In the Life Science industry, the race is on to earn the prestigious ISO 13485 certification as soon as possible, since it prepares companies for the future EU MDR audit. If you're in the life science industry and after the ISO 13485 certification, this blog post will guide your first steps.
ISO 13485 calls for a lot of work. Where do you even begin?
The first step towards implementing a solution for the ‘quality of science’ is to know the most critical Procedures and Processes within your organization. Knowing these will help in writing a comprehensive Quality Manual that will establish robust Quality Management Practices within an organization.
If you already have the Quality Manual outline in mind, we’ll help you get everything in order. All you need is our enterprise ready e-QMS platform to implement the QMS practices compliant with ISO 13485.
Let’s move on to explain how Scilife enables its users to earn the ISO Certification through its innovative features.
Feature #1:
Document Control
Scilife’s Document Control Module helps you manage your documents in the cloud.
Key benefits include:
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- Storing your documents on our highly secure cloud-based platform
- Ability to manage different types of of documents
- Documents can be stored in different folders
- You decide who has access to which documents, by assigning user roles
- Documents can be electronically signed by author, reviewer and approver
Why do you need a Document Control Module for ISO 13485 certification? Well, that’s because ISO 13485 mentions various types of documents that a life science company should maintain for implementation of the Quality Management System (QMS) in the organization. You can store and manage all these documents in the Document Control Module without worrying about manual workflow execution, versioning, backup and storage space. It’s a lot less hassle!
General Requirements mentioned in ISO 13485:2016
The Quality Manual is the first document that is mentioned in the 4.2.1 of ISO 13485:2016 standard. It is a document that:
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- Formally stipulates the organizational vision about quality with clear statements on quality policy and quality objectives.
- Decides the hierarchy of documents within a QMS.
Once the quality manual is in place, the other documents related to Procedures, Processes, Work Instruction, Templates, and Forms follow.
Control of Documents mentioned in ISO 13485:2016
The 4.2.4. of ISO 13485:2016 states that a documented procedure shall define following controls:
| Requirement | How Scilife does it for you |
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Review and approve documents for adequacy prior to issue. |
Scilife creates a smooth digitized workflow, saving you a lot of time and manual effort. |
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Review, update as necessary and re-approve documents. |
Scilife automates this workflow too. All documents can be ‘force reviewed’ by authorized users at any time. After the necessary changes have been made, the document is automatically pushed through the re-approval process. |
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Ensure that the current revision status of any changes to documents are identified. |
Scilife captures this all in the audit trail. |
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Ensure that relevant versions of applicable documents are available at points of use. |
All you need to do is click on ‘document revision history’. No manual effort needed! |
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Ensure that documents remain legible and readily identifiable. |
A softcopy is always more legible than a handwritten document. The document type and document title are mandatory fields to start creating the document. Therefore the documents can be easily identified with the document type, document title and auto assigned versions. |
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Ensure that documents remain legible and readily identifiable. |
Scilife provides you with a folder management system that supports you to segregate different documents and allow controlled user access to them. |
| Prevent deterioration or loss of documents. | Scilife is a paperless system, and hence deterioration of documents is impossible. However, we guarantee the protection of digital documents by ensuring a strong backup strategy. We use the best cloud service platform, i.e., Amazon Web Services (AWS), and at the same time, we also use S3 services for Amazon. The S3 services ensure data is securely stored in three geographically separate locations globally. |
| Prevent the unintended use of obsolete documents and apply suitable identification to them. | Scilife’s Document Control Module enables you to mark documents as obsolete and thereby separates them from other documents. |
| The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions. | While Scilife provides you with an automated workflow to do this, the approving function is decided by the organizational policies, procedures and processes. |
| The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements. | This is also largely dependent on the organizational policies, procedures and processes. However, as Scilife is 21 CFR Part 11 compliant, it is not possible to delete any document from the system and hence you can be 100% sure of complying with this requirement. |
To summarise it all, in a paper-based QMS you need a document library and trained resources to create, edit, store and approve formalized documents. However, there is a smarter way of doing it; by using Scilife’s Document Control Module. Scilife's Document Control module allows users to create, edit, revise, store and push the documents through approval cycles digitally in the cloud.
