Auditing of Quality Systems of Medical Device Manufacturers Part 1: General Requirements

12. Corrective action follow-up

Corrective action and related subsequent audits should be completed within a time period agreed between the manufacturer and the auditing organisation. The auditing organisation may request from the manufacturer follow up reports on the implementation and results of corrective action. Such reports should be reviewed by the auditing organisation and the review results communicated to the manufacturer.

Annex A

List of organisations represented on Study Group 4: Auditing.

Australia Therapeutic Goods Administration

Canada Health Canada

Europe European Commission DG III

Medical Devices Agency

Notified Bodies

(BSi, TÜV Product Service)

Technical Research Centre of Finland (VTT) (to January 1995)

Norwegian Board of Health (from June 1995)

European Industrial Federations:

(COCIR, EUCOMED, EUROM VI etc.)

Japan Ministry of Health and Welfare (MHW)

Japan Federation of Medical Devices Associations (JFMDA)

USA Food and Drug Administration

Health Industry Manufacturers Association

Annex B

List of references to the relevant regulations applicable to manufacturers of medical devices and which include compliance with quality system requirements.

Australia

Therapeutic Goods Act, 1989. This covers both product registration and manufacturing compliance.

Therapeutic Goods (Manufacturing Principles) as currently determined.

Canada

Food and Drugs Act, R.S. c F-27, s.1

Medical Devices Regulations, Schedule 1101, effective July 1st, 1998

Paragraphs 32(2)(f), (3)(f) and (4)(p) of the Medical Devices Regulations, concerning quality system requirements, come into force on July 1st, 2001.

Europe

COUNCIL DIRECTIVE 90/385/EEC of 20 June 1990 concerning active implantable medical devices.

COUNCIL DIRECTIVE 93/42/EEC of 14 JUNE 1993 concerning medical devices.

Japan

Quality Assurance Standard for Medical Devices

(28 December 1994: Yakuhatsu No. 1128)

Pharmaceutical Affairs Law

USA

Title 21 Code of Federal Regulations, Part 820.

Federal Food, Drug, and Cosmetic Act, Section 520 f(1) and Section 501 (h)

Annex C

Relevant auditing organisations responsible for enforcement of the regulations listed in Annex B

Australia

Therapeutic Goods Administration

Canada

The Therapeutic Products Programme of Health Canada has the final authority for enforcement of the Act and Regulations listed in Annex B. Compliance strategy for quality systems requirements, including regulatory audit strategy, is presently under development.

Europe

Regulatory audits are conducted by Notified Bodies designated by the Member States’ Competent Authorities under the Directives 90/385/EEC and 93/42/EEC. The Notified Bodies are listed in the Official Journal which is updated from time to time (e.g. OJC 172 of 15 June 1996)

Japan

The MHW takes the final responsibility for enforcement of the relevant law and regulations, and the prefectural governments implement the site audits of the medical device manufacturers.

USA

U.S. Food & Drug Administration

Annex D

Definitions of 'manufacturer' applicable to the regulations listed in Annex B.

Australia

“Manufacture”, in relation to therapeutic goods, means:

(a) to produce the goods; or

(b) to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.

“Manufacturing premises” means premises (including premises that comprise 2 or more sites):

(a) that are for use in the manufacture of a particular kind of therapeutic goods; and

(b) at which the same persons have control of the management of the production of the goods and the procedures for quality control.

Canada

'Manufacturer' of a medical device means a person who sells the medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Europe

Article 1: Definitions, scope: section (f)

`Manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

Japan

No definition of “manufacturer” exists but it can be interpreted as follows in accordance with the relevant definitions in the Pharmaceutical Affairs Law.

“Manufacturer” of medical devices means any person who industrially manufactures medical devices with a licence for manufacturing medical devices and any person who has not obtained the licence shall not industrially manufacture medical devices.

A license for manufacturing medical devices is issued by the prefectural governor under the final responsibility of the Minister of Health and Welfare and ensures that the manufacturer has the ability to manufacture the medical devices, whether the manufacturing facilities have sufficient structure or equipment, manufacturing and control procedures, and human resources to properly deal with the medical devices.

USA

Title 21 CFR Section 820.3 Definitions.

Subsection (o)

Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilisation, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Annex E

References

[1]	ISO 10011-1 : 1990, Guidelines for auditing quality systems - Part 1: Auditing
[2]	ISO 10011-2 : 1991, Guidelines for auditing quality systems - Part 2: Qualification criteria for quality system auditors
[3]	ISO 10011-3 : 1991, Guidelines for auditing quality systems - Part 3: Management of audit programmes
[4]	ISO 8402 : 1994, Quality management and quality assurance - Vocabulary
[5]	ISO 14011: 1996, Guidelines for Environmental Auditing – General principles

LIST OF SUPPLEMENTS

Number	Title	Study Group 4 Reference	Date
1	Audit language requirements	SG4(99)14	29/6/99