ISO 9001 / 9002 INTERNATIONAL STANDARD

Clause 4.1 -MANAGEMENT RESPONSIBILITY

CLAUSE 4.1.1 - Quality Policy

To comply with this requirement you must have a written Quality Policy for the organization. This Quality Policy document should be signed by the Chief Executive of the organization, or else by the current senior management for the site in question. You must also ensure that the Quality Policy, its objectives and statement of intent are established and identified within the Quality Manual.

The following criteria must be fulfilled:

• Your Company must have a comprehensive Quality Policy, which must be applicable to the expectations of its Customers.
• This Quality Policy should ideally be included in the Quality Manual as well as being publically available (e.g.on display or accessible via a computer network, etc)
• the objective of the Quality Policy must have been determined and there should be 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, mission statements, training manuals, advertising literature, etc. must be consistent with the Quality Statement.

It is necessary for companies to clearly establish goals and appraise the needs and expectations of customers. As the goals will change and evolve these could be documented and expressed in a quality improvement plan which must be thoroughly examined at management reviews. (discussed below).

CLAUSE 4.1.2.1 - Organization : Responsibility and Authority

To satisfy this requirement you must ensure that:

• the Quality Manual contains an Organizational Chart, or refers to such a chart (e.g. defines a document number for the chart, etc).
• that the Chart is current, authorised and issued as a controlled document. (see section 4.5)
• the management function responsible for quality is clearly identified.
• the responsibilities and authorities of all key personnel are identified.
• it is recommended that you name the senior members of staff, although this is not compulsory.

CLAUSE 4.1.2.2 - 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 work which may affect the quality of the product or service have sufficient training and resources to allow them to carry out their duties.
• Training records should be maintained to provide evidence which demonstrates that suitable training has been provided. (see section 4.18)
• Training records are treated as Quality Records and managed as such.
• You should establish the division between the responsibility for the work and the responsibility for performing assessments. Until recently it was common for these 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. (see section 4.10)

CLAUSE 4.1.2.3 - Organization : Management Representative

The company must 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 within section 4.1.2.1 of the Quality Manual. (see above)

Note : The management representative must be a member of the management team. A formal mechanism must exist to enable the management representative to report to management on system, process or product failures with a view to continually improving the quality system.

CLAUSE 4.1.3 - Management Review

According to ISO 9000, the management of the Company are required to assess the suitability and effectiveness of the quality system, at regular intervals, so that they may identify areas where improvements can be made.

the following are generally-accepted methods of satisfying this requirement :

• all affected groups are represented at management review meetings.
• the review process is described in the relevant procedure.
• minutes of meetings are kept, to show what decisions were made and who was responsible for their implementation. These records should be treated as quality records and managed at such.
• reviews are held at regular intervals (at least once per year, preferably twice, but probably not more than four times per year).
• Evidence needs to be provided to demonstrate that reviews are planned, effective and that corrective action decisions are made and implemented.

Note : The review must determine whether the stated quality objectives have been achieved. This can only be done by stating the objective targets for quality system improvements within the Quality Manual and assessing if these have been achieved.