ISO 9001 DOCUMENT REQUIREMENTS

8/12/2019 ISO 9001 DOCUMENT REQUIREMENTS

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Automated Packaging

Understanding ISO 9001 /

Documentation Requirements


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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

GAP ANALYSIS Of ISO-9001


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4. Too many work instructions to control

5. Internal audits not auditing to a processapproach system.

6. Process approach not mentioned

7. SGS

GAP ANALYSIS Of ISO-9001


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Internal StandardOrganizationISO-9001:2008Piece Of ThePuzzle


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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 PolicyQuality 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.

4.2.3 Control of Documents:Approval of documents prior to use

Documented procedure

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 ProcedureRemain legible

Readily identifiable

Retrievable

Storage

Protection

Retention time and disposition of records.

Clause 4Quality 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)


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5.1 Management Commitment:Top Management shall:

Communicate importance of meeting customers requirements

Establish a Quality Policy

Establish Quality Objectives

Conduct Management Reviews

Ensure availability of Resources

5.2 Customer FocusRequirements Determined

Requirements are met

Aim to enhance customer satisfaction

5.3 Quality PolicyAppropriate to the Organization

Commitment to comply with requirements

Framework for establishing and reviewing Quality Objectives

Communicated and understood

Reviewed continually

5.4. Quality ObjectivesEstablished

Meet requirements for product

Measurable and consistent with the Quality Policy

5.5 Responsibility, Authority and CommunicationResponsibility and Authority is defined and communicated

Appoint a Member of Management for Management Reviews

Process are established, implemented and maintainedReport to Top Management

Promotion of Customer Requirements

Appropriate communication process established and takes place

5.6 Management ReviewTop Management must attend

Planned Intervals

Review Input

Review Output

1 CommandmentThou shall have Management Commitment

Management

Responsibility

Clause 5Management ResponsibilityTop

Management shall provide evidence of its

commitment to the development, implementation and

continually improving the QMS system. (6 elements)


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6.1 Provision of ResourcesDetermine and provide resources needed

to implement and maintain Quality System

continually improve its effectiveness

enhance customer satisfaction

meeting customer requirements

6.2 Human ResourcesCompetent Personnel

Appropriate education, training, skills and experience

6.3 InfrastructureDetermine, provide and maintain to achieve product requirements

Infrastructure includes:

building

workspace

associated utilitiesprocess equipment (both hardware and software)

supporting services (transport and communication)

6.4 Work EnvironmentDetermine and Manage to achieve product requirements

Resource

Management

Clause 6Resource ManagementSets 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)


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7.1 Planning of Product RealizationPlan and develop process

Consistent with requirements

Maintain quality objective

Establish documents

Provide resources specific to process

Verification, validation, monitoring, inspection and test activities for product acceptance

Records as evidence that processes and product meet requirements

7.2 Customer-related ProcessesDetermination of requirements related to the product

Review of requirement related to the product

7.3 Design and DevelopmentNo Applicable to CRT

7.4 PurchasingPurchasing Process

Purchasing InformationVerification of purchased product

7.5 Production and Service ProvisionControl 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 DevicesDetermine what monitoring and measurement devices needed

Devices needed to provide evidence of conformity

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

Clause 7Product Realization

Sets requirements to plan, operate and control

the specific QMS processes that determine

design, produce and deliverAPSs product and

services. (6 elements)

ManagementAnalysis and

Improvement


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8.1 GeneralDemonstrate conformity of product

Ensure conformity to the quality management system

Continually improve the effectiveness

8.2 Monitoring and Measurement

8.2.1 Customer SatisfactionMonitor information relating to customer perception

8.2.2 Internal AuditAudits 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 ProcessesApply suitable methods for monitoring and measuring the process

Demonstrate ability to achieve planned results of the process

8.2.4 Monitoring and Measurement of ProductCharacteristics of the product requirements are met

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.

Management

Analysis and

Improvement

Clause 8Measurement, Analysis and Improvement

Sets requirements to plan, measure, analysis and improve

processes that demonstrate product and QMS conformityand continually improve QMS effectiveness. (10 elements)


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8.3 Control of Nonconforming ProductEnsure nonconforming product is identified and controlled


Take action to eliminate nonconforming material

Release nonconforming product by relevant authority only

Prevent its original intended use by taking action

Maintain records

Re-verification to demonstrate conformity

Product is detected after delivery, action must be taken

8.4 Analysis of DataDetermine, 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 Improvement8.5.1 Continual ImprovementContinually improve through use of

Quality Policy

Quality Objectives

Audit Results

Analysis of Data

Corrective and Preventive Action

Management Review

8.5.2Corrective ActionTake action to eliminate the cause of nonconformities

Appropriate to the effects of the nonconformities encountered


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

8.5.3 Preventive ActionDetermine action to eliminate the causes of potential nonconformities

Be appropriate to the effects of the potential problems


determine potential nonconformities

determine and implement action

maintain recordsreview preventive action

Management

Analysis and

Improvement


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Internal Standard Organization

ISO 9001:2008 Quality Management Systems

Management

Responsibility

QualityManagement

System

Resource

Management

Management

Analysis and

Improvement

ManagementAnalysis and

Improvement


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ISO DOCUMENTATION


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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.


