CENELEC
Project
| Reference | EN ISO 13485:2012 |
|---|---|
| Title | Medical devices - Quality management systems - Requirements for regulatory purposes |
| Project Number | 24011 |
| Abstract/Scope | SO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If 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 regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2012-02-17 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC), AIMD (90/385/EEC), IVD (98/79/EC) |
|---|---|
| Mandate(s) | M/023 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62A |
|---|---|
| Reference Document | ISO 13485:2003 (EQV) |
| ICS | |
| Keywords | |
| Note | Supersedes EN ISO 13485:2003 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
|
Clause
|
Categories - Aspects
|
Product Life Cycle
|
Information
|
|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2012-01-24 |
|---|---|
| date of Availability (DAV) (2) | 2012-02-17 |
| date of Announcement (DOA) (3) | - |
| date of Publication (DOP) (4) | - |
| date of Withdrawal (DOW) (5) | - |
Relations
| Supersedes | EN ISO 13485:2003 |
|---|---|
| Superseded by | |
| Normative reference (6) |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
