Difference between ISO 9001 Certification and ISO 13485 Certification

What is ISO 9001 Certification?

ISO 9001 Certification is the Quality Management System for the organization to develop and enhance the quality in the process and procedure continually. It demonstrates the ability to meet customer requirements and needs by providing them high-quality products and services.


ISO 9001 Certification is the only standard with a powerful business improvement tool, providing the outline for managing framework and provide guidance to effectively accomplish the compliance of standard and regulatory requirements.

What is ISO 13485 Certification?

ISO 13485 Certification is the Quality Management for Medical Devices helps to bring out an effective solution to meet the comprehensive requirements for a QMS. This standard is to support medical devices to test the effectiveness of the system. It provides to build a level of confidence in the ability to provide the accurate result to its customers.

What is ISO 13485 dependent on?

The inquiry everybody is posing is the reason 13485:2016 is so not the same as 9001:2015 when 13485:2016 came out only a half year after 9001:2015 was delivered. Sadly, redresses on the ISO 13485:2003 consumed most of the day. The new form of ISO 13485 Certification was fit to be delivered in 2016 even though it depended on ISO 9001:2008. Thus, when ISO 9001:2015 was at last delivered with the new construction, 13485:2016 was additionally effectively prepared for discharge with the ISO 9001:2008 design. The ISO association chose to deliver 13485 with the old construction.


Also, Check —>> ISO 9001 Certification in Sri Lanka

ISO 9001 Certification versus ISO 13485 Certification – How are they comparative?

Other than these distinctions in the construction, there are likewise similarities between ISO 9001:2015 and ISO 13485:2016:


Risk-based methodology: Both norms accentuate the need to move toward both creation and business from a dangerous point of view and to settle on significant choices dependent on a dangerous investigation.


Process approach: Both guidelines utilize the Plan-Do-Check-Act (PDCA) measure approach.


Customer Focus: Both principles are worked around guaranteeing that client necessities are met.


Employee Competency: Both guidelines require an association to decide the capability of representatives so they can accomplish the work doled out to them as per administrative necessities.
In ISO 13485:2016, the maker should show consistency with administrative necessities in 58 spots. For correlation, in ISO 9001:2015 the term ”administrative prerequisites” is just referenced multiple times.

What are the extra necessities in ISO 13485 Certification?

After some data included the early on the area that fundamentally tailors the content to the clinical gadget industry, the first incorporations are in quite a while and definitions. There are 14 new terms utilized by the clinical gadget industry. The contrasts between makers, shippers, wholesalers, and terms, for example, clinical assessment and post-market reconnaissance are explicitly clarified.


Also, Check —>> ISO 13485 Certification in Sri Lanka


Recorded underneath are extra necessities for ISO 13485 Certification when contrasted with ISO 9001 Certification:


Condition 4 – Quality Management System

  • Actions needed to keep up adequacy of the QMS (area 4.1)
  • Changes to QMS documentation should be assessed for their effect and controlled (area 4.1.4)
  • Control and the board of reevaluated measures (segment 4.1.5)
  • Documented method for programming approval (segment 4.1.6)
  • Documentation necessities per guidelines (segment 4.2.1)
  • Quality manual, to incorporate the extent of the QMS and diagram of documentation utilized (segment 4.2.2)
  • Documented document for every clinical gadget kept up by the association (segment 4.2.3)
  • Document controls to survey and support preceding use; re-endorsement by an assigned capacity with relevant data and control of out of date report to incorporate in any event the lifetime of clinical gadget it relates to (or indicated by law) (segment 4.2.3)
  • Records kept up for at any rate the lifetime of the clinical gadget or as indicated by law (segment 4.2.4)

Condition 5 – Management Responsibility

  • Management obligation to guarantee the viability of the QMS (segment 5.1)
  • Management Rep to advance attention to administrative prerequisites (segment 5.5.2)
  • Management audit to incorporate a survey of overhauled administrative prerequisites (area 5.6.2) and yield to distinguish upgrades for QMS adequacy (segment 5.6.3)

Condition 6 – Resource Management
Requirements for the workplace, including tidiness of dress, brief work conditions, and polluted item controls (segment 6.4)
Condition 7 – Product Realization

  • Procedures for hazard the board related with item acknowledgment arranging (area 7.1)
  • Advisory sees added to client correspondence channels (segment 7.2.3)

Condition 8 – Measurement, Analysis, and Improvement

  • Documented method needed for a criticism framework to set up if the organization has met client necessities (area 8.2.1)
  • Additional necessities on observing and estimation of item incorporate distinguishing proof of the workforce performing assessments (segment 8.2.4)
  • Inclusion of the acknowledgment of a non-conformance just if administrative necessities are as yet met, and control and approval of revamping directions (area 8.3)
  • Feedback remembered for examination of information (segment 8.4)
  • The area on progress general prerequisites incorporates the adequacy of the QMS and record of client objections, including those not followed by restorative activities and warning when needed by public or local guidelines (segment 8.5.1)
  • Including update of reports in the activities made for restorative moves (segment 8.5.2)
  • Including records of examinations for restorative and preventive activities (area 8.5.2 and 8.5.3)
  • Including viability in the survey of remedial and preventive activities (area 8.5.2 and 8.5.3)

On the off chance that your association is at all engaged with the medical device industry, ISO 13485 Certification is the QMS standard you should take a gander at for extra prerequisites far over ISO 9001 Certification.

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