Professional Documents
Culture Documents
7. SGS
4.1
General Requirements :
Shall establish, document, implement and maintain. Identify the processes needed; Determine the sequence needed; Determine criteria and methods needed; Availability of resources necessary to support an operation; Monitor, measure and analyze the processes; Implement actions necessary to achieve planned results.
4.2
Documentation Requirements:
Quality Policy Quality Goals Quality Manual Procedures: 6 Required Maintain records: 13 different types
4.2.2
Quality Manual:
Scope Justification for any Exclusions , Reference to Procedures, Description of the interaction between processes.
Clause 4 Quality Management System Sets requirements to identify, plan, document, operate and control QMS processes and to continually improve the effectiveness of our QMS system. (5 elements)
4.2.4
Control of Records:
Documented Procedure Remain legible Readily identifiable Retrievable Storage Protection Retention time and disposition of records.
Management Responsibility
#1 Commandment
Thou shall have Management Commitment
Clause 5 Management Responsibility Top Management shall provide evidence of its commitment to the development, implementation and continually improving the QMS system. (6 elements)
6.3 Infrastructure
Determine, provide and maintain to achieve product requirements Infrastructure includes: building workspace associated utilities process equipment (both hardware and software) supporting services (transport and communication)
Resource Management
Clause 6 Resource Management Sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements. (4 elements)
Clause 7 Product Realization Sets requirements to plan, operate and control the specific QMS processes that determine design, produce and deliver APSs product and services. (6 elements)
7.4 Purchasing
Purchasing Process Purchasing Information Verification of purchased product
8.1 General
Demonstrate conformity of product Ensure conformity to the quality management system Continually improve the effectiveness
Clause 8 Measurement, Analysis and Improvement Sets requirements to plan, measure, analysis and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness. (10 elements)
8.5.2Corrective Action
Take action to eliminate the cause of nonconformities Appropriate to the effects of the nonconformities encountered Documented Procedure review nonconformities determining the causes evaluating the need for action ensure nonconformities do not recur determining and implementing action needed records of results reviewing corrective actions
Internal Standard Organization ISO 9001:2008 Quality Management Systems Quality Management System Resource Management Management Analysis and Improvement Management Responsibility
ISO DOCUMENTATION
To some companies, the point of ISO 9001 registration is to get a certificate. While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized by an organization. The QMS Quality Management System must be planned and implemented by Top Management. In most cases the understanding of the requirements is that a lot of procedures and documents are needed. So the myth of ISO 9001 being a documentation nightmare is still a common misconception at many levels of management.
To some organization, the point of ISO 9001 registration is to get a certificate to convince customers that procedures are in place and they comply to the standard. A certificate can be a very expensive piece of paper if that is the only benefit realized by an organization.
The (QMS) Quality Management System must be planned and implemented by Top Management.
One of the major issues of the previous revision of the standard was that it required extensive documentation. The new revised standard has significantly reduced mandatory documented procedures. It has given greater flexibility to determine the documented procedures and instructions based on the nature of activities and processes.
6 Required Procedures:
The old adage frequently applied to ISO 9001 is Say what you do and do what you say. Some of us seem to take this to mean Write down everything you do, but that is not required by the standard. The actual requirement is that processes are well-defined and responsibilities clearly communicated. This can be accomplished through a lot of methods that require little documentation, such as training. The key concept is that the goal is to use the ISO 9001 standard to improve our business, and if it becomes a burdensome paper bureaucracy, then that is probably not happening. Using a Leaner (meaning not wasteful) approach to ISO 9001 is one way to ensure saving time in our documentation and cost in revising / reviewing documents.
Repeats Standards
Repeats Standards
The Quality Manual must be reviewed and implemented by Top Management. The QMS Quality Management System documentation must be reviewed and implemented by Process Owned Management.
The goal of our QMS Quality Management System procedures is to document key processes. The ISO 9001 Standard does not specify any format for writing procedures, nor does it specify a length. Since no one wants to read long-winded, boring procedures why write them? Why not write one, two or three page procedures using brief and easy to understand? I am proposing using a LEAN approach which makes procedures more useful so they can benefit us instead of being a paper burden.
