ISO 9001:2015 Implementation Programme

5 phases with 27 activties, undertaken over a 35 week duration

Activity

Duration Activity Not

Phase

Activity Description Participants/Responsibilities Deliverables/Outputs Start Date Finish Date

(Days) Progress % Complete

The first critical step in the development and implementation of a QMS is the formal endorsement
and commitment of Top management. The proposed development and implementation of the
Top management must
QMS should be formally documented and include the proposed implementation strategy, a broad
ensure that the finances to and understood [Enter start [Enter finish [Enter
1 1 timeline and an estimated budget. The appointment of a professional Quality Manager or Top Management #VALUE! #VALUE!
support the QMS will be date] date] progress %]
Management Representative is a key factor successful QMS implementation. It is strongly
available
recommended that a full-time staff member be appointed at a senior level, and it is beneficial for
the implementation process if they have knowledge of the business

Read them both and make yourself familiar with their language and concepts. Although they are
Purchase and read copies of both written in a dense, formal language, the clause titles in ISO 9001:2015 are fairly self-
Top Management [Enter start [Enter finish [Enter
1 2 ISO 9000:2015 and ISO explanatory. Identify the processes that comprise your management system and determine which #VALUE! #VALUE!
Management Representative date] date] progress %]
9001:2015 processes are responsible for meeting which requirements. Establish the QMS Implementation
Team.

Provide an overview of the
ISO 9001:2015 requirements
1 3 to key personnel, including
those taking part in the QMS
Implementation Team
An introductory training session for all staff involved in the QMS should be organized, starting with
the QMS Implementation Team including Top management. A basic introductory ISO training
course helps to ensure the successful implementation of a QMS by providing sound understanding
Whole Organization
of the principles and practices pertaining to ISO 9001. Ideally, this course should be provided by a
Top Management [Enter start [Enter finish [Enter
registered training organization with expertise in this area. If a staff member has to conduct the #VALUE! #VALUE!
Management Representative date] date] progress %]
training session, they must have a sound and demonstrated background in the subject matter
QMS Implementation Team
combined with, wherever possible, formal training skills. Involve employees in developing and
improving the system, through awareness sessions, flowcharting, team reviews and experience
feedback.

Review all existing management system practices, controls and documentation using the
requirements of ISO 9001:2015 as the criteria. Try to understand each business process in context All Managers
of each of the requirements of the standards by comparing different activities and processes with Heads of Department
Conduct a gap analysis of
what the standards requires. A gap analysis is a technique to clearly identify which clauses of ISO Top Management [Enter start [Enter finish [Enter
1 4 your current management #VALUE! #VALUE!
9001 are currently not being fully addressed (or not addressed at all) and to develop remedial Management Representative date] date] progress %]
system
actions. The gap analysis should be conducted by members of the QMS Implementation Team. Process owners
Gap analyses should be conducted with small groups of staff, including the process owner of each QMS Implementation Team
process.

The organization has to establish its vision consistent with its mission and identify the strategic
Establish the strategic
directions and interested party requirements consistent to its context. Identify the processes Top Management
direction of your company [Enter start [Enter finish [Enter
1 5 needed for the QMS. The scope must set out what your company does and what it delivers. It Management Representative #VALUE! #VALUE!
and implement the risks and date] date] progress %]
should include products and services. It must be done with consideration to the context. Ensure QMS Implementation Team
opportunities procedure
staff understand the risks and opportunities that affect their work.

Review the quality policy to determine whether it is appropriate to the context of the organization Top Management
Establish and communicate
and its purpose. Ensure the quality objectives are consistent with the quality policy. Set objectives Management Representative [Enter start [Enter finish [Enter
1 6 the quality policy, objectives Management plans specifying: #VALUE! #VALUE!
per function and identify measurable performance indicators to enable tracking of their status. QMS Implementation Team date] date] progress %]
and performance indicators
Staff must know the quality policy and how the objectives relate to their work. Heads of Department

https://www.iso-9001-checklist.co.uk/iso-9001-implementation-guide.htm
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ISO 9001:2015 Implementation Programme
5 phases with 27 activties, undertaken over a 35 week duration
Activity

Duration Activity Not

Phase

Activity Description Participants/Responsibilities Deliverables/Outputs Start Date Finish Date

