ISO 13485:2016

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.

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.

Why Must You Contact Blue Wolf Certification For Achieving ISO 13485?

  • 100% compliance
  • Reliable customer service
  • Assistance from certified and renowned auditors
  • Comprehensive services - stage 1 & 2 audits, issuing certification, and surveillance audit
  • Customized solutions to meet individual system needs
  • Affordable charges

Frequently Asked Questions

1. What is ISO 13485?
ISO 13485 is the quality management standard for the quality management standard for the medical device industry. It helps companies to meet the requirements of medical device customers, which is to get recovered fast.
2. Is It Necessary To Hire a Professional Audit specialist To Achieve ISO 13485?
Yes, the role of a certified audit specialist is indispensable in attaining the ISO 13485 certification. They have proper industry experience and market knowledge. Their expertise helps a company to conduct audits in a time-bound and cost-effective manner.
3. How much does it cost to get the ISO 13485 certification?
The cost depends on the size and type of your medical device company.
4. Why Audit is important in achieving ISO 13485 accreditation?
● The audit evaluates the performance from a financial point of view
● It detects errors and determines their impact on the process
● It allows the management to get a better understanding regarding the improvement process
● It adds value to the overall QMS process

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