Assessor:

Date:
Area Assessed:

PLAN Clause Value

4.1
Organisation
Understand the determine,
needs & monitor and review
expectations external
of interested and internal
parties that areissues 1
relevant to the QMS (including applicable statutory and regularory 4.2
requirements). 3
Scope is defined and documented ref 4.3 a-c 4.3 4
justifications 4.3 5
Processes determined and identify documented information 4.4 'a-h' 3
Top management leadership & commitment is demonstrated 5.1 5
Top management carries out / demonstrates a-j 5
Top management leadership & commitment with respect to customer 5.1.2
focus ref a-c 5
documented 5.2 2
There is a mechanism for policy communication, available to interested parties 2
Policy has a commitment to satisfy appl requirements & Continual
Improvement 2
Policy is subject to periodic review 2
Roles, Responsibilities, Authorities assigned, understood & communicated 5.3
ref a-e 3

BSI
Actions to address risk & opportunity have been considered 6.1 1
Evaluate the effectiveness of actions 1
A programme is established to achieving objectives 6.2 2
Objectives are documented and measurable where practicable 2
Objectives are consistent with the Policy and applicable requirements 2
Objectives are determined by a-e (SMART) 2
Objectives are relevant to product/service, monitored and communicated 2
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 4
Determine, maintain infrastructure e.g. buildings, equipment's, hardware,
software, IT 5
Environmental capabilities determined and provided e.g. social, physical,
psychological, environmental 5
Valid & reliable monitoring and measuring results determined e.g.
calibration, testing of equipment, safeguarded 5
Documentation of calibration & maintenance are retained 5
Measurement
Organizationaltraceability
knowledge requirements
determined, &have been identified
maintained to achieve 5
conformity of products & services e.g. (learning from internal sources
successful projects, failed projects and external sources e.g. standards,
conferences etc. 5
Competence & Training of person(s) under the organisations control are 7.2
identified 5
Appropriate documentation information is maintained 5
A method is in place to evaluate the effectiveness of training/competence
provision 5
Person(s) awareness of the QMS incl Policy, Objectives, contribution, 7.3
implications 5
Communication of QMS is clearly and concise 7.4 5
Creation & Updating of documentation shall ensure a-b 7.5 3
A method is in place for document control 3
The method includes 7.5.3.1 a-b 3
The method includes 7.5.3.2 a-d 3
Documented information of external origin required shal be identified, as
appropriate and controlled 3
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 3

Controls include the management of change 1

Outsourced processes are controlled (see 8.4) 3
Controls for a to e have been implemented & maintained 1
A process for Customer communication has been established includes a-e 8.2 2
A process to determine & maintain requirements relating to
products/services 3

A process to review requirements relating to products / services 3

Documented
A information
process to determine describing
the stages forthe results
design of the review
& development 3
1
Operations that have been outsourced (a-c) are controlled 8.3
8.4 3
A process for evaluation, selection, monitoring, re evaluation of external
providers 3
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 2
Documented information of the results of evaluation, monitoring
performance and re evaluations 2
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 3
Documented information to control of production/service provision 2
Identification & traceability to ensure conformity 2
Identify, verify, protect, safeguard customer property provided for use 2
Documentation on results of changes, reviews of changes, personnel
authorizing changes shall be kept 2
Documented information for release of products/services including points a 8.6 2
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 2
Documented information kept on actions taken 8.7.2 a-d 2
CHECK and ACT Clause Value
A process is in place for monitoring & measuring 9.1 3
Process determines a-d 1
Documented information of results shall be kept 3
Customer Satisfaction is monitored 3

BSI
A process is in place for analysis & evaluation a-g 3
Results of analysis & evaluation is kept and used at Management review 3
Audits are carried out at planned intervals 9.2 3
Audit programme considers objectives, status, importance, prev audit results 3
Audit results are provided to relevant Management 3
Documented information of audit results kept & maintained 3
CA & opps to avoid potential risk shall be taken without undue delay 1
Auditors are impartial & objective 3
Top management review of QMS at defined intervals 9.3 5
Documented information of management review are maintained 3
Requirements a to f are included as input to the review 3
Requirements a to c are included as output from review 3
A process to determine and select opps for improvement to improve the 10
QMS, product, services to customer a-c 3
A process to ensure appropriate CA has been taken based on the nature of
the N/c a-f 3
N/C evaluated in order not to recur 3
CA to be reviewed for effectiveness 3
Documented information kept and maintained 3
Continual Improvement from outputs of analysis & evaluation, 10.3
Management review 3
Consider opportunities for improvement 3

BSI
Comments
We need to create a procedure "organisation context" and determine, monitor and review external and
internal issues
Expectation of external intersted parties are identified however expectation of internal parties are not
identified
The scope is identified but not documented
The exclusions are identified
Processes ared determined but not documented

The new policy and objectifs should be created

Update communication procedure

The new policy should be created

Role and responsability are understood but we should create a new manual define responsabilities

BSI
Identify risks soon
Evaluate actions after the implementation
Create an action plan to acheive objective
The new objectifs should be created
The new objectifs should be created
The new objectifs should be created
Update communication procedure
create a new program for any changes

create a new program for any changes

Upadate Ressources planning

perform a social activities 'team bulding, birthday, breakfast

Training plan QMS

Update documented information procedure

Update documented information procedure
Update documented information procedure
Update documented information procedure

Update documented information procedure

Comments

BSI
Procedure, daily reports, QMR will be updated

create a new program for any changes

Update memorundumof understanding

Update communication procedure

Quick info, manuals

New Audit plan

Update the form of receipt of goods

N/A

Update communication procedure

Update communication procedure

Procedures, instructions,..
Create a new documented information procedure
Create a new documented information procedure
Create a new documented information procedure

Create a new documented information procedure

Create a new procedure

Create a new procedure
Comments
QMR,

we will add other departments on survey, COMPASS

BSI
COMPASS

Updated audit program

Updated audit program
Audit report

Plan an internal auditor training for new auditor team

Yearly
Update review meeting minutes according new ISO version
Update review meeting minutes according new ISO version
Update review meeting minutes according new ISO version

Any requested improvment possibility will be taken in considaration

COMPASS
COMPASS
COMPASS
COMPASS

review meeting
review meeting

BSI
 Plan

Context

5
Support 3.25
4 Risks & changes
4.375 3
2
1 1
0
2 3.25
Objectives Leadership
1.5555555556
2

Policy Planning

Check/Act

Monitor/Measure

2.6666666667
Continual Improvement Internal Audit
3 2.6666666667

3 3.5

N/C, CA Management Review

 3 3.5

N/C, CA Management Review

 Do

anges Operation Planning & Control

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

2
2 2.75

2 2
Release of Products & Services Documented information
ship 2 2.2

Product & Service provision Control

ew
ew
ation of Requirements

ented information