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ISO 13485:2016

ISO 13485:2016 - Global Quality Management Standard for Medical Devices

Are your customers satisfied with the service you provide? Are you selling reliable medical devices? Enhance the quality of the devices with ISO 13485 certification. Get globally acknowledged by meeting the best industry practices!

Application

Application

Transfer

Stage 1 and 2 certification audits

Maintaining certification

Annual surveillance audits

Re Certification

Re-Certification

What is ISO 13485 certification?

What is ISO 13485 certification?

The ISO 13485 standard is widely known for offering a practical set of quality clauses to the medical device industry. Published in 1996 by the International Organization for Standardization, the standard went through several amendments until the latest version came in 2016. The standard aims to help companies in the medical device industry to effectively manufacture and supply premium-quality products. ISO 13485 sets guidelines, policies, and fundamental requirements to maintain an effective quality assurance program.

When it comes to quality management, the universally known and acknowledged benchmark is set by ISO 9001. ISO 13485 considers the predominant clauses designed by ISO 9001. The quality control standard for medical devices incorporates those clauses into its conditions. The adaptation of the original quality requirements gave a more descriptive shape to ISO 13485, which helps to maintain regulatory compliance as well.

The quality assurance/management business standards follow a “plan, do, check, act” protocol. It allows the companies to maintain a consistent process for designing, manufacturing, storing, supplying, installing, and disposing of medical devices. Companies eager to accomplish the certification must invest time in decoding the terms and definitions associated with the clauses. They must meet each clause to meet customer requirements and compliance.

The certification acts as a competitive shield for companies. It supports companies to acquire customer trust, which helps to strengthen the brand name and presence.

Which organizational practices are covered by ISO 13485?

ISO 13485 certification helps to develop the best practices for manufacturing and supplying medical devices that augment medical recovery. Like any other quality management system, it provides the opportunity to detect internal system risks that can disrupt business operations. ISO 13485 is known for helping companies with the following aspects -

  • A company establishes its name when it satisfies its customers. In the medical device industry, customers are happy when they receive reliable service from the devices. ISO 13485 helps to improve the credibility of the operations. Companies implement top industry practices like optimization of relevant resources and ethical use of every asset with the help of the standard.
  • Evidence-based decision-making is necessary. With the support of ISO 13485, companies can make effective decisions based on documents. The standard asks management to document every detail related to design, manufacturing, supply and installation of the devices. The standard generates awareness among the management and key stakeholders. It becomes clear that each decision to employ action plans to amend procedures must be based on data.
  • Involving stakeholders in the decision-making process is one of the pivotal industry practices that companies often fail to accomplish. The inclusion of stakeholder opinions is a must when new operations are being pursued. Their proactive involvement is a must for ensuring quality service. Stakeholder integrity is possible when leadership is enabled with commitment and transparency. ISO 13485 sets the clause of leadership where it says the management must take the responsibility of generating awareness and involve every stakeholder in the continual development process. The standard offers a systematic manual that guides management.
  • ISO 13485 guides on understanding customer preferences and expectations. It is necessary to comprehend the motive behind a customer’s interest in a product. Their buying patterns change from time to time. The clauses of ISO 13485 help companies identify their core interest. As a result, companies find it more enthusiastic to meet the priorities of their target customer. Therefore, customer satisfaction increases over time and it strengthens the revenue margin.

Certification Process

  1. 1. Internal audit – The audit checks the performance of the quality management system after it goes through a modification phase. It helps to find areas of possible improvement. Thus, allowing the management to implement better corrective measures to meet the clauses of the ISO standard.
  2. 2. Request generation – Relevant strategies are applied after checking the gaps between the system and the objectives. Once the compliance ground is accomplished, companies must choose a reliable certification body. The further assessments depend on the contract established between the company and the certification authority.
  3. 3. Stage 1 – Audit – As instructed by the certification authority, a third-party team of auditors analyzes the documents of the management process. They check both the compulsory and voluntary standards.
  4. 4. Stage 2 – Audit – At this point, the audit specialists issue reports as deduced from the previous stage. In case there is any nonconformity, the report will highlight that.
Certification Process

Compliance Requirements of ISO 13485:2016

ISO 13485:2016 stipulates the requirements of a fully fledged Quality Management System (QMS) specific to the medical device design, development, production, installation, and servicing. To be compliant, organizations are required to:

  • Establish a strong scope and policy of quality, in line with organizational objectives and requirements.
  • Document procedures and processes such as design controls, risk management, evaluation of the supplier, product realization, and corrective action.
  • Establish stringent risk-based thinking- recognizing hazards, assessing risks, and managing risks across the product life cycle.
  • Have strong traceability, and more so in device history, components, and change management.
  • Carry out timely internal audits, management reviews, and continuously upgrade QMS.
  • Maintain product security and vigilance to the law, such as alert complaint management, follow-up watch, and a rectifying action mechanism.

Common Non-conformities of ISO 13485:2016

Common audit deficiency findings are:

  1. 1. Imperfect or un-updated records on designs, procedures, or traceability matrices.
  2. 2. Poor risk management, like risks not being dealt with effectively by evaluating them adequately, recording them properly, and not properly countering the risks.
  3. 3. Weak controls of suppliers, such as a lack of supplier evaluation, audit, or missing performance monitoring.
  4. 4. Poor CAPA systems- problems are resolved, but not through root-cause analysis or subsequent verification of effectiveness.
  5. 5. Lapses in traceability, and especially in the connection between design outputs and discrete batches or serial numbers.
  6. 6. Neglected post-market surveillance, such as missing complaint records or failure to analyze service data for improvements.

Such non-conformities may affect the safety of the products, their regulatory acceptance, and customer confidence.

Common Non-conformities of ISO 13485:2016

FAQs

What is ISO 13485?

It's the international standard for quality management systems specific to medical devices, ensuring consistent design, production, and regulatory compliance.

What is the point of traceability?

With traceability, every component and batch of devices is tracked, so it is controllable, and in case of necessity, effective recalling can be implemented.

What is risk-based thinking?

It implies anticipating possible risks and carrying out control measures during the product lifecycle in order to cause minimal damage and to provide protection.

How should organizations manage non-conformities?

Through inquiry to find root causes, use of corrective actions, checking the efficacy, and instituting changes to the QMS systems in a systematic manner.