MODULE 1 - CONTENT

Module 1 - Introduction to ISO 9001

i. Introduction & suggested reading
ii. What is ISO 9001?
iii. The structure of ISO 9001
iv. Quality management principles in ISO 9001
v. Introduction to the Quality Management System
vi. Implementing ISO 9001 requirements
vii. Implementing ISO 9001 as a project
viii. Documenting ISO 9001 requirements
ix. ISO 9001 Benefits
x. Related documentation
xi. Practice exam
 MODULE 2 - CONTENT
Module 2 - The planning phase
i. Introduction & suggested reading
ii. Understanding your organization and its context [clause 4.1]
iii. Understanding the needs and expectations of interested parties [clause 4.2]
iv. Determining the scope of the QMS [clause 4.3]
v. Leadership and commitment [clause 5.1]
vi. Quality Policy [clause 5.2]
vii. Organizational roles, responsibilities and authorities [clause 5.3]
viii. Addressing risks and opportunities [clause 6.1]
ix. Quality objectives [clause 6.2]
x. Resources [clause 7.1]
xi. Competence [clause 7.2]
xii. Awareness [clause 7.3]
xiii. Communication [clause 7.4]
xiv. Documented information [clause 7.5]
xv. Related documentation
xvi. Practice exam
 MODULE 3 - CONTENT
Module 3 - Operation
 i. Introduction & suggested reading
 ii. Operational planning and control [clause 8.1]
 iii. Requirements for products and services [clause 8.2]
 iv. Design and development of planning and inputs [clause 8.3]
 v. Design and development controls, outputs and changes [clause 8.3]
 vi. Control of externally provided processes, products and services [clause 8.4]
 vii. Control of production and service provision [clauses 8.5 ]
 viii. Post production activities [clauses 8.5 and 8.6]
 ix. Control of nonconforming outputs [clause 8.7]
 x. Operating the QMS [clause 8]
 xi. Related documentation
 xii. Practice exam
 MODULE 4 – CONTENT
Module 4 - The Check and Act phases
 i. Introduction & suggested reading
 ii. Monitoring, measurement, analysis and evaluation [clause 9.1]
 iii. Internal audit [clause 9.2]
 iv. Management review [clause 9.3]
 v. Nonconformities and corrective actions [clause 10.1]
 vi. Continual improvement [clause 10.2]
 vii. Related documentation
 viii. Practice exam
 MODULE 5 - CONTENT
Module 5 - Introduction to the internal audit
i. Introduction & suggested reading
ii. Internal vs. external audit
iii. The main purpose of the internal audit
iv. Requirements of ISO 9001
v. Criteria for selecting the internal auditor
vi. The audit findings
vii. Nonconformities
viii. Observations
ix. Major and minor nonconformities
x. Definition of major nonconformity
xi. ISO 19011
xii. Related documentation
xiii. Practice exam
 MODULE 6 - CONTENT
Module 6 - Organizing the internal audit
i. Introduction & suggested reading
ii. Organizing the internal audit
iii. Internal audit procedure
iv. Annual audit program
v. Audit plan for an individual audit
vi. Related documentation
vii. Practice exam
 MODULE 7 - CONTENT
Module 7 - Internal audit elements
• i. Introduction & suggested reading
• ii. Internal audit elements
• iii. Document review
• iv. Creation of the checklist
• v. Internal audit report
• vi. Corrective action requests
• vii. Corrective action follow up
• viii. Related documentation
• ix. Practice exam
 MODULE 8 – CONTENT
Module 8 - The main audit
• i. Introduction & suggested reading
• ii. Auditor assumptions
• iii. Techniques for finding evidence
• iv. Sampling the records
• v. Recording the evidence
• vi. Interviewing techniques
• vii. Related documentation
• viii. Practice exam
• ix. Instructions for taking the exam and obtaining the certificate
 RELATED DOCUMENTATION
Related documentation
The following highlights are the QMS related documentation:
• • Matrix of Key Performance Indicators – The matrix of key performance indicators is the listing of
the important factors that the company has chosen to track to ensure maintenance of the processes.
• • Data Analysis Report – The data analysis report is the statement detailing the analysed data for the
management review meeting.
• • Procedure for Measuring Customer Satisfaction – The purpose of this procedure is to describe
methods for gathering and using information about a customer satisfaction in order to establish a system
for monitoring customer satisfaction.
• • Monitoring of Customer Satisfaction – The monitoring of customer satisfaction is the document
that contains the plan for collecting, analysing and reviewing the data on customer satisfaction.
• • Internal Audit Program – The internal audit program is the document to record the yearly schedule
for internal audits.
• • Internal Audit Report – The internal audit report is the document used to report on the findings of
an internal audit.
• • Internal Audit Checklist – The internal audit checklist is the list of questions required to ensure the
management system is implemented and maintained. The listing includes over 100 questions to ensure
each requirement of the ISO 9001 standard is implemented and maintained within the quality
management system, and includes the ability for the company to add additional questions to suit
additional company needs.
• • Procedure for Management Review – The purpose of this procedure is to ensure systematic and
periodic review of Quality System Management by the Top Management in order to evaluate possibilities
for improvement and needs for changes, including Quality Policy and Quality Objectives.