ISO 13485 Certification in Bangladesh

ISO 13485 Certification in Bangladesh post will help you to know who needs this certificate, cost of the certificate and how to obtain this iso 13485:2016 certificate.

ISO 13485 is the certificate for medical device manufacturers. Who wants to develop the quality of the medical devices including face mask, surgical mask, gown as well as other PPE they need this standard. If you have this certificate you can export your medical items to many countries.

To export your mask or other medical PPE in EU market CE mark is necessary. But due to lack of lab test facility in Bangladesh it is difficult to obtain CE marking certificate from notified body of EU. Considering this problem obtaining ISO 13485 certificate is easier and cost savvy.

To know the cost and procedure you may call 01742125232 for ISO 13485 Certification in Bangladesh.

ISO 27001 Certification Bangladesh

ISO 27001 Certification is the standard for information security management. The company who is concerned about his information or data may be interested to adopt ISO 27001 certification. Usually IT firm, bank, insurance company ecommerce sites, outsourcing company or any type of financial organizations need this standard.

Now online hacking and stealing data is very common problem around the world. So, each financial organization is in great risk to save itself from online robbery. Any time data can be stolen and financially you can be looser. So, there is no reason waiting to adopt ISO 27001 Certification.

With this ISMS standard a company can demonstrate to its existing and potential customers, suppliers and shareholders the integrity of its data and systems and commitment to information security. It helps to get new business opportunities with security-conscious customers.

CALL 017421252 FOR QUOTE OF 27001

Some regular jobs are done like monitoring online server activities, keeping record, analysing those record and taking corrective action against any incident (if) and that are the regular practice according to the ISMS Standard requirements.

Taking certification from AAS on ISO/IEC 27001 information security certification means better-performing processes, increasingly skillful talent and more sustainable customer relationships. AAS has already certified several financial and IT firms in Bangladesh successfully including Uttara Bank Ltd.

iso 27001 certification

AAS has most experienced ISO/IEC 27001 Lead Auditor. Not only that 27001 Lead implementer list are also available from AAS to implement 27K guidelines properly before certification to 27001:2013 standard. AAS has certified many organizations including Uttara Bank, CDBL.

CALL 01742125232 TO GET CERTIFIED ON 27001

27001 Standard should be implemented strictly before going to certification. If it is not implemented properly then there will be a possible risk in your system. So, hiring a skilled lead implementer is your first job before ISMS Certification.

The iso 27001:2013 standard can improve employee ethics and strengthen the nature of confidentiality throughout the workplace. It also allows you to enforce information security and reduce the possible accident, risk of hack, cheat, fraud, information loss and disclosure.

Finding an expert ISO 27001 lead implementer who have been working in this industry is a tough job. You can rest on AAS to find your right 27001 consultant to develop your processes before moving to 27K certification. To connect with AAS you may go this page or to know the required documents you may visit required documents for ISO 27001 certification Bangladesh

Context of the organization

It is the fourth clause of ISO 9001:2015 standard. Context means circumstances or condition of the company. So, in this clause details idea of the company should be clarified including what kind of product or services it provides, what are the necessary processes what are the external and internal issues, who are the interested parties what is the scope of the quality management system etc should be mentioned clearly before proceed to certification to ISO 9001:2015.

There are four sub clauses of this principal clause number 4. They are: 4.1 Understanding the organization and its context , 4.2 Understanding the needs and expectations of interested parties, 4.3 Determining the scope of the quality management system, 4.4 Quality management system and its processes

4.1: Understanding the organization and its context : The organization shall determine, regularly monitor & review the external and internal issues. External issues are legal, technological, competitive, market, cultural, social and economic environments, whether international, national etc. Internal issues are organizational values, culture, knowledge, and performance.

4.2: Understanding the needs and expectations of interested parties: Two things are mentioned in this sub clause. That are: determine the interested parties and assess the requirements of those parties which are relevant to its QMS. It can vary company to company. However the common interested parties are: customers, owners, employees, providers, bankers, regulators, unions, partners, community, news media, competitors, law enforcement, emergency responders etc.

4.3: Determining the scope of the quality management system: It is one of the required and mandatory requirements for company and it shall be maintained as documented information. Scope determining time the following things should be considered: a) external and internal issues (see 4.1); b) requirements of relevant interested parties (see 4.2); c) products and services of organization. The organization shall apply all the requirements of this QMS standard 9001:2015. However, provide logical justification if any clause is not applicable in scope of quality management system.

4.4: Quality management system and its processes: Determining the processes and showing their interactions among the processes is mandatory for effective implementation of the qms in the organization. In the processes following things should be included: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. Documented information and retain documented information for the processes is also necessary. During the audit these documented information and retain documented information will be reviewed by the auditor. Go to read about ISO 9001 Clause number 5 

Scope

The first clause of ISO 9001 2015 is scope. Two things have been told in this clause. One is which kind of company needs this quality management system standard and why it is need? If we say who needs then the answer is any kind and any size of organization can adopt this standard

If we go why needs then two answers will come there first of all: If any company wants to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and secondly if any organization wants to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

In the clause 2 and 3 there is references of ISO 9000:2015 for normative reference, terms and definitions. So, there is no more to learn from those two clauses. However to know more about clause number 4 you may visit this post

9001:2015 Clauses

There is 10 major clauses in ISO 9001:2015 Standard and there are many sub and sub sub clauses of those major clauses. Major clauses are mentioned in below:

  • Scope
  • Normative References
  • Terms and Definitions
  • Context of the Organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement