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9001:2008
DOCUMENTATION REQUIREMENTS
PART I
HENRY JOHN NUEVA
Training and Program Development Specialist
ISO
9001:2008
ISO
9001:2008
ABOUT ISO?
ISO (International Organization for Standardization) with central
secretariat located at Geneva Switzerland is an independent, non-
governmental international organization with a membership of
163 national standards bodies.
Through its members, it brings together experts to share
knowledge and develop voluntary, consensus-based, market
relevant International Standards that support innovation and
provide solutions to global challenges.
ISO
9001:2008
WHAT ARE
STANDARDS?
International Standards make things work. They give world-class
specifications for products, services and systems, to ensure
quality, safety and efficiency. They are instrumental in
facilitating international trade.
ISO has published 21788 International Standards and related
documents, covering almost every industry, from technology, to
food safety, to agriculture and healthcare. ISO International
Standards impact everyone, everywhere.
ISO
9001:2008
What is ISO 9001:2008?
ISO 9001:2008 specifies requirements for a Quality Management
System-QMS where an organization needs to demonstrate its
ability to consistently provide product that meets customer and
applicable statutory and regulatory requirements, and aims to
enhance customer satisfaction through the effective application
of the system, including processes for continual improvement of
the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended
to be applicable to all organizations, regardless of type, size and
product provided.
ISO
9001:2008
Clause 4.2.1 General
The quality management system shall include:
a) Documented statements of a quality policy and quailty
objectives;
b) A quality manual
c) Documented procedures and records required by the
International Standard;
d) Documents, including records, determined by the
organization to be necessary to ensure the effective planning,
operation, and control of its processes.
ISO
9001:2008
The Principle
Documents and Records required by the organization must ensure
effective planning , operation and control process.
ISO
9001:2008
Quality Manual must align to Quality
Policy set by Top Management.
Procedures must meet the requirements
spelled out in the Quality Manual.
Work Instruction must follow the
procedures’ requirements.
The top level documents are more broad
and general in term of contents. In
vice versa, lower level documents are
more detail and use for daily processes.
ISO
9001:2008
QMS Documentation
Organization Requirements
a) A specific documents, including documented procedures and
records as required by ISO 9001
b) A specific documents, including records as required by your
organization to ensure the effective planning, operation, and
control of your QMS.
c) Extent of the quality management system documentation can
differ from one organization to another due to
1. Size of organization and type of activities
2. Complexity of processes and their interactions
3. The competence of personnel
d) The documentation can be in any form or type of medium
ISO
9001:2008
What’s a DOCUMENT?
1) A document is information and its supporting medium
2) The medium can be paper, magnetic, electronic or optical
computer disc, photograph or master sample or a
combination thereof
3) A sets of documents, for example :
*Specifications and records = Documentation
AS DEFINED UNDER ISO 9000:2005
ISO
9001:2008
Documented Procedure
 The Term “Documented Procedure” means that the procedure
is :
a) Established
b) Documented
c) Implemented
d) Maintained
 A single document may address the requirements for one or
more procedures.
 A requirement for a documented procedure may be covered
by more than one document.
ISO
9001:2008
What’s a RECORD?
1) A record is a document stating results achieved or providing
evidence of activities performed.
2) Records can be used, for example, to document traceability
and to provide evidence of verification, preventive action and
corrective action
3) Generally records need not be under revision control.
AS DEFINED UNDER ISO 9000:2005
ISO
9001:2008
Documents Required
ISO
9001:2008
1.Clause 5.3 Quality Policy
Clause 5.3 originated at Clause 5- Management Responsibility
Top Management shall ensure that the Quality Policy
1) Is appropriate to the purpose of the organization;
2) Includes a commitment to comply with requirements and
continually improve the effectiveness of the quality
management system;
3) Provides a framework for establishing and reviewing quality
objectives;
4) Is communicated and understood within the organization,
and is reviewed for continuing sustainability
*Top Management = Person or group of people who directs and
controls an organization at the highest level
ISO
9001:2008
2.Clause 5.4.1 Quality Objectives
Top Management must establish Quality Objectives. Quality
objectives must:
1) Measurable and align with Quality Policy for commitment of
continual improvement
2) Include meeting customer’s requirements and other
requirements determined by the organization
3) Must periodical review and monitor the result and provide
necessary corrective actions. (Check: ISO Clause 8.2.3
Monitoring and Measurement Process)
* Create a Quality Objectives Register to record all quality
objectives as set/approved by top management
ISO
9001:2008
Characteristics of Quality Policy
towards the Organization
Provides top
management’s
vision on
quality
management
for the
organization
Provides the
organization
with focused
direction like
high level
goals and
objectives
Must be consistent
with the scope of the
organization’s QMS
and other business,
management and
organizational
strategies within
ISO
9001:2008
Clause 5.4.1 Audit Checklist
An audit checklist should cover the following areas:
 Check for evidence of how top management shows its
commitment to:
1) Communicating to the organization the importance of
meeting client/customer as well statutory and regulatory
requirements;
2) Establishing the Quality Policy;
3) Ensuring that quality objectives are established;
4) Conducting management reviews;
5) Ensuring the availability of resources
ISO
9001:2008
Clause 5.4.1 Audit Checklist
 Look for the following:
1) How its made clear how a Customer requirement is
translated into action;
2) How the Quality Policy is communicated regularly;
3) How Quality objectives are established and by whom that
reviews are held regularly on the status of business
operations;
4) How resources are allocated to the functional areas.
