ISO 9001:2015 Implementation Timeline

Mar 2017

Sept 2015 Sept 2016 Sept 2017 Sept 2018

No audit based on 9001:2008 is no

ISO 9001:2015 No New 9001:2008 ISO 9001:2008 for
released. certificate after this. more valid
existing companies.
 No Quality Manual

How Quality Manual is Used?

New Employee Training

Index of Company Procedures

Vendor / Contractor Selection

Desktop Audit by External Auditors

To External Customers
 No Quality Manual

You still might need the Quality Manual.

Cross Reference Table

Clause Interpretations

Quality Brochure for Clients/Employee

 Knowledge as a Resource

ISO 9001:2015

7.1.6 Organizational Knowledge

determine the knowledge necessary

maintained and be made available

acquire or access any necessary additional

knowledge
 Knowledge as a Resource

Two types of Knowledge

Explicit Knowledge or Formal Knowledge

Tacit Knowledge
 Knowledge as a Resource

ISO 9001:2015 - 7.1.6 Organizational Knowledge

Two sources of Knowledge

internal sources (e.g. intellectual property;

knowledge gained from experience; lessons
learned from failures and successful projects;
capturing and sharing undocumented
knowledge and experience; the results of
improvements in processes, products and
services);
external sources ( e.g. standards; academia;
conferences; gathering knowledge from
customers or external providers).
 Knowledge as a Resource

Quick Actions

Start collecting data

Analyze data to find the hidden truth

Protect Knowledge

Reuse existing knowledge/copy

Acquire additional Knowledge

 Risks and Opportunities

6.1 Actions to address risks and opportunities

4.1 Understanding the organization and its context

The organization shall monitor and review

information about these external and internal
issues.
Issues can include positive and negative factors
or conditions for consideration.
4.2 Understanding the needs and expectations of interested parties

The organization shall monitor and review

information about these interested parties and
their relevant requirements.
 Risks and Opportunities

6.1 Actions to address risks and opportunities

6.1.2 Determine Risk

a) assurance to achieve its intended results

b) enhance desirable effects
c) prevent, or reduce, undesired effects
d) achieve improvement
6.1.2 Plan and Take Action

1) integrate actions into its QMS processes.

2) evaluate the effectiveness of these actions
Actions to be proportionate to the potential
impact on the conformity.
 Risks and Opportunities

6.1 Actions to address risks and opportunities

Prioritize Risks

Probability and Impact Matrix

Each risk is analyzed for probability and Impact
and is assigned

Risk score = Probability x Impact

 Risks and Opportunities

6.1 Actions to address risks and opportunities

Very Low Medium High Very

Low High

Very Medium Medium High High High

High

High Low Medium Medium High High

Probability

Medium Low Medium Medium Medium High

Low Low Low Medium Medium Medium

Very Low Low Low Low Medium

Low

Impact
 Risks and Opportunities

6.1 Actions to address risks and opportunities

Negative Risk Positive Risk

Avoid Exploit
Mitigate Enhance
Transfer Share
Accept Accept