1§ Name The name of the association shall be: SWEDISH ASSOCIATION OF REGULATED QUALITY ASSURANCE, abbreviated as SARQA
The association has no office, the address for taxation and banking purposes shall be updated as required and specified by the Chairman and Treasurer.
2§ Objectives SARQA is a non-profit Association.
The objectives for which the Association is established are:
- To evaluate and appraise the Quality Assurance aspects of regulations, guidelines and principles, related to the life science area. This includes all Quality Assurance aspects from development to commercial manufacturing of pharmaceuticals, biologicals, medical device products and cosmetics. Focus is given to the guidelines generally known as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) and other relevant quality standards.
- To be a forum for discussion and to promote and participate in meetings, congresses, and symposia, which allow exchange of information on the applications of Quality Assurance.
- To promote training and scientific methodology in Quality Assurance by advancing the professional competency of its members and to promote co-operative relations with allied organisations.
- To advance standards of the Quality Assurance profession.
- To co-ordinate comments on Quality Assurance matters and direct these comments to appropriate authorities.
3§ Membership Membership is open to any professional working with /or interested in Quality Assurance within the life science segment.
A written application for membership should be submitted to the Board via email or automated application on the SARQA website. An annual membership fee applies. Membership continues as long as the annual membership fee is paid.
All members who have paid the annual membership fee are eligible for election to the Board; to any other position; to vote on election of officers and to vote on any issue for resolution put to the members.
Resignation of membership shall be by letter to the Treasurer of the Board. The membership fee will not be refunded.
Membership of the Association is personal and is not transferable. Company Memberships are not offered.
Members who have made large contributions to the Association can be elected as honorary, lifetime members. Honorary members have the same rights as ordinary members but are not required to pay the membership fee. Honorary members will be nominated by the Board and elected at an Annual General Meeting. Honorary membership continues indefinitely as long as the honorary member chooses to continue.
A register of members is maintained by the Board.
4§ Organisation The work within the Association will be executed by:
- the Annual General Meeting (AGM) which is the highest decision-making body
- the Extra Ordinary Meeting (EOM)
- the Board
- any committee or ”ad hoc group” established by the Board or AGM
5§ Annual General Meeting (AGM) The Annual General Meeting (AGM) of the Association will be held each year, for the purpose of electing members of the Board, for receiving the reports of Chairman, Secretary and Treasurer and for discussion of matters put forward by members of the Association or the Board.
Members shall be notified of the date of the AGM at least two months in advance.
The Secretary must be informed of all matters for discussion at least six weeks prior to the AGM so that they can be placed on the agenda. The Secretary will ensure that the agenda, the annual report and the proposals from the nominating committee are circulated to all members at least two weeks prior to the AGM.
The AGM will be held before end of April and at a place determined by the Board.
The agenda of the AGM shall always contain the following items:
- Has the AGM been announced correctly?
- Approval of the agenda
- Appoint a Chairman and Secretary for the AGM
- Appoint two AGM member attendees to check the Minutes
- The Annual Report of the Board
- The Treasurer’s Report (including financial statement)
- The Auditors’ Report and Conclusion
- Acceptance of the Annual Report and approval of the financial statement (for the resigning Board)
- Presentation and approval of the budget for the coming year
- Approval of the annual membership fee for the next membership year.
- Election of required Board members (deputy Chairman, Secretary, Treasurer and Ordinary Members).
- Election of two Auditors and a Deputy Auditor
- Election of a nominating committee
- Election of an archive responsible person (when applicable)
- Other topics (any other business)
- Discussion and approval of the program for the next year
6§ Extra Ordinary Meeting (EOM) An Extra Ordinary Meeting (EOM) may be called by the Board or 25 % of the members.
Members shall be notified of the date and reason for an EOM at least one month prior to an EOM. The agenda must be circulated to all members at least two weeks prior to the extra ordinary meeting by the Secretary.
The agenda of the EOM shall always contain items numbers 1-4 from the AGM agenda.
7§ The Board The Association will be administrated by a Board consisting of a Chairman, a deputy Chairman, the immediate-past Chairman, a Secretary, a Treasurer and at least two Ordinary Members.
