The ISO 9001 standard requires an organization to identify, verify, protect and safeguard what

The "ISO 9001 version 2015 Requirements" quiz will help you understand the main requirements of the standard.

Inhaltsverzeichnis Show

What are the 7 main clauses of ISO 9001 2015?
What are the 10 clauses of ISO 9001?
How do you manage knowledge of the organization according to ISO 9001?
What is monitoring and measurement results in ISO 9001?

The questions (requirements) included in this quiz are 60 of the 309 in the standard, but don't worry. These 60 requirements are among the most important. So do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, unless of course you are a little genius!

Based on the ISO 9001: 2015 the 309 requirements (verb shall) of clauses 4 to 10 are as follows:

Remark. Any requirement normally begins with "The organization shall...". For simplicity's sake we present the requirements directly, starting with the verb.

ISO 9001 - Requirements and comments

Clause, sub-clause

Requirement

Comment, link

Context of the organization

4.1

The organization and its context

4.1

Determine external and internal issues Understand everything that can influence the purpose and strategic direction of the company (corporate culture, innovation, strategic direction, competition, market, compliance obligation) 2 4.1 Monitor and review information about issues Issue: what one can gain or lose during an activity (factors, conditions) 4.2

Needs and expectations of interested parties

4.2 a Identify the interested parties "There is only one valid definition of a business purpose: to create a customer". Peter Drucker. List of relevant interested parties 4

4.2 b

Clarify the requirements of interested parties Each need and expectation is unique. Aim for a partnership in the long term

4.2

Monitor and review information about interested parties and their requirements Before accepting an order 4.3

Scope of the quality management system

4.3

Define the scope of the QMS Geographic and organizational scope available to interested parties

4.3 a

Take into account the external and internal issues Cf. sub-clause 4.1

4.3 b

Take into account the requirements of interested parties Cf. sub-clause 4.2

4.3 c

Take into account the products and services All products and services proposed by the company without exception 10

4.3

Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS The requirements of the standard become internal requirements 11 4.3 Maintain the scope of the QMS as documented information Cf. sub-clause 7.5. Include all products and services

4.3

Include in the scope of the QMS justification for any requirements which cannot be met Every requirement of the ISO 9001 standard which cannot be applied in the company implies a justification 4.4

Quality management system and its processes

4.4.1

Establish, implement, maintain and improve a process-based QMS The company is free to decide how to apply the QMS without forgetting the issues (see sub-clause 4.1) and requirements (see sub-clause 4.2) 14 4.4.1 Determine the needed processes and their application "If you cannot describe what you are doing as a process, you do not know what you're doing". Edwards Deming. Process map

4.4.1 a

Determine process inputs and outputs Process sheet 16 4.4.1 b Determine the sequence and interaction of processes Flowchart 17 4.4.1 c Determine the criteria and methods to control processes Tools of the quality manager 18 4.4.1 d Determine and ensure the resources Needed to support processes. Cf. sub-clause 7.1 19 4.4.1 e Assign process responsibilities and authorities Job description of process owners 20 4.4.1 f Take into account the risks and opportunities for each process Plan and implement actions to address these risks, cf. sub-clause 6.1 21 4.4.1 g Evaluate processes and if necessary modify them Identify methods to monitor, measure, check and modify processes. Cf. sub-clause 9.1.1 22 4.4.1 h Determine the improvement opportunities of processes and the QMS Cf. sub-clause 10.1

4.4.2

Maintain documented information on process operation Cf. sub-clause 7.5. The bare essential is sufficient. Use process map

4.4.2

Retain documented information on process operation Cf. sub-clause 7.5. The goal is to ensure that processes' results are those planned 5

Leadership

5.1

Leadership and commitment

5.1.1

General

5.1.1 a

Assume responsibility for the effectiveness of the QMS "When you sweep the stairs, you start at the top". Romanian proverb. Top management demonstrates leadership (assumes its responsibility and commitment). Focus on quality and customers 26 5.1.1 b Establish a quality policy and quality objectives The policy and the objectives are compatible with strategic direction and context of the company

5.1.1 c

Integrate QMS requirements in the internal process requirements Cf. sub-clause 4.4 and sub-clause 7.1.4

5.1.1 d

Raise awareness of the process approach and risk-based approach Cf. sub-clause 0.3 (introduction) and sub-clause 6.1