ISO-9001:2008 Standard
Quality Manual, Quality Policy
Level 1
Level 2
Level 3 Level 4
Plastics Operations Training Instructions, Work Instructions, Operator Instructions
TOP Level Core Manual Level 1 The Quality Manual is the core of the quality system gives a brief description of APSs quality policy, objectives and is separate and distinct from the (QMS) Quality Management System procedures. The purpose of this level of documentation is used externally / internally to introduce our (QMS) Quality Management System to our customers and other external organizations or individuals to show that Top Managements is commitment in implementing and complying with ISO-9001:2008 requirements.
QMS Quality Systems Procedures Process Approach Level 2 Uses a process approach (QMS) Quality Management System that which define the methods, interaction, assign responsibilities and authorities, tasks and activities in meeting ISO 9001:2008 requirements.
Section 4.1 c) of the ISO 9001:2008 standard requires we are to determine criteria and methods needed to ensure that both the operation and control of processes are effective. It does not require the methods and criteria to be defined in procedures; other methods may be used.
This level of documentation is very detailed on "how" to accomplish a specific job, task or assignment. For example, a work instruction could be developed for a product with step-by-step instructions including such detail as testing requirements.
Individual work instructions are very specific to the process(s). Supplemental documentation may be used including User's Manuals, Engineering or Technical Manuals, Technical Support notes, Manufacturing Notes, etc., in order to create detailed work instructions.
The last level of documentation can include forms, records, checklists, surveys, and other documents used in the production or delivery of a product or service.
Policy
Analysis of Data
Management Review
Quality Objectives
Quality Planning
Sales
Printing
Converting
Input
Shipped Internally
Output
SOPs
Purchasing Maintenance
Customer Satisfaction
COPs
Inputs What Come in And What Does The Customer Want? Enter details of the actual inputs required by the process. Enter internal requirements, external requirements, tools, materials, schedules etc.
Process
Name OF Process Name Of Owner
Output What do you expect And What Does The Customer Get?
Requirements
Operational Control / How Enter details objectives, measurables of the process effectiveness, targets, and results etc.
Requirements
Enter details of the actual output of the process, records, customer quality Products, customer satisfaction, etc.
Key Criteria / Measure Enter how is the analysis of the process effectiveness accomplished? details objectives, measurables of the process effectiveness, targets, and results etc.
ISO-9001, Cross-Functional Audit Team, CAR System, Business Plan, Performance Measurables
Output Requirements
Inputs Requirements
Process Audited
Management Responsibility
ISO Requirements, Resources, Infrastructure, Plant Layout, Required Records, Customer Specifics, Training, Quality Objectives, Communication
Policy, Objectives, Customer Satisfaction, QMS Compliance, Controlled Records, Continual Improvements
Operational Control / QMS Procedures QMS Procedures, Core Clauses: Customer Specifics, 4.1, 4.2, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 7.2.3, 7.3.4, 8.2.1, 8.4, 8.5
Key Criteria / Measure Internal Audits, Performance Measurables, Management Review, Customer Satisfaction, CAR System, measurables of the process effectiveness, targets, and results etc.
BEDFORD AUDITOR:
2nd Shift 3 r d S h i f t
1 st Sh i f t
Evaluation Guideline
Rating Guideline Score (%) 3 Is In Place And Being Followed 90 -100 Classification Complies
Audit Results
Total Possible Points
Total Points This Audit Audit Classification Overall Audit Score 0 0 Major -100.000%
75 89
-
Observation
Minor Issue
MP!
N/A
61 - 74 60 Or Less
Question Does Not Apply Results Major7.1 Major7.2 Major7.3 Major7.4 Major7.5 Major7.6 Major8.1 Major8.2 Major8.3 Major8.4 Major8.5 Major Planning of Product Realization Customer-Related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Equipment General Monitoring and Measuring 8.4 Analysis of Data Analysis of Data Improvement AIB Pest Control Clause Score 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% Results Major Major Major Major Major Major Major Major Major Major Major Major
4.1 4.2 5.1 5.2 5.3 5.4 5.5 5.6 6.1 6.2 6.3 6.4
General Requirements Documentation Requirements Management Commitment Customer Focus Quality Policy Planning
SGS Registrar
CE FICCI
Quality Policy
With the dedication of all employees, we as a company constantly strive to meet our customer needs through quality and continuous improvements.
Environmental Policy
With the dedication of all employees, we as a company constantly strive to protect the environment and prevent pollution through continual improvement and compliance to environmental regulations and procedures.