The document discusses documentation requirements for ISO 9001 certification. It notes that some organizations see ISO certification as simply a way to get a certificate, but that the true value comes from implementing an effective quality management system. It emphasizes that top management must plan and implement the QMS. The document also discusses reducing documentation requirements in the revised ISO 9001 standard and taking a lean approach to documentation to avoid creating an unnecessary paperwork burden. It proposes a tiered documentation structure with a high-level quality manual at the top level and more detailed procedures, instructions, and records at lower levels.

1. Automated Packaging
Understanding ISO 9001 /
Documentation Requirements

2. GAP ANALYSIS Of ISO-
9001
1. Minimum knowledge (ISO Requirements)
2. Current quality manual repeats the standard
(Not used)
3. QPM procedures missing that show compliance
to key processes and interaction with ISO

3. GAP ANALYSIS Of ISO-
9001
4. Too many work instructions to control
5. Internal audits not auditing to a process
approach system.
6. Process approach not mentioned
7. SGS

5. Internal
Standard
Organization
ISO-9001:2008
Piece Of The
Puzzle

6. 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 4.2.3 Control of Documents:
control QMS processes and to continually improve the Approval of documents prior to use
Documented procedure
effectiveness of our QMS system. (5 elements) Review and update and re-approval
Changes and current revision is identified
Current revisions available at use
Remain legible
External documents are identified
Distribution controlled
Prevent use of obsolete documents
Apply suitable identification if retained for any purpose.
4.2.4 Control of Records:
Documented Procedure
Remain legible
Readily identifiable
Retrievable
Storage
Protection
Retention time and disposition of records.

7. 5.1 Management Commitment:
Top Management shall:
Communicate importance of meeting customers requirements
Establish a Quality Policy Management
Establish Quality Objectives
Conduct Management Reviews
Ensure availability of Resources Responsibility
5.2 Customer Focus
Requirements Determined
Requirements are met
Aim to enhance customer satisfaction
5.3 Quality Policy
Appropriate to the Organization
Commitment to comply with requirements
Framework for establishing and reviewing Quality Objectives
Communicated and understood
Reviewed continually
#1 Commandment
5.4. Quality Objectives
Established Thou shall have Management
Meet requirements for product Commitment
Measurable and consistent with the Quality Policy
Clause 5 – Management Responsibility – Top
5.5 Responsibility, Authority and Communication
Responsibility and Authority is defined and communicated Management shall provide evidence of its
Appoint a Member of Management for Management Reviews commitment to the development, implementation and
Process are established, implemented and maintained
Report to Top Management
continually improving the QMS system. (6 elements)
Promotion of Customer Requirements
Appropriate communication process established and takes place
5.6 Management Review
Top Management must attend
Planned Intervals
Review Input
Review Output

8. 6.1 Provision of Resources
Determine and provide resources needed
to implement and maintain Quality System
continually improve its effectiveness
enhance customer satisfaction
meeting customer requirements
6.2 Human Resources
Competent Personnel
Appropriate education, training, skills and experience
Resource
6.3 Infrastructure
Determine, provide and maintain to achieve product requirements
Infrastructure includes:
Management
building
workspace
associated utilities
process equipment (both hardware and software)
supporting services (transport and communication)
6.4 Work Environment
Determine and Manage to achieve product requirements
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)

9. 7.1 Planning of Product Realization
Plan and develop process
Consistent with requirements
Maintain quality objective
Establish documents
Clause 7 – Product Realization Provide resources specific to process
Sets requirements to plan, operate and control Verification, validation, monitoring, inspection and test activities for product acceptance
Records as evidence that processes and product meet requirements
the specific QMS processes that determine
design, produce and deliver APS’s product 7.2 Customer-related Processes
and services. (6 elements) Determination of requirements related to the product
Review of requirement related to the product
7.3 Design and Development
No Applicable to CRT
7.4 Purchasing
Purchasing Process
Purchasing Information
Verification of purchased product
7.5 Production and Service Provision
Control of production and service provision
Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of Product
7.6 Control of Monitoring and Measuring Devices
Management Determine what monitoring and measurement devices needed
Devices needed to provide evidence of conformity
Analysis and Establish processes were monitoring and measurement can be carried out
Processes carried out that is consistent with requirements
Measuring equipment calibrated, prior to use, against standards and verification recorded
Improvement