5.1.1 e

Provide the necessary resources for the QMS Cf. sub-clause 7.1

5.1.1 f

Raise awareness on the importance of an effective and conforming QMS Third quality management principle (engagement of people)

5.1.1 g

Ensure the achievement of intended results of the QMS Essential commitment of top management

5.1.1 h

Support the staff contribution to the effectiveness of the QMS "Employees first, customers second". Vineet Nayar

5.1.1 i

Promote continual improvement Cf. sub-clause 10.3

5.1.1 j

Support the leadership of managers Responsibility and authority of managers are backed at all times by top management

5.1.2

Customer focus

5.1.2 a

Determine and meet customer, statutory and regulatory requirements Top management demonstrates leadership (assumes its responsibility and commitment) permanently

5.1.2 b

Determine and address the potential risks and opportunities Any risk and opportunity that may influence the conformity of products and services and customer satisfaction. Preserving the goal to always provide compliant products and services

5.1.2 c

Maintain the objective of better satisfying the customer First quality management principle (customer focus) 5.2

Policy

5.2.1

Establishing the quality policy

5.2.1 a

Establish, implement and maintain a suitable quality policy Top management applies a policy adapted to the purpose, strategic direction, culture and business context 39 5.2.1 b Provide a framework to define and review the quality objectives Cf. sub-clause 6.2 40 5.2.1 c Include meeting the applicable requirements Cf. sub-clause 9.1.3 41 5.2.1 d Include a commitment to continuously improve the QMS Cf. sub-clause 10.3 5.2.2

Communicating the quality policy

42 5.2.2 a Maintain the quality policy as documented information And make it available inside the company. Cf. sub-clause 7.5 43 5.2.2 b Communicate the quality policy So it is understand and applied, cf. sub-clause 7.4 44 5.2.2 c Keep the quality policy available The quality policy cannot be a confidential document, it is available to relevant interested parties

5.3

Roles, responsibilities, authorities

5.3

Define and communicate the responsibilities and authorities Top management assigns all relevant roles in the QMS

5.3 a

Define and communicate the responsibilities and authorities Top management assigns all relevant roles according to the requirements of the ISO 9001 standard

5.3 b

Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that processes deliver expected results

5.3 c

Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that reporting on the performance of the QMS and improvement opportunities is done, cf. sub-clause 10.1

5.3 d

Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that customer focus is ensured (first quality management principle)

5.3 e

Define and communicate the responsibilities and authorities Top management assigns all relevant roles so that implemented changes to the QMS do not affect its integrity

Planning

6.1

Actions to address risks and opportunities

6.1.1 a

Take into account risks and opportunities In order to ensure that the QMS can achieve its expected results, cf. sub-clauses 4.1 (context) and 4.2 (interested parties). "Any decision involves a risk". Peter Barge 52 6.1.1 b Take into account opportunities In order to increase the desirable effects (positive impact)

6.1.1 c

Take into account risks In order to reduce the undesirable effects (negative impacts) 54 6.1.1 d Take into account risks and opportunities In order to confirm the approach of continual improvement, cf. sub-clause 10.3 55 6.1.2 a Plan actions to address risks and opportunities Take into account risks in every process 56 6.1.2 b 1 Plan the way to implement actions Define how to integrate actions in the QMS processes, cf. sub-clause 4.4 57 6.1.2 b 2 Plan the way to evaluate actions Follow the results of each action 58 6.1.2 Adapt actions to risks and opportunities Compared to the potential impact on the conformity of products and services

6.2

Quality objectives

6.2.1

Establish quality objectives for processes "He who has no goals will not achieve them". Sun Tzu" 60 6.2.1 a Choose quality objectives Clarify criteria for setting objectives that are consistent with the quality policy

6.2.1 b

Use measurable objectives And realistic

6.2.1 c

Consider applicable requirements Cf. sub-clause 4.2 63 6.2.1 d Adopt relevant objectives In order to ensure the conformity of products and services and improved customer satisfaction 64 6.2.1 e Monitor objectives Frequently

6.2.1 f

Communicate on objectives At all levels 66 6.2.1 g Update objectives During management review, cf. sub-clause 9.3 67

