17025 Tier 3 4.1 Organization

Question 1

4.1.2

Answer 1

It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this international Standard and to satisfy the needs of the customer, the regularitory authorities or organizations providing recognition

Question 2

4.1.3

Answer 2

The management system shall cover work carried out in the laboratory’s permanent facilities, at site away from its permanent facilities, or in associated temporary or mobile facilities

Question 3

4.1.4

Answer 3

If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest

Question 4

4.1.5

Answer 4

The laboratory Shall

See Tier 3 / 4.1.5

Question 5

4.1.6

Answer 5

Top Management Shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system

Question 6

4.2.1

Answer 6

The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programs, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.

Question 7

4.2.2

Answer 7

The laboratory’s management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following
Please see Tier 3 /. 4.2.2

Question 8

4.2.3

Answer 8

Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness

Question 9

4.2.4

Answer 9

Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements

Question 10

4.2.5

Answer 10

The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system

Question 11

4.2.6

Answer 11

The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this international Standard, shall be defined in the quality manual

Question 12

4.2.7

Answer 12

Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.

Question 13

4.3.1 General

Answer 13

The laboratory shall establish and maintain procedures to control all documents that form part of its management system ( internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals

Question 14

4.3.2

Answer 14

Document Approval and Issue

4.3.2.1 - All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue. A Master list for an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and be readily available to preclude the use of invalid and/or obsolete documents

Question 15

4.3.2.2

Answer 15

The procedure(s) adopted shall ensure that:
  A) authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed:
  B) documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements
  C) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use
  D) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked

Question 16

4.3.2.3

Answer 16

Management system documents generated by the laboratory shall be uniquely identified. Such identification shall include the date of issue and/or revision identification, page numbering, the total number of pages or mark to signify the end of the document, and the issuing authority(ies).

Question 17

4.3.3.1

Answer 17

Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval

Question 18

4.1.1

Answer 18

The laboratory or the organization of which it is part shall be an entity that can be held legally responsible