CLAUSE 4:
Quality Management System
4.1 Title: General Requirements
Dominion Taping & Reeling maintains, and controls Quality System procedures
(SOPs) that reflect the standards
defined in ISO 9001:2000 International Standard.
Dominion Taping & Reeling utilizes quality planning
that is consistent to the standards defined in this policy and formatted to Dominion Taping & Reeling’s methods
of operation. Our total system will serve as our quality plan unless our customer
requires otherwise.
If a customer requests DTR to deviate from our normal SOP’s, the request will
be evaluated by the manager on duty. If manager decides to deviate from the normal
SOP, the customer will be required to give written approval for the customized procedure.
4.2 Title: Documentation Requirements
4.2.1 GENERAL (Includes 4.2.2 Quality Manual)
· Dominion Taping & Reeling maintains a
documented quality system as a means to ensure that all products and services conform to specified requirements. The quality system is structured with 4 levels of documentation
that are defined in this policy.
·
Level 1: Quality Management
System Manual
The manual describes Dominion Taping & Reeling’s quality policy and the general
company-wide structure and methods for maintaining the quality management system.
Level 2: Standard Operating Procedures (SOP)
Procedures are used to specify WHO does WHAT, WHEN, HOW it is done, WHAT DOCUMENTATION is used to verify that the quality
activity was executed as required and WHERE the next step is performed as required
by the ISO Standard.
Level 3: Operating instructions
Refers to operating instructions and manuals provided for and located with individual
pieces of equipment.
Level 4:
Records and Form
Forms, designated (FORM) refers to tags,
labels, stickers, preprinted sheets, stamps, and other means used to identify the status of materials, products, equipment,
gauges, and other devices used in the company to achieve the specified requirements.
These will be referred to in the appropriate level procedure.
Records are maintained by Dominion Taping
& Reeling in conjunction with SOP’s to provide assurance/evidence that the required product or service quality was
achieved, and to ensure that the company’s quality system has been implemented correctly.
4.2.3
Control of Documents
GENERAL
·
Dominion Taping & Reeling Inc., per QMS-4.5-SOP, maintains
procedures to control all documents and data that relate to the requirements of this standard and are necessary to ensure
adequate control. Documents and data may be in the form of any printed or electronic
media.
DOCUMENT AND
DATA APPROVAL AND ISSUE
· The Quality Manager
and the Management Representative are responsible for ensuring that all Quality System Documents have the following controls
in place:
A.)
Documents, prior to distribution and use, are reviewed and have provisions for review/approval signatures and a means
for indicating the document revision level.
B.)
Documents are numbered and assigned to an individual or area of use. A
master list is kept to indicate the document/rev. level/copy number, and the names and location of all controlled documents.
C.)
Obsolete documents are removed from all points of issue and use.
D.)
Any obsolete documents retained for legal or historical information purposes
are appropriately identified.
DOCUMENT
AND DATA CHANGES
Document changes and modifications
are reviewed and approved by the same personnel or departments that performed the original review and approval unless specifically
designated otherwise. In those situations, all pertinent background information
is provided or is available to the qualified designees in order to allow for an accurate and consistent review and approval. A written record indicating the nature of document changes shall be maintained and
stored with management review meeting minutes.
4.2.4 CONtrol of Quality Records
GENERAL
·
Dominion Taping & Reeling maintains documented procedures for the identification, collection, filing, storage,
and disposition of all quality records. Quality records are maintained for the
following reasons;
1. Demonstrate conformance
to specified requirements.
2. Historical value to monitor effectiveness
of quality system.
· Procedures
are detailed in QMS-4.16-SOP.
CONTROL OF QUALITY RECORDS
·
All quality records are stored either as hard copy and/or electronic media.
· All Department Managers have
the authority and responsibility to store the quality records in such a way that they are readily retrievable, and in an environment
to prevent damage, loss, or deterioration.
·
Appropriate retention times for a specified quality record are defined in QMS-4.16-SOP.
·
Quality Management System (QMS) Records include:
1. Management
Review
2. Approved
Supplier List (ASL)
3. Instrument
Calibration Logs
4. Internal
and External Audit Records
5. Corrective
and Preventative Action Records
6. Training
Records
