ISO 13485 ISO 13485:2016 lists

ISO 13485:2016 lists the prerequisites for a quality management system for an organisation that

provides medical devices and related services and constantly demonstrates its eligibility to meet

customer and applicable regulatory requirement. The companies that areIso 13485:2016 certified

are involved in one or more of the stages like design and development, production, storage,

distribution, installation, servicing of medical design. This International Standard aims to allow global

alignment of suitable regulatory requirements for quality management systems applicable to

enterprises involved in one or more phases of a medical device's life cycle.

Suppliers or external parties who provide product, which includes QMS and related services can also

get ISO 13485:2016 certified. This global standard is mandatory in some countries.

The ISO 13485 is a process approach of quality management system. A process can be defined as any

action that accepts input and transforms it to output Frequently, the output of one operation

becomes the input to the next. The "process approach" refers to the implementation of a system of

processes within an organisation, as well as the identification and interactions of these processes,

and their management to create the intended outcome. When used as part of a quality

management system, this method emphasises the importance of:

a) comprehending and fulfilling requirements;

b) looking at processes from the standpoint of added value;

c) getting process performance results

The latest version ISO 13485 for ISO medical devices was developed on March 2016.Except when

otherwise stated, the requirements of ISO 13485:2016 apply to all companies, regardless of their

size or kind.

Audits can be carried out in three ways:

1. On-site audits take a full day to complete. The number of days required for an audit is

determined by various factors, including the organization's size, complexity, risk, and nature.

For registrars to calculate audit time, the International Accreditation Forum (IAF) has

established standards.

2. Web meetings, teleconferencing, and electronic process verification can all be used to

conduct remote audits. Remote audits are less prevalent and, in most cases, ineffective

compared to on-site audits.

3. Internal audits are not usually synonymous with self-audits. You can ask your customer to

perform a self-audit to eliminate the need for them to use their resources while still

providing some assurance that you are following criteria.

What changes did the current revision of ISO 13485 bring to auditing?

Several additional clauses have been added to the ISO 13485:2003 and 2016 standards. The auditor

will be expected to check that the company fulfil these standards and all of the other requirements.

This is why, as the company begins their road towards ISO 13485:2016 certification, the company

should do a gap analysis to identify any potential nonconformities that might be present in these

areas so that you may resolve them prior to your certification assessment.