TRAINING FOR ADMIN AREA INTERNAL AUDITORS ON ISO 9001:2015

TRAINING FOR ADMIN AREA INTERNAL AUDITORS ON ISO 9001:2015

Update of ISO 9001

Deming's Quote

Development of ISO 9001 (1)

Development of ISO 9001 (2)

Benefit of ISO 9001

Main Objectives for ISO 9001:2015

Key Perspectives for the revision

Road Map ISO 9001:2015

Transition Period - Implementation


ISO and the International Accreditation Forum IAF agreed about a period of three years for the transition from the ISO 9001:2008 to the new ISO 9001:2015.

The transition period started with the publication of the revised Standard, in September 2015.

ISO 9001 Development Process

ISO 9001:2015 Rumors

ISO 9001:2015 Rumors (1)

ISO 9001:2015 Rumors (2)

ISO 9001:2015 Rumors (3)



ISO 9001:2015 Rumors (4)

Basic Changes

Basic Changes 1

Basic Changes 2

Basic Differences in Terminology

ISO 9001:2015 Structure & Rationale

Structure

A Consolidated Structure for the Management System


High Level Structure, the same basic text, common terms and basic definitions are defined and will shape, where possible, the core of revised management system standards ISO 9001.


Organizations that implement multiple management systems (e.g quality, environment, information security) can achieve better integration and easier implementation.

ISO 9001:2015 Standard Clauses

ISO 9001:2015 Internal Rationale

ISO 9001: 2015 Context of the organization

Context of the organization - Interested Parties - Needs and Expectations

Context of the organization - Operating Environment (1)

Context of the organization - Operating Environment (2)

  • Information on external & internal issues can be found from many sources, such as:

  1. Through internally documented information and meetings
  2. National and international press
  3. Web Sites
  4. Publications from national statistical offices and other government  departments
  5. Professional and technical publications
  6. Relevant organizations
  7. Meetings with clients and related stakeholders and professional associations

Interested parties

Guidance of the interested parties

Clarifying interested parties and their relationships

Simply listing suppliers, customers, communities etc. is not enough to meet the requirements of the standard i.e understanding the needs and expectations of relevant interested parties. The information must be more meaningful by grouping interested parties based on their relationship with the organization:

  • Responsibility - investors, etc.
  • Influence - pressure groups, etc.
  • Proximity - neighbors, etc.
  • Dependency - employees, etc.
  • Representation - trade unions, etc.
  • Authority - regulators, etc.

New ISO 9001:2015 Structure

Definition of the Interested Parties

Risk Management

Risk Definition

Risk in the clauses of ISO 9001:2015

What shall an organization do?

Documented Information

Documented Information (1)

Documented Information (2)

Process Approach

Process Approach (1)

Process Approach (2)

Process Approach (3)

Process Approach (4)

Process-oriented Auditing

Turtle Diagram

Audit focused on processes

Clause 9.2 of ISO 9001:2015

A process oriented audit starts with some general questions of process control in order to conclude in the content and the scope of a process:

General question of process controlling

When controlling an operational process, it is important to determine the process and process system to which it belongs. A lot of companies seem to have spent no adequate time in the good design of the processes that it is no wonder why it is so difficult to achieve the desirable results.


The design of business processes means that each item has been identified. As internal auditors, we would like to clarify if the participants in the process (employees) understand their processes. The use of the tools "SIPOC + PDCA" is a good step in order to begin with.

General Questions of process oriented audit (1)

Describe the business process you use and how it is related to the other processes necessary for the QMS:

SIPOC


1. Who are the suppliers (S) of the process?

2. Which are the inputs (I) necessary for the process (materials, information)?

3. Which are the steps of the process (P) that transform the inputs to outputs?

4. Which are the outputs (O) that come from the process?

5. Who are the customers (C) that take the outputs of the process?



General Questions of process oriented audit (2)

PDCA


1.PLAN (P): Which are the policies, procedures, forms, records or other information that have been developed for the process?

2.DO (D):  Which are the data that you monitor or you collect?

3.CHECK (C):  Which are the criteria, the objectives, the Key Performance Indicators (KPI) that you compare to the data? How do you analyze the data of your process?

4.ACT (A): Which are the actions have been taken in order to correct or avoid (8.5.2, 8.5.3) the non-conformances or defects in the process?


How do you monitor and control these documents/ records?

