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Management system for systematic quality work (SOSFS 2011:9)

This is an English translation of the regulation. Please note that this is an unofficial translation. It is the Swedish version that is valid.

The Board’s administrative provisions and general advice are published in SOSFS.

  • The provisions are binding regulations.
  • The general advice includes recommendations on how a provision can or should be applied and do not exclude other ways of achieving the objectives set out in the provision.

Socialstyrelsen annually provides a list of valid provisions and general advice. 

SOSFS provisions and general guidelines on the management system for systematic quality work

as stablished on 28 June 2011.

Socialstyrelsen provides the following under section 14 of the Ordinance (1993:1090) on Support and Service for Persons with Certain Disabilities, and Chapter 8 Section 5 of the Social Services Ordinance (2001:937), Chapter 4 Sections 2 and 3 of the Ordinance (1985:796) with certain authorities for Socialstyrelsen to issue provisions etc., and Chapter 8 Section 5 first paragraph 1 and 4 and second paragraph of the Ordinance (2010:1369) on Patient Safety, and decides on the following general advice.

Chapter 1 Scope of application

Section 1 These provisions shall be applied in work with systematic and continuous development and quality assurance in activities under

1. Section 31 of the Health and Medical Services Act (1982:763),

2. Section 16 of the Dental Services Act (1985:125),

3. Section 6 of the Act (1993:387) concerning Support and Service for Persons with Certain Functional Impairments ( LSS), and

4. Chapter 3 Section 3 third paragraph of the Social Services Act (2001:453).

Section 2 The provisions shall also be applied in systematic patient safety work that care providers shall carry out under Chapter 3 of the Patient Safety Act (2010:659).

Chapter 2 Definitions

Section 1 In these provisions and general advice:

health care and medical services refer to

 

activities covered by the Health and Medical Services Act (1982:763), the Dental Services Act (1985:125) and the Act (2001:499) on the Circumcision of Boys, as well as activities in retail trade of pharmaceuticals under the Act on Trade in Pharmaceuticals (2009:366).

care providers refer to

 a state authority, county council and municipality in the case of such health and medical care that an authority, county council or municipality is responsible for, and other legal entity or individual entrepreneur who carries out health and medical care 

provider of social services refers to

1. social services’ social board or similar municipal board, in the case of such social services that the municipality is responsible for,
2. the National Board of Institutional Care, when an authority carries out social services, and
3. other legal entity or individual entrepreneur who carries out social service activities covered by the provision in Chapter 3 Section 3 third paragraph of the Social Services Act (2001:453). In such activities are included those carried out under the Act (1990:52) with Specific Provisions on the Care of Young Persons or under the Act (1988:870) on the Care of Drug Abusers in certain cases 

those who operate under Act concerning Support and Service for Persons with Certain Functional Impairments (LSS) refers to

1. municipal boards, in respect of such activities under the legislation on support and service to persons with certain functional impairments for which a municipality or county council is responsible, and
2. other legal person or individual entrepreneur who operates under legislation concerning support and service for persons with certain functional impairments 

Management system refers to

a system for determining principles for the management of operations 

process refers to 

a series of activities that promote a specific objective or an intended result 

quality refers to 

an activity meeting the requirements and objectives relating to activities in accordance with the laws and other provisions on health and medical care, social services, and support and service to certain persons with certain functional impairments and decisions issued by virtue of such provisions
For healthcare providers that only carry out activities covered by the Act (2001:499) on the Circumcision of Boys or the Act on trade in Pharmaceuticals (2009:366), these provisions and general advice refer to quality only inasmuch as an activity meets the requirements and objectives relating to activities under Chapter 3 of the Act on Patient Safety (2010:659) 

self-monitoring refers to

systematic monitoring and evaluation of own activities as well as verification that they are carried out according to the processes and procedures that are included in the activities’ management system 

 care injury refers to

suffering, physical or psychological injury or illness and death that could have been avoided if adequate measures had been taken during the patient’s contact with health and medical care 

 serious care injury

care injury that is permanent and not minor, or
1. that has lead to the patient having a significantly greater need for care or has died. 

