QMS DOCUMENTS
An ISO 9001 structure typically organizes itself into 4 levels:
Policy - the company’s position or intention for its operation
Procedure - responsibilities and processes for how the company operates to comply with its policies
Work Instruction - step-by-step instructions for a specific job or task
Forms and Records - recorded information demonstrating compliance with documented requirements
Quality Control Manual The QCM must contain written procedures that are communicated and followed by all affected personnel.
The written quality manual must clearly state company policies and operational procedures for all QM Activities
At a minimum, the quality control manual shall contain:
A Quality Policy statement, (signed and dated) by executive management.
A current organization chart, (signed and dated) by management, matching the management structure of the QM Function (group, division department, etc.) and its place in any parent organization.
The reporting relationship among management, technical operations, support services, and the QM system.
Procedures for control (including distribution) and maintenance of all QM procedures, corporate recordkeeping, and records retention policy.
Job descriptions of key staff and reference to the job descriptions of other staff.
Identification of company's approved signatories (when relevant).
Company procedure to achieve traceability of measurements against industry standards and manufacturer's recommendations.
Company's general scope of QM duties and tests (the precise scope of QM duties shall be tailored by the specific contract or work order).
Clear reference to the QS duties (inspections), verification, and test procedures to be used.
Procedures for performing QS inspections and tests.
Reference to any QS duties, equipment, and reference measurement standards used.
Reference to procedures for QS duties, calibration, and equipment maintenance (as required).
Procedures for handling non-conforming work and rework.
Quality Plans
1. Documentation You need to define and document requirements for quality to meet job specifications. These Quality plans are consistent with the company quality system and will be documented in a format as required per company procedures or job specification required format. It will have:
Preparation of quality plans
Identification and acquisition of any controls, processes, or equipment needed to achieve the required quality.
Ensuring compatibility of the production process and the applicable documentation.
Issuing of revisions as needed to continue improvement and meet requirements.
Work Plans
You have a separate written work plan, including an inspection plan for each job phase. An approved plan is prepared for each task that requires performance of productive work prior to the start of work on that specific project. The plan is revised and updated to stay current with all contract requirements. The plan is a compilation of all processes that make up the required work. Each process will include at a minimum:
A written description of the process.
Qualification requirement for personnel performing the work.
Methods used to ensure personnel accomplishing the procedure have direct knowledge of the requirements prior to beginning work.
Methods used to control procedure.
Acceptance and rejection criteria.
Procedures for Project Document Review
We need to establish and maintain documented procedures for project documentation review. Before submission of a bid, tender, proposal or acceptance of a contract the project documents are reviewed to ensure that:
Requirements are adequately defined and documented.
Documentation that all ambiguities and differences are resolved and approved.
You have the capability to meet all contract and specification requirements.
Document and Data Control
The company has implemented and maintains documented procedures to control all documents and data that relate to the requirements of QS1. Individual documents are clearly legible and have a unique numbering system for identification where applicable
Policy - the company’s position or intention for its operation
Procedure - responsibilities and processes for how the company operates to comply with its policies
Work Instruction - step-by-step instructions for a specific job or task
Forms and Records - recorded information demonstrating compliance with documented requirements
Quality Control Manual The QCM must contain written procedures that are communicated and followed by all affected personnel.
The written quality manual must clearly state company policies and operational procedures for all QM Activities
At a minimum, the quality control manual shall contain:
A Quality Policy statement, (signed and dated) by executive management.
A current organization chart, (signed and dated) by management, matching the management structure of the QM Function (group, division department, etc.) and its place in any parent organization.
The reporting relationship among management, technical operations, support services, and the QM system.
Procedures for control (including distribution) and maintenance of all QM procedures, corporate recordkeeping, and records retention policy.
Job descriptions of key staff and reference to the job descriptions of other staff.
Identification of company's approved signatories (when relevant).
Company procedure to achieve traceability of measurements against industry standards and manufacturer's recommendations.
Company's general scope of QM duties and tests (the precise scope of QM duties shall be tailored by the specific contract or work order).
Clear reference to the QS duties (inspections), verification, and test procedures to be used.
Procedures for performing QS inspections and tests.
Reference to any QS duties, equipment, and reference measurement standards used.
Reference to procedures for QS duties, calibration, and equipment maintenance (as required).
Procedures for handling non-conforming work and rework.
Quality Plans
1. Documentation You need to define and document requirements for quality to meet job specifications. These Quality plans are consistent with the company quality system and will be documented in a format as required per company procedures or job specification required format. It will have:
Preparation of quality plans
Identification and acquisition of any controls, processes, or equipment needed to achieve the required quality.
Ensuring compatibility of the production process and the applicable documentation.
Issuing of revisions as needed to continue improvement and meet requirements.
Work Plans
You have a separate written work plan, including an inspection plan for each job phase. An approved plan is prepared for each task that requires performance of productive work prior to the start of work on that specific project. The plan is revised and updated to stay current with all contract requirements. The plan is a compilation of all processes that make up the required work. Each process will include at a minimum:
A written description of the process.
Qualification requirement for personnel performing the work.
Methods used to ensure personnel accomplishing the procedure have direct knowledge of the requirements prior to beginning work.
Methods used to control procedure.
Acceptance and rejection criteria.
Procedures for Project Document Review
We need to establish and maintain documented procedures for project documentation review. Before submission of a bid, tender, proposal or acceptance of a contract the project documents are reviewed to ensure that:
Requirements are adequately defined and documented.
Documentation that all ambiguities and differences are resolved and approved.
You have the capability to meet all contract and specification requirements.
Document and Data Control
The company has implemented and maintains documented procedures to control all documents and data that relate to the requirements of QS1. Individual documents are clearly legible and have a unique numbering system for identification where applicable