Feature #2:
Record Control
4.2.5 of ISO 13485:2016 that states that, “The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records.” If you read carefully, you will see that these requirements are no different than 21 CFR Part 11 requirements. Scilife is fully compliant with 21 CFR Part 11. We support you in achieving this as follows:
| Requirement | How Scilife does it for you |
| Identification of Documents | Scilife enables users to create different document types. While creating a Document Type, the user needs to give input regarding the document type prefix, document standard format, approval cycle for that specific document type, and storage site (folder location) for storing the document. Therefore, once all necessary document types are created, every new document can be assigned to the relevant document type. Every document will get a unique document identification number with the help of a predefined document type prefix. For example, if you define 'SOP' as the prefix for the document type- Standard Operating Procedure, then the first document that you will create using this document type will automatically get a unique identifier of 'SOP-1: [Your Title]'. Assigning a unique and relevant document title is the user's responsibility. This process ensures that every document gets a unique identifier. |
| Storage | The documents are automatically stored in the cloud storage space. It is possible to perform live edits in documents without having to save the document multiple times. |
| Security | It is possible to restrict or limit users' access rights while creating a user in Scilife eQMS. Only valid users with Scilife credentials can access the e-QMS. The access can be restricted as a read-only user, regular user, managerial user, or administrative user depending on the user's roles and responsibilities within the organization. The administrator can restrict access by assigning users to relevant user groups. |
| Integrity | An automatically generated Audit Trail is recorded for every document in Scilife e-QMS. This means that every small change is recorded with the Time-Stamp and the person's user details making the change. Making it impossible for anyone to tamper with the documents. If a document is deleted, the user or auditor can still find the document in the deleted items. It is not possible to delete the documents that are already in the deleted documents. Meaning Scilife ensures 100% data integrity for you. |
| Retrieval | It is effortless to retrieve a document in Scilife e-QMS. The user simply has to enter the title or document number in the search bar. It automatically retrieves all the documents with associated search results. A considerable advantage when compared with the manual search of documents in a paper-based system. |
Feature #3:
Events
Section 5.6 of ISO 13485:2016 requires medical device manufacturers to perform a management review of all the Quality Management processes, and the inputs to the review are mentioned in 5.6.2. The input to management defines activities such as complaint handling processes, reporting to regulatory authorities, monitoring measurement of processes and products. It is essential to record all these events for use as input in the management review process. The Events Module in Scilife helps you document all these events, assign a process cause, and perform a risk assessment to investigate the event's root cause as required by 4.1.2 of ISO 13485.
Feature #4:
CAPAs
ISO 13485:2016 mentions corrective action in 8.5.2 for reviewing nonconformities (Events), determining the cause of non-conformities, and eliminating the cause of non-conformities through Corrective or Preventive Actions (CAPAs). Scilife’s CAPAs Module streamlines this effortlessly. Writing CAPAs and Events has never been so easy!
Feature #5:
Audit
Vendor or supplier qualification is a crucial requirement mentioned in 7.4.1 of ISO 13485:2016. It states that, “The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information. The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be:
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- based on the supplier’s ability to provide product that meets the organization’s requirements;
- based on the performance of the supplier;
- based on the effect of the purchased product on the quality of the medical device;
- proportionate to the risk associated with the medical device.
- based on the supplier’s ability to provide product that meets the organization’s requirements;
The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process.
Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.
Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained (see 4.2.5).”
Scilife supports its users in achieving this with the help of the Audit Module. Scilife users can easily leverage the Audit Module to record supplier audit information such as risk assessment and performance in their e-QMS.
Apart from this, the Audit Module is also useful to record internal audit findings for management review.
Conclusion
In a nutshell, Scilife empowers you with all the necessary infrastructure for establishing a fully compliant and streamlined electronic Quality Management System within your organization. The best part, our e-QMS is fully cloud-based and easy to use; requiring no physical storage space, hardware or special workforce!
Curious about how Scilife Smart QMS for Medical Devices can boost your business?
