ISO 9001 & ISO 13485

ISO 13485 for medical device quality control having several similar nature with ISO 9001.

Today, we are looking at the differences and similarities between these two criteria, and if life sciences firms and associated services require both certificates. ISO 13485 is a quality system for the medical device industry and its effectively covers ISO 9001 with some additional requirements.

Is that comparing ISO 9001 and ISO 13485 is a valuable exercise. By understanding the differences between these two standards, you have to learn where device manufacturers need to raise the bar on quality.

Similarities between ISO 9001 and ISO 13485

ISO 9001 & ISO 13485 both are basically about precisely the exact same things- helping in businesses to create always safe, higher quality solutions.

• Risk- reduction: These two criteria highlights the need for associations to integrate risk into production and design.
• Plan-Do-Check-Act: They utilize the Plan-Do-Check-Act procedure strategy regardless of how the two criteria don’t share exactly the same structure.
• Client focus: ISO 9001 and ISO 13485 are constructed around ensuring customer expectations are met.
• QMS needs: Organizations will need effective procedures and resources such as document control, Employee training, Audits and Corrective Action.

ISO 13485 builds on the requirement of ISO 9001 by addressing the responsibility of the manufacturer for “maintaining the quality management system.”

• Include regulatory document with system documentation.
• The QMS includes a file for identifying product related documents.
• A master record device must specifically define QMS requirement.
• Changes to QMS documentation must be reviewed and approved by the original approving functions.
• Manufacturer is required to analyse data standards based on product and its requirements.

Differences between ISO 9001 and ISO 13485:

In a lot of ways they are alike, but there are important ways that they’re different.

• Aims and results: ISO 9001 requirements are skewed heavily towards ensuring client focus and satisfaction. ISO 13485 puts emphasis on medical devices for safety.
• Continuous focus: ISO 9001 currently requires producer to reveal constant improvement and on the other side, ISO 13485 just needs demonstrating effective implementation and maintenance of the grade system.
• Documentation: For ISO 13485’s documentation demands are a lot more extensive than people at ISO 9001.
• Regulatory compliance: ISO 13485 is closely connected to regulatory demands, particularly towards criticism handling, regulatory alarms, and post market surveillance.

What are the additional requirements in ISO 13485-:

Quality Management System

• Effectiveness of the QMS.
• QMS documentation changes musst be evaluated for their impact.
• Control and management of outsourced processes.
• Documented procedure for software validation.
• Documented procedure for software validation.
• Organization should maintain each medical device file.

Management Responsibility

• Ensure effectiveness of the QMS by the management commitment.
• Promote awareness of regulatory requirements.
• Management review for revised regulatory requirements.

Resource Management

• Requirements for work environment, including cleanliness of clothing, temporary work conditions, and product control.

Product Realization

• Risk management procedures is associated with product realization planning.
• Advisory notices added to customer communication center.
• Development and Design procedures need to be documented

Measurement, Analysis and Improvement

• Documented procedure required for a feedback system.
• Additional requirements of inspection of product.
• Feedback included in analysis of data.
• Including update of documents in the taken actions.
• Including investigation records.

For, ISO 9001 and ISO 13485 certification you can easily reach to one of the best ISO consultant for training, consultant, development, and certification provider, i.e. FINECERT.

Our presence is globally and waiting to serve you for your business to get ISO certified under standards. We will help you in every step until your business get certified. ISO 9001 certification in Saudi Arabia, Oman, Nigeria, Qatar, South Africa; ISO 13485 consultant in Saudi Arabia, Oman. Qatar, South Africa, Nigeria. For more ISO certification inquiries, you can write to us at contact@finecert.com or visit us at www.finecert.com.

How to choose the Right ISO consultant?

In the present competitive marketplace demand for quality services and products, so that deliver exceptional customer experience. Globally recognized as a quality first brand can be the key for achieving a competitive edge in today’s growing global marketplace. If you are considering certification, choosing the right ISO consultant is a critical decision that will shows how efficiently your certification process will take place.

In the process of ISO certification, your consultant plays a very important role in terms of providing solutions for problems you may not have even realized. Hence your consultant should have knowledge on the process to get certified.

Checklist for choosing the right ISO Consultant?

• Do they have the required knowledge and expertise on the specific standard you are looking to get certified to?
• What is their history within your industry? Can they provide you with client history within your industry?
• Do you trust this consultant and does your organizational culture match with this individual or consulting team?
• Does this consultant change their services to meet different requirements and unique challenges?
• Are they result-oriented and willing to outline specific KPI’s that will ensure your certification is a value-added process?
•     The cost of their services is fair for the benefits you will receive?

While considering your ISO consultant, it is important to look at the bigger picture. Consider the time involved with your consultant, your trust and confidence in their work, and the value you believe their work will have in improving your operations. This is a lengthy process depending on your current status with the standard you wish to be certified to, so choosing the best consultant for your specific needs will make your time and investment well worth it in the end if you choose the right consultant for your organization.

How It Will be Benefit your Company?

ISO certification currently exist in numerous areas of business and industry, from social responsibility and energy management to medical devices. It is important to have ISO Standards in place so that consistency is maintained at every step of the way. Each and every ISO certification has got separate criteria and standards and is always classified numerically.