10. 8.1 General
Demonstrate conformity of product
Ensure conformity to the quality management system
Continually improve the effectiveness
Clause 8 – Measurement, Analysis and Improvement
8.2 Monitoring and Measurement Sets requirements to plan, measure, analysis and improve
8.2.1 Customer Satisfaction processes that demonstrate product and QMS conformity
Monitor information relating to customer perception
and continually improve QMS effectiveness. (10 elements)
8.2.2 Internal Audit
Audits at planned intervals
Audits conducted on planned arrangements
Audits conducted on International Standard
Audit conducted on the Quality Management System
Documented Procedure
Define scope, frequency and methods
Determine status and importance
Results of previous audits shall be taken in consideration
Auditor can not audit their own work
Corrective Action must be taken without delay
Follow-up activities required.
8.2.3 Monitoring and Measurement of Processes
Apply suitable methods for monitoring and measuring the process
Demonstrate ability to achieve planned results of the process
8.2.4 Monitoring and Measurement of Product
Characteristics of the product requirements are met
Management
Characteristics are measured at different stages of the process
Records of conformity is maintained
Records must have authorized personnel listed
Product release and service delivery can not happen until planned arrangements are satisfactory.
Analysis and
Improvement

11. 8.3 Control of Nonconforming Product
Ensure nonconforming product is identified and controlled
Documented Procedure
8.5.3 Preventive Action
Take action to eliminate nonconforming material
Determine action to eliminate the causes of potential nonconformities
Release nonconforming product by relevant authority only
Be appropriate to the effects of the potential problems
Prevent its original intended use by taking action
Documented Procedure
Maintain records
determine potential nonconformities
Re-verification to demonstrate conformity
determine and implement action
Product is detected after delivery, action must be taken
maintain records
review preventive action
8.4 Analysis of Data
Determine, collect and analyze data for suitability and effectiveness
Provide information relating to
Customer Satisfaction
Conformity to Product Requirements
Characteristics and trends of process and product
Opportunities for preventive action
Suppliers
8.5 Improvement
8.5.1 Continual Improvement
Continually improve through use of
Quality Policy
Quality Objectives
Audit Results
Analysis of Data
Corrective and Preventive Action
Management Review
8.5.2Corrective Action
Take action to eliminate the cause of nonconformities
Appropriate to the effects of the nonconformities encountered
Documented Procedure
Management
Analysis and
review nonconformities
determining the causes
evaluating the need for action
ensure nonconformities do not recur
determining and implementing action needed
records of results
Improvement
reviewing corrective actions

12. Internal Standard Organization
ISO 9001:2008 Quality Management Systems
Quality Management
Management Responsibility
System
Resource
Management
Management
Management
Analysis and
Analysis and
Improvement
Improvement

13. ISO DOCUMENTATION

14. 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.

15. 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.

16. 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.

17. 4.2 DOCUMENTATION REQUIREMENTS
21 Required Records:
5.6.1 Management reviews
6.2.2 (e) Education, training, skills and experience
7.1 (d) Company-defined records needed to provide evidence that the realization processes
and resulting product fulfill requirements
7.2.2 Results of the review of requirements related to the product and actions arising from
the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 (d) As required by the organization to demonstrate the validation of processes where
the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 (a) Basis used for calibration or verification of measuring equipment where no
international or national measurement standards exist
6 Required Procedures: 7.6 Validity of the previous measuring results when the measuring equipment is found not
to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including
concessions obtained
8.5.2 Results of corrective action
8.5.3 Results of preventive action

18. So does our Quality Management System have to be
complicated and cumbersome?
Complying with ISO 9001:2008 does not have to be a
“document nightmare.” Understanding the requirements of
the standard and developing ways to meet them is what we
need, “A review of the standard”.
ISO 9001 can only be a documentation nightmare if we
choose to make it so.
We Need To Avoid Drowning
in Detail…..

19. 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.

20. ISO 9001 Quality Management
System
There is nothing in the ISO requirements that says a Quality Manual /
QMS Quality Management System procedures needs to be 50 pages
or more. However, most Quality Manual seem to follow the pattern of
addressing each and every ISO 9001 “shall” statement by essentially
repeating the standard’s requirements as we have in our APS Quality
Manual. This is an incredible waste of time and cost! (see examples)
•Waste is hidden in all processes
•Identifying and eliminating waste
•When waste is identified, it becomes clear that it
adds no value to the customer and increases our
operating cost.