ISO
9001:2008
3.Clause 4.2.2 Quality Manual
Organization must establish and maintain a Quality Manual.
Quality Manual include information of organization’s key
processes and must include:
1) The scope of the QMS
2) Any exclusion clause of QMS does not apply in the
organization but limit t ISO 9001 within Clause 7
3) The documented procedures established for QMS and the
reference of them
4) A description of the sequence and interaction of the
processes including in the QMS
ISO
9001:2008
Sample Quality Manual
ISO
9001:2008
4.Clause 7.1 Quality Plan
 A document specifying which procedures and associated
resources shall be applied by whom and when to a specific
project, product, process or contract
 These procedures generally include those referring to quality
management processes and to Product Realization Process
 A quality plan often makes reference to parts of quality
manual or to procedure document
 A quality plan is generally one of the results of quality
planning
ISO
9001:2008
Clause 7.1 Audit Checklist
An audit checklist should cover the following areas:
 Are the processes needed for product realization planned,
developed and documented in a quality plan?
Are the following determined in the quality plan, as
appropriate:
1) Quality objectives for product, project or contract
2) Need to establish processes/ documents
3) Need to provide resources/facilities
4) Required verification, validation, monitoring inspection, test
activities & criteria for acceptance
5) Records to provide evidence of conformity to established
processes & product requirements
ISO
9001:2008
 Interview those employees responsible for launching new
products, services and processes:
1) Is there a plan on how existing products/services will be
produced or supplied? Is there a flowchart of the main steps?
2) Is a plan in place for introducing : New products? New
Services? New contracts? New processes? New projects?
New locations? New computer systems?
3) Any example of this “New” activities in the past 12 months?
If so, was a plan followed/ Is a checklist used? How was
implementation of all the critical steps managed?
4) How is the transition from “New” to “Normal operations”
managed?
5) How are new processes monitored and measured? How are
any new records identified? What is the result/output of any
planning activities?
ISO
9001:2008
Sample Quality Project Plan
ISO
9001:2008
ISO
9001:2008
ISO
9001:2008
ISO
9001:2008
ISO
9001:2008
ISO
9001:2008
ISO
9001:2008
Top management shall ensure that responsibilities and authorities
are defined and communicated within the organization. Clause
5.5.1 defines Responsibility & Authority and the best tool to
utilize such is the organization chart
1) Organization Chart defines the arrangement of an
organization’s structure in terms of responsibilities,
authorities, and relationships between people
2) Arrangement is generally orderly
3) A formal expression of the organizational structure is often
provided in a quality manual or a quality plan for a project
4) The scope of an organizational structure can include relevant
interfaces to external organizations
5. Clause 5.5.1 Organization Chart
ISO
9001:2008
Check for continuation...

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ISO 9001 2008 Part I

  • 1. 9001:2008 DOCUMENTATION REQUIREMENTS PART I HENRY JOHN NUEVA Training and Program Development Specialist
  • 2. ISO 9001:2008 ISO 9001:2008 ABOUT ISO? ISO (International Organization for Standardization) with central secretariat located at Geneva Switzerland is an independent, non- governmental international organization with a membership of 163 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.
  • 3. ISO 9001:2008 WHAT ARE STANDARDS? International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade. ISO has published 21788 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.
  • 4. ISO 9001:2008 What is ISO 9001:2008? ISO 9001:2008 specifies requirements for a Quality Management System-QMS where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
  • 5. ISO 9001:2008 Clause 4.2.1 General The quality management system shall include: a) Documented statements of a quality policy and quailty objectives; b) A quality manual c) Documented procedures and records required by the International Standard; d) Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes.
  • 6. ISO 9001:2008 The Principle Documents and Records required by the organization must ensure effective planning , operation and control process.
  • 7. ISO 9001:2008 Quality Manual must align to Quality Policy set by Top Management. Procedures must meet the requirements spelled out in the Quality Manual. Work Instruction must follow the procedures’ requirements. The top level documents are more broad and general in term of contents. In vice versa, lower level documents are more detail and use for daily processes.
