by Abdul Halim | Sep 29, 2019 | ISO Standard
ISO has published more than 19500(appr) standards. But all standards are not popular or adopted worldwide by the organizations as the following standards. Following ISO Standards are the most popular standards around the world:
- ISO 9001(Quality Management System Standard)
- ISO 14001(Environmental Management System Standard)
- ISO 27001(Information Security Management System Standard)
- ISO 22000(Food Safety Management System Standard)
- ISO 13485(Medical Devices -Quality Management System)
- ISO 50001(Energy Management System)
- ISO 2000-1(IT Service Management System)
- ISO 22301(Business Continuity Management System)
- ISO 39001(Road Traffic Safety Management System )
- ISO 28000(Supply Chain Security Management System)
Source: https://isotc.iso.org/livelink/livelink/fetch/-8853493/8853511/8853520/18808772/00._Overall_results_and_explanatory_note_on_2017_Survey_results.pdf?nodeid=19208898&vernum=-2
by Abdul Halim | Aug 28, 2019 | ISO Certification
The country who is industrially strong is adopting more ISO Certificates. This indicates ISO certification can help to maintain standard in your production line. So, worldwide industrialist countries are taking more and more ISO Certificate for their industries. Have a look the top ten countries who are holding the top ten position for ISO certification.
- China
- Italy
- Germany
- Japan
- India
- England
- Spain
- USA
- France
- Australia
Source: https://www.researchgate.net/figure/Top-10-countries-for-ISO-9001-certificates_tbl1_308751478
by Abdul Halim | Jul 30, 2019 | ISO 13485
ISO Certificate for medical device manufacturer in Bangladesh is available from AAS. To maintain quality for medical devices there is a standard which is ISO 13485. The latest version of this standard is 13485:2016. The first version of this standard was 13485:1996 and the second version was 13485:2003. Now all those two versions have been expired.
There is a good similarity between the two standards of ISO 9001 and ISO 13485. However, some differences are still there. Like ISO 9001 is focused on Continual improvement approach but ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
The second requirement is customer satisfaction for 9001 but 13485 does not require it.
For both the standards regulatory body’s requirement is must. In the USA FDA approval is must and for the EU market Medical Devices Directives 93/42/EEC is required. Many developing countries they do not have any specific guideline from their government end. In that case they can follow the above mentioned two guidelines.
6.4.2 Contamination control is mandatory for 13485:2016 but in 9001 there is no such clause. 5.2 indicates about the Cleanliness of product for 13485.
There is many similarities in both the standards like SOP, procedures, Design, preservation of products, identification of production process, corrective and preventive action, monitoring and measurement of equipment, calibration for the monitoring devices, Internal audit, data analysis etc are common for both the standards.
In Bangladesh there are many medical device manufacturers who are exporting those devices in abroad. They need certificate on ISO 13485 to export those products like face mask, medical face mask, gown, coverall, surgical face mask etc. AAS is the authorized channel partner of the certification body IQS Audits and ITCC International which are located in the UK. If you have this certificate you can export your products worldwide.
To get quotation in the shortest time you may contact this page
by Abdul Halim | Jun 29, 2019 | iso certification process
Apply for ISO Certification is very common question to new comers who are searching for ISO Certification for their organization. I hope this post will help them to get idea about iso certification process. This post is the common certification process for all ISO standards like 9001, 14001, 45001, 27001 etc. Following step by step process will show you how to apply for ISO Certification in Bangladesh:
- Find Certification body from Google
- Discuss with Certification Body about the process and cost
- Apply for Certification
- Make advance payment
- Prepare ISO guidelines
- Implement ISO guidelines
- Do Internal Audit
- Take CA Plan
- Invite CB to perform audit
- Wait for Certificate
If you have question to know more do not forget to post your question at the below of this post or simply visit this page to contact directly with certification body office in Bangladesh. You can send email from that page also to know about apply for ISO Certification.
by Abdul Halim | May 30, 2019 | ISO 14001
ISO 14001 certification for environment
ISO 14001 is environmental management system standard. It is a very effective tool to minimize environmental impacts from the aspects of a factory. Nowadays environment is in great risk. To save our environment this standard can help a company to minimize the environmental damages from various aspects.
Main ingredients of environment are land, air, sound, water, tress, animal, people etc. These major things are badly affected by the factories, power plants, vehicles and others.
Most of the factories do not care about the impacts from their aspects. Though there is local environmental rules and regulations but most of them are not applied properly in a factory. They are not also checked by the regulatory body sincerely. So, environment pollution is not protected well by local environment laws. Specially in developing countries it is neglected badly. In this case international organization for standardization (ISO) are contributing a lot by publishing the ISO 14001 standard.
Without proper implementation you cannot achieve ISO 14001 Certificate. Before obtaining this iso 14001 Certification you need to establish documents and implement all requirements of ISO 14001 :2015 throughout the organization. Then it is mandatory to attend in external audit. You will have to perform internal audit too regularly before and after certification body audit.
Even after obtaining certification you will have to attend in Surveillance audit regularly. Usually once in a year. During the audit NC, Observations and OFI may raised. Against any findings you will have to take corrective action which is mandatory. So, adopting ISO 14001 certification means you are committed to follow the EMS guidelines. If you do not follow those guidelines your certificate may be suspended.
So, adopting ISO 14001 certification is more effective rather than local environmental laws. It does not mean you will not take environment license from the local authority. Legal all certifications are mandatory to run an organization. Not only that during CB audit those legal things are checked by the 14001 auditor.
So, adopting local and international environmental standard 14001 standard can help to save our environment. In this regard both the government, industry owners, stake holders, donors, importers, international agencies,multinational corporations all can contribute to save our environment. ISO 14001 auditors have a great contribution too for proper implementation of EMS standard. Because they works directly with the organization.
Temperature of the environment is growing unexpectedly. In summer season it is very tough to stay outside. So, life is becoming more stressful and harder for common people who work in the open place. In this regard government, industrially developed countries and international agencies should come ahead to reduce temperature of the environment.
ISO 14001 can guide you how to reduce carbon emission level in the air, water pollution, power consumption control, minimization of sound pollution and air pollution etc.
Like other management system standards it has 10 clauses. Those are: Scope, Normative References, Terms and Definitions, Context of the organization, Leadership, Planning, Support, Operation, Performance Evaluation and Improvement. To read more you may visit this page.
If you are looking for ISO 14001 Certification for your organization then AAS can be your trusted partner to implement ISO 14001 guidelines in your organization. AAS has expert ISO 14001 auditors and consultants in Bangladesh. To adopt ISO 14001 standard in your factory or organization you may contact here