21. ISO 9001 Quality Management
System
Clause 4.2.2 of ISO 9001:2008 states the following:
The organization shall establish and maintain a quality
manual that includes;
a)the scope of the quality management system, including
details of and justification for any exclusions.
b)the documented procedures established for the (QMS)
Quality Management System, or reference to them.
c)and a description of the interaction between the
processes of the (QMS) Quality Management System.

22. APS Current Quality Manual
Repeats Standards

23. APS Current Quality Manual
Repeats Standards
Over 1500 Work Instructions

24. Leaner ISO 9001
QMS – Quality Management System
Purposing a revised Quality Manual
Core Quality Manual for all of Plastic
Operations with basic statements showing
Top Managements commitment to comply
with ISO-9001:2008
See attached Quality Manual examples
If approved my management to move forward.
This quality manual will replace the current
APS manual in lotus notes

25. Purposed QMS
Quality Management System Procedures
Interact With Other Clauses And
Elements Of The Standard

26. Purposed Quality Management System
Revised Format
Purposed 24 QMS
Procedures
Interact With Other Clauses And
Elements Of The Standard
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.

27. Lean ISO 9001
Quality Management Systems
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.

28. ISO- Level 1
9001:2008
Standard Quality Manual,
Quality Policy
Level 2
(QMS)
Quality Management System
Procedures
Level 3
Plastics Operations
Training Instructions, Work Instructions,
Operator Instructions
Level 4
Records, Forms, historical data

29. TOP Level Core Manual
Level 1
The Quality Manual is the core of the quality system gives a
brief description of APS’s 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.

30. 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.

31. Work Instructions
Level 3
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.

32. Level 4 - Forms and other
Documents
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.

33. ISO-9001:2008 Clause .2
Process Approach
What Is Process Approach?

34. Promote Clause .2 Process Approach
The ISO-9001:2008 Standard promotes the adoption of a
process approach when developing, implementing and
improving the effectiveness of a QMS System.

35. Clause .2 Process Approach
(COP’s)
"Core" processes (also known as Customer-Oriented-
Processes) are product realization processes that determine
customer requirements. These processes have a direct
impact on the customer.
Examples of core processes include:
•Design & Development
•Production (manufacturing, outsourcing, testing, etc.)
•Invoicing

36. Clause .2 Process Approach
(SOP’s)
“These processes ('SOPs') (also known as Support-
Oriented-Processes) provide the necessary resources to
COP’s to facilitate product realization.
Some support functions are:
Purchasing - Supplier management processes,
Requisitions, Request for Quote
Others – Quality, HR, IT, Engineering, Training

37. Clause .2 Process Approach
(MOP’s)
“These processes ('MOPs') (also known as Management-
Oriented Processes) provide the commitment, leadership,
resources, review and decision-making by Top
Management.
Examples of management processes include:
•Quality policy and objectives
•Planning (Strategic, Operational)
•Resource management
•Customer focus
•Management reviews
•Corrective Action
•Control of documents and records

38. Clause .2 Process Approach
MOP’s MOP’s Management Oriented Processes
Continual Improvement, Internal Customer Analysis of
Policy
Corrective & Preventive Action Auditing Satisfaction Data
Management Quality Quality
Review Objectives Planning
Customer Needs / Requirements
COP’s
Customer Satisfaction
CORE PROCESSES = COP’s Customer Oriented Process
Customer Art, Imaging, Shipped Shipping
Sales Graphics Extruding
Service Plates Internally
Printing Converting
Input Output
Shipped
Internally
SOP’s Support Oriented Processes
Control of Control of
Purchasing Maintenance Training Calibration
Documents Records

39. Promoting The Use Of Process
Approach During Internal Auditing

40. A Change In Internal Auditing
Process Based Auditing
Current Internal Audits: are conducted as an independent examination or
review of the single process (Department).
Proposed Processed Based
Audits audit reviews system of linked processes such as Inputs: that come
Process
into the process, Outputs: of what you expect from the process .
Each process uses resources to transform inputs into outputs. Since the output
of one process becomes the input of another process, processes interact and
are interrelated by means of such input-output relationships. These process
interactions create a single process-based QMS system.
system
Using Turtle
Diagrams