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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.


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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 mandatorydocumented procedures. It has given greater flexibility to

determine the documented procedures and instructions

based on the nature of activities and processes.


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5.6.1 Management reviews6.2.2 (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 actions7.4.1 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

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 actions8.2.4 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

6 Required Procedures:

21 Required Records:

4.2 DOCUMENTATION REQUIREMENTS


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So does our Quality Management System have to be

complicated and cumbersome?

We Need To Avoid Drowningin Detail..

Complying with ISO 9001:2008 does not have to be adocument 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.


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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 notrequired 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) approachto ISO 9001 is one way to ensure saving time in our

documentation and cost in revising / reviewing documents.


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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 standards requirements as we have in our APS Quality

Manual.This is an incredible waste of time and cost! (see examples)

ISO 9001 Quality Management

System

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.


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ISO 9001 Quality Management

System

Clause 4.2.2 of ISO 9001:2008 states the following:

The organization shallestablish and maintain a quality

manual that includes;

a) the scope of the quality management system, includingdetails 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.


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APS Current Quality Manual

Repeats Standards


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APS Current Quality Manual

Repeats Standards

Over 1500 Work Instructions


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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

Leaner ISO 9001

QMSQuality Management System


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Purposed QMS

Quality Management System Procedures

Interact With Other Clauses AndElements Of The Standard


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Interact With Other Clauses And

Elements Of The Standard

Purposed Quality Management System

Revised Format

Purposed 24 QMS

Procedures

The Quality Manual must be reviewed and implemented byTop Management.

The QMS Quality Management System documentation

must be reviewed and implemented by Process Owned

Management.


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The goal of our QMS Quality Management System procedures

is to document key processes. The ISO 9001 Standard doesnot specify any format for writing procedures, nor does it

specify a length. Since no one wants to read long-winded,

boring procedureswhy write them? Why not write one, two

or three page procedures using brief and easy to

understand? I am proposing using a LEANapproach whichmakes procedures more useful so they can benefit us instead

of being a paper burden.

Lean ISO 9001

Quality Management Systems


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Quality Manual,Quality Policy

(QMS)

Quality Management System

Procedures

Plastics Operations

Training Instructions, Work Instructions,

Operator Instructions

Records, Forms, historical data

ISO-9001:2008Standard Level 1

Level 2

Level 3

Level 4


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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-9001:2008requirements.


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QMSQuality Systems Procedures

Process Approach

Level 2 Uses a process approach (QMS) QualityManagement 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 inprocedures; other methods may be used.


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Work Instructions

Level 3

This level of documentation is very detailed on "how" toaccomplish 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'sManuals, Engineering or Technical Manuals, Technical

Support notes, Manufacturing Notes, etc., in order to create

detailed work instructions.


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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.

Level 4 - Forms and other

Documents


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ISO-9001:2008 Clause .2

Process Approach

What Is Process Approach?


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The ISO-9001:2008 Standard promotes the adoption of aprocess approach when developing, implementing and

improving the effectiveness of a QMS System.

Promote Clause .2 Process Approach


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"Core" processes (also known as Customer-Oriented-

Processes) are product realization processes that determine

customer requirements. These processes have a directimpact on the customer.

Examples of core processes include:

Design & DevelopmentProduction (manufacturing, outsourcing, testing, etc.)

Invoicing

(COPs)

Clause .2 Process Approach


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These processes ('SOPs') (also known as Support-

Oriented-Processes) provide the necessary resources to

COPs to facilitate product realization.

Some support functions are:

Purchasing - Supplier management processes,

Requisitions, Request for Quote

OthersQuality, HR, IT, Engineering, Training

(SOPs)



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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 managementCustomer focus

Management reviews

Corrective Action

Control of documents and records

(MOPs)


Clause 2 Process Approach


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MOPs MOPs Management Oriented Processes

CORE PROCESSES = COPs Customer Oriented Process

Support Oriented Processes

CustomerNeeds/Requirements

CustomerSatisfac

tion

Control of

Documents

Control of

Records

Customer

SatisfactionContinual Improvement,

Corrective & Preventive Action

Internal

Auditing

Quality

Planning

Quality

Objectives

Management

Review

COPs

Sales GraphicsArt, Imaging,

PlatesCustomer

ServiceExtruding

Printing Converting

Shipped

Internally

Shipped

Internally

Shipping

SOPsCalibrationTrainingMaintenancePurchasing

Analysis of

DataPolicy

Input Output


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Promoting The Use Of Process

Approach During Internal Auditing


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Process Based AuditingCurrent Internal Audits: are conducted as an independent examination or reviewof the single process (Department).