Chapter 3 Responsibility for and the use of a management system

Section 1 A care provider or the provider of social services or activities under LSS shall be responsible for a management system for such activities. The management system shall be used to systematically and continuously develop and assure the quality of activities carried out.

Section 2 A care provider or the provider of social services or activities under LSS shall, with the support of the management system, plan, manage, monitor, follow up, evaluate, and improve such activities.

Section 3 A care provider or provider of social services or activities under LSS shall specify how the tasks that are included in the work to be effected through systematic and continuous development and quality assurance will be assigned within the overall activities.

Chapter 4 Basic structure of the management system

Section 1 A care provider or provider of social services or activities under LSS shall adapt the management system to the type and scope of its activities.

General advice

Standards, technical specifications and models of quality and operations development can provide support when a management system is being built up.


Processes and procedures

Section 2 A care provider or provider of social services or activities under LSS shall identify, describe and establish the processes in the activities that are necessary to assure the quality of such activities.

Section 3 Under section 2, a care provider or provider of social services or activities under LSS shall in each process

  1. identify the activities involved, and
  2. determine the order of such activities.

Section 4 A care provider or provider of social services or activities under LSS shall create and establish the processes that are necessary to assure the quality of such activities.

The procedures shall describe a specific approach to how activities will be performed, as well as specifying how the responsibility for their performance is allocated within the organisation.

Cooperation between social services and LSS

Section 5 Those who provide social services or activities under LSS shall identify the processes as in Section 2 in which cooperation is required to assure the quality of measures provided in the activities.

It must be clear from the processes and procedures how cooperation will carried out in their activities.

From the processes and procedures it must also be ensured that cooperation is made possible with other activities in social services or under LSS and with care providers, public authorities, associations and other organisations.

Health care and medical services

Section 6 The care provider shall identify the processes as defined in Section 2 where cooperation is needed to prevent patients from suffering from any care injury.

It must be clear from the processes and procedures how cooperation will carried out in their activities.

From the processes and procedures it must also be ensured that cooperation is made possible with other care providers and with activities in social services or under LSS and with public authorities.

Chapter 5 Systematic improvement work: Risk analysis

Section 1 The care provider or the provider of social services or activities under LSS shall continuously assess whether there is a risk that events could occur that could involve deficiencies in the quality of activities.

For each such event, the care provider or provider of social services or activities under LSS shall

  1. estimate the probability that the event will occur, and
  2. assess the negative consequences that could result from the event.

Self-monitoring

Section 2 A care provider or provider of social services or activities under LSS shall carry out self-monitoring

Self-monitoring shall be carried out as often and as much as is required for the care provider or the provider of social services or activities under LSS to be able to assure the quality of the activities.

General advice

Self-monitoring may include

  • comparisons of the results of the activities with data from the national and regional quality register, as in Chapter 7 of the Act on Patient Data (2008:355),
  • comparison of the results of the activities with data from open comparisons, as well with the results of other activities
  • comparison of the current results of the activities with earlier results,
  • target group surveys,
  • reviews of journals, files and other documentation,
  • examination of whether there are approaches and attitudes among the staff could lead to deficiencies in the quality of the activities,
  • analysis of data from patients’ councils, and
  • collection of viewpoints from auditors and stakeholders.

Investigation of deviations

Complaints and viewpoints

Section 3 A care provider or provider of social services or activities under LSS shall receive and investigate complaints and viewpoints on the quality of their activities from

  1. care and nursing recipients and their close family,
  2. personnel,
  3. care providers,
  4. providers of social services,
  5. those who carry out activities under LSS, authorities, and associations, other organisations and interested parties.

Reporting obligation

Section 4 Provisions on reporting obligation

  1. for health and medical care personnel are in Chapter 6 Section 4 of the Act on Patient Safety (2010:659),
  2. for those who carry out functions in the social services or the National Board of Institutional Care are found in Chapter 14 Section 3 of the Social Services Act (2001:453), and
  3. for those who carry out functions in activities under the legislation concerning support and service for persons with certain functional impairments is found in Section 24 b of LSS.

