If your company is determined to implement a Quality Management System under the ISO 13485 “Sanitary Product”, ISO 13485 consultants can advise you. For ISO 9001 certification costs, contact ISO 9001 consultant.
Methodology of work as an ISO 13485 consultants’ standard
ISO certificationis specialized in the implementation of Quality Management Systems under the ISO 13485 Standard for importers, manufacturers and marketers of medical devices. ISO 13485 consultants offer the necessary advice to design, document, implement and maintain a Quality Management System, by Standard 13485, in importing companies, manufacturers or marketers of sanitary products.
As an ISO 13485 consultant, the following activities are included:
- Project presentation and data collection
- Preparation of the necessary Management System documentation
- Advice for the realization of Technical Instructions
- Training
- Implantation
- Internal Audit
- Review by Management
- Presentation of the Certification application
- On-site support during the certification audit
- If necessary, modifications to the System determined by the auditor
The first step as ISO 13485 consultants is to help the client define the scope of the ISO 13485 quality system to be certified.After defining this scope, the Consultant explains the Implementation of a Quality Management System under the ISO 13485 standard, thus initiating the Data Collection phase.
In this Data Collection Phase, the Consultant knows:
The characteristics of the company in terms of its organization,
- Methods
- Techniques, etc.
To capture in the documentation of the Quality Management System, the reality of the company that is reflected in the Quality Manual, General Procedures of the System and Technical Instructions.
The ISO 13485 consultants group develops the documentation of the System in full collaboration with the client:
Avoiding as much as possible bureaucratization and
Increasing its flexibility before any change due to modification of techniques, resources, etc
In this sense, the procedures that we consider necessary for the organization are elaborated and those required by the ISO 13485 Standard for medical devices.
Because the ISO 13485 Quality Management System must be tailored to each company, in parallel to the documentation development, the Consultant supports the company to implement the documented Organizational System.
We at ISO Certifications understands that, as a general rule, it is more convenient to prepare simple, easy and understood documentation for all company personnel than excessively complicated documentation that is impossible to understand and implement.
Once the documentation has been developed, the ISO 13485 Internal Audit is carried out by another consultant or ISO 9001 consultant other than the one who has carried out the development of the System to determine the degree of implementation achieved by the company and corrects deviations for the ISO 13485 standard that we detect.
Steps to be followed by the ISO 13485 Consultant before Certifying:
Before the visit of the Certifying Entity, after the internal Audit, the following must be carried out:
The first Review of the System by the Management will be guided by the consultant assigned to the project, who will prepare the corresponding minutes at the end of the project.
To finalize the project, ISO 13485 Consultants accompany the company’s managers, during the days of the Audit under the ISO 13485 Standard, by the Certifying Entity.
Likewise, ISO 13485 Consultants will advise the company on how to correct the different deviations that it may detect to obtain the Certification as soon as possible.
Benefits of hiring an ISO 13485 consultancy
An ISO 13485 consultancy can advise you during the project, reducing implementation times and guaranteeing the project’s success.
An ISO13485 consulting firm with sufficient experience will help you develop a Quality Management System fully adapted to your organization, avoiding bureaucratization.
An ISO 13485 standard consultancy can guide and escort you to get a quality certification and that the implementation of the System is an improvement for your organization.
How to select a suitable ISO 13485 consultancy for your project
To choose the ISO 13485 standard consultancy appropriate to your project, you must take into account the following aspects:
- Experience of the ISO 13485 Consultants in implementing ISO 13485 quality systems in organizations similar to yours
- References of the Certifying Entities about the consultancy
- Image of the consulting firm ISO 13485 (year of establishment, references, commercial department, etc.)
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