Activity : QMS Gap Analysis

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Related
Clause Task fulfil Not fulfil N/A
Questions

1 4.1 Determine purpose and strategic direction

Determine intended result(s) of its QMS
Determine external and internal issues
Monitor and review external and internal issue information
1 4.2 Determine interested parties
Determine their requirements
Monitor and review interested parties and requirement information
1 4.3 Determine and make available documented information scope
Justify any instances where a requirement cannot be applied
2 4.4 Determine the processes needed
Determine the inputs, outputs, sequence, interaction and performance
indicators
Maintain/retain documented information for support and confidence
Top management - ensure QMS policy and objectives are compatible with
3 5.1
strategic direction and context
Top management - ensure integration of QMS requirements into
organization’s business processes

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Top management - ensure resources available

Top management - communicate importance and of conforming
Top management - ensure QMS achieves intended outcome(s)
Top management - ensure engaging directing and supporting persons
Top management - ensure promoting improvement
Top management – ensure support of other relevant management roles
Top management – ensure promoting use of the process approach and risk-
based thinking
Top management – take accountability of effectiveness of QMS
Top management – ensure customer focus, focus on maintaining enhanced
3 5.1.2 customer satisfaction and risk/opportunities/legal etc. are determined and
addressed
3 5.2 Top management – establish, implement and maintain a quality policy
Top management - ensure policy is appropriate to organization’s purpose,
context and supports strategic direction
Top management – ensure policy provides framework for quality objectives
Top management - ensure policy includes commitment to satisfy applicable
requirements
Top management – ensure policy includes a commitment to continually
improve the QMS

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Top management – ensure policy available and maintained as documented

information
Top management – ensure policy is communicated, understood and applied
within the organization
Top management – ensure policy is available to relevant interested parties
Top management – ensure roles, responsibilities and authorities are assigned,
4 5.3
communicated and understood
Top management – assign responsibility and authority for ensuring the QMS
conforms to the requirements of the standard
Top management – assign responsibility and authority for ensuring processes
are delivering intended outputs
Top management – assign responsibility and authority for reporting on the
performance of the QMS to top management and opportunities
Top management – assign responsibility and authority for ensuring customer
focus and integrity of the QMS
5 6.1.1 Determine the risks and opportunities that need to be addressed
Plan how to address the risks and opportunities and how to integrate and
evaluate them
6 6.2 Establish QMS objectives and retain documented information
Monitor, communicate and update QMS objectives
Planning to achieve QMS objectives

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7 6.3 Changes to the QMS carried out in a planned manner

8 7.1 Determine and provide resources needed
Consider capabilities, constraints on internal resources
Consider needs from external providers
8 7.1.2 Determine and provide persons necessary for the QMS and processes
8 7.1.3 Determine, provide, maintain infrastructure for its processes
8 7.1.4 Determine, provide, maintain environment for its processes
8 7.1.5 Determine and provide resources needed for monitoring and measuring
Retain documented information of monitoring and measuring resources
Where measurement traceability is required, ensure measuring equipment are
verified…
9 7.1.6 Determine, maintain and make available the necessary knowledge
Determine how to acquire or access necessary additional knowledge
9 7.2 Determine necessary competence
Ensure persons are then competent on the basis of…
Take action to acquire this competence
Evaluate the effectiveness of the actions taken
Retain appropriate documented evidence

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Ensure person(s) who work under the control are aware of… including quality
10 7.3
objectives
Determine the internal/external communications relevant to its QMS, including
10 7.4
on what it will communicate and who communicates
Determine when it will communicate
Determine with whom to communicate and how
11 7.5.1 Establish documented information required by this Standard
Establish documented information required for QMS effectiveness
11 7.5.2 Ensure appropriate identification and description
Ensure appropriate format and media
Ensure review and approval for suitability and adequacy
11 7.5.3 Ensure availability and suitability for use
Ensure adequately protected and from unintended alterations
Control distribution, access, retrieval and use
Control storage, preservation and legibility preservation
Control changes (version control)
Control retention and disposition
Identify and control documented information of external origin

