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BOS ISO 13485:2016

P592.80

Medical devices — Quality management systems —Requirements for regulatory purposes

SKU: BOS ISO 13485:2016 Category: Product ID: 27620

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Description

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that
consistently meet customer and applicable regulatory requirements. Such organizations can be involved
in one or more stages of the life-cycle, including design and development, production, storage and
distribution, installation, or servicing of a medical device and design and development or provision of
associated activities (e.g. technical support). This International Standard can also be used by suppliers
or external parties that provide product, including quality management system-related services to such
organizations.
Requirements of this International Standard are applicable to organizations regardless of their size
and regardless of their type except where explicitly stated. Wherever requirements are specified as
applying to medical devices, the requirements apply equally to associated services as supplied by the
organization.
The processes required by this International Standard that are applicable to the organization, but
are not performed by the organization, are the responsibility of the organization and are accounted
for in the organization’s quality management system by monitoring, maintaining, and controlling the
processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can
be used as a justification for their exclusion from the quality management system. These regulatory
requirements can provide alternative approaches that are to be addressed in the quality management
system. It is the responsibility of the organization to ensure that claims of conformity to this
International Standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the
activities undertaken by the organization or the nature of the medical device for which the quality
management system is applied, the organization does not need to include such a requirement in its
quality management system. For any clause that is determined to be not applicable, the organization
records the justification as described in 4.2.2.

IMPARTIALITY AND CONFIDENTIALITY STATEMENT
The Botswana Bureau of Standards (BOBS) understands the importance of impartiality and confidentiality in carrying out its management system certification activities. BOBS management is committed to gaining and maintaining the reputation, credibility and ultimately, confidence of its stakeholders in rendering its certification services. Additionally, BOBS strives to continuously manage foreseen potential conflicts of duty and interest and ensures objectivity of its activities under the management system certification. To achieve the above, BOBS shall identify, analyse, record and manage potential conflict of duty and interest to ensure that certification services are not provided within relationships that have been identified to pose an unacceptable threat to impartiality. An Impartiality Committee shall periodically review activities of the certification function to verify commitment to credibility and fairness. The Committee shall further assist in the development of policies relating to impartiality of providing certification activities. BOBS is committed to maintaining in strict confidence all information accessed while rendering the certification services and shall ensure that such information is not divulged to third parties without the Client’s written consent unless if required by law.
Demand Quality

When things don't work as they should, it often means that standards are absent.

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