ISO 9002 INTERNATIONAL STANDARD
A BRIEF EXPLANATION OF THE TWENTY CLAUSES
Clause 4.1MANAGEMENT RESPONSIBILITYCLAUSE 4.1.1 "QUALITY POLICY"
To comply with this requirement there must be a written Quality Policy for the organization. This Quality Policy document must be signed by the currentmanagement for the location or site in question. It must also be ensured that the Quality Policy, the objectives and the statement of intent are established andidentified in the Quality Manual.
The following criteria must be fulfilled:
The company has a brief but comprehensive Quality Policy.This Quality Policy should be included in the Quality Manual as well as being on public display.Quality Objectives have been established by management and there is a statement outlining the intent to deliver against these objectives.
The company must ensure that:
The Quality Policy is communicated throughout the organization.All employees, at all levels, receive the same message from management. All statements relating to quality that are in documents, training manuals,advertising literature, etc. must be consistent with the Quality Statement.Any changes must be issued in a controlled manner and must be properly communicated to all employees.It is now necessary for companies to clearly establish goals and appraise the needs and expectations of customers. As the goals will change and evolve thesecould be documented and expressed in a quality improvement plan which must be thoroughly examined at management reviews. (discussed below).
CLAUSE 184.108.40.206 "ORGANIZATION: RESPONSIBILITY AND AUTHORITY"
To satisfy this requirement the company must ensure that:
The Quality Manual contains an Organizational Chart.The Organizational Chart is current, authorized and issued as a controlled document.The management function responsible for quality is clearly identified.The responsibilities and authority of the Quality function are clearly defined.Responsibility and authority under this clause have been extended to cover product processes and quality system non-conformances. This now places greater emphasis on internal quality system activities such as internal quality audits, corrective/preventative actions and management review.
CLAUSE 220.127.116.11 "ORGANIZATION: RESOURCES"
The company must ensure that:
Adequate resources are provided to allow the effective and efficient operation of the Quality Management system.All personnel involved in the verification of the quality of work have sufficient training and resources to allow them to carry out their duties.All operations involved in the verification of work are identified.Training records are maintained to provide evidence demonstrating that suitable training has been provided.Training records are treated as Quality Records and managed as such.Establish a clear division between the responsibility for the work and the responsibility for performing assessments. Until recently it was normal to have thesedifferent tasks carried by different groups reporting to different managers but there is no reason why self checking cannot be employed with the same person performing both roles but work must also be subjected to independent verification.Adequate training is provided to do both roles and keep the roles separate.
Resources required must be adequately identified in the quality system: for example Human Resources will be identified under clause 4.18 (Training) and Calibration under clause (4.11)
CLAUSE 18.104.22.168 "MANAGEMENT REPRESENTATIVE"
The company needs to ensure that:
A member of the management team is clearly identified as the person with responsibility for implementing and maintaining the requirements of ISO 9000.This authority is formally defined by some method such as job description, organizational chart or Quality Manual.
The management representative must be a member of the management team. A formal mechanism must exist to facilitate the management representative toreport to management on system, process or product failures with a view to continually improving the quality system. The standard suggests that theManagement Representative be the liaison person with external parties.
CLAUSE 4.1.3 "MANAGEMENT REVIEW"
According to ISO 9002 management are required to assess the suitability and effectiveness of the quality system, at regular intervals, so that they may identifyareas where improvements can be made.It is suggested that:All affected groups are represented at management review meetings.The review process is described in the Quality Manual.Minutes of meetings are kept, to show what decisions were made and who was responsible for their implementation.Reviews are held at regular intervals (at least once per year).Evidence needs to be provided for external auditors to demonstrate that reviews are planned, effective and that corrective action decisions are made andimplemented. It should be noted that the last section of this particular ISO 9002 requirement specifies that records of management reviews are required.Management review records should be treated as quality records and managed at such.
The review must now, in addition to assessing the continuing suitability and effectiveness of the system, determine whether the stated quality objectives havebeen achieved. This can only be done by agreeing objective targets for quality system improvements and assessing if these have been achieved