6.2.1

Maintain documented information on the quality objectives Cf. sub-clause 7.5 68

6.2.2 a

Plan how to do In order to achieve quality objectives 69

6.2.2 b

Plan necessary resources In order to achieve quality objectives 70

6.2.2 c

Plan responsibilities In order to achieve quality objectives 71

6.2.2 d

Plan deadlines In order to achieve quality objectives 72

6.2.2 e

Plan the way to evaluate results In order to achieve quality objectives 6.3

Planning of changes

6.3 Plan the need for changes of the QMS "The only person who likes change is a wet baby". Cf. sub-clause 4.4

6.3 a Plan the changes Taking into account the purpose of the change and the possible consequences

6.3 b Plan the changes Taking into account the maintenance of the integrity of the QMS

6.3 c Plan the changes Taking into account the available resources

6.3 d Plan the changes Taking into account the assigned responsibilities and authorities 7

Support

7.1

Resources

7.1.1

General

7.1.1 Provide the necessary resources In order to support the QMS

7.1.1 a Take into account existing resources And their capabilities and constrains

7.1.1 b Take into account the need for the use of external providers In order to provide necessary services not available inside the company 7.1.2

People

7.1.2 Provide suitable people for the effective operation of the QMS and its processes "But in the long run - and I emphasize this - no matter how good or successful you are or how clever or crafty, your business and its future are in the hands of the people you hire". Akio Morita

7.1.3

Infrastructure

7.1.3 Provide and maintain the infrastructure necessary to the functioning of processes In order to achieve conformity of products and services. Examples: buildings, equipment, transportation, hardware, software

7.1.4

Process environment

7.1.4 Provide and maintain the suitable environment necessary to the functioning of processes In order to achieve conformity of products and services. Examples: corporate culture, work atmosphere, temperature, ergonomics 7.1.5

Monitoring and measuring resources

7.1.5.1

General

7.1.5.1 Provide suitable monitoring and measuring resources In order to obtain expected inspection results

7.1.5.1 a

Provide adequate resources to the specific inspections To inspect is to monitor and measure. Cf. sub-clause 7.2 86 7.1.5.1 b Maintain resources In order to ensure fitness for their purpose 87 7.1.5.1 Retain documented information on the adequacy of inspection resources Cf. sub-clause 7.5 7.1.5.2

Measurement traceability

88 7.1.5.2 a Verify or calibrate regularly the measuring equipment In order to have confidence in the measurement results. When no such standards exist retain documented information on the reference used, cf. sub-clause 7.5 89 7.1.5.2 b Identify the measuring equipment In order to monitor the validity of their calibration (or verification) 90 7.1.5.2 c Protect the measuring equipment Against activities that may invalidate the results of the measurement (settings or deterioration) 91 7.1.5.2 Conduct corrective action on previous measurement results When the verification or calibration of a measuring instrument is not in conformity

7.1.6

Organizational knowledge 92 7.1.6 Determine the necessary knowledge In order to control the processes and the conformity of products and services 93 7.1.6 Acquire, maintain and make organizational knowledge available to the extend necessary In order to maintain the performance of the QMS 94 7.1.6 Take into account the need for additional knowledge When needs and trends have changed 7.2

Competence

95 7.2 a Determine the necessary competence Clarify quality competence requirements. Identify people who have an influence on the quality performance 96 7.2 b Ensure the competence Which are based on appropriate training or experience 97 7.2 c Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities Training, coaching, external providers 98 7.2 d Retain documented information on staff competence Cf. sub-clause 7.5 7.3 Awareness

99 7.3 a Ensure the staff is aware of the quality policy Including people who carry out work under the company's control. Cf. sub-clause 5.2 100 7.3 b Ensure the staff is aware of the quality objectives Cf. sub-clause 6.2 101 7.3 c Ensure the staff is aware of its contribution In order to improve the performance of the QMS 102 7.3 d Ensure the staff is aware of negative impacts If QMS requirements are not met 7.4

Communication

103 7.4 a Define the subjects on which to communicate Internally and externally. "Good news walks, bad news runs". Swedish proverb 104 7.4 b Define when to communicate Respond quickly to claims 105 7.4 c Define with whom to communicate Communication goes both ways

