Category Archives: ISO 9001:2015

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Guidance for Implementation of Quality Management Systems for Certification to the ISO 9001:2015 Standard

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Risk Assessments and Management Methods for ISO Management Systems

Important enhancements have been made to the QMSCAPA™ software module for Risk Assessments and Management.

The QMSCAPA Risk Assessment (RA) module consist of:

  • Table of Risk Assessments (current and historical assessments)
    • A sub-table of specific aspects of the risk assessments
    • A look-up table of the risk impact values with regard to the
      • Probability (P) {likelihood}
      • Severity (S) {impact}
      • Detection (D) {overall detection ability reduces risk
    • Five user-defined boundaries, e.g. Very Low, Low, Medium, High, Very High.

The impact values are used to calculate the Risk Priority Number (RPN) for each aspect.

RPN = (P * S * D)

The module is developed around the concepts typically found in a Failure Mode Effects Analysis (FMEA).

The single-user version of QMSCAPA software may be downloaded free of charge, simply click here to join the QMSCAPA users-group.

The Risk Assessments browse table can store a large number of current and/or historical assessments.

  1. The browse window contains sort tabs for instant viewing of data according to the key value of the Tab.
  2. Risk assessments can be performed and recorded for virtually any type of risk related to the organization, relevant interested parties, product, service, staff, logistics, transportation, and cost, including environmental, health and safety.
  3. View RiskAspects button: Opens a sub-table of related aspects to the highlighted risk assessment may be viewed, added, edited or deleted as needed.
  4. RIP icon button: Access the Relevant Interested Parties table (RIP).
  5. Print Assessment button: Use the button to print a Risk Assessment, which includes all aspects and impacts recorded.
  6. Copy Assessment or Template button: The copy button control copies the currently highlight assessment record.
  7. The tab 10) Templates applies a filter that only shows the Risk Assessments designed to be templates.

The Risk Aspect module form is configured with 4 main Tabs or sections:

  1. The General Tab contains information about the failure (generic for incident, breach, non-conformance). The assessment calculation tool (pre and post mitigation results) is designed for rating or assessing a specific aspect of the Risk identified and associated in the Risk Assessment Table. Therefore, a one to many relationship exist between the Risk (parent table) and the Aspects (child table).
  2. Tab 2) contains fields for additional consequences.
  3. Tab 3) contains fields for mitigation or risk treatment actions.
  4. Tab 3) contains a method of generating risk impact statement based upon availability, confidentiality, integrity and financial effect.

1) General tab

(A) In the form image below/right, Describe the failure and the failure mode.

(B) Describe what may cause the failure and the failure effect.

(C) The impact values for calculating the Risk Priority Number (RPN) (pre-mitigation treatments); see the look-up table for impact values:

  • RPN = Probability (P) * Severity (S) * Detection

(D) The impact values for calculating the Risk Priority Number (RPN) (post-mitigation treatments);

(E) Look-up Tables for Response to Risk Aspect and the current/last Status of the Risk Aspect.

(F) The RPN can report the pre or post-mitigation action [√] RPN Post Mitigation Action is check-box.

Additional QMSCAPA risk assessment and management information has been published at

ISO 9001:2008 vs. ISO 9001:2015 (2013 CD)

ISO-9001-2015-COMPAREDA Focus on Clause 4

A direct clause by clause comparison of ISO 9001:2008 vs. ISO 9001:2015 is difficult at best. Eight clauses in the 2008 version are replaced by ten in the 2013 committee draft.

Clauses 1 through 3 have the least changes, sans the word ‘continual’. Clause 4 is a major rewrite and suggest a new approach to documentation and planning requirements.  The process model and role is expanded to included expected output, risks of conformity for goods and services. Plus, customer satisfaction if unintended outputs are delivered or process interaction is ineffective.

ISO 9001:2008

ISO 9001:2015

4 Quality Management System

4.1 QMS: General Requirements

The organization will establish, document, implement, maintain and continually improve a Quality Management System (QMS).

This is where we find the Requirement to identify processes that need to be controlled, and determine how they interrelate.

The organization must also determine how to control any outsourced processes.Steps that need to be taken are:

  • Identify the processes needed for the QMS
  • Determine the sequence and interaction of these processes
  • Determine criteria and methods required to ensure the effective operation and control of these processes
  • Ensure the availability of information necessary to support the operation and monitoring of these processes
  • Measure, monitor and analyze these processes and implement action necessary to achieve planned results and continual improvement

This section does not address the documentation of the processes. It focuses on the development and implementation of the process and goes on to require that they are managed and continually improved.

4.2 Documentation Requirements

4.2.1 General

Quality management system documentation must include:

  • Documented procedures required by the standard
  • Documents required by the organization for effective operation and process control
  • Quality policy and objectives

The standard only identifies six places where a documented procedure is
required. The organization determines if additional documentation is

The only documented procedures specifically required by ISO 9001:2008
are procedures for:

  • Document Control (now appears in 7.5.3)
  • Control of Quality Records
  • Internal Quality Audits
  • Control of Nonconformity
  • Corrective Action
  • Preventive Action

However, this does not mean that they are the only procedures required.
You must identify what else is required in your organization. In 4.1,
the standard asks organizations to Identify key processes and their

You will need to document your key processes. Key processes must be
identified early in your transition to the new revision. This will help
you identify procedures and work instructions needed for effective
operation and control of key processes.

From the list of key processes, additional needed documentation must be
developed to meet each organization’s needs.

4.2.2 Quality Manual (does not appear in the 2013 CD)

The standard also requires a documented quality policy and objectives.