Section 5 Provisions on the obligation

  1. for care providers to investigate events in activities which have caused or could cause care injuries is found in Chapter 3 Section 3 of the Act on Patient Safety (2010:659),
  2. for the provider of social services to immediately document, investigate and correct or remove poor conditions or a substantial risk of poor conditions are in Chapter 14 Section 6 of the Social Services Act (2001:453), and
  3. for the provider of activities under LSS to immediately document, investigate and correct or remove poor conditions or a substantial risk of poor conditions are in Chapter 24e in LSS.

Summary and analysis
Section 6 Received reports, complaints and viewpoints are to be compiled and analysed so that care providers or providers of social services or activities under LSS can see patterns or trends that indicate deficiencies in the quality of such services.

Improvement measures in activities

Section 7 On the basis of the results of those activities listed in sections 1 to 6, measures necessary for ensuring the quality of operations shall be taken.

Improvement of processes and procedures

Section 8 If the results of the activities specified in sections 1 to 6 indicate that processes and procedures are not adequate for safeguarding the quality of activities, processes and procedures must be improved.

Chapter 6 Participation of personnel in quality work

Section 1 A care provider or the provider of social services or activities under LSS must ensure that its employees are working in accordance with the processes and procedures that are included in the management system.

Section 2 According to Chapter 6 Section 4 of the Act on Patient Safety (2010:659), health and medical personnel must contribute to maintaining high patient safety.

Section 3 Chapter 14 section 2 of the Social Services Act (2001:453) and Section 24 (a) LSS state that all parties that carry out functions within social services or activities under LSS are obliged to participate in quality work for their activities.

Chapter 7 Documentation obligation

Section 1 Work related to the systematic and continuous development and quality assurance of activities must be documented.

General advice

Care providers included under Chapter 1 Section 1 paragraphs 1 and 2 or parties that carry out social services or activities under LSS, should annually draw up a coherent quality report with full documentation, in which it should be stated

  • How the work with systematic and continuous development and quality assurance has been carried out during the previous calendar year,
  • what measures have been taken to assure the quality of the activities, and
  • what results have been achieved.

The report should have such a level of detail

  • that it is possible to assess how work with systematic and continuous development and quality assurance has been conducted in different aspects of the activities, and
  • that the information needs of external stakeholders have been satisfied. The report should be made available to anyone who wishes to read it.

Section 2 According to Chapter 3 Section 10 of the Act on Patient Safety (2010:659), the care provider must annually draw up a patient safety report by 1 March.

In addition to that stated in Chapter 3 Section10 of the Act on Patient Safety, the patient safety report shall contain information on how

  1. responsibility under Chapter 3 Section 9 of the Patient Safety Act has been allocated,
  2. patient safety through self-monitoring in accordance with Chapter 5 Section 2 has been followed up and evaluated,
  3. cooperation under Chapter 4 Section 6 has been enabled to prevent patients suffering from care injury
  4. risks of care injuries have been handled in accordance with Chapter 5,
  5. reports as under Chapter 6 Section 4 of the Patient Safety Act have been handled, and
  6. complaints and viewpoints received have been handled, in accordance with Chapter 5  Section 3 and which are of importance to patient safety.

The patient safety report must also indicate how many events were investigated in accordance with Chapter 3 paragraph 3 of the Patient Safety Act during the preceding calendar year and how many care injuries were assessed as serious.

Section 3 of the patient safety report must have such a level of detail

  1. that it is possible to judge how systematic patient safety work has been carried out in the different aspects of activities, and
  2. that the information needs of external stakeholders have been satisfied.

Chapter 8 Exemption provision

Section 1 Socialstyrelsen may grant exemption for certain activities from one or more of the provisions in Chapters 3 – 7, if there are special grounds.


1. This provision enters into force on 1 January 2012.

2. Through the provision, the following are abrogated:

– The provisions of Socialstyrelsen (SOSFS 2005:12) concerning the management system for quality and patient safety in health and medical care
– The Swedish provisions and general advice of Socialstyrelsen (SOSFS 2006:11) on quality management systems in activities under the Social Services Act (SoL), the Act on Care of the Young (LVU), the Act on Care of Drug and Alcohol Abusers (LVM) and the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS).