This article focusses on offering an explicit overview on how a quality manual for developing an efficient QMS abided by the ISO 13485 requirements should be ideally prepared.
Quality assurance is an imperative aspect for every business, especially if it deals directly with the healthcare and wellbeing of the public. Considering the complexities involved in running a medical device manufacturing company, it is of utmost importance for the owner to get their operations ISO 13485 certified. ISO 13485 is the universally accepted ISO standard meant for developing an efficient QMS for medical device manufacturers. Manufacturing ISO 13485 medical devices actually helps you demonstrate the fact that all your production processes are being practiced as per the highest industrial standards to deliver products that are of premium quality.
Producing and utilising quality-assured medical devices comes with a multitude of benefits for both manufacturers, healthcare professionals, and patients. So, considering the same, if you’re planning to get your medical device manufacturing business certified, preparing a quality manual is one of the primary steps of seeking an the ISO 13485 certification.
Why do you need the ISO 13548 certification as a medical device manufacturer?
Having a set of well-defined guidelines is something extremely important for avoiding the unnecessary risks involved with delivering low-quality or faulty products to clients. To combat the same, it becomes important for you to prepare an exclusive quality manual where a list of the ISO 13485 requirements and protocols would be listed to help businesses in achieving the certification. Ideally, this would be considered a part of your well-structured Quality Management System (QMS) which would mainly consist of multiple elements including comprehensive documentation of all the procedures, policies, quality plans, regulations, and records of the organisation that should be dealt with strategic focus.
Here’s a detailed overview on how to prepare an all-inclusive quality manual for achieving an ISO 13485 certification by seeking professional advice of qualified consultants.
Hierarchy of the QMS
It is important to note all the requirements for maintaining a QMS and other organisational practices in a comprehensive, single document. Some of the major requirements which must be included in the quality manual are:
• Scope of the QMS
• All the Standard Operating Procedures (SOPs) of your QMS
• Interactions in between the QMS processes
• Outline of the QMS documentation structure
As this standard offers flexibility to the organisations in structuring the quality manual, a number of work instructions, procedures, and forms can be included in the guidelines for satisfying these needs.
Simplified guide
While creating a quality manual for ISO 13485, you don’t always need to make it unnecessarily elaborative. This means you don’t always want to complicate the processes on your own or prepare a document that’s excessively big or ambiguous for your employees to interpret. Your focus should always be to ensure that the document succeeds in conveying comprehensive information on all the requirements and protocols to be met along with proper justification on any kind of regulations which your company is exempted from. It should ideally convey information on the organisational process flow along with the relationships in between all the procedures by using various types of graphical communication tools like flow charts.
Structure of the document
All the guidelines being mentioned in the quality manual must follow a systematically defined structure for accurate and precise demonstration. Make use of a logical approach to numbering procedures and nomenclature along with creating digital links in between the documents of your eQMS (Electronic QMS) for developing simple-to-use and logical navigation. The quality manual should ideally be comprised of all the guidelines in the first section followed by procedures and work instructions. While specifying all the definitions and rules, make sure there’s a proper link to all the document records for demonstrating transparency and authenticity.
The bottom line: Inculcating a quality-driven work culture
The main objective of preparing a quality manual for your medical device manufacturing organisation is to describe an QMS that is developed to ensure you can deliver ISO 13485 medical devices to your clients. If an individual, be it an external auditor or a new employee of your organisation, wants to have comprehensive information on your QMS as a whole, then this document will comprise of all that they need to fulfill their purpose. Make sure your manual isn’t too lengthy without giving necessary information. It should be precise and capable of providing a detailed overview of what an ISO 13485 certified company should be ideally like.
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