The PROGRAM of QMS
Development
Implementation
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
ISO 9001:2015
Certification
Preparation
2016 Centauri Business Group Inc. support@[Link]
QMS Program
QMS
Development
(5-6 months)
QMS
Implementation
(4-5 months)
ISO 9001:2015
Certification
Preparation
(2-4 months)
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
During the Initial audit assess the
Initial audit of the
organization
Evaluation of existing
management system
As-is
following:
a) definition of the structure;
b) processes definiteness and inter
relationship;
c) management, technology, and design
documentation availability, completeness
and structuring;
d) the adequacy and control of resources.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
The following QMS processes can be accepted as the base:
Management review (cl.5; 9.3 ISO 9001:2015); Actions to
address risks and opportunities methodology (cl. 6.1);
Control of personnel (cl.7.1.2; 7.2); Technical support
Definition of QMS
(cl.7.1.3.b); Control of monitoring and measuring
resources (cl.7.1.5); Internal communication (cl.7.3);
Processes and their
Control of documented information (cl.7.5.2; 7.5.3);
Owners.
(cl.8.2.1.b; 8.2.1.d; 8.2.2; 8.2.3); Customer
Marketing activity (cl.8.2.1.a); Contract analysis
communication (cl.8.2.1.c); Design and development of
products and services (cl.8.3); Control of external
providers of products and services (cl.8.4); Production and
service provision (cl.8.5.1; 8.5.2; 8.5.3; 8.5.4; 8.6); Postdelivery activity (cl.8.5.5); Control of nonconforming
process outputs, products and services (cl.8.7); 'Internal
Audit (cl.9.2); 'Corrective action (cl. 10.2)
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
QMS development team should
include:
- quality manager representative;
Forming of the QMS
development team
- process owners;
- coordinators (employees who are
responsible for QMS operating state
maintenance, for example, Quality
control and Audit department
employees).
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
QMS Development Order:
-
appoints
Quality
Manual
representative;
Executives order for
QMS development
establishes
development
actions
(this
for
the
Program
QMS
can
be
used as a basis);
- assigns Team members responsibilities
and authorities;
- establishes the development stages
periods and deadlines.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
It is a good practice to have a 24-hour
training course. Quality management
representative or the external consultant
ISO 9001:2015 QMS
can provide the training.
Development team
training
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Development of the
Organizations
Mission
Strategy
Quality Policy
Quality Objectives
Recommendations
ISO 9001:2015 does not require the
Organization to have a mission, this is - a
good practice. It is beneficial to include
Mission into the Quality policy rather than
having it as a separate document.
The presence of Strategic direction is
determined by the requirements of clause.
5.1.1.b, 5.2.a.
The requirements for Quality policy and
objectives are set out in separate clauses of
ISO 9001:2015 - 5.2 and 6.2 respectively.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Recommendations
QMS Processes
In
development
expedient
QMS
processes
to
use
implementation
development,
the
Process
steps
it
is
approach
(cl.4.4
ISO
9001:2015):
- Process models development;
-
Linking
process
models
in
the
Organizations business model;
- Processes criteria definition;
- Ensuring monitoring, measurement,
analysis and evaluation;
Processes to improvement mechanisms
development.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
1. QMS Development
Content of Activities
Development of the first
edition of the backbone
of the Organizations
standards.
Recommendations
A list of QMS Processes documented
procedures (outlined in sec.1.2 of this
document) can be set as a basis.
It is acceptable to reduce the number of
documented procedures giving detailed
description of the processes in the
corresponding section of the Quality
Manual (QM).
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
2. QMS Implementation
Content of Activities
Employees training
Recommendations
During the Initial audit assess the
following:
a) definition of the structure;
b) processes definiteness and inter
relationship;
c) management, technology, and design
documentation availability, completeness
and structuring;
d) the adequacy and control of resources.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
2. QMS Implementation
Content of Activities
Validation and approval
of system QSP
Checking the third
level QMS normative
documentation.
Recommendations
It is important to involve all QSP users in the
validation and get proposals for corrections
from them.
The following is attributed to the QMS third
level normative documents:
- Subdivisions provisions,
- Job descriptions,
- Operating procedures, and others.
At this point, link the existing QMS third level
normative documents to the QSP and develop
the missing documents.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
2. QMS Implementation
Content of Activities
Quality Manual
Development
Quality Manual
Template
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
3. ISO 9001:2015 Certification Preparation
Content of Activities
Recommendations
QMS Internal auditors
training
Conducting of internal
preliminary audit
This Program sections 3.2 and 3.3 activities
can be conducted 2-3 times until the
Leadership understands that the QMS is
functioning well and the decision to enter
into a contract with the Certification body is
made.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
3. ISO 9001:2015 Certification Preparation
Content of Activities
Corrective actions based on
the internal audit results.
Signing a contract with the
Certification body.
Conducting of Certification
audit and nonconformities
elimination.
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
2016 Centauri Business Group Inc. support@[Link]
Questions? Comments? support@[Link]
Related ISO 9001:2015 Documents and Templates
ISO 9001:2015 Quality
Manual Template
Set of 6 Essential
Quality System
Procedures
ISO 9001:2015 Audit
Checklist
Download the PROGRAM
in table format (PDF)
The PROGRAM of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation
ISO 9001:2015
Overview
Presentation for
Training
Full list of ISO 9001:2015
Documents and Templates
2016 Centauri Business Group Inc. support@[Link]