Leadership

Leadership

The  new standard contains significantly increased requirements for Top Management commitment and involvement


  • with respect to the Quality Management System
  • with respect to Customer Focus

Food for thought

Food For Thought (1)

Food for thought (2)

Food for thought (3)

ANNEX

A consolidated structure for the Management System (1)

A consolidated structure for the Management System (2)

Context of the organization - Operating Environment (1)

Context of the organization - Operating Environment (2)

Context of the organization - SWOT Analysis

Context of the organization - Operating Environment (3)

Context of the organization

Interested Parties

Clarifying Interested Parties and their Relationships

Questions and answers

1. ISO 9001:2015 requires the use and implementation of ISO 31000 (“Risk management- Principles and guidelines”)

  • True
  • False

2. What is part of the rationale for the QMP 1- Customer Focus?

  • A. Better understanding of customer needs
  • B. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization
  • C. Customer needs shall be known and evaluated
  • D. Customer focus is achieved when an organization responds to complaints in a timely manner

3. The organization shall retain documented information on the quality objectives?

  • True
  • False

4. One of the key purposes of quality management system is to act as a preventive tool. Consequently, this International Standard does not have a separate clause or sub-clause titled “Preventive action”

  • True
  • False

5. To meet ISO 9001, an organization has to identify in their Quality Management System (more than one answer is possible)

  • A. Management processes
  • B. All the processes needed
  • C. Support processes
  • D. Key processes
  • E. The process sequence and interaction

6. The changes in the structure and terminology of ISO 9001:2015, in comparison with ISO 9001:2008, shall be reflected in the documentation of an organization’s quality management system?

  • True
  • False

7. The scope of the Quality Management System shall be maintained as documented information?

  • True
  • False

8. Quality objectives shall be:

  • A. Communicated by a scorecard
  • B. Measurable
  • C. Communicated
  • D. Updated quarterly
  • E. (B) and (C) are correct
  • F. (B) and (D) are correct
  • G. All answers are correct

9. “Risk Based Thinking”:

  • A. The concept of risk-based thinking has always been implicit in ISO 9001. ISO 9001:2015 makes it more explicit
  • B. Requires the elimination of all possible sources of risk
  • C. Is something completely new in ISO 9001
  • D. Is part of the preventive action process

10. What is the correct answer?

  • A. The organization can decide to determine additional needs and expectations that will assist it to meet its quality objectives
  • B. It is at the organization’s discretion whether or not to accept additional requirements to satisfy interested parties beyond what is required by 9001:2015
  • C. (A) and (B) are correct
  • D. None of the above is correct

11. How long is the transition period to ISO 9001:2015 from ISO 9001:2008?

  • A. 1 year
  • B. 18 months
  • C. 3 years

12. A process….

  • A. is always corresponding to a department within an organization
  • B. is generally planned and carried out under controlled condition to add value
  • C. only applies in the production area
  • D. is a set of interrelated or interacting activities which transforms inputs into outputs
  • E. (B) and (D) are correct
  • F. (C) and (D) are correct

13. Documented information can refer to:

  • A. the quality management system, including related processes
  • B. information created in order for the organization to operate (documentation)
  • C. evidence of results achieved (records)
  • D. all answers above are correct
  • E. answers (B) and (C) are correct

14. The revised standard will require organizations to use the term “Documented information” instead of “documents” and “records” in their quality management system?

  • True
  • False

15. Choose the typical general questions of process oriented audit (more than one answer is possible)

  • A. Which are the inputs (I) necessary for the process?
  • B. Which are the outputs (O) that come from the process?
  • C. Who are the customers (C) that took the outputs of the process?
  • D. Which are the written procedures that describe this process?
  • E. Which are the information- materials necessary for the process?
  • F. How do you analyse the data of your process?

16. Top Management is necessary to (more than one answer is possible):

  • A. hire an experienced Quality Manager in order to implement the transition to the revised ISO 9001:2015 standard and maintain the quality management system
  • B. promote the use of the process approach and risk- based thinking
  • C. ensure that the resources needed for the quality management system are available
  • D. engage, direct and support persons to contribute to the effectiveness of the QMS
  • E. demonstrate commitment with respect to customer focus

17. Top Management shall review the organization’s QMS, at planned intervals (at least 1 or 2 per year) in order to (more than one answer is possible):

  • A. ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization
  • B. get informed about the QMS and how the Quality Manager runs the QMS throughout the year or the six months period of time because Top Management does not have any specific knowledge about it
  • C. conclude in management review outputs such as: opportunities for improvement, any need for changes to the QMS, resource needs, documented information as evidence of the results of management reviews