A quality manual must be created and maintained that includes :

A description of the sequence and interaction of the processes included in the quality management system (QMS)

Identification of permissible exclusions

4.2.3 Control of documents

You must have a system in place to control your documents- your quality
manual, procedures and work instructions

Establish a process to approve documents, control the revision and
distribution of the documents, and control changes to the documents

You must make sure that people are working from the current, correct

Quality records must be controlled and protected, quality records are
your evidence of complying with your quality system

Have a process in place that identifies what quality records you have,
where they are kept, how long they are kept, how they are protected from

Most companies will use a “Master List” to list the current revision and
location of each document. Online systems work very well for document
control if electronic files are protected from change.

Recording the distribution of documents is important; if a document is
revised all previous revisions of the document must be replaced. This is
only possible if you know where all those copies are.

Documents must be reviewed on a regular basis to make sure they are up
to date. Some organizations may choose to review all documents on a
regular basis. For example, annually. However, there is not a
requirement to do it on a regular basis, but “as necessary”.

This could be with regular use, and during internal audits. If employees
are using the documents they should be watching for documents that need
updating, and submitting document change requests. The internal audit
program measures compliance with documentation requirements (along with
other requirements) and should identify required revisions.

In other words, if staff are using the system as it is designed,
documents are continually updated, reviewed and revised and an annual
review step is not necessary to build into the system.

4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

A table works well for listing all your quality records, where they are
generated and stored, how long they are stored and who is responsible
for them. Include a requirement in your procedure that says quality
records must be legible.

The procedure must address storage, retention times and disposition. If
you archive records either on-site or off-site include your process in
your procedure.

ISO does not specify how long you have to keep your records, but
remember that the auditor will want to see six months to a year worth of

4 Context of the organization

4.1 Understanding the organization and its context

The terms ‘document’ and `record’ have both been replaced throughout the requirements text by ‘documented information’. The word ‘shall’ appears 133 times; the word ‘documented’ appears 47 times.

The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality Management system. The organization shall update such determinations when needed.

When determining relevant external and internal issues, the organization shall consider those arising from:

a) changes and trends which can have an impact on the objectives of the organization;
b) relationships with, and perceptions and values of relevant interested parties;
c) governance issues, strategic priorities, internal policies and commitments; and
d) resource availability and priorities and technological change.

Note 1
Understanding the external context can be facilitated by considering issues arising from legal, Technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local.

Note 2 
When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.

4.2 Understanding the needs and expectations of interested parties

The organization shall determine

a) the interested parties that are relevant to the quality management system, and
b) the requirements of these interested parties

The organization shall update such determinations in order to understand and anticipate needs or expectations affecting customer requirements and customer satisfaction.

The organization shall consider the following relevant interested parties:

a) direct customers;
b) end users;
c) suppliers, distributors, retailers or others
involved in the supply chain;
d) regulators; and
e) any other relevant interested parties.

Note: Addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities.

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider

a) the external and internal issues referred to in 4.1, and
b) the requirements referred to in 4.2.

The scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included.

When stating the scope, the organization shall document and justify any decision not to apply a requirement of this International Standard and to exclude it from the scope of the quality
management system. Any such exclusion shall be limited to clause 7.1.4 (Monitoring and measuring devices) and 8 (Operations) and shall not affect the organization’s ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.

Note: An external provider can be a supplier or a sister organization (such as a headquarters or alternate site location) that is outside of the organization’s quality management system. The scope shall be available as documented information.

4.4 Quality management system

4.4.1 General

The organization shall establish, implement, maintain and (continual deleted) improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

4.4.2 Process approach

The organization shall apply a process approach to its quality management system. The organization shall:

a) determine the processes needed for the quality management system and their application throughout the organization;
b) determine the inputs required and the outputs expected from each process;
c) determine the sequence and interaction of these processes;
d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;
e) determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these processes are effective;
f) determine the resources and ensure their availability;
g) assign responsibilities and authorities for processes;
h) implement actions necessary to achieve planned
i) monitor, analyse and change, if needed, these processes ensuring that they continue to deliver the intended outputs; and
j) ensure continual improvement of these processes.

ISO 9001:2008 Compared to ISO 9001:2015 (2013 Committee Draft)

ISO 9001:2015 Part 1: Quality Management Principles


This document introduces the seven quality management principles (QMP) on which the quality management system standards of the ISO 9000 series are based and the essential importance for establishing communications for nonconformity and corrective actions.

The principles were developed and updated by international experts of ISO/TC 176, which is responsible for developing and maintaining the ISO 9000 series on quality management standards. This guidance document provides a “statement’ describing each principle and a “rationale’ explaining why an organization should address the principle.

QMP 1 — Customer Focus

a)      Statement – The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.

b)      Rationale – Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization.

QMP 2 — Leadership

a)      Statement – Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.

b)      Rationale – Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives.

QMP 3 — Engagement of People (involvement in 2008)

a)      Statement – It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value.

b)      Rationale – To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.

QMP 4 — Process Approach

a)      Statement – Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

b)      Rationale – The quality management system is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.

QMP 5 — Improvement (continual improvement in 2008)

a)      Statement – Successful organizations have an ongoing focus on improvement.

b)      Rationale – Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

QMP 6 — Evidence-based Decision Making (factual approach to decision making)

a)      Statement – Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

b)      Rationale – Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.

QMP 7 — Relationship Management (mutually beneficial supplier relationships in 2008)

a)      Statement – For sustained success, organizations manage their relationships with interested parties, such as suppliers.

b)      Rationale – Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance.

Essential to the seven QMPs is the organization should establish an effective communications method for notifying the organization of nonconformities.

System approach to management, which appears in the 2008 version has been somewhat commingled into the 2015 seven principles.