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ISO 13485 Certification In Saudi Arabia

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Saudi Arabia requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485 Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

Medical Devices

ISO 13485 Certification In Oman

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Oman requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

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ISO 13485 Certification In Iraq

with No Comment

 

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Iraq requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

 

Medical Devices

How To Get ISO 13485 Certification In Jordan

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Jordan requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

 

Medical Devices

How To Get ISO 13485 Certification In Lebanon

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Lebanon requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Oman with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP

Medical Devices

How To Get ISO 13485 Certification In Israel?

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Israel requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance To ISO 13485 Requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Israel with Qualitcert. Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

Medical Devices

How To Get ISO 13485 Certification In Italy

with No Comment

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Italy requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485:2016; Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Italy with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

5

ISO 13485 Certification Process And Its Cost?

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In the current marketplace many small and medium business owners feel that they cannot afford ISO certification. Unfortunately, this means that they miss out on the many financial benefits of achieving ISO 13485 certification. Kwalitycert aim to provide a cost-effective way for businesses improvement to get ISO certified. This is achieved by streamlining the overall process, allowing you to apply for and obtain your certification on-time, without any hassle. This means that you’ll start saving money from the very beginning of the process, which will continue as your business adopts the practices needed to maximize your resources.

The total cost of ISO 13485 certification in Kenya depends on various factors specific to each organization and involves the following factors:

  • Your industry sector
  • How many offices you have
  • Your annual turnover
  • How many employees you have
  • Single Site or multiple site
  • Intent/1st surveillance/2nd Surveillance
  • Recertification

Kenya is receiving more investments from Europe and America thus the requirement of the compliance is very high. New Certifications that Integrate with various standards like FSSC 22000 Certification, BRC Certification are in demand this can be achieved by having the most basic certification that is skeleton for all food safety certification – ISO 22000 Certification in Kenya. ISO Certification in Kenya can also benefit with ISO 22000 as HACCP Certification in Kenya is also included in Implementation.

Medical Devices

ISO 13485 Certification In Peru

with No Comment

“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.

ISO 13485 Certification incorporates 8-clauses, three of which give direction on the expected utilization of the standard. The staying five provisos give the system to what is required of associations committed to clinical gadget creation. In this way, this is what to expect so as to accomplish consistence.

6 steps to ISO 13485:2016 certification
Planning the quality system. S
Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
Implementing design controls.
Documents, records, and training.
Management processes.
The Certification audit.

Benefits of ISO 13485 Certification
Expansion in national and international market Access (Increase device sales by accessing more national and international markets.)
Meet and regularly monitor Regulatory Requirements
Gain a competitive edge
Reduced cost of sales
Improved performance

Integrated Services :
ISO 13485 can be integrated with ISO 9001
ISO 13485 can be integrated with ISO 14001
ISO 13485 can be integrated with ISO 45001
ISO 13485 can be integrated with ISO 27001
ISO 13485 can be integrated with CE Compliance and certification

Medical Devices

ISO 13485 Certification In Poland

with No Comment

“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.

ISO 13485 Certification incorporates 8-clauses, three of which give direction on the expected utilization of the standard. The staying five provisos give the system to what is required of associations committed to clinical gadget creation. In this way, this is what to expect so as to accomplish consistence.

6 steps to ISO 13485:2016 certification
Planning the quality system. S
Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
Implementing design controls.
Documents, records, and training.
Management processes.
The Certification audit.

Benefits of ISO 13485 Certification
Expansion in national and international market Access (Increase device sales by accessing more national and international markets.)
Meet and regularly monitor Regulatory Requirements
Gain a competitive edge
Reduced cost of sales
Improved performance

Integrated Services :
ISO 13485 can be integrated with ISO 9001
ISO 13485 can be integrated with ISO 14001
ISO 13485 can be integrated with ISO 45001
ISO 13485 can be integrated with ISO 27001
ISO 13485 can be integrated with CE Compliance and certification