(Days) Progress % Complete

Adjusting the QMS documents should also be expected as staff become accustomed to the
requirements and begin to suggest improvements in usability. Meet and discuss the requirements
of ISO 9001 clause 7.5 and the quality management system and consider:
Implement the documented · Amending and implementing the procedure Document Control Team
[Enter start [Enter finish [Enter
1 7 information procedure and · Review and approval forms QMS Implementation Team #VALUE! #VALUE!
date] date] progress %]
train staff in its use · Agree document identification system and naming conventions Information Technology
· Establish filing system/Integrate with existing system
· Ensure all staff know which forms to use, how to complete and process them
· Ensure all staff know which types of documented information that applies to their work
Meet and discuss the requirements of ISO 9001 clause 9.1.2 and the quality management system
and consider: Management Representative
Implement the customer [Enter start [Enter finish [Enter
1 8 · Amending and implementing the procedure Operational Managers #VALUE! #VALUE!
satisfaction procedure date] date] progress %]
Process Owners

Meet and discuss the requirements of ISO 9001 clause 8.7 and 10.2 and the quality management
system and consider: Management Representative
· Amending and implementing the procedure Operational Managers
Implement the nonconformity
Process Owners [Enter start [Enter finish [Enter
1 9 and corrective action #VALUE! #VALUE!
All Managers date] date] progress %]
procedure
Heads of Department
Affected staff

Meet and discuss the requirements of ISO 9001 clause 9.2 and the quality management system
and consider:
Implement the internal audit Management Representative [Enter start [Enter finish [Enter
1 10 #VALUE! #VALUE!
procedure Internal Auditors date] date] progress %]

Undertake the 1st
1 11 management review and
select a Certification Body
Top management to perform a review of progress and to identify areas of weakness and take
corrective action as required. Certification Body selection criteria may include:
· Must have clients from our industry (i.e. our competitors) Top Management
[Enter start [Enter finish [Enter
· Must offer CVs of their auditors for review Management Representative #VALUE! #VALUE!
date] date] progress %]
· Must deliver well-crafted nonconformity statements Heads of Department
Information on selecting a certification body is available:
http://www.iso.org/iso/home/standards/certification.htm

Meet and discuss the process requirements of ISO 9001 clause 8.0 and the quality management
Process Owners
system and consider scheduling sessions with the authors of the operating procedures and other
Implement or document your All Managers [Enter start [Enter finish [Enter
2 12 supporting documents to provide assistance in developing documents that are consistent with the #VALUE! #VALUE!
operational procedures Heads of Department date] date] progress %]
set quality objectives and to the relevant requirements of ISO 9001 standard. If your operational
Supervisors
procedures are effective and define how your key processes operate, keep them!

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ISO 9001:2015 Implementation Programme
5 phases with 27 activties, undertaken over a 35 week duration
Activity

Duration Activity Not

Phase

Activity Description Participants/Responsibilities Deliverables/Outputs Start Date Finish Date

(Days) Progress % Complete

Meet and discuss the process requirements of ISO 9001 clause 8.4 and the quality management
Implement the purchasing system and consider: All divisions with contractors [Enter start [Enter finish [Enter
2 13 #VALUE! #VALUE!
and procurement procedure working for their behalf date] date] progress %]

Meet and discuss the process requirements of ISO 9001 clauses 7.2 and 7.3 and the quality
management system and consider:
Implement the competence Human Resources [Enter start [Enter finish [Enter
2 14 #VALUE! #VALUE!
and awareness procedure Management Representative date] date] progress %]

Meet and discuss the process requirements of ISO 9001 clause 7.1 and the quality management Top Management
system and consider: Management Representative
Align with supporting [Enter start [Enter finish [Enter
2 15 · The capabilities of existing internal resources Accounting/Finance #VALUE! #VALUE!
processes date] date] progress %]
· The constraints on existing internal resources Information Technology
· What needs to be obtained from external providers Safety and Security

Members of Top Management should assist the Management Representative in drafting the
Amend the quality manual
quality management system manual and preparing its scope. If your existing quality manual fits Top Management [Enter start [Enter finish [Enter
2 16 template and undertake the #VALUE! #VALUE!
your business and your customers require it, keep it! Top management to perform a review of Management Representative date] date] progress %]
2nd management review
progress and to identify areas of weakness and take corrective action as required.

Select external training Discuss the requirements for internal auditing and teach the participants on how to audit a QMS.
[Enter start [Enter finish [Enter
3 17 providers and begin internal Based on education and experience auditors must pass 1-or 2-day external auditor course and Internal Auditors #VALUE! #VALUE!
date] date] progress %]
auditor training exam.

