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ISO13485 Medical Devices (QMS)
Device and related services that consistently meet customer and applicable regulatory requirementsAdopting this standard is beneficial to the organization in many ways:Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.
ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices.All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization.Companies that achieve ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase products of consistent high quality.
ISO 13485 will benefit customers, suppliers, management, and especially workersRapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done. Continuous assessment, improvement, and re-registration of systems.
ISO 13485 certification is advantageous to medical device companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.
ISO 13485 compliant management systems adopt a risk management approach, which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.
Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace.
ISO9001 Quality Management System (QMS)
ISO 9001 standards main objective is to obtain quality management systems that will be of actual advantage to your organization to assist & manage your business successfully and put in place best practice tactic.
ISO 9001 certification will give your organization the quality systems that will provide the base to better customer satisfaction, staff motivation, and continual improvement.
The ISO 9001 certificate is suitable for all types and sizes of organization and is well recognized around the world as a very useful quality management system.
It is suitable for organisations in all business sectors and will help your organization to improve management processes to participate locally and/or globally.
The process encompasses the entire organizations and requires senior management buy-in; it is not just a function of the Quality Department.
To attain ISO 9001 certification your business needs to display that it can meet the regulatory requirements and submit an application to the system effectively to give genuine assistance to your customers.
The Results of Certification to ISO 9001
Well defined and documented procedures improve the regularity of productivity. Quality is constantly calculated. Procedures make sure corrective action is taken whenever failings arise. Deficiency rates reduce. Deficiency is trapped in advance and is corrected at alesser cost. Defining procedures identifies current practices that are outdated or incompetent. Documented procedures are easier for new workers to follow. Organizations preserve or increase market share, increasing sales or revenues.
Benefits of ISO 9001 Certification
A well designed and implemented QMS, based on ISO 9001 has been exposed to give organizations with the following benefits:
You'll know more quickly if things are going wrong, and where; you stop spending money or wasting time on the same old problems. Many problems will disappear because you know how to prevent them; if they do come up, you'll know how to fix them faster. Better management control and reporting - which means that you know how your business is doing. You will have fewer problems with failures in service or product quality. Youwill have reliable, repeatable processes and a general system. Your people know what toperform and how you want it done. You will have more business, because you can sell to new markets or having the support will distinguish you in the market.
ISO14001 Environment Management System (EMS)
ISO 14001 standards main objective is to obtain environment management systems that help organization to minimize how their processes negatively affect the organization.Compliance with applicable laws, regulations and all other environmental regulations and continually improvement in its operations and processes.
ISO 14001 and 9001 are similar to each other pertaining processes of quality management system of how a product is produced, rather than to the product itself. As with ISO 9001 certification is performed by third party organizations rather than beingawarded by ISO directly. ISO 14001 is known as a common management system standard, meaning that it is appropriate to any organization looking for to improve and manage assets more effectively. This includes: Single -site companies to large incorporated companies High-risk organizations to low-risk service organizations. Manufacturing, processing and the service industries, including local governments. All industry sectors including public and private sectors Original equipment manufacturers and their suppliers. BASIC PRINCIPLES AND METHODOLOGY: PLAN~DO~CHECK~ACT (PDCA-CYCLE)——BASED ON WELL IDENTIFIED PROCESS ※ Plan--establish objectives and processes required ※ Do-Implement the Processes ※ Check-Measure and monitor the process and report results ※ Act-Measure and Monitor the process and report results
ISO45001 Occupational Health Safety & Management System
ISO 45001 (Occupational Health Safety & Management System) Occupational Health Safety & Management System (OHSAS) ISO 45001   is an international specification of standards. ISO 45001is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organization to control occupational health and safety risks. It was developed in response to widespread demand for a recognized standard against which to be certified and assessed. Main areas that will be assessed by ISO 45001   standard ? Main areas that will be assessed by ISO 45001   standard? Management system in place Planning and risk assessment Staff awareness and training Safety management systems communication Awareness towards emergency preparedness Continual improvement and monitoring
ISO22301 Business Continuity Management System Certification

Overview of ISO22301 Business Continuity Management System Standard

The ISO22301 management system framework can help enterprises to formulate an integrated management process plan, enable enterprises to identify and analyze potential disasters, help them determine the threats to enterprise operations caused by possible shocks, and provide an effective management mechanism to prevent or offset these threats and reduce the losses caused by disasters to enterprises. The overall BCM plan must be managed by defining the scope, risk assessment, business continuity management strategy, business continuity objectives, development plans, education and training, exercises, testing, review and continuous improvement.

Benefits of ISO22301 certification

The ISO22301 inspection activities help improve business through planned and effective BCM at all levels, including:

1. Identify and understand key business processes and the impact of their interruptions within the organization.

2. Enhance the elasticity, resilience and sustainability of the organization.

3. It has the advantage of surpassing competitors with weak elasticity.

4. A positive message is conveyed to the media and stakeholders to deal with the crisis.

5. Improve the impression of insurance companies on organizational risk management, thereby reducing premiums.

6. Meet the expectations of regulators, insurance companies, business partners and other major stakeholders.

7. Significantly reduce the financial impact in the event of an accident, damage or even disaster.

8. Increase the survival opportunities of both the organization and employees.

9. Maintain or even enhance reputation by demonstrating a professional approach to managing disruption.

10. If the contract or agreement promises to deal with events and business interruption in a timely and orderly manner at an acceptable pre-defined level to ensure continuous business operation.

11. Encourage cross team and cross organization coordination.

12. Demonstrate credible responsiveness through scenario drills.

13. Demonstrate the management commitment of overall risk management with visible evidence.

ISO27001 Certification

Information Security Management System

ISMS (Information Security Management System) is a set of policies related to IT relatedrisks or information security management system.

The information security management system helps us manage the information assets of the organization's IT department according to the following requirements:

International standard ISO 27001. Provide us with a very safe data management structure and its hazards?

Information is a very important asset of any organization. Like other important businessassets, information is valuable to the organization, so it needs to be properly protected. ISMS is a very important part of the entire management system. Based on the business risk approach, it operates, establishes, implements, monitors, reviews, maintains and improves the information security management system. It always follows the PDCA cycle.

Design, evaluate, and select appropriate control requirements plans.

Implement and operate A to control the execution of the call.

Check and evaluate performance call checks.

Changes made to peak performance calls take effect.

Advantages of ISO/IEC 27001 ISMS (Information Security Management System)

An independent framework that takes into account all legal and regulatory requirements.

Be able to prove and independently guarantee internal organizational control.

Senior management's commitment to customer and business information security.

Gain competitive advantage in the organization.

Formalization, namely independent verification, is a process, procedure and document.

Help identify and meet contractual and regulatory requirements.

Demonstrate to customers that their information security is being taken seriously.

ASCP Services is an ISO13485, 9001, 14001, 45001, 22301, 27001 certification body approved by the Certification and Accreditation Administration of the People's Republic of China. Approval No.: CNCA-R-2020-723.
Daisy  创意中心总监 / 架构师
Sample of management system certificate(1)

Sample of management system certificate(1)

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ISO9001
ISO9001
ISO14001
ISO14001
ISO45001
ISO45001
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