Difference
between ISO 13485 and ISO 9001 are -
The
type of Product or Services-: Being a medical service industry, one is supposed
to implement very stringent controls on the specification of the products and
the raw materials used to manufacture the final product. This is the point
where ISO 13485 dominates ISO 9001. The specific clauses of ISO 13485 where it
overshadows ISO 9001 are Terminology of medical device industry, Training of
staff members, work environment protection by prevention and control of
contamination, Risk management control, Advisory notes communication, and
performance evaluation as per design and product validation, monitoring and
recording of product performance and non-conforming product.
Regulatory
Requirements-: For medical industries, the regulatory requirements are stricter
as compared to generic industries. ISO 9001 does not specify requirements for
the medical industry but ISO 13485 has complete quality management system for
the medical devices manufacturing industries and medical service providers.
Documentation
and its effective control-: A medical device manufacturing industry must have
an effective document control system which should have the documents including
General description, Specification of the product in detail, Manufacturing
processes, Installation processes and servicing processes. Quality manual
should be there with the QMS (Quality Management System). Job responsibilities
of the authorities must be mentioned, defined and communicated, all maintenance
activities that are carried out daily, weekly, monthly and annually, health and
cleanliness of the workers must be specified, records should be maintained of
every product’s batch sterilization, product conformity in documented form,
close communication channel with the customers must be established, complaints
recording and resolution must be done timely having corrective and preventive
actions specified for each complaint in documented form and its closure with
the agreement of the customer must be ensured at all costs. Thorough
traceability of marketed product must be ensured by documents and records.
Customer
Satisfaction-: ISO 9001 revolves around customer satisfaction no matter which
type of the business or products or services you offer to the customers in the
market.
Continual
Improvement Cycle-: ISO 9001 owns a continual improvement cycle and its
effective implementation while ISO 13485 requirements indicate to maintain the
effectiveness of continuous improvement in the management system. The
difference in approach between the two ISO standards will definitely make the
organizational structure slightly changed from each other.
Scope
of both ISO standards-: ISO 9001 is a way more different than ISO 13485
as ISO 9001 defines the quality requirement for generic industries while ISO
13485 specifies the requirements for the medical device industries. Being a
medical devices manufacturing industry, it is not only important to accomplish
customers’ satisfaction but it is equally important to meet legal requirements
and quality requirements are more stressed upon in ISO 13485 specifically in
medical device files, history recording, customer complaint handling, reporting,
product compliance, waste handling and regulating quality control.
Focus-:
The primary difference between ISO 9001 and ISO 13485 is their primary factor
to focus on. ISO 9001 is customer oriented and to make every effort to minimize
or eliminate the risks that can negatively effect on customer satisfaction. The
focus of ISO 13485 is majorly on laws and regulations that are enforced on
medical devices industries ensuring human safety.
Product
Realization-: ISO 13485 puts stress on the design and development of new and
existing products within product realization. ISO 9001 puts a strong emphasis
on operational cycles through which final product gets developed aiming to
develop peerless, unmatched and flawless quality product that pleases and
satisfies the customers and customers’ requirements making it easy to achieve
customers’ retention.
User questions & answers