  • 8. ISO 9001:2008 QMS Documentation Organization Requirements a) A specific documents, including documented procedures and records as required by ISO 9001 b) A specific documents, including records as required by your organization to ensure the effective planning, operation, and control of your QMS. c) Extent of the quality management system documentation can differ from one organization to another due to 1. Size of organization and type of activities 2. Complexity of processes and their interactions 3. The competence of personnel d) The documentation can be in any form or type of medium
  • 9. ISO 9001:2008 What’s a DOCUMENT? 1) A document is information and its supporting medium 2) The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample or a combination thereof 3) A sets of documents, for example : *Specifications and records = Documentation AS DEFINED UNDER ISO 9000:2005
  • 10. ISO 9001:2008 Documented Procedure  The Term “Documented Procedure” means that the procedure is : a) Established b) Documented c) Implemented d) Maintained  A single document may address the requirements for one or more procedures.  A requirement for a documented procedure may be covered by more than one document.
  • 11. ISO 9001:2008 What’s a RECORD? 1) A record is a document stating results achieved or providing evidence of activities performed. 2) Records can be used, for example, to document traceability and to provide evidence of verification, preventive action and corrective action 3) Generally records need not be under revision control. AS DEFINED UNDER ISO 9000:2005
  • 13. ISO 9001:2008 1.Clause 5.3 Quality Policy Clause 5.3 originated at Clause 5- Management Responsibility Top Management shall ensure that the Quality Policy 1) Is appropriate to the purpose of the organization; 2) Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system; 3) Provides a framework for establishing and reviewing quality objectives; 4) Is communicated and understood within the organization, and is reviewed for continuing sustainability *Top Management = Person or group of people who directs and controls an organization at the highest level
  • 14. ISO 9001:2008 2.Clause 5.4.1 Quality Objectives Top Management must establish Quality Objectives. Quality objectives must: 1) Measurable and align with Quality Policy for commitment of continual improvement 2) Include meeting customer’s requirements and other requirements determined by the organization 3) Must periodical review and monitor the result and provide necessary corrective actions. (Check: ISO Clause 8.2.3 Monitoring and Measurement Process) * Create a Quality Objectives Register to record all quality objectives as set/approved by top management
  • 15. ISO 9001:2008 Characteristics of Quality Policy towards the Organization Provides top management’s vision on quality management for the organization Provides the organization with focused direction like high level goals and objectives Must be consistent with the scope of the organization’s QMS and other business, management and organizational strategies within
  • 16. ISO 9001:2008 Clause 5.4.1 Audit Checklist An audit checklist should cover the following areas:  Check for evidence of how top management shows its commitment to: 1) Communicating to the organization the importance of meeting client/customer as well statutory and regulatory requirements; 2) Establishing the Quality Policy; 3) Ensuring that quality objectives are established; 4) Conducting management reviews; 5) Ensuring the availability of resources
  • 17. ISO 9001:2008 Clause 5.4.1 Audit Checklist  Look for the following: 1) How its made clear how a Customer requirement is translated into action; 2) How the Quality Policy is communicated regularly; 3) How Quality objectives are established and by whom that reviews are held regularly on the status of business operations; 4) How resources are allocated to the functional areas.
  • 18. ISO 9001:2008 3.Clause 4.2.2 Quality Manual Organization must establish and maintain a Quality Manual. Quality Manual include information of organization’s key processes and must include: 1) The scope of the QMS 2) Any exclusion clause of QMS does not apply in the organization but limit t ISO 9001 within Clause 7 3) The documented procedures established for QMS and the reference of them 4) A description of the sequence and interaction of the processes including in the QMS
  • 20. ISO 9001:2008 4.Clause 7.1 Quality Plan  A document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract  These procedures generally include those referring to quality management processes and to Product Realization Process  A quality plan often makes reference to parts of quality manual or to procedure document  A quality plan is generally one of the results of quality planning
  • 21. ISO 9001:2008 Clause 7.1 Audit Checklist An audit checklist should cover the following areas:  Are the processes needed for product realization planned, developed and documented in a quality plan? Are the following determined in the quality plan, as appropriate: 1) Quality objectives for product, project or contract 2) Need to establish processes/ documents 3) Need to provide resources/facilities 4) Required verification, validation, monitoring inspection, test activities & criteria for acceptance 5) Records to provide evidence of conformity to established processes & product requirements
  • 22. ISO 9001:2008  Interview those employees responsible for launching new products, services and processes: 1) Is there a plan on how existing products/services will be produced or supplied? Is there a flowchart of the main steps? 2) Is a plan in place for introducing : New products? New Services? New contracts? New processes? New projects? New locations? New computer systems? 3) Any example of this “New” activities in the past 12 months? If so, was a plan followed/ Is a checklist used? How was implementation of all the critical steps managed? 4) How is the transition from “New” to “Normal operations” managed? 5) How are new processes monitored and measured? How are any new records identified? What is the result/output of any planning activities?
  • 30. ISO 9001:2008 Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. Clause 5.5.1 defines Responsibility & Authority and the best tool to utilize such is the organization chart 1) Organization Chart defines the arrangement of an organization’s structure in terms of responsibilities, authorities, and relationships between people 2) Arrangement is generally orderly 3) A formal expression of the organizational structure is often provided in a quality manual or a quality plan for a project 4) The scope of an organizational structure can include relevant interfaces to external organizations 5. Clause 5.5.1 Organization Chart