Proposed Processed Based Audits

Process audit reviews system of linked processes such as Inputs: that come intothe process, Outputs: of what you expect from the process .

A Change In Internal Auditing

Using Turtle Diagrams

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.

http://www.google.com/imgres?hl=en&sa=X&biw=1440&bih=698&tbm=isch&prmd=imvnsfd&tbnid=pi9Rkvk4pPWrcM:&imgrefurl=http://www.pic2fly.com/Turtle+Diagrams.html&docid=Yf0j1yd0I4lH1M&itg=1&imgurl=http://www.feartheturtle09.com/wp-content/uploads/2010/11/turtle.png&w=330&h=324&ei=AH8MUMyWO8qPrgGp8JjGCg&zoom=1&iact=hc&vpx=951&vpy=284&dur=78&hovh=222&hovw=227&tx=119&ty=146&sig=105742729986590589351&page=3&tbnh=154&tbnw=157&start=43&ndsp=26&ved=1t:429,r:24,s:43,i:290


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Clause .2 Process ApproachTurtle Diagram

R

equirements

R

equirements

ProcessName OF Process

Name Of Owner

With Who / Responsible Parties

Enter details of the personnel involved,training, skills and competence criteria

etc.

Resource's / With What

Detail what are the necessary

machines, raw materials, equipment,software infrastructure etc.

Key Criteria / Measure

Enter how is the analysis of the process

effectiveness accomplished?

details objectives, measurables of the

process effectiveness, targets, and resultsetc.

Operational Control / How

Enter details objectives, measurables of

the process effectiveness, targets, and

results etc.

Inputs What Come in

And What Does The

Customer Want?

Enter details of the

actual inputs requiredby the process.

Enter internal

requirements, external

requirements, tools,

materials, schedules etc.

Output What do you

expect And What

Does The Customer

Get?

Enter details of theactual output of the

process, records,

customer quality

Products, customersatisfaction, etc.



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Turtle Diagram

Inputs

R

equirements

Output

R

equirements

Process AuditedManagement

Responsibility

With Who / Responsible Parties

Top Management, Department

Managers

Resources / With What

ISO-9001, Cross-Functional Audit

Team, CAR System, Business Plan,Performance Measurables

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.

Inputs What Come in

And What Does The

Customer Want?

ISO Requirements,

Resources,

Infrastructure, Plant

Layout, Required

Records, Customer

Specifics, Training,

Quality Objectives,Communication

Output What do you

expect

Policy, Objectives,

Customer Satisfaction,

QMS Compliance,

Controlled Records,

Continual

Improvements

0730 INTERNAL AUDIT REPORT


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Master Audit Checklist Score 0730MANUFACTURING INTERNAL AUDIT REPORTBEDFORDFACILITY AUDITED: STREETSBORO

DATE OF AUDIT:

SHIFT(s) AUDITED: 1st Shift

GARFIEL SANTA FE S P O K E Y S E R

AUDITEE(S)

AUDITEE(S)

AUDITOR:

2nd Shift 3rd Shi f t

Evaluation Guideline Audit ResultsRating Guideline Score (%) Classification

Total Possible Points

Total Points This Audit

Audit Classification

Overall Audit Score

03 Is In Place And Being Followed 90 -100 Complies

2 In Place But Not Being Followed For All Processes 75 -89 Observation 0

1

MP!Is In Place But Not Being Followed 61 - 74 Minor Issue Major

Not In Place And No Evidence 60 Or Less -100.000%

N/A Not Applicable Question Does Not Apply

Clause Score Results Clause Score Results

4.1 General Requirements 0.0% Major7.1 Planning of Product Realization 0.0% Major

4.2 Documentation Requirements 0.0% Major7.2 Customer-Related Processes 0.0% Major

5.1 Management Commitment 0.0% Major7.3 Design and Development 0.0% Major

5.2 Customer Focus 0.0% Major7.4 Purchasing 0.0% Major

5.3 Quality Policy 0.0% Major7.5 Production and Service Provision 0.0% Major

5.4 Planning 0.0% Major7.6Control of Monitoring and Measuring

Equipment0.0% Major

5.5

Responsibility, Authority and Communication

0.0% Major8.1 General 0.0% Major

5.6 Management Review 0.0% Major8.2 Monitoring and Measuring 0.0% Major

6.1 Provision of Resources 0.0% Major8.3 8.4 Analysis of Data 0.0% Major

6.2 Human Resources 0.0% Major8.4 Analysis of Data 0.0% Major

6.3 Infrastructure 0.0% Major8.5 Improvement 0.0% Major

6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major


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SGS Registrar


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With the dedication of all employees, we as a company

constantly strive to meet our customer needs through

quality and continuous improvements.

With the dedication of all employees, we as a companyconstantly strive to protect the environment and

prevent pollution through continual improvement and

compliance to environmental regulations and

procedures.

Quality Policy

Environmental Policy

Examples For Revision Of Our Policies


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Thats a wrap!

Thank you!