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
Understand the needs & expectations of interested parties that are issues 4.1 1
relevant to the QMS (including applicable statutory and regularory 4.2
requirements). 1
Scope is defined and documented ref 4.3 a-c 4.3 1
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
Top management leadership & commitment with respect to customer 5.1.2
focus ref a-c 1
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
Roles, Responsibilities, Authorities assigned, understood & communicated 5.3
ref a-e 1
Actions to address risk & opportunity have been considered 6.1 1

©BSI
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
Organizationaltraceability
knowledge requirements
determined, &have been identified
maintained to achieve 1
conformity of products & services e.g. (learning from internal sources
successful projects, failed projects and external sources e.g. standards,
conferences etc. 1
Competence & Training of person(s) under the organisations control are 7.2
identified 1
Appropriate documentation information is maintained 1
A method is in place to evaluate the effectiveness of training/competence
provision 1
Person(s) awareness of the QMS incl Policy, Objectives, contribution, 7.3
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

©BSI
Operations needing controls have been determined to meet the 8.1
requirements for the 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
A process for control of production/service provision, e.g. Determining the 8.5
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

©BSI
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 8.6 1
A process is in place for control of non conforming process outputs, 8.7
product/ service 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 10
QMS, 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
Continual Improvement from outputs of analysis & evaluation, 10.3
Management review 1
Consider opportunities for improvement 1

©BSI
 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

©BSI
Comments

©BSI
©BSI
Comments

©BSI
 Plan

Context

5
Support 4
3
2
1
0

Objectives Leadership

Planning

Check/Act

Monitor/Measure

4
Continual Improvement Internal Audit
2
0

N/C, CA Management Review

N/C, CA Management Review
 Do

Operation Planning & Control

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

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

Product & Service provision Control

dit

iew
iew
ermination of Requirements

esign & Development