BS EN ISO 9001:2015

Management System
Gap Analysis Review

Assessor:
Date:
Area Assessed:

PLAN Clause Value

Organisation determine, monitor and review external and internal issues 4.1 1
Understand the needs & expectations of interested parties that are relevant to the 4.2
QMS (including applicable statutory and regularory requirements). 1
Scope is defined and documented ref 4.3 a-c 4.3 1
The scope incl products/services covered by the QMS and any justifications 4.3 1
Processes determined ref a-h and identify documented information 4.4 1
Top management leadership & commitment is demonstrated 5.1 1
Top management carries out / demonstrates a-j 1
5.1.2
Top management leadership & commitment with respect to customer focus ref a-c 1
Policy is appropriate, provides a framework for objectives, and is documented 5.2 1
There is a mechanism for policy communication, available to interested parties 1

Policy has a commitment to satisfy appl requirements & Continual Improvement 1

Policy is subject to periodic review 1
5.3
Roles, Responsibilities, Authorities assigned, understood & communicated ref a-e 1
Actions to address risk & opportunity have been considered 6.1 1

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Evaluate the effectiveness of actions 1
A programme is established to achieving objectives 6.2 1
Objectives are documented and measurable where practicable 1
Objectives are consistent with the Policy and applicable requirements 1
Objectives are determined by a-e (SMART) 1
Objectives are relevant to product/service, monitored and communicated 1
A method is in place for planning of changes to the QMS 6.3 1
Considering Resources, Purpose, Integrity, reallocation or allocation of
responsibilities & authorities 1
Resources established for the effectiveness of the QMS and its processes 7.1 1
Determine, maintain infrastructure e.g. buildings, equipment's, hardware, software,
IT 1
Environmental capabilities determined and provided e.g. social, physical,
psychological, environmental 1
Valid & reliable monitoring and measuring results determined e.g. calibration, testing
of equipment, safeguarded 1
Documentation of calibration & maintenance are retained 1
Measurement traceability requirements have been identified 1
Organizational knowledge determined, & maintained to achieve conformity of
products & services e.g. (learning from internal sources successful projects, failed
projects and external sources e.g. standards, conferences etc. 1
7.2
Competence & Training of person(s) under the organisations control are identified 1
Appropriate documentation information is maintained 1

A method is in place to evaluate the effectiveness of training/competence provision 1

7.3
Person(s) awareness of the QMS incl Policy, Objectives, contribution, implications 1
Communication of QMS is clearly and concise 7.4 1
Creation & Updating of documentation shall ensure a-b 7.5 1
A method is in place for document control 1
The method includes 7.5.3.1 a-b 1
The method includes 7.5.3.2 a-d 1
Documented information of external origin required shal be identified, as appropriate
and controlled 1
DO Clause Column1

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Operations needing controls have been determined to meet the requirements for the 8.1
provision of products and services (see 4.4), and to implement the actions
determined in clause 6, by a-e 1

Controls include the management of change 1

Outsourced processes are controlled (see 8.4) 1
Controls for a to e have been implemented & maintained 1
A process for Customer communication has been established includes a-e 8.2 1

A process to determine & maintain requirements relating to products/services 1

A process to review requirements relating to products / services 1

Documented information describing the results of the review 1
A process to determine the stages for design & development 8.3 1
To include design Planning a-j 1
To include design Inputs a-e 1
To include design Controls a-f 1
To include design Outputs a-d 1
Process to include design & development changes a-d 1
Documented information to confirm design & development requirements have been
met 1
Operations that have been outsourced (a-c) are controlled 8.4 1

A process for evaluation, selection, monitoring, re evaluation of external providers 1

Process to include review of competence and qualification of person(s) 1
A process for communication to external providers to meet requirements of
product/service 1
Documented information of the results of evaluation, monitoring performance and re
evaluations 1
8.5
A process for control of production/service provision, e.g. Determining the things you
need to do and how you are going to ensure these are communicated a-h 1
Documented information to control of production/service provision 1
Identification & traceability to ensure conformity 1
Identify, verify, protect, safeguard customer property provided for use 1
Ensure preservation of product during production/service provision 1
A process for post delivery activities e.g. warranty provisions, contractual obligations,
recycling services, final disposal (a-e) 1

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Documentation on results of changes, reviews of changes, personnel authorizing
changes shall be kept 1
Documented information for release of products/services including points a-b 8.6 1
A process is in place for control of non conforming process outputs, product/ service 8.7
that do not conform. Actions can include a-d 1
Documented information kept on actions taken 8.7.2 a-d 1
CHECK and ACT Clause Value
A process is in place for monitoring & measuring 9.1 1
Process determines a-d 1
Documented information of results shall be kept 1
Customer Satisfaction is monitored 1
A process is in place for analysis & evaluation a-g 1
Results of analysis & evaluation is kept and used at Management review 1
Audits are carried out at planned intervals 9.2 1
Audit programme considers objectives, status, importance, prev audit results 1
Audit results are provided to relevant Management 1
Documented information of audit results kept & maintained 1
CA & opps to avoid potential risk shall be taken without undue delay 1
Auditors are impartial & objective 1
Top management review of QMS at defined intervals 9.3 1
Documented information of management review are maintained 1
Requirements a to f are included as input to the review 1
Requirements a to c are included as output from review 1
A process to determine and select opps for improvement to improve the QMS, 10
product, services to customer a-c 1
A process to ensure appropriate CA has been taken based on the nature of the N/c
a-f 1
N/C evaluated in order not to recur 1
CA to be reviewed for effectiveness 1
Documented information kept and maintained 1
10.3
Continual Improvement from outputs of analysis & evaluation, Management review 1
Consider opportunities for improvement 1

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 Complete findings below identifying areas of compliance and areas where gaps
appear. Use the Key to identify a point score for each applicable section;
where necessary, provide comments to explain findings. The data entered will
populate the graphs (tab 2) to identify compliance/gaps against each element
of BS EN ISO 9001:2015

Comments

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Comments

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Comments

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 Plan

Context

5
Support 4
3
2
1
0

Objectives Leadership

Planning

Check/Act

Monitor/Measure

5
4
3
Continual Improvement 2 Internal Audit
1
0

N/C, CA Management Review

N/C, CA Management Review
 Do

Operation Planning & Control

Control of N/C Process, Product, Service 5 Determination of Requirements

4
3
2
1
0
Release of Products & Services Design & Development
ership

Product & Service provision Control

dit

ew
ew
on of Requirements

Development