There are numerous benefits of obtaining ISO certification, especially for the small business owners. One of the main benefits of getting ISO certification is that it can make your business more productive and enhance its overall efficiency. This can surely help you out when you are trying to beat the market competition. There are also substantial marketing benefits from ISO certification as you can earn the confidence of your customers and reassure them that you and your company always provide the finest quality standards.

Here are some other key advantages from an ISO certification that you will get:

·  All the systems and processes in your company are evaluated and standardized to ensure optimum quality.

·   It also becomes easier for you to explain them properly to your personnel.

·   Training all new employees becomes a lot easier.

·   It helps to ensure improved customer satisfaction

·   Any kind of problems or issues are detected more easy and quickly which allows the company to come up with improved solutions.

·   Better understanding of the various customer needs.

·  Better market image of your business.

·   The suppliers tend to work more like business partners.

·   Overall communication procedures are improved greatly.

·   Your employees can develop better and enhanced knowledge about your company.

·   Improved participation and teamwork by your employees.

In your business, having an ISO certification can help you to effectively define your objectives in a clear manner so that you can smoothly review them. The ISO certification can also improve communications. Additionally ISO can assist you to reduce your inventory by making use of better communication methods and regular follow ups.

Finecert ISO consultants offers world class ISO services as Training, Consulting, Certification, Implementation, in most of the countries.

• ISO 9001
• ISO 14001
•  ISO 22000
•  ISO 27001
•  ISO 45001

To know more about how you can get your organization ISO certified.Get in touch with us and get your business certified with our best efforts. We provides best ISO certification in many areas of the world. You can write us at contact@finecert.com or visit www.finecert.com.

ISO 9001 Certification in Saudi Arabia

Saudi Arabia one of the biggest countries in Middle East. ISO certification in Saudi Arabia is one of the most known and implemented certification across the country. To sustain in market in Today’s world, ISO certification in Riyadh and ISO certification in Jeddah has become very important for competition in the economy of this Country.

Saudi Arabia is home for every kind of industries like information technology, manufacturing, Oil and Gas, mining, schools, construction and many more.

Now, the interesting concept is What is ISO? And What it does?

ISO is International Organization for Standardization, This is one of the few globally recognized standard for publishing and revising organization, it’s non profitable and Non- governmental. Major work of this organization is to publish standard and to revise the standards according to the development across the globe. Started in 1947, and Today became so popular that it has more than 22000 standards with its name published by this organization. Every standard aims to improve organization and also the humanity and is available to the globe.

Today, ISO is so popular that ISO Certification services in Saudi has became one of the requirements from the govt. to get it to any business which is given by the government bodies. ISO has published standards to help almost every kind of business sector across the globe which are certifiable standards and a lot of companies have adopted these standards by implementing the practices in their activities to see their organization growth and also to achieve success.

Those who got ISO 9001 certification in Saudi Arabia will know how important it is and how it is recognized and used worldwide. It is important to have a quality management system(QMS).The ISO 9001certification in Riyadh is one of those international standards that provide certain requirements for a QMS and number of organization are taking benefits of having ISO 9001 certification to their organization.

Process- ISO Certification in Saudi Arabia

• The very first standard comes into mind when you think about the ISO is a quality management system, QMS is such a diversified standard, it can be fit into anykind of industries, irrespective of their size and nature. Major focus from this standard is customer satisfaction and improvement.
• Process is as simple as getting ISO certification in Saudi Arabia to help you with the highest standards in Saudi Arabia into your company by improving your policies and procedures and acting upon the requirements from the standards to make sure that will be hassle free environment to bring out the best in you.
• Then it will audited by the audit services in Saudi Arabia depending upon you will be certified for ISO in Saudi Arabia. We will make it simple and improve your effectiveness of the implementation without creating any interference to your running business.
• Safety and Health is one of the important aspects of any industry if they have to be successful in achieving what they want, ISO has also published standard on occupational health and safety management system which takes care of all the other requirements from the health and safety aspect in a company.

ISO consultancy services in Saudi will take care of all the requirements to help you get certified for ISO in Saudi Arabia.

ISO 9001:2015 certification- Benefits

If you are familiar with ISO 9001 standard you will know the ISO 9001:2015 benefits accrued from consent. Having ISO 9001 standard will boost performance and overall productivity.

• Suitable for both large and small organization.
• Better internal management
• Increase in efficiency, productivity and profit
• Less wastage
• Improved customer retention and acquisition
• Globally recognized
• Compatible with other ISO Standard.

Being an ISO Consulting firm in Saudi Arabia we will make sure that your business is not affected while implementing ISO certification into your organization.

There are few simple principle which Finecert follow to make sure that you comply with all the requirements of ISO in Saudi Arabia to help your company to be certified with minimal efforts and maximum output at the same time making sure that ISO cost in Saudi Arabia is within your allocated budget.

Still thinking on how to get ISO certification in Saudi Arabia? No need to worry, solution is get in touch with us and you can see yourself get certified within no time, there are multiple ways with which you can get connected with us- write us on contact@finecert.com or visit www.finecert.com.