ISO 27001 Requirement

by | Nov 30, 2019 | iso 27001

ISO 27001 requirement post will help them who are looking for ISMS Certification for their organizations. Establishing document is a first and basic part for ISO 27001:2013 Certification. Take a short look from below to know the mandatory documents for ISMS Certification:

  • ISMS Scope
  • Information Security Policy
  • Information security Objectives
  • Risk Treatment Plan
  • Risk treatment methodology/process
  • Statement of applicability
  • Internal Audit
  • Management Review Meeting
  • NC Record
  • CA Plan
  • Competence evidence
  • Operational planning and control
  • Result of risk assessment
  • Result of risk treatment

Calibration and ISO Standards

by | Oct 30, 2019 | Calibration

Calibration and ISO standards post will help you about calibration requirements in ISO Standards for ISO Certification on various standards. Specially for management system standard ie ISO 9001; it is mandatory to do calibration.

ISO 9001:2015 Clause 7.1.5.2

Calibration for monitoring devices is very important to get accurate reading from the machine, equipment, tools and devices. In the clause 7.1.5.2 of ISO 9001 it is written about the calibration of monitoring devices or tools. Now it is a question which tools should be calibrated? Actually it depends on factory activities. However most common measuring tools like measurement tape, light box, slide caliper, micro meter, weight scale, digital weight scale, thermometer, moisture meter, hygrometer, beaker, cylinder, temperature gauge, volt meter, ampere meter, oscilloscope etc.

ISO 14001:2015 and 45001:2018 Clause 9.1 Monitoring and measurement

In Environmental Management System standard and in OH&S management system standard it is also told about calibration for  measurement devices Like Carbon emission level  measurement tool, PH meter, The organization shall establish, implement and maintain a procedure(s) to monitor and measure, on a regular basis, the key characteristics of its operations that can have a significant environmental impact. The procedure(s) shall include the documenting of information to monitor performance, applicable operational controls and conformity with the organization’s environmental objectives and targets.
The organization shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained and shall retain associated records

The organisation must ensure that monitoring and measurement equipment such as sampling pumps, noise monitors, toxic gas detection equipment, is calibrated or verified and that it is correctly used and maintained. It is told in ISO 45001:2018

Where from calibration can be done?

Calibration can be done from 17025 accredited lab. There are few accredited labs in Dhaka which are accredited by  NABL.  Only accredited lab can ensure that your device is OK. Only accredited lab can confirm that the reading of the device is accurate  They follow international guide line to calibrate your devices. Usually once in a year calibration should be done.

What you should know before calibration?

You should check if the lab has accreditation certificate to calibrate the specific item. There may some tricks about it. So, verify first if the calibration lab has approval to calibrate the device or equipment. And if the master device is calibrated from accreditation body.

To read in details you may visit https://www.aas-bd.com/blog/instrument-calibration.

Top ten ISO Standards

by | 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:

  1. ISO 9001(Quality Management System Standard)
  2. ISO 14001(Environmental Management System Standard)
  3. ISO 27001(Information Security Management System Standard)
  4. ISO 22000(Food Safety Management System Standard)
  5. ISO 13485(Medical Devices -Quality Management System)
  6. ISO 50001(Energy Management System)
  7. ISO 2000-1(IT Service Management System)
  8. ISO 22301(Business Continuity Management System)
  9. ISO 39001(Road Traffic Safety Management System )
  10. 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

Top ten iso certified countries

by | 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.

  1. China
  2. Italy
  3. Germany
  4. Japan
  5. India
  6. England
  7.  Spain
  8. USA
  9. France
  10. Australia

Source: https://www.researchgate.net/figure/Top-10-countries-for-ISO-9001-certificates_tbl1_308751478

ISO Certificate for Medical Device Manufacturer

by | 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