

Small people, big world star Matt Roloff and his girlfriend, Karyn Chandlerhave revealed their big summer plans in a new...

Mike Shouhed wants Reza Farahan to apologize for being a ‘traitor’ Mike Shouhed wants Reza Farahan to apologize for being a ‘traitor’
Entertainment3 months ago

Mike Shouhed wants Reza Farahan to apologize for being a ‘traitor’

Shouhed says his Shahs of Sunset co-star “cuts deep and says things that are hard to forgive.” While a sexting...

Joey Lawrence and Samantha Cope are engaged Joey Lawrence and Samantha Cope are engaged
Entertainment3 months ago

Joey Lawrence and Samantha Cope are engaged

He put a ring on it! Joey lawrence is engaged to the actress Samantha cope one year after filing for...

Christine Applegate was diagnosed with multiple sclerosis Christine Applegate was diagnosed with multiple sclerosis
Entertainment3 months ago

Christine Applegate was diagnosed with multiple sclerosis

August 10, 2021 Christine Applegate was diagnosed with multiple sclerosis (MS). Christina Applegate The 49-year-old actress took to Twitter on...

UK advertisers form tapestry with clients Coel, Fassbender, Foy – News Block UK advertisers form tapestry with clients Coel, Fassbender, Foy – News Block
Entertainment3 months ago

UK advertisers form tapestry with clients Coel, Fassbender, Foy – News Block

EXCLUSIVE: UK advertisers Donna Mills and Emma Jackson, longtime representatives of London-based Premier Communications, have launched the new advertising agency...

Christina Applegate: actress reveals multiple sclerosis diagnosis Christina Applegate: actress reveals multiple sclerosis diagnosis
Entertainment3 months ago

Christina Applegate: actress reveals multiple sclerosis diagnosis

prime time Emmy-winning actor Christina applegate has revealed a multiple sclerosis condition through a Twitter post late on Monday night....

Prince Harry and Meghan Markle wanted to move to New Zealand in 2018 Prince Harry and Meghan Markle wanted to move to New Zealand in 2018
Entertainment3 months ago

Prince Harry and Meghan Markle wanted to move to New Zealand in 2018

Prince harry and Meghan Markle according to Queen Elizabeth IIRepresentative to New Zealand, Governor General Patsy Reddy… She said Associated...

Alarming new UN climate report says humanity has really screwed itself up Alarming new UN climate report says humanity has really screwed itself up
Entertainment3 months ago

Alarming new UN climate report says humanity has really screwed itself up

The last evaluation of climate science is a “code red for humanity,” the United Nations chief said on Monday, while...

Advertisement

Tech

Tech1 week ago

How to Provide Cybersecurity for Firefox

Mozilla Firefox is one of the first browsers that come to mind when thinking about the best privacy-oriented browsers available...

Tech4 weeks ago

6 Important Questions to Ask Your Internet Provider

Choosing the best internet provider can be challenging, especially when you don’t know what questions to ask. You want to...

Tech1 month ago

How Serious is Plagiarism in College?

Studying in college often demands writing essays and course papers. You may study technical subjects and do not have many...

Tech1 month ago

Three Possible Ways of How You Can Transfer Contacts from Outlook to iPhone

MS Outlook plays an important role in putting daily life in order, especially with regard to email management. If you...

Tech1 month ago

Importance of Email Validation

According to recent stats, 30% of users change their email every year. Therefore, if your mailing list is more than...

Tech1 month ago

Before Doing Virtual Staging, Here’s What You Should Know

The majority of people today go online to look for homes. When a potential buyer spots a house online that...

Tech1 month ago

What Technologies are Online Casinos Using?

Online casinos have become an ideal choice for a lot of players, especially because they let players take their games...

Tech2 months ago

Grow Your Brand With These 5 Social Media Tips

Whether you’re operating a new business or working to grow your brand, social media is an excellent place to start....

Tech2 months ago

Is Mining Ethereum Still Profitable in 2021?

Globally, there have been lots of innovations and modernization in different aspects of life. This fact has contributed to the...

Tech2 months ago

Popularity Of the Blockchain Technology: How Familiar Are You with It?

Cryptocurrencies are a form of digital currency that stands out because it is decentralized. Cryptocurrency also stands out because it...

Advertisement
Advertisement