Perform an elemental internal audit of selected functions and areas using the audit programme Internal Auditors
Begin internal auditing (See [Enter start [Enter finish [Enter
3 18 and audit checklists. Ensure that the auditors do not audit their own functions or processes. All Top Management #VALUE! #VALUE!
ISO 9001:2015 Clause 9.2) date] date] progress %]
staff should be provided with adequate lead time to prepare for the audit. Management Representative

Internal Auditors
Root-cause analysis workshop
Assist the process owners in determining root-causes and finding solutions through workshops Top Management [Enter start [Enter finish [Enter
3 19 (See ISO 9001:2015 Clause #VALUE! #VALUE!
and training on 5-Whys analysis, Fishbone Diagrams, or 8 Dimensions (8D) analysis techniques. Management Representative analysis findings date] date] progress %]
9.1.3)
Process Owners & Personnel
Implement the corrective The process owners should implement the corrective actions to address the audit findings. The
Process Owners [Enter start [Enter finish [Enter
3 20 actions based on the internal documented corrective actions must be submitted to the Management Representative for #VALUE! #VALUE!
Management Representative date] date] progress %]
audit findings approval.
Top management to perform a review of progress and to identify areas of weakness and take
corrective action as required.
· Quality objective and their performance indicators
Top Management
Undertake the 3rd · Verification of completed corrective actions [Enter start [Enter finish [Enter
3 21 Management Representative #VALUE! #VALUE!
management review · Results of internal audits and their analysis date] date] progress %]
Heads of Department
· Customer feedback/satisfaction
· Performance evaluation
· External providers’ performance, etc.

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ISO 9001:2015 Implementation Programme
5 phases with 27 activties, undertaken over a 35 week duration
Activity

Duration Activity Not

Phase

Activity Description Participants/Responsibilities Deliverables/Outputs Start Date Finish Date

(Days) Progress % Complete

Once you have implemented the new key requirements and have dealt with any corrective actions,
it is suggested that the Management Representative should carry out at least one other internal Top Management
(element) audit in readiness for the Certification Body’s 1st stage audit. Top management should Management Representative [Enter start [Enter finish [Enter
4 22 Conduct readiness review #VALUE! #VALUE!
ensure that corrective action is undertaken on any adverse 1st stage audit findings without delay. QMS Implementation Team date] date] progress %]
Make any necessary changes to the quality management system and the documentation Process owners
information.

The organization should liaise with the certification body to establish dates for the audit that suit
Certification Body 1st Stage Management Representative [Enter start [Enter finish [Enter
4 23 all concerned. All staff should be provided with adequate lead time to prepare for the audit. All #VALUE! #VALUE!
Audit Certification Auditor(s) date] date] progress %]
documentation that may be needed during the 1st stage audit should be easily accessible.

Top management should ensure that corrective action is undertaken on any adverse 1st stage
Whole Organization
Address 1st stage audit audit findings without delay. Make any necessary changes to the quality management system and [Enter start [Enter finish [Enter
4 24 Management Representative #VALUE! #VALUE!
findings the documentation information. The Management Representative should address the issues raised date] date] progress %]
QMS Implementation Team
by the Certification Body to ensure a successful 2nd stage audit.

Certification Audit by the Registrar. At this stage, you should receive a Recommendation for Whole Organization
Certification Body 2nd Stage [Enter start [Enter finish [Enter
5 25 Certification to ISO 9001:2015. All documentation that may be needed during the 2nd stage audit Management Representative #VALUE! #VALUE!
Audit date] date] progress %]
should be easily accessible Certification Auditor(s)
Top management should ensure that corrective action is undertaken on any adverse 2nd stage
Address 2nd stage audit audit findings without delay. Make any necessary changes to the quality management system and Management Representative [Enter start [Enter finish [Enter
5 26 #VALUE! #VALUE!
findings the documentation information. The documented corrective actions must be submitted to the QMS Implementation Team date] date] progress %]
Certification Body for approval.
The documented corrective actions are verified by the Certification Body for final approval for
Certification Body to verify certification to ISO 9001:2015. It is imperative that the achievement of certification of compliance Whole Organization
[Enter start [Enter finish [Enter
5 27 and close-out 2nd stage audit to ISO 9001:2015 is appropriately recognized by Top management and celebrated by all staff. Management Representative #VALUE! #VALUE!
date] date] progress %]
findings Certification of compliance provides an excellent baseline on which to measure ongoing Certification Auditor(s)
improvement of the organization.

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