Quality Management Systems
Manage the quality of your medical devices with the global standard - ISO 13485. Get certified to enhance the reliability of your products. Increase brand strength with customer trust. Hire us to get support for completing all the steps for a seamless accreditation.
ISO 13485 is the international quality management standard designed specifically for the medical device industry. It was originally published by the International Organization for Standardization in 1996. The fundamental aim was to set guidelines, policies, and requirements for maintaining a comprehensive quality control program to design and manufacture effective medical devices. The latest version was published in 2016. It harmonizes with the clauses and purposes of ISO 9001, the universal quality management standard. ISO 13485 is adapted to the 2008 process-based model version of ISO 9001. However, unlike ISO 9001, ISO 13485 offers a more descriptive, industry-based standard to comply with the regulatory terms and conditions for medical devices.
The standard has a basic “plan, do, check, act” format, which helps management maintain consistency in design, manufacturing, storage, distribution, installation, and disposal of medical devices. To implement the standard and get certified, the clauses of the standard need to be understood and met, including policies, procedures, but records as evidence of compliance. The clauses are designed with the aim of promoting patient safety.
An ISO 13485 certified company enjoys many benefits over non-certified competitors including customer confidence and trust. In some cases, ISO 13485 compliance and certification is a requirement for certain segments. Without certification recognition, it can be more difficult to compete. in addition, ISO 13485 certification increases the confidence level and the quality performance of the organization. Compliance to the standard prepares a company to understand customer requirements through awareness, stakeholder engagement, and leadership, thereby setting up an organization for more sales.
The medical device sector is increasingly competitive as the demand for devices is always high on the curve. If quality products are not delivered, the target market will soon shift to other vendors.
1. Improves credibility: An ISO 13485 company’s credibility internally and externally is improved when it produces high-quality medical devices, this is a key outcome of ISO 13485 compliance and certification. Management is improved with the implementation of quality management practices. Certification provides customers with evidence of ethical use, optimization of relevant resources, and good manufacturing procedures. Gradually, customers grow to trust the brand and brand loyalty is therefore strengthened. The result is more likely to be better margins and stable revenue. ISO 13485 can be a powerful marketing tool.
2. Improved management from evidence-based decision making: ISO 13485 upgrades management performance by generating awareness. They can focus on the quality goal with the production, design, supply, and installation of the mechanisms. Authorities can easily take decisions based on the data provided to them continually. The data allow them to make decisions based on real-time evidence and facts. Evidence-based decision-making helps to augment the modification process in the existing management system as well.
3. Continual improvement: The fundamental nature of the global quality management standard is to ensure that the system has enough opportunities for continuing improvement. ISO 13485 is no exception to that. The protocol helps to implement a streamlined framework that detects errors, ensures stakeholder commitment that leads to high-quality performance, and helps with strategic leadership.
4. Customer satisfaction: The primary goal of ISO 13485 is to enhance customer satisfaction. For that, the certification enables the companies to understand the expectations of the interested parties. When a company invests in customer preferences and values their emotions with the products, they automatically get energized for meeting their satisfaction level. ISO 13485 promotes such values and increases the confidence level to identify buying preferences. As a result, their needs are optimized with resource mobilization and effective operations.
5. Stakeholder proactivity: A company cannot succeed without stakeholder integrity and proactive involvement. Through leadership, commitment, and transparent communication, ISO 13485 prepares the stakeholders and interested parties to engage in decision-making. Consequently, every step is enhanced and effectively processed with the help of the systematic template provided by the global standard.
There are precisely five elements that justify the nature, role, and responsibilities of the ISO 13485 standard. To implement ISO 13485-approved system, a company must incorporate the following -
The most crucial element of the standard is implementing and maintaining a quality management system. The requirements for employing an effective QMS must be determined by the authorities. Besides, a risk-based approach to timely control the procedures is required too. The quality management process must work in a sequence. The interaction between the procedures is to be monitored, tracked and evaluated timely.
The second element is management responsibility or leadership and commitment. In terms of responsibilities, authorities should do the following -
In terms of resources, a company needs to acquire and maintain infrastructure, contamination control, human resources, technical element, and the work environment.
Product realization encompasses the design and implementation of quality requirements for the devices. The management must outline the work environment and define the process and the infrastructure. Also, employee qualification and training should be reviewed by the leaders as well.
The last element is demonstrating conformity. The management must be able to ensure that all the required measures have been taken to adhere to the regulatory terms and conditions.
The certification process is as follows:
Commitment - In the first stage, a trusted certification body is selected. The authority sets an audit date.
Pres-assessment - If the clients wish, an assessment before the two rounds of audits are done.
Stage 1 Audit - The scope of the management system is monitored and reviewed. The external auditors check whether internal assessments have been done from time to time or not. If everything passes each requirement of the standard, the auditors confirm the stage 2 audit. Only certified auditors are given the responsibility.
