STANDARD OPERATING PROCEDURE

300.30.2

STANDARD OPERATING PROCEDURE
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PURPOSE

To describe the elements of the quality system in accordance with clause 4.2 of ISO†9001 and the corresponding clauses of international standard ISO†9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors to understand and implement management responsibilities described in the procedure. The ISO†9000 systems coordinator (management representa­tive) is responsible for SOP compliance.

PROCEDURE

The company has established and maintained the following documented quality system as a means of ensuring that the product/services conform to specified requirements of this international standard.

QUALITY SYSTEMs

1. Top management is committed to the development and implemen­tation of the quality management system and to continually improv­ing its effectiveness by:

Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements

Establishing the quality policy

Ensuring that quality objectives are established

Conducting management reviews and ensuring the availability of resources

STANDARD OPERATING PROCEDURE
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The quality objectives, including those needed to meet require­ments for the product, are established at relevant functions and levels within the organization. The quality objectives are measur­able and consistent with the q 22322c223w uality policy.

The key quality management system documentation includes:

Documented statements of the quality policy and quality objectives

A quality manual

Documented procedures required by this international standard

Documents needed by the organization to ensure the effective planning, operation, and control of its processes

Quality records required by this international standard

The distribution of quality management system documentation is controlled. The documented quality management system gives due consideration to the following elements:

All resources and skills needed to achieve the required quality

The compatibility of procedures and applicable documentation

Updating of verification techniques and equipment

Identification and development of measurement requirements that exceed present capabilities

Verification during product development

Defining levels of acceptable quality, including subjective standards

Identification, preparation, and retention of quality records

Identifying the processes needed for the quality management system and their application throughout the organization

Determination of the sequence and interaction of these processes

Determination of criteria and methods needed to ensure that both the operation and control of these processes are effective

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Ensuring the availability of resources and information necessary to support the operation and monitoring of these processes

Monitoring, measurement, and analysis of these processes and implementation of actions necessary to achieve planned results and continual improvement of these processes.

The quality manual outlines the structure of the quality manage­ment system and reference procedures.

The contents of the quality manual include:

The scope of the quality management system, including details of and justification for any exclusions

The documented procedures established for the quality man­agement system or reference to them

A description of the interaction between the processes of the quality management system

The contents of the quality management system documentation differ from one department to another due to:

The size of the department and type of activities

The complexity of processes and their interactions

The competence of personnel

The procedures/work instructions are documented, describing all quality-related activities and authorities (provide details in a sepa­rate work instruction manual).

The processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, and measurement.

Concerning the outsourced processes that affect product conformity with requirements, the organization ensures their control and iden­tification within the quality management system.

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The documentation is maintained both in hardware and software form as appropriate to the company’s operations.

Personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience.

The planning of the quality management system is carried out in order to meet the quality objectives, maintain the system integrity when changes to the quality management system are planned and implemented, and develop the processes needed for product real­ization. Planning of product realization is consistent with the require­ments of the other processes of the quality management system.

In planning product realization, the organization determines the following, as appropriate:

Quality objectives and requirements for the product

The need to establish processes and documents and provide resources specific to the product

Required verification, validation, monitoring, inspection, and test activities specific to fulfill the product requirements

Records needed to provide evidence that the realization pro­cesses and resulting product fulfill requirements

Quality plans are prepared in accordance with the requirements of the standard where applicable (provide details).

The output of this planning is maintained in a suitable form according to the organization’s method of operations.

The responsibilities and authorities are defined in the following quality matrix in Table 1, based on the ISO†9001, ISO†9002, and ISO†9003 series of standards with a corresponding clause of inter­national standard ISO†9001:2000. Amend the matrix to suit your company’s operations.

STANDARD OPERATING PROCEDURE
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RESPONSIBILITIES AND AUTHORITY IN THE QUALITY SYSTEM

The quality planning matrix is described in Table 1

.

STANDARD OPERATING PROCEDURE
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DOCUMENTATION

Quality manual

Standard operating procedures/training records

Work instructions manual/training records

Training manual/training records

Equipment manual/training records

REASONS FOR REVISION

mm-dd-yy1) First time issued for (your company name).

STANDARD OPERATING PROCEDURE
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STANDARD OPERATING PROCEDURE
YOUR COMPANY NAME HERE