41. Clause .2 Process Approach
Turtle Diagram
Resource's / With What With Who / Responsible Parties
Detail what are the necessary Enter details of the personnel involved,
machines, raw materials, equipment, training, skills and competence
software infrastructure etc. criteria etc.
Inputs What Come in Output What do you
And What Does The expect And What
Requirements
Requirements
Customer Want? Does The Customer
Process Get?
Enter details of the
actual inputs required Name OF Process Enter details of the
by the process. Name Of Owner actual output of the
process, records,
Enter internal customer quality
requirements, external Products, customer
requirements, tools, satisfaction, etc.
materials, schedules etc.
Key Criteria / Measure
Operational Control / How Enter how is the analysis of the process
effectiveness accomplished?
Enter details objectives, measurables of details objectives, measurables of
the process effectiveness, targets, and the process effectiveness, targets, and
results etc. results etc.

42. Clause .2 Process Approach
Turtle Diagram
Resources / With What With Who / Responsible Parties
ISO-9001, Cross-Functional Audit Top Management, Department
Team, CAR System, Business Plan, Managers
Performance Measurables
Inputs What Come in
And What Does The
Requirements
Requirements
Output What do you
Customer Want?
Process Audited expect
Output
Inputs
ISO Requirements,
Resources, Management Policy, Objectives,
Infrastructure, Plant Responsibility Customer
Layout, Required Satisfaction, QMS
Records, Customer Compliance,
Specifics, Training, Controlled Records,
Quality Objectives, Continual
Communication Improvements
Operational Control / Key Criteria / Measure
QMS Procedures
Internal Audits, Performance
QMS Procedures, Core Clauses: Measurables, Management Review,
Customer Specifics, 4.1, 4.2, 5.1, Customer Satisfaction, CAR
5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 7.2.3, System, measurables of the process
7.3.4, 8.2.1, 8.4, 8.5 effectiveness, targets, and results
etc.

43. Master Audit Checklist Score 0730MANUFACTURING INTERNAL AUDIT REPORT
BEDFORD GARFIEL ❑ SANTA FE ❑ SPO KEYSER
FACILITY AUDITED: STREETSBORO DATE OF
❑
❑
AUDIT: AUDITOR: AUDITEE(S)
SHIFT(s) AUDITED: ❑ 1st Shift 2nd Shift ❑ 3rd Shift AUDITEE(S)
Evaluation Guideline Audit Results
Rating Guideline Score (%) Classification
3 Is In Place And Being Followed 90 -100 Complies Total Possible Points 0
2 In Place But Not Being Followed For All Processes 75 89- Observation Total Points This Audit 0
1 Is In Place But Not Being Followed 61 - 74 Minor Issue Audit Classification Major
MP! Not In Place And No Evidence 60 Or Less Overall Audit Score -100.000%
N/A Not Applicable Question Does Not Apply
Clause Score Results Clause Score Results
4.1 General Requirements 0.0% Major 7.1 Planning of Product Realization 0.0% Major
4.2 Documentation Requirements 0.0% Major 7.2 Customer-Related Processes 0.0% Major
5.1 Management Commitment 0.0% Major 7.3 Design and Development 0.0% Major
5.2 Customer Focus 0.0% Major 7.4 Purchasing 0.0% Major
5.3 Quality Policy 0.0% Major 7.5 Production and Service Provision 0.0% Major
Control of Monitoring and Measuring
5.4 Planning 0.0% Major 7.6 Equipment 0.0% Major
Responsibility, Authority and Communication
5.5 0.0% Major 8.1 General 0.0% Major
5.6 Management Review 0.0% Major 8.2 Monitoring and Measuring 0.0% Major
6.1 Provision of Resources 0.0% Major 8.3 8.4 Analysis of Data 0.0% Major
6.2 Human Resources 0.0% Major 8.4 Analysis of Data 0.0% Major
6.3 Infrastructure 0.0% Major 8.5 Improvement 0.0% Major
6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major

45. SGS Registrar

46. FICCI
CE
Examples For Revision Of Our Policies
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.

47. That’s a wrap!
Thank you!