Stage 2 Audit - After processing the result of the stage 1 audit, the second round is conducted by the lead auditor. The personnel checks and gives the final approval only if all the clauses are effectively met.
Issuing the certification - With the successful completion of the two rounds of audits and assessment, the certification body issues the certification.
Surveillance Audits - Every certification lasts for 3 years. The external certification body organizes annual audit programs to ensure ongoing compliance.
See what our clients have to say about Blue Wolf
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Quality Manager, Unity Tactical
“We chose Blue Wolf as a recommendation from Compliancehelp and we found the process to be as smooth with Blue Wolf as it has been with our consultant.”
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Quality Manager, Lowe Rental
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Q: What would you say to those who are considering Blue Wolf for their ISO certification audit?
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CEO, Alvarez Wind Energy Services LLC.
“Would give them a 10 out of 10 and would highly recommend them to anybody looking to get ISO certification in the future.
The audit was very very smooth.
The day one audit was helpful, because although there weren’t any findings made he did make some recommendations to our QMS and our on-time delivery matrix which we incorporated on that same day, once again with Lee’s help We updated our QMS same day, got it to the auditor and he was very happy to see the changes we had made, even though they weren’t going to be any findings they were just recommendations, I think it did smooth the process through.
Seth was fantastic, very easy to work with, once we got through the time zone issues, very professional, knew what he was doing, knew where to look, and I assume he knows where the holes typically are. He also made a lot of accommodations to where we are in the world and helping us getting that certification.”
President, Electrical Contact International
“We were very happy with the service, and I would definitely recommend them for anybody who is looking to gain ISO accreditation.
The auditor was very knowledgeable, very understanding, very helpful.
It wasn’t just a scrutiny of your documentation and processes, it was actually a helpful process, constructive in the feedback that was given.
The auditor was very professional throughout the whole process. Very punctual, always on time, ready to go.
Was again open and honest about the whole process, so myself and business partner knew exactly what to expect for each day for each part of the process.
Yes, I would recommend Blue Wolf. They were very professional throughout the whole process. The auditors were very knowledgeable and helpful and made the whole process of the ISO external audit very easy and comfortable, and we would definitely recommend for anyone looking to gain ISO accreditation.”
Founder, Elite Wind.
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CEO, HQS Automotive.
Our experience has been that this process in working with the auditors has shown us more ways to improve internally than what we expected
Founder, Art Advertising
One of the best business decisions I think we’ve made in the entire time we’ve been here in the company.
Founder, Art Advertising
When we first started the process of looking at the standard, we were afraid we would have to force our company into a new way of doing almost everything in doing our business. And we were very pleased to find out that the standard was meant to fit how we already were doing things. And Blue Wolf and Seth really helped us in the audit to not feel so intimidated by it, but to understand it, yes that the way we are doing it does fit the standard, and instead of just criticizing where we were coming short, he gave us advice and suggestions on how the standard is actually meant to be used, to improve how we are doing things, not to force us into a certain way of somebody else doing it.
Our experience has been that this process in working with the auditors has shown us more ways to improve internally than what we expected, and we would recommend going through this for anybody that’s considering it.
Founder, Art Advertising
After a lot of research and careful review of our options we chose to work with Blue Wolf, and we know now that we made the right decision. It’s been a great process, and I would recommend to anyone that is considering ISO 9001 to at least have a conversation with them. I don’t think you would regret it at all.
At the very beginning of this process, I think we can safely say we were very nervous about it and apprehensive about doing it. After our auditor Seth Shea arrived, we realized again what a great decision we made. He’s made this process way much easier than we thought it might be, not as scary. And the insight he’s given us, and the observations and suggestions has been one of the most… really one of the best business decisions I think we’ve made in the entire time we’ve been here in the company.
Founder, Art Advertising
Firstly, on behalf of Adam and myself, we would like to thank you both very much for providing us with the support and service during our ISO accreditation and certification process.
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Mechpro
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Affordable Staff
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Affordable Staff
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After his first day of the audit: “I’ve been through so many audits you can’t even count. Your approach is by far superior than any other audit I’ve ever been through. The contrast was night and day. I’ve got some younger people who don’t have quite the same experience as I do, and their ability to feel like they could be participatory, have value and be respected throughout the process was outstanding. I have not made a better choice in picking a company to work with us in an audit process prior to you. You’re going to be here every year if I can help it. And if ownership changes and they want to do something different, I’ll fight to keep this process going because it has so much value.”
Imerys
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Imerys, Quality Manager
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CHS Broadbent, National EMS Director
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Automated Wellhead. Operations manager
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Safety Administrator, Clark Bros, Inc.
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Inks Production Engineer, NovaCentrix
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Senior Director, PEO/HR + Payroll Operations, Choice Employer Solutions, Inc.
