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PCT International Search and Preliminary Examination Guidelines


Chapter 21 Common Quality Framework for International Search and Preliminary Examination

7. Documentation

21.22  The QMS of each Authority needs to be clearly described and implemented so that all processes in the Authority and the resulting products and services can be monitored, controlled, and checked for conformity.

21.23  Therefore the Authority shall provide a reference for its staff and management, which documents all the procedures and processes affecting the quality of work, such as classification, search, examination and related administrative work. In the reference it is to be indicated where instructions on the procedures to be followed may be found.

21.24  The following list indicates the items which are considered to be the type of content which should be documented:

(i) the quality policy of the Authority including a clear statement of commitment to the QMS from top management;

(ii) the scope of the QMS, including details of and justification for any exclusions;

(iii) the organizational structure of the Authority and the responsibilities of each of its departments;

(iv) the documented processes carried out in the Authority such as receipt of incoming applications, classification, distribution, search, examination, publication and support processes, and procedures established for the QMS, or references to them;

(v) the resources available for carrying out the processes and implementing the procedures; and

(vi) a description of the interaction between the processes and the procedures of the QMS.

21.25 The following list indicates the types of records that each Authority should maintain:

(i) a definition of which documents are kept and where they are kept

(ii) results of management review;

(iii) training, skills and experience of personnel;

(iv) evidence of conformity of processes, resulting products and services in terms of quality standards;

(v) results of reviews of requirements relating to products;

(vi) the search and examination processes carried out on each application;

(vii) data allowing individual work to be tracked and traced;

(viii) records of QMS audits;

(ix) actions taken re. non-conforming product, e.g. examples of corrections;

(x) actions taken re. corrective action;

(xi) actions taken re. preventative action; and

(xii) search process documentation as set out in Section 7.