ISO 9001 Lead Auditor Training

MODULE 2 - ISO 9001 QMS Documentation

2.3 ISO 9001 Quality Planning
Quality planning is an integral part of the quality management system. It is performed for the activities and resources necessary to satisfy the quality policy and objectives (see sub-module 1.2).

Quality planning considers:
• Customer needs and expectations
• Resources and competencies
• Design and operation compatibility
• Lessons from prior experiences
• Verification and validation activities
• Measuring and monitoring devices
• Acceptance criteria and records
• Product and process performance
• Opportunities for improvement
• Risk assessment and mitigation

Quality planning should be done in conjunction with the review of requirements related to the product, and through all phases of designing and producing a new product or service. Quality planning may reference existing controls, procedures, processes, and criteria. The output of quality planning is a quality plan, which may exist in many forms such as planning minutes or a completed planning checklist. Evidence of quality planning will be discussed later in this ISO 9001 Lead Auditor Training Course.

2.3.1 ISO 9001 Quality Plan
• May relate to a specific product (or group of similar product), service, contract or project.
• Specifies the sequence of processing activities; quality requirements and resources; acceptance criteria; frequency, scope and responsibility for measuring, monitoring, inspections and tests; measuring devices to be used; and records kept
• Used by operational personnel to ensure specific quality requirements are met
• May make reference to other procedures and specifications
• May become a record if verification or inspection results are recorded on the document.

2.4 Application of ISO 9001 QMS Documentation
The documentation heirarchy described in section 2.2 should be applied with flexibility.
ISO 9001 Auditor Training - The format of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity.
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
A large, multi-national organization may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

Other factors that might affect the extent of documentation, include:
• Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures in order to implement an effective QMS.

• Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. In order to demonstrate conformity with ISO 9001:2000, however, the organization must be able to provide objective evidence that its QMS has been effectively implemented.

Top management commitment is paramount to successful implementation and registration. This is perhaps the most frequent reason for failure to obtain successful registration. Management must provide the leadership, organization, resources, and their involvement to ensure success. Lack of management commitment will be noticed by employees and affect their own attitude and support of the system.

Evidence of adequate QMS documentation be discussed later in this ISO 9001 Auditor Training Course.

The system must be formal, which means it must be documented, approved, communicated, available, and personnel trained in its consistent use.

The ISO 9001 standard specifies requirements that emphasize prevention. Methods employed to implement the quality system must focus on controlling and managing processes on a proactive basis, rather than a reactive basis.

Planning and proving controls and processes prior to full implementation is a big part of a successful prevention based approach. Personnel must be trained to ensure their understanding and use of the quality management system.

Proper channels of communication must be established to ensure active participation, teamwork, and cooperation of all personnel. In the quality system development and implementation process, top management must frequently review progress and take steps to resolve any hurdles and conflicts.

To learn more about ISO 9001 documentation visit "Understanding ISO 9001" for a detailed explanation of all ISO 9001 requirements

2.5 ISO 9001 Documentation Review
Generally the following questions need to be addressed:
• Are all requirements addressed?
• Does the documentation scope match the audit scope?
• Is top management commitment defined?
• Have the responsibilities been defined?
• Has the documentation structure been defined?
• Are methods described consistent with the requirements?
• Are documentation levels referenced?
• Is there adequate documentation control?

ISO 9001 Auditor Training - Most Registrars conduct a review (stagr 1) of a company’s readiness and documentation, weeks or months in advance of the stage 2 implementation audit. This is done for a number of reasons. If there are any omissions or deficiencies in the documentation, the auditor must point these out to the company, through the issue of a (documentation) nonconformity.

The company will have the opportunity to correct these, as well as, implement the corrected requirements.

Some Registrars may require anywhere from 1 to 3 months after the stage 1 review before they will conduct the stage 2 implementation audit.

ISO 9000 Training - If the review reveals that the organization's readiness and documentation is inadequate, the auditee and client must be notified. Further resources should not be spent on the audit until all shortcomings are addressed to the satisfaction of the auditor and client.

2.6  Benefits of an Effective ISO 9001 Quality Management System
Documents are an important part of a quality management system since they communicate intent and initiate consistent action. The benefits of a documented and conforming quality management system include:

External
• Improves customer confidence and satisfaction
• Improves conformity to quality requirements
• Increases competitive edge and market share

Internal
• Improves efficiency and productivity
• Reduces waste, inefficiencies, and defects
• Facilitates continual improvement
• Improves process consistency and stability
• Provides basis for training programs
• Improves employee motivation and participation
• Contributes to provision of objective evidence
• Improves supplier performance
• Increases profitability

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.