106

7.4 d

Define how to communicate Orally, in writing; Internet, video

107

7.4 e

Assign who will communicate The one who is closest to the subject 7.5

Documented information

7.5.1

General

108 7.5.1 a Include the documented information required by the ISO 9001 standard Documented information to maintain (documented procedures) :

scope of the QMS (sub-clause 4.3)
process control (sub-clause 4.4.2 a)
quality policy (sub-clause 5.2.2 a)
quality objectives (sub-clause 6.2.1)
operational control (sub-clause 8.1)

Documented information to retain (records) :

process performance (sub-clause 4.4.2 b)
fitness for purpose of inspection resources (sub-clause 7.1.5.1)
calibration (sub-clause 7.1.5.2)
staff competence (sub-clause 7.2)
necessary for the effectiveness of the QMS (sub-clause 7.5.1)
achieving processes as planned, conformity of products and services (sub-clause 8.1)
results of the review of products and services' old and new requirements (sub-clause 8.2.3.2)
design and development inputs (sub-clause 8.3.3)
design and development expected results, reviews, verifications and validations (sub-clause 8.3.4)
design and development outputs (sub-clause 8.3.5)
design and development changes (sub-clause 8.3.6)
evaluation activities and actions of external providers (sub-clause 8.4.1)
product and service characteristics or activities to be performed, results to be achieved (sub-clause 8.5.1)
traceability of products and services (sub-clause 8.5.2)
situation of the property of a customer (sub-clause 8.5.3)
results of the review of changes (sub-clause 8.5.6)
release of products and services (sub-clause 8.6)
treatment of nonconforming products and services (sub-clause 8.7.2)
inspection results (sub-clause 9.1.1)
audit programme and audit results (sub-clause 9.2.2)
management review outputs (sub-clause 9.3.3)
nonconformities, actions and results (sub-clause 10.2.2)

109 7.5.1 b Select the documented information deemed necessary to the effectiveness of the QMS "Spoken words fly away, written one stay". Latin proverb 7.5.2

Creating and updating

110 7.5.2 a Create, identify and describe the documented information Codification, title, author, subject, product 111 7.5.2 b Choose the format and the media of the documented information Language, graphics; paper, electronic 112 7.5.2 c Review and approve the adequacy of the documented information Who writes, codifies, who approves 7.5.3

Control of documented information

113 7.5.3.1 a Control the availability of the documented information Where and when required in a form that is suitable for use 114 7.5.3.1 b Control the protection of the documented information Loss of confidentiality, loss of integrity, misuse 115 7.5.3.2 a Control the distribution, access and use of the documented information Who is in charge, method to use, rule to follow 116 7.5.3.2 b Control the storage of the documented information Including preservation, protection and readability 117 7.5.3.2 c Control the changes of the documented information Use of updated versions, restricted access to obsolete versions 118 7.5.3.2 d Control the retention time and the removal of the documented information Retention period, disposal method 119 7.5.3.2 Control the documented information of external origin Unique codification, access, protection 120 7.5.3.2 Protect the documented information Who has the right to read, who has the right to change 8

Operation

Do 8.1

Operational planning and control

121 8.1 a Plan and determine the requirements for the products and services By controlling processes. Cf. sub-clauses 4.4 et 6.1 122 8.1 b 1 Establish the criteria For processes 123 8.1 b 2 Establish the criteria For the acceptance of conforming products and services 124 8.1 c Determine necessary resources Needed to achieve conformity of products and services 125 8.1 d Control the processes In accordance with the criteria of sub-clauses 8.1 b 1 and 8.1 b 2 126 8.1 e 1 Determine, maintain and retain the documented information on process control To have confidence that the process results are as expected. Cf. sub-clause 7.5 127 8.1 e 2 Determine, maintain and retain the documented information on product and service conformity Meet applicable requirements. Cf. sub-clause 7.5 128 8.1 Control planned and unplanned changes Analyse the consequences of unplanned changes, actions to limit the effects 129 8.1 Control the outsourced processes Cf. sub-clause 8.4 8.2

Requirements for products and services

8.2.1

Customer communication

130 8.2.1 a Provide information to customers Related to products and services 131 8.2.1 b Control communication with customers Related to contracts, orders, changes and consultations 132 8.2.1 c Control communication with customers Regarding the perception, opinions, complaints and recommendations. "The most important thing in communication is hearing what is not said". Peter Drucker 133 8.2.1 d Control communication with customers Regarding their property. Cf. sub-clause 8.5.3 134 8.2.1 e Control communication with customers Regarding specific requirements for contingency actions 8.2.2

