. 2012 Jun 3;17(4):190–199. doi: 10.1016/j.rpor.2012.05.001

Table 2.

Organizational standards.

Category	Standard
Documentation and records
QMS systemic documentation	1. The institution has put in place a QMS systemic documentation in line with national requirements, i.e. (a) quality book including: • QMS scope (e.g. radiotherapy), • quality policy, • quality plan(s), • quality objectives, • tools to measure achievement of objectives, • process map (description of basic and support processes being executed and relationships between them), • procedures, instructions and other systemic documents or references thereto; (b) general procedures including: • supervision over documentation, • supervision over records, • internal audits, • procedure for non-conformities, • corrective and preventive actions, • code of diagnostic, interventional or therapeutic procedure, applicable to a given organizational unit, developed in compliance with legal requirements, (c) handling instructions and user manuals of radiological equipment, (d) information concerning testing methods for internal controls of physical parameters of radiological equipment and accessory devices, (e) information concerning results of tests of internal controls of physical parameters of radiological equipment and accessory devices, and acceptance tests, (f) information concerning personnel qualifications and training, (g) description of methodology used for internal clinical audits, (h) information concerning results of internal clinical audits and any corrective or preventive measures, (i) information concerning interim reviews of quality management system, (j) standards for describing examination results and procedures applicable to the results and other documentation, 2. The institution shall develop and document individual record templates (forms, schedules, plans). 3. All systemic documents shall be up-dated, authorized and archived according to QMS requirements and national laws. 4. Out-of-date documents and records shall be withdrawn and destroyed. 5. Archival copies shall be held exclusively by Representative for QMS in Radiotherapy. 6. Systemic documentation shall be systematically reviewed, updated and improved (at least once a year). 7. Documentation updates shall be authorized, dated and numbered. 8. The institution shall hold annual management review schedules – management meetings. 9. Input data for management reviews include: • audit results, • patient satisfaction survey analyses, • process functioning and treatment effectiveness, • event and non-conformity reports, • corrective and preventive action status, • results of follow-up measures, • comments, conclusions, points for improvement.

Category

Standard

Documentation and records

QMS systemic documentation

1. The institution has put in place a QMS systemic documentation in line with national requirements, i.e.
(a) quality book including:
  • QMS scope (e.g. radiotherapy),
  • quality policy,
  • quality plan(s),
  • quality objectives,
  • tools to measure achievement of objectives,
  • process map (description of basic and support processes being executed and relationships between them),
  • procedures, instructions and other systemic documents or references thereto;
(b) general procedures including:
  • supervision over documentation,
  • supervision over records,
  • internal audits,
  • procedure for non-conformities,
  • corrective and preventive actions,
  • code of diagnostic, interventional or therapeutic procedure, applicable to a given organizational unit, developed in compliance with legal requirements,
(c) handling instructions and user manuals of radiological equipment,
(d) information concerning testing methods for internal controls of physical parameters of radiological equipment and accessory devices,
(e) information concerning results of tests of internal controls of physical parameters of radiological equipment and accessory devices, and acceptance tests,
(f) information concerning personnel qualifications and training,
(g) description of methodology used for internal clinical audits,
(h) information concerning results of internal clinical audits and any corrective or preventive measures,
(i) information concerning interim reviews of quality management system,
(j) standards for describing examination results and procedures applicable to the results and other documentation,
2. The institution shall develop and document individual record templates (forms, schedules, plans).
3. All systemic documents shall be up-dated, authorized and archived according to QMS requirements and national laws.
4. Out-of-date documents and records shall be withdrawn and destroyed.
5. Archival copies shall be held exclusively by Representative for QMS in Radiotherapy.
6. Systemic documentation shall be systematically reviewed, updated and improved (at least once a year).
7. Documentation updates shall be authorized, dated and numbered.
8. The institution shall hold annual management review schedules – management meetings.
9. Input data for management reviews include:
• audit results,
• patient satisfaction survey analyses,
• process functioning and treatment effectiveness,
• event and non-conformity reports,
• corrective and preventive action status,
• results of follow-up measures,
• comments, conclusions, points for improvement.