ISO 13485:2016

What is ISO 13485?

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.

What are the Main Benefits of ISO 13485?

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.

What are the key elements of the ISO 13485 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 -

Element 1 - A Quality Management System

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.

Element 2 - Management Responsibility

The second element is management responsibility or leadership and commitment. In terms of responsibilities, authorities should do the following -

Establishing and communicating high-value quality policies
Communicating the necessity of accomplishing clauses
Ensuring quality objectives
Performing reviews
Ensuring the availability of relevant resources

Element 3 - Resource Management

In terms of resources, a company needs to acquire and maintain infrastructure, contamination control, human resources, technical element, and the work environment.

Element 4 - Product Realization

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.

Element 5 - Measurement, evaluation, and improvement

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.

Certification Process

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.

Client Testimonials

See what our clients have to say about Blue Wolf

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.

Your professional and knowledgeable approach and support has been very much appreciated.

Adam

Mechpro

The experience was overwhelmingly really good. I thought we were ready but there were some lightbulb moments. It was a logical process. The auditor was patient. We wanted the certification for areas of opportunity and we had many recommendations. I appreciated the audit. I haven’t heard anything negative out of the process to date. It’s been good.

Tracey Costin

Affordable Staff

I’ve never been involved in auditing before. Completely new. Was not sure what to expect. The process was seamless. There were some good recommendations. I was made to feel comfortable. The process worked quite well. I’m feeling more than ready for the next audit. There was so much going on at the time of the audit that I just wanted to go back to the audit, it was more relaxing.

Eva Judge

Affordable Staff

“One of the greatest things that initially sold me on BLUE WOLF was your approach towards partnering, understanding, and treating us with respect towards where we are at in compliance with the standard.“
“I was nervous about it until we spoke on the phone in the premeeting. Once you started talking about your approach and your process I was sold. But to see it in real life and to see it actually come true was even more (…)”
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.”

Joseph Shushok

Imerys

I’ve never been a part of one of these. I have learned absolutely so much. It was a privilege to be a part of this. I don’t ever want to experience an audit a different way.

Jama Morrison

Imerys, Quality Manager

If everybody could have an audit experience like this, more and more people would actually consider an ISO certification. Because so many people hear so many things about it, stressful myths, and everyone has a bad auditor experience from somewhere else. If more people could experience an audit this way, they wouldn’t have any reason to fear ISO.

Milo Fruk

CHS Broadbent, National EMS Director

I’ve seen some really bad crap auditors. Even I learned a whole lot from what we just went through with Seth that I didn’t even understand about the standard before.

Nick Maes

Automated Wellhead. Operations manager

“Blue Wolf has been great with providing us with clarity and direction so that our team can focus on the important aspects of our quality and safety management systems. What seemed like a very intimidating process to achieve ISO accreditation was made simple by Blue Wolf and their team. Their knowledge and our processes have added value and elevated our quality and safety program to another level. Thank you, Seth Shea, and the Blue Wolf team for a wonderful ongoing experience.”

Cynthia Sayer

Safety Administrator, Clark Bros, Inc.

“Streamlined. Easy to communicate, easy to talk to. Relaxed, didn’t feel pressured. Recommended for future ISO projects.”

Andrew Stewart

Inks Production Engineer, NovaCentrix

“We completed our audit today with 1 minor non-conformance and 2 observations. I would highly recommend Blue Wolf certifications to anyone else your company is working with. Our auditor Seth was so personable, made the audit process as relaxed and comfortable as possible, made our staff feel comfortable talking to him, and he was very thorough in his findings. He makes you feel like you are working together, which is HUGE and really rare in a company/auditor relationship.”

Kerry Ashby

Senior Director, PEO/HR + Payroll Operations, Choice Employer Solutions, Inc.

ISO 13485:2016 - Implement Quality Management System For Medical Devices