Determining the requirements related to products and services

135 8.2.2 a 1 Develop specific activities for products and services In order to clarify statutory and regulatory requirements 136 8.2.2 a 2 Define internal requirements Related to processes, products and services. And check that the requirements can be met 137 8.2.2 b Be able to respond to claims In a relevant way (with facts) 8.2.3 Review of requirements related to products and services 138 8.2.3.1 Be able to respond to customers Regarding requirements of proposed products and services 139 8.2.3.1 a Review explicit customer requirements Before order acceptance. Including delivery and post-delivery activities requirements 140 8.2.3.1 b Review implicit customer requirements Before order acceptance. Unformulated requirements but necessary for specified use or use intended by the customer 141

8.2.3.1 c

Review internal requirements Between requirements of an order and those previously expressed 142

8.2.3.1 d

Review statutory and regulatory requirements Applicable to the products and services 143 8.2.3.1 e Review gaps Between requirements of an order (or contract) and those previously expressed 144 8.2.3.1 Resolve gaps Before order acceptance and commitment to provide products and services 145 8.2.3.1 Confirm requirements before accepting an order When requirements are not documented 146 8.2.3.2 a Retain the documented information on the results of the reviews of requirements Cf. sub-clause 7.5 147 8.2.3.2 b Retain the documented information on any new or changed requirement for the products and services Cf. sub-clause 7.5 8.2.4 Changes to requirements for products and services 148 8.2.4 Communicate changes to relevant persons After changing requirements in the documented information 8.3

Design and development of products and services

8.3.1

General

149 8.3.1 Establish, implement and maintain a process of design and development When the product or service requirements are not yet defined. "I have not failed. I just found 10,000 ways that will not work". Thomas Edison 8.3.2 Design and development planning 150 8.3.2 a Plan the design and development stages Taking into account the specificity of design and development activities 151 8.3.2 b Plan the design and development stages Taking into account the process requirements and applicable reviews 152 8.3.2 c Plan the design and development stages Taking into account the verification and validation activities 153 8.3.2 d Plan the design and development stages Taking into account the necessary responsibilities and authorities 154 8.3.2 e Plan the design and development stages Taking into account the needs of internal and external resources 155 8.3.2 f Plan the design and development stages Taking into account the relations between persons participating in the design and development 156 8.3.2 g Plan the design and development stages Taking into account the need for involvement of customers and users 157 8.3.2 h Plan the design and development stages Taking into account the requirements for subsequent products and services 158 8.3.2 i Plan the design and development stages Taking into account the level of control expected by interested parties 159 8.3.2 j Plan the design and development stages Taking into account the documented information meeting design and development requirements. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6 8.3.3

Design and development inputs

160 8.3.3 Determine essential requirements On specific types of products and services from design and development 161 8.3.3 a Determine functional requirements Taking into account also the performance requirements 162 8.3.3 b Clarify inputs Taking into account the information from similar activities 163 8.3.3 c Clarify inputs Taking into account the statutory and regulatory requirements 164 8.3.3 d Clarify inputs Taking into account the corporate culture, internal rules of art 165 8.3.3 e Clarify inputs Taking into account the potential consequences of product and service failure 166 8.3.3 Check that the input items are complete and unambiguous In order to realize suitable design and development process 167 8.3.3 Resolve potential conflicts between inputs In order to obtain complete and unambiguous inputs 168 8.3.3 Retain the documented information on design and development inputs Cf. sub-clause 7.5 8.3.4

Design and development controls

169 8.3.4 a Define clearly the expected results Regarding processes, products and services 170 8.3.4 b Conduct reviews as planned Regarding processes, products and services 171 8.3.4 c Check that outputs meet input requirements Cf. sub-clause 8.3.5 172 8.3.4 d Validate products and services To ensure that the specified application requirements or those for the intended use are satisfied 173 8.3.4 e Take actions in response to identified problems During reviews, verifications and validations 174 8.3.4 f Ensure that the documented information is retained Cf. sub-clause 7.5. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6 8.3.5 Design and development outputs 175 8.3.5 a Ensure that outputs meet input requirements Cf. sub-clause 8.3.3 176 8.3.5 b Ensure that outputs are in line with the subsequent processes Regarding the products and services 177 8.3.5 c Ensure that outputs include monitoring and measuring requirements Including acceptance criteria 178 8.3.5 d Ensure that outputs are suitable for their intended use Proper use or planned by the customer in complete safety 179 8.3.5 Retain the documented information on outputs Cf. sub-clause 7.5 8.3.6

