Having a quality management system based on ISO 13485 standards at an early stage can help gain regulatory approvals from a variety of EU countries. Quick certification can mean quicker access to markets.
The longer medical device manufacturers stay in the review stage, the more costly dealys to market become.
It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
Benefits of ISO 13485 for medical device manufacturers:
- Increases customer confidence
Certification establishes a company’s commitment to quality, which often leads to increased customer confidence
- Improves marketing and promotional opportunities
A certified company will receive a certificate. This can displayed on all marketing materials to improve credibility and gain a competitive advantage
- Products to market quicker
ISO 13485 certification allows medical device manufacturers meet quality system requirements of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EEC) and Active Implantable Medication Device Directive (90/385/EEC) with less difficulty, which speeds up product launches
- Promotes better communication and fewer deviations
ISO 13485 promotes harmonisation of regulatory requirements on an international scale. Harmonisation allows medical device manufacturers and other quality experts to communicate using a standardised language. This helps avoid misunderstandings resulting in deviations, non-conformances and other quality events that could cause patient harm, regulatory sanctions and loss of revenue
- Improves business performance
Improved products and processes help device manufacturers deliver high quality products without embarrassing product recalls and costly regulatory sanctions. This leads to increased customer satisfaction and better relationships with suppliers and stakeholders
Helping you prepare for ISO 13485 certification
If you’re looking to obtain ISO 13485 certification, then it’s important to understand the requirements of regulators and customers, as well as what a 13485-compliant management system involves.
Your first step to creating a management system should be to draft a quality manual. The manual outlines an organisation’s goals, processes and procedures for compliance and quality management.
If you’re a small device manufacturer, chances are, you‘re unlikely to have the time, resources and expertise in house to identify and solve all problems relating to a successful outcome.
This is where an independent quality management consultant can help by acting on your behalf to ensure you have the right systems in place and liaise with the registration authority.
Choosing a competent consultant who understands your business and has experience with similar products is crucial. The consultant should align their knowledge with your requirements and those of your customers.
After the quality manual has been written and a management system implemented, you then need to look for a certification body.
The certification process is divided into five stages.
Stage 1: Inquiry
ISO does not perform certification audits or issue certificates. This is carried out by an external certification body or registrar.
Inquiries will include discussions between registrar and company. This will include requirements and the certification process as well as the registrar’s knowledge and experience.
Stage 2: Application
If the fact-finding meeting goes well, the company will be asked to fill out a certification application form, which can be obtained online. The registrar will review the completed application form, as well as the information gathered during the inquiry phase, and provide the company with a quote. Obviously, if the company has chosen to follow ISO’s advice, it will be requesting and receiving multiple quotes, from multiple registration bodies. Once a registrar has been selected, the company is ready for the documentation review.
Stage 3: Documentation review
The registrar will assess how the company’s documented quality processes comply with ISO 13485. The company may decide to conduct a trial audit or pre-assessment to get a feel of the registrar’s auditing style and if there are any quality areas deficient.
Stage 4: Final certification audit
For certification, stages 1 and 2 must be carried out before final certification. The duration of audits must comply with the IAF MD9 guidance document. Section 0.2 of ISO 13485 requires auditors to use a ‘process approach’ auditing style, as opposed to a checklist approach. The process approach uses a plan, do, check and act cycle.
Stage 5: Ongoing monitoring
Annual monitoring audits are recommended to check progress and make amendments. Audits should be scheduled in advance of the company’s anniversary date. A complete assessment restarts every three years.
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