The Chairman, the Treasurer and the immediate past-Chairman are independently authorized to sign for the Association with full financial responsibility and authority for all bank accounts held in the Association’s name.
The Chairman shall be elected for one year. Chairmanship is circulated in the following way. Deputy Chairman (year 1) becomes Chairman (year 2) and immediate-past Chairman (year 3).
Other board members will be elected for a period of two years, may be re-elected for one additional period and shall then leave all positions for one year before being available for re-election.
The Board shall execute the program approved during the AGM and propose a program for the next year in order to preserve continuity.
The Board shall appoint representatives to different associations and groups within the program.
The Board shall hold regular meetings and maintain Minutes for these meetings. The Secretary (or agreed deputy) shall keep meeting Minutes and circulate these minutes for approval.
In a situation where a Board Member cannot continue in their elected post and chooses to resign, the Board will approve a deputising of the responsibility of this Board Member. An EOM is required to allow another Board Member, other than the Chairman, Treasurer or immediate past-chairman to be granted financial responsibility and bank account authority. The Auditors and nominating committee will be informed of any resignation.
8§ Auditors Two Auditors and a Deputy Auditor will be elected by the members present at the AGM for a period of two years and may be re-elected.
9§ Nominating committee A nominating committee will consist of three persons. Two persons will be elected for a period of two years, and may be re-elected, by the members present at the AGM. The immediate-past Chairman will act as Chairman within this committee.
The nominating committee shall propose candidates for election to the Board, as auditors, nominating committee and an archive responsible person. As a guiding principle, the nominating committee have equal opportunity and endeavour to ensure that representation in the Board reflects the members in the Association.
10§ Finance The financial year of the Association will run from 1 January to 31 December. The audited accounts of the Association will be presented at the AGM. A membership fee paid by a new member during the last quarter of year 1 will cover the membership fee also for year 2 and will as such be part of year 2’s accounting and financial statement.
All members pay an annual membership fee set by the Board and approved at the AGM.
Invoices for annual membership fees will be issued by the Treasurer (or nominated board member) according to the decision by the AGM of the previous year. Memberships not renewed prior to 27 February of the year of activity will be deemed to have lapsed.
Receipts for paid membership fees can be issued by the Treasurer (or nominated board member) upon request.
11§ Accounts The Treasurer of the Association is responsible for the maintenance of financial accounts with respect to all money received and Association expenditure.
The Treasurer shall balance the books as soon as possible the year after the financial year and send the accounts for annual revision by the Auditors. The accounts and Minutes from all Board meetings held during the financial year shall be available to the Auditors before end of February the year after the financial year.
The Treasurer is responsible for submitting the tax declaration to the tax authorities as per taxation requirements for non-profit associations.
Should the Treasurer be prevented from executing any of their duties, another Board Member with financial authority (the Chairman or immediate past-Chairman) can act as a deputy. Treasurer deputy situations are decided among the Board and recorded in the Minutes of Board meetings.
12§ Archiving Documents, primarily from the Secretary and Treasurer, will be archived for the time required by law or by the decision of the Board when there is no legal requirement. The location of the Archive will be determined by the Board.
An archive responsible person will be elected at the AGM for a period of five years.
13§ Constitution Any clauses of the Constitution may be amended or cancelled and new clauses may be added by resolution passed at any AGM or EOM, provided that the proposal to make such an amendment, cancellation or addition has been submitted to the Secretary two months prior to such a Meeting.
14§ Reimbursement The Association reimburses Board members for all reasonable costs they incur in the execution of their duties. The Board shall approve reimbursements of all costs prior to payment. Reimbursement decisions shall appear in the Minutes of Board meetings.
The Association reimburses individuals for costs incurred in connection with execution of the program. Receipts are required as evidence of costs incurred.
15§ Dissolution If the Association is dissolved and there remains a net liability or deficit this will be discharged by equal contribution from all members of the Association at the time of dissolution. If the Association is dissolved and there remains a net surplus, this will be disbursed by equal distribution to all members of the Association at the time of dissolution.