Design and development changes

180 8.3.6 Identify, review and control the changes made to inputs and outputs To ensure that the changes have no impact on meeting the requirements 181 8.3.6 a Retain the documented information on changes Cf. sub-clause 7.5 182 8.3.6 b Retain the documented information on results of reviews Cf. sub-clause 7.5 183 8.3.6 c Retain the documented information on who authorized the changes Cf. sub-clause 7.5 184 8.3.6 d Retain the documented information on actions In order to prevent negative impacts. Cf. sub-clause 7.5 8.4

External providers

8.4.1

General

185 8.4.1 Ensure that the outputs of external providers meet specified requirements "You can outsource the activity, but you cannot outsource risk". Michael Gallagher 186 8.4.1 a Apply the requirements for the control of products and services provided by external providers When the products and services are integrated internally 187 8.4.1 b Apply the requirements for the control of products and services When the products and services are provided directly to customers by external providers on behalf of the company 188 8.4.1 c Apply the requirements for the control of process done by external providers When a decision has been made to outsource the process 189 8.4.1 Establish and implement evaluation and selection criteria of external providers and monitor their performance Including regular re-evaluation 190 8.4.1 Retain the documented information on the results of the evaluation and monitoring Cf. sub-clause 7.5 8.4.2

Type and extent of control

191 8.4.2 Ensure the level of control of external providers on meeting the requirements In order that the provision of external providers do not affect the conformity of products and services delivered to the customer 192 8.4.2 a Ensure that the processes of external providers are controlled In conformity with the external service provider QMS. Any outsourced process is included in the scope of the QMS 193 8.4.2 b Define how to control the external provider and its process outputs The level of control (or influence) of an external service provider is sometimes a very sensitive area. Stay alert and caring! 194 8.4.2 c 1 Take into account the potential impact of the outputs of the external provider On meeting the requirements of products and services delivered to the customer and on statutory and regulatory requirements 195 8.4.2 c 2 Take into account the control of the external provider And effectiveness of this control 196 8.4.2 d Define how to control the outputs of externally provided processes Verification and other activities necessary to ensure that the provision of external providers does not affect the conformity of products and services delivered to the customer 8.4.3

Information for external providers

197 8.4.3 Check the adequacy of the requirements And only after communicate them to the external provider 198 8.4.3 a Communicate the requirements to the external provider Regarding the processes, products and services to provide 199 8.4.3 b 1 Communicate the requirements to the external provider Regarding the approval of products and services 200 8.4.3 b 2 Communicate the requirements to the external provider Regarding the approval of methods, processes and equipment 201 8.4.3 b 3 Communicate the requirements to the external provider Regarding the approval of the release of products and services 202 8.4.3 c Communicate the requirements to the external provider Regarding the competence (including required qualifications) 203 8.4.3 d Communicate the requirements to the external provider Regarding the relations between the external provider and the company 204 8.4.3 e Communicate the requirements to the external provider Regarding the control and monitoring of the external provider's performance 205 8.4.3 f Communicate the requirements to the external provider Regarding the verification or validation activities that the company or its customer intends to realize at the external provider's premises 8.5

Production and service provision

8.5.1

Control of production and service provision

206 8.5.1 Apply controlled conditions of production and service provision Including delivery and post-delivery activities 207 8.5.1 a 1 Save documented information of specifications of products and services and the expected activities Cf. sub-clause 7.5 208 8.5.1 a 2 Save the documented information of results to be achieved Cf. sub-clause 7.5. "A quality control that does not show results is no control". Kaoru Ishikawa 209 8.5.1 b Include in the controlled conditions the inspection resources Cf. sub-clause 7.1.5 210 8.5.1 c Include in the controlled conditions the inspection activities To verify that the appropriate stages of the processes' outputs meet the criteria 211 8.5.1 d Include in the controlled conditions adequate infrastructure and environment Cf. sub-clauses 7.1.3 et 7.1.4 212 8.5.1 e Include in the controlled conditions the staff competence Including the necessary qualification, cf. sub-clause 7.2 213 8.5.1 f Include in the controlled conditions the validation of the ability of a process to achieve the expected results Only in the case when the outputs cannot be checked a posteriori 214 8.5.1 g Include in the controlled conditions the actions to prevent human error Use tools such as Poka-Yoke 215 8.5.1 h Include in the controlled conditions the activities of release, delivery and post-delivery Cf. sub-clause 8.6 and sub-clause 8.5.5 8.5.2

