ISO 13485 is a benchmark under the International Organization for Standardization. It came into existence in the year 2003. This benchmark symbolizes the prerequisites for an all-inclusive Quality Management System for the planning and manufacturing of healthcare equipments.
The ISO 13485 benchmark is a successor of the following benchmarks:
- EN 46001 (1997)
- EN 46002 (1997)
- ISO 13485 (which came into existence in 1996)
- ISO 13488 (released in 1996 as well)
The advantages of ISO 13485 are manifold including the following:
- Savings in overhead costs
- Better productivity
- Assured quality
- Better risk management
- Enhanced capability to comply with customer needs
How much time does it take for ISO 13485 certification?
The volume of time needed for accomplishing ISO 13485 certification differs considerably from one organization to another. It has been witnessed that among thousands of healthcare equipment manufacturers and in vitro diagnostics firms which have been carrying out their businesses for quite a number of years, most of them can attain ISO 13485 within a period of four to seven months provided they take the assistance of external advisors.
Naturally, there is a question why the procedure is too lengthy. The main cause behind this is that as soon as you’re ISO 13485 quality management system is in force, it is necessary for you that you produce formal documentation with the help of enforced methods that are going to be supported by documents at the time of your next registration audit under the supervision of an authorized agency. You can enforce an ISO 13485 quality management system within a period of 1-2 months. However, it will be quite hard for you to get the certification if you don’t have the auditable documents with you.
Factors which influence the time it requires to accomplish ISO 13485 Certification
The salient factors which influence the time required to accomplish this certification are as follows:
1) Allocation of resources – Having adequate domestic resources is important
2) Dedication of senior management – The senior management should give due importance to this certification
3) Size of the organization and complicated nature of the manufacturing procedure – If the size of the organization is too big and it has offices in different locations, and then it will take more time to accomplish the standard. In addition, it also takes time to attain if the manufacturing procedure of the organization is complicated in nature, for example sterilization business.
What are the stages of ISO 13485 Certification Process?
Normally, the stages of this certification process are as follows:
- Analysis, planning and commencement of the project
- Preparing records and enforcement
- Internal auditing
- Audit and system modification
What should you do to get ready for ISO 13485 certification?
Given below are four steps that you should adopt while you are applying for this certification:
- Distinguishing the fundamental ISO 13485 needs and in which manner they are relevant to your enterprise
- Set quality objectives and know how they can be assimilated with your business activities in the best possible manner
- Distinguishing the guidelines of the quality management system and devising and enforcing a completely recorded scheme
- Studying and choosing an authorized certification agency
Typically, ISO 13485 certificates are issued by authorized agencies in approximately six to eight weeks following a positive endorsement for issuing the credential.
Author bio: Sam Payn is a dedicated blog writer who constantly focuses on topics related to ISO and quality management systems.