This document discusses ISO 9001:2015 requirements for quality management system documentation. It covers the purpose and benefits of a quality management system. The key requirements for quality system documentation include establishing, documenting, implementing, maintaining and improving the effectiveness of the quality system. The core documentation includes a quality manual, quality policy, objectives, procedures, processes and records. The document also discusses controlling documented information, including approval, identification, format, changes and retention. It provides examples of document structure, layout and control status indicators.

1. ISO 9001:2015
Quality Management System

2. Introduction
QMS Structure and Style
Documenting the QMS
Controlling the QMS

3. Learning Objectives
a.Understand the documentation requirements
of ISO 9001:2015;
b.Know the structure of QMS documentation;
c. Know the different types of QMS documents;
d.Understand the requirements for controlling
Documented Information of the QMS

4. SECTION I
INTRODUCTION

5. What is Quality Management System?
A formalized system that documents
processes, procedures, and
responsibilities for achieving quality
policies and objectives.

6. Principles of ISO 9001:2015 - QMS

7. Key Benefits of ISO 9001:2015 QMS
Meeting the customer requirements;
 Meeting organization requirements;
More efficient ways of working will save time, money and resources;
Defining, improving and controlling processes;
Reducing waste
Preventing mistakes
Lowering cost
Facilitating and identifying training opportunities
Engaging staff
Setting organization-wide direction
Producing consistent results
operational performance will cut errors and increase

8. ISO 9001:2015 Documentation Requirements
The ISO 9001:2015 documents basic
requirements for an organization to:
Establish;
Document;
Implement; and
maintain
a quality management system and
continually improve its effectiveness in
accordance with the requirements of the
International Standard.

9. ISO 9001:2015 Documentation Requirements
There are specific ISO 9001:2015 documentation
requirements that need to be fulfill which provides
better control over implemented QMS system.
Quality Manual
Quality Policy
Quality Objectives
Quality Procedures
Process Approach
Standard Operating Procedures
Sample Forms and Templates
Work Instructions
Quality Guidelines

10. •Provides the design and
specification of a quality
management system by
defining the QMS scope
and applicability,
operating policies, and
related information about
the QMS.
Quality Manual
 Varies in detail and format to
suit the size and complexity of
an organization

11. Contents of the Quality
Manual
0 - Preliminary Information
 Approval
 Users Guide
 Table of Contents
1 - Introduction (e.g. About the organization)
2 - Overview of the QMS (Scope, Applicability, Business
Process Map, Table of Organization
3 - Terms and Definitions (Terms and acronyms used in
the QMS; List of applicable legal requirements)
4 to10 - Operating Policies Annexes (essential supporting
information about the QMS)

12. Quality Objectives
• Result to be achieved related
to quality
• Aim, goal, or target
• Intended outcome
• Specified for relevant
functions, levels and
processes

13. Procedure: Describes the process.
Work Instructions: Tells how to perform the process.
Forms, Tables, etc.: Places to record the results of
tests, audits, etc.
Guidelines: Specifies general rules, instructions,
recommendations, directions, regulation, rule, guiding
principles, principles, or suggestions; sometimes
contextually appearing as Do’s and Dont’s. Unlike
procedure or work instruction, not structured as a
process flow
Procedures describe an overall process such as "Purchasing", where as
work instructions would describe a more detailed portion of the
procedure such as "Completing a PO" or "Ordering supplies".

14. Section 2
QMS Structure and Style

15. • QMS Scope
The major activities and outputs
around which the Quality
Management System is established
• Applicability
An evaluation and declaration of the
requirements that apply and does
not apply to the QMS.

16. • There are many QMS documents.
• The QMS structure provides a hierarchy
or system of establishing and
controlling the QMS documents
• Usually consist of 3-4 levels – the higher
level the document is, the lesser
amount of documentation there are
QMS Structure

17. QMS Structure

18. PDEA QMS Structure
1st Level
Quality Manual
The primary document that governs and defines the scope, objectives, outlines and
processes of the Quality Management System.
This document describes the purpose for PDEA and why it is desired. Included in the 1st
Level of QMS Documentation Structure are Statutory Law and Legal Requirements,
Quality and Operational Policies.
2nd Level
Operating Procedures and Guidelines
The document that describes the actual processes and define the responsibilities and
controls applied in the quality management systems. These documents explain how the
policies described in the Quality Policy are implemented.
3rd Level
Work Instructions, Forms, and Records conference notice, minutes of the meetings, process
documentation reports, plans and programs, references, etc. These documents also include
external generated references, product specifications, work instructions, service
requirements, industry standards, records and the likes.

19. Section 3
Documenting the QMS

20. 1) Communicate information
2) Evidence conformity
3) Share knowledge
4) Disseminate and preserve lessons
learned.
QMS documentation refers to documented information
maintained and retained in a Quality Management System
(QMS).
Objectives of QMS Documentation

21. GOAL of ISO 9001:2015
Documentation
To establish a
“Documented QMS”, NOT a
“system of documents”

22. Qualities of Good Documentation
• Clear
• Concise
• User friendly
Note:
• Avoid Drowning in Detail
• poorly written procedures
• Avoid Creating too much or too little

23. The KISS Principle
• Keep It Short and Simple !
• Short words, sentences and paragraphs
• Avoid jargon that is not easily understood
• Use easy-to-understand, direct, frank, straight
words
• Simplify, where practicable! Take advantage of
using pictures, flow charts, pictograms, and
cartoons to clarify ideas, concepts, reminders,
and instructions!

24. Section 4
Controlling the QMS

25. Documented Information
Clause 7.5
Documented Information – information
required to be controlled, maintained and
retained by an organization and the medium
on which it is contained.
Note: Documented information generically represent
“document”, ”documented procedure” and “record” in the
2015 version of ISO 9001.

26. Documented Information
Documented Information – used to describe all
QMS document and record requirements
Documents – shall be “maintained” (procedures
“controlled” with versions)
Records – shall be “retained”; evidence of activity
Note: documents maybe retained if prior versions
are required to be kept/archived.

27. Indicating Control Status
a. distribution, access, retrieval and use;
b. Storage and preservation, including preservation
of eligibility;
c. Control of changes (version control); and
d. Retention and disposition

28. Documented Information
Creating and updating
• Identification and Description
• Format
• Review and approval for
suitability and adequacy

29. Document Layout
Purpose:
 To provide a distinctive physical appearance of QMS
documents
o The physical layout and appearance of headers,
approval block and footer o Required section headings
o Numbering or coding scheme
o Specifications for fonts (style or font, size, etc.)
o Conventions for flow charts (if used)

30. Approving and Organizing
QMS Documentation
Establish:
Reviewing and approving authorities
Purpose of document review:
-confirmation of adequacy of document
Purpose of document approval:
-authorization for use or application

31. Approving and Organizing
QMS Documentation

32. Indicating Control Status

33. Indicating Control Status
Changes to documents are requested
by completing ‘Document Request
Form (DRF).
Revised documents shall
accompany by an
accomplished revision history
form.

34. Document Control
Mechanism
• A documented system procedure •
Managed by a document controller
(Controller of Documented Information) •
Covers control of creation, revision, deletion
/ cancellation, and superseded (obsolete)
documents
One person is designated as the Document Control Coordinator.
This person – keeps the master list up-to-date – Makes
revisions to documents – Distributes revised documents –
Collects the outdated documents

35. Thank you!