Identification and traceability

216 8.5.2 Use appropriate means to control the unique identification of process outputs In order to ensure the conformity of products and services when needed 217 8.5.2 Inspect processes throughout the production and service provision In order to identify the status of process outputs 218 8.5.2 Control the traceability of process outputs When traceability is a requirement, the unique identification is used 219 8.5.2 Retain the documented information on traceability Cf. sub-clause 7.5. When traceability is a requirement, the unique identification of outputs is used 8.5.3

Property belonging to customers or external providers

220 8.5.3 Exercise care with property owned by customer or external provider During its use or protection 221 8.5.3 Identify, check, protect, monitor and safeguard customer or external provider property When used or incorporated with updated labels 222 8.5.3 Notify the customer or external provider when his property has been damaged or lost and maintain the documented information on the situation Following incorrect or improper use. Cf. sub-clause 7.5. 8.5.4

Preservation

223 8.5.4 Preserve the process outputs throughout production and service provision activities Some examples of preservation methods: identification, packaging, handling, storage, transport, protection 8.5.5

Post-delivery activities

224 8.5.5 Meet the requirements for post-delivery activities Examples of post-delivery activities: exchange new product, maintenance, recycling, final disposal 225 8.5.5 a Take into account statutory and regulatory requirements Cf. sub-clause 4.2 226 8.5.5 b Take into account negative impacts related to products and services These are consequences of potential risks 227 8.5.5 c Take into account the nature, the intended use and lifetime of products and services When the extent of post-delivery activities has been clarified 228 8.5.5 d Take into account the requirements of interested parties And customers especially 229 8.5.5 e Take into account customer feedback Of interested parties, when the extent of post-delivery activities has been clarified 8.5.6

Control of changes

230 8.5.6 Review and control unplanned changes Cf. sub-clause 6.3 (planned changes) 231 8.5.6 Retain the documented information on unplanned changes Cf. sub-clause 7.5. Include the results of reviews, the authorization of changes and actions implemented 8.6

Release of products and services

232 8.6 Check products and services with activities at appropiate stages "Inspection does not improve quality, nor guarantee quality". Edwards Deming 233 8.6 Release products and services after verification of conformity Unless written approval (concession) by a competent authority or client 234 8.6 Retain the documented information on the release of products and services Cf. sub-clause 7.5. 235 8.6 a Include in the documented information evidence of conformity These are the results of inspections compared to the acceptance criteria 236 8.6 b Include in the documented information the traceability of products and services Including the person having authorized the release 8.7

Control of nonconforming outputs

237 8.7.1 Identify and treat nonconforming process, products and services outputs Marking and isolation to prevent unintended use or mixing with conforming outputs 238 8.7.1 Carry out corrective actions commensurate to impacts Including after delivery. Cf. sub-clause 10.2 239 8.7.1 Carry out corrective actions on post-delivery activities Cf. sub-clause 8.5.5 240 8.7.1 a Handle nonconforming outputs with corrections Repeat work, retouching, repair, recycling 241 8.7.1 b Handle nonconforming outputs by segregation Including customer returns or products and services not released 242 8.7.1 c Inform the customer Cf. sub-clause 7.4 243 8.7.1 d Handle nonconforming outputs by asking authorization To use in is (acceptance under concession) 244 8.7.1 Check conformity after any correction After any correction go through the normal flow 245 8.7.2 a Retain the documented information on the description of nonconformities Cf. sub-clause 7.5. 246 8.7.2 b Retain the documented information on implemented actions Cf. sub-clause 7.5. 247 8.7.2 c Retain the documented information on approved concessions Cf. sub-clause 7.5. 248 8.7.2 d Retain the documented information on the person having decided the handling of the nonconformities Cf. sub-clause 7.5 9

