ISO13485:2016 is a management system used by companies, such as ours, producing medical equipment. Companies use ISO13485 to show that their standards and processes lead to the production of medical devices and equipment that consistently meets the needs of their clients.
We at Pro-Lab Diagnostics have been proudly certified since 2004, demonstrating a long term and reliable commitment to making sure our lab products are the best you can get.
Read on to find out more about how we use ISO1345 to provide you with better quality lab equipment.
ISO1345 Medical Devices is a quality management system used by companies designing and producing medical devices.
It allows us to demonstrate that we have thought about the processes we know will produce the best quality medical devices and lab equipment. We need to demonstrate that we have implemented and maintained those processes.
In our opinion, this is one of the most important standards. It helps to reduce the risk of undergoing medical procedures.
Imagine if there was no standard unifying the world on the production of safe medical equipment. It could compromise the safety of operations, the accuracy of test results, and the efficacy of treatments.
“ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.”Peter Linders, Chair of the ISO technical committee
We are audited annually to ensure we comply.
ISO13485 is an international standard. Medical device manufacturers all over the world use this to unify their design and manufacture of medical equipment.
The European Union Directives prefer this standard is met before devices can be supplied to EU countries.
It is also harmonised with several other standards, such as European medical device directives EN 46003:1999, EN ISO 13485:2000 and EN ISO 13488:2000.
Mexico has a standard used internally that is broadly in line with this standard, the NOM-241-SSA1-2012 Good Manufacturing Practices For Medical Devices.
It is often used in conjunction with ISO9001, a continuous improvement quality management system.
ISO9001 is a broad QMS standard that is implemented by companies all over the world in every sector imaginable.
ISO13485 applies solely to companies issuing, manufacturing and designing medical devices.
Unlike ISO9001, it has requirements for:
Iso13485 covers eight sections. One to three are introductory and covers the scope, T&Cs and normative references.
Section Four -Quality Management System.
Here it is quite like ISO9001 in that it talks about the documentation needed, how it should be controlled, the records that should be kept and how those records are regulated. A quality manual is also required.
Each process must be assessed to review how effectively the company set out, implement, and control it. We must also demonstrate we have analysed and measured the efficacy of the processes.
This section puts the responsibility of managing the processes and control on the management team. It sets out their responsibilities. Management must be included in:
Section six sets out the need for ensuring there is sufficient staff to carry out the processes. But more importantly that the staff have the appropriate level of skills, expertise, and qualifications needed to carry out the design and manufacturing of the medical devices.
We must demonstrate we have a recruitment and training process that enables us to be certain we are recruiting the best people to our team.
The infrastructure needs to be demonstrably sufficient. This includes the building, tech, and equipment.
The work environment needs to be sufficient to produce products that conform to the standards. This includes a safe, clean workplace that enables contamination control.
This stipulates that processes should be put in place to ensure any product is carefully planned out, that it will meet the requirements of the customer, and that risks have been controlled.
We need to create and disseminate the appropriate documentation to the end-user and specify the device outputs and inputs. We also need to verify and validate the product to show it has met the requirements.
This is a very large section because it covers not just the manufacture of medical devices, but also how they are bought, installed, serviced, cleaned, traced, and identified. We choose which clauses are most relevant to us.
Section eight specifies we need to:
a) demonstrate the conformity of the product;
b) ensure conformity of the quality management system;
c) maintain the effectiveness of the quality management system
It stipulates that we must gather customer feedback, have a complaints procedure, run internal audits, report to regulatory bodies, monitor the product and process and control non-conforming products. It ensures our QMS is fit for its purpose.
If you would like to learn more about how we adhere to ISO13485:2016 and other standards, please get in touch.
We are a friendly, family-like business based in the Wirral. We absolutely love talking to customers past, present and future.