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Questions

12 8.1 Plan, implement and control processes to meet requirements

Implement plans from clause 6
Keep documented information to provide confidence, and demonstrate
conformity
Determine requirements for the products and services
Establish criteria for processes and acceptance of products and services
Determine resources needed
Implement control of processes according to criteria
Control planned change
Review consequences of unintended changes
Take action to mitigate adverse effects
Control outsourced processes (with 8.4)
13 8.2.1 Communicate with customers, including a) – e)
13 8.2.2 Determine requirements, including a) – b)
13 8.2.3 Review/confirm requirements, and prior to any commitments, including a) – e)
8.2.3.2
/ Retain documented information describing the review/changes, including new
requirements/relevant persons being aware
8.2.4

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14 8.3.1 Establish a design and development process

14 8.3.2 Consider a) – j) to determine the stages and controls needed
14 8.3.3 Determine design and development inputs a) – e)
14 8.3.4 Ensure design and development controls include a) – f)
14 8.3.5 Ensure design and development outputs achieve a) – d)
Retain documented information relating to 8.3.2/3/4/5/6
14 8.3.6 Review, control and identify changes during design and development
Ensure externally provided processes, products and services conform to
15 8.4.1
requirements
Apply requirements for control when a), b), or c) are provided
Determine/apply criteria for evaluation, selection, monitoring and re-
evaluation
Retain documented information of the results of evaluation…
Consider a) to d) for types and extent of control (externally provided
15 8.4.2
processes, products and services)
15 8.4.3 Communicate requirements (and ensure adequacy): a) – f)
16 8.5.1 Implement controlled conditions, including as applicable: a) – h)
17 8.5.2 Use suitable means to identify outputs (where necessary)

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Identify the status of process outputs (monitoring and measuring

requirements)
Control unique identification of process outputs (if required)
Retain documented information necessary for traceability
18 8.5.3 Exercise care with property belonging to customers or external providers
Identify, verify, protect and safeguard property
Report if incorrectly used, lost, damaged or unsuitable for use
19 8.5.4 Ensure preservation of outputs
19 8.5.5 Meet requirements for post-delivery activities
Consider a) – e) when determining the extent of activities
20 8.5.6 Review and control changes
Retain documented information describing the results…
Implement planned arrangements and retain evidence of conformity with
20 8.6
acceptance criteria
Release products and services only after planned arrangements completed…
Documented information provides traceability to the person(s) authorizing
release
21 8.7 Identify and control nonconforming outputs.
Take action (including detection during or after release/provision)

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Deal with the nonconformity in one or more of the following ways a) – d)

Verify conformity to requirements after correction
Retain documented information of actions taken etc.
22 9.1 Determine what needs to be monitored and measured
Determine the methods to ensure valid results
Determine when it shall be performed
When the results shall be analysed and evaluated
Retain documented information as evidence of the results
Evaluate the QMS performance and its effectiveness
22 9.1.2 Monitor customer perceptions (requirements met)
Determine methods for obtaining and using this information
23 9.1.3 Analyse and evaluate appropriate data and information
Use the output to evaluate: a) to g)
23 9.2 Conduct internal audits at planned intervals
Ensure audit objectives cover conformance of own QMS, the Standard, and its
effectiveness
Plan,… an audit programme(s), including…
Ensure audit programme(s) take into consideration…

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Define audit criteria and scope for each audit

Select objective, impartial auditors
Ensure results of audits are reported to management
Take correction and corrective actions
Retain documented information as evidence of the above
24 9.3 Top management – review QMS at planned intervals
Include for consideration those requirements stated (note additions to HLS)
Include outputs as stated (including resource needs)
Retain documented information as evidence of review results
25 10.1 Determine, select and implement opportunities for improvement a) – c)
25 10.2 React to nonconformities (10.2 is 10.1 in HLS)
Take control and correct them
Deal with the consequences
Evaluate need for action to eliminate the causes by…
Implement any action needed
Review effectiveness of any corrective action and update risks and
opportunities
Make changes to the QMS if necessary

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Questions

Retain documented information as evidence of its: nature, actions and results

Continually improve the suitability, adequacy and effectiveness of the QMS
25 10.3
(10.3 is 10.2 in the HLS)
Consider results to confirm areas of underperformance or opportunities

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