Performance evaluation

Check 9.1

Monitoring, measurement, analysis and evaluation

9.1.1

General

249 9.1.1 a Determine what is necessary to inspect "If you can’t measure it, you can’t manage it". Peter Drucker 250 9.1.1 b Determine the methods for inspection, analysis and evaluation In order to ensure valid results 251 9.1.1 c Determine when to inspect At key stages (essential) or upon the customer's request 252 9.1.1 d Determine when to analyse and evaluate inspection results When that brings added value 253 9.1.1 Evaluate the performance and effectiveness of the QMS In order to ensure that specified requirements are met 254 9.1.1 Retain the documented information on the inspection results Cf. sub-clause 7.5 9.1.2

Customer satisfaction

255 9.1.2 Regularly monitor customer perception about their level of satisfaction "The only measure of quality is customer satisfaction" 256 9.1.2 Determine methods for obtaining and using customer information Satisfaction surveys, claims, customer returns, recommendations 9.1.3

Analysis and evaluation

257 9.1.3 Analyse and evaluate inspection data "Get the facts, analyze them and then do what seems right". Robert Waterman 258 9.1.3 a Use analysis results In order to evaluate how requirements are met. Cf. sub-clause 4.2 259 9.1.3 b Use analysis results In order to evaluate the level of customer satisfaction. Cf. sub-clause 9.1.2 260 9.1.3 c Use analysis results In order to evaluate the performance and effectiveness of the QMS 261 9.1.3 d Use analysis results In order to evaluate the effectiveness of planning. Cf. sub-clause 8.1 262 9.1.3 e Use analysis results In order to evaluate the effectiveness of actions implemented to address risks and opportunities. Cf. sub-clause 6.1 263 9.1.3 f Use analysis results In order to evaluate the performance of external providers. Cf. sub-clause 8.4 264 9.1.3 g Use analysis results In order to evaluate the improvement opportunities of the QMS. Cf. sub-clause 10.3 9.2

Internal audit

265 9.2.1 a 1 Conduct regularly planned internal audits In order to determine whether the QMS meets internal company requirements. Cf. ISO 19011 266 9.2.1 a 2 Conduct regularly planned internal audits In order to determine whether the QMS meets requirements of the ISO 9001 standard 267 9.2.1 b Conduct regularly planned internal audits In order to determine whether the QMS is effectively implemented and maintained 268 9.2.2 a Plan, establish, implement and update an audit programme Include the frequency, methods, responsibilities, planning requirements (audit programme) and reporting requirements (audit report) 269 9.2.2 a Take into account in the audit programme essential points Essentials points :

process importance
changes having an impact on the company
results of previous audits

"The quality control should verify the process, not the product". Edwards Deming 270 9.2.2 b Define the scope and audit criteria Limit the area to be audited; use specific and known by the auditee criteria 271 9.2.2 c Select auditors Do not audit your department. "No one is judge in his own case". Latin proverb 272 9.2.2 d Communicate audit results to management concerned Cf. sub-clause 7.4 273 9.2.2 e Undertake a correction quickly and corrective actions if necessary Cf. sub-clause 10.2 274 9.2.2 f Retain the documented information on the audit programme and the audit reports Cf. sub-clause 7.5 9.3

Management review

9.3.1

General

275 9.3.1 Proceed at least once a year to review the QMS In order to confirm that it is still relevant, appropriate and effective. "No system is perfect" 9.3.2

Management review inputs

276 9.3.2 a Plan and carry out the management review Regarding the status of actions of the previous review 277 9.3.2 b Carry out the management review taking into account the changes of external and internal issues for the QMS Including strategic direction 278 9.3.2 c 1 Take into account the information on the performance of the QMS and trends Customer satisfaction, feedback. Cf. sub-clauses 8.7 et 10.2 279 9.3.2 c 2 Take into account the information on the performance of the QMS and trends The achievement of quality objectives, cf. sub-clause 6.2 280 9.3.2 c 3 Take into account the information on the performance of the QMS and trends Process performance and conformity of outputs. Cf. sub-clause 9.1 281 9.3.2 c 4 Take into account the information on the performance of the QMS and trends Nonconformities and corrective actions. Cf. sub-clause 10.2 282 9.3.2 c 5 Take into account the information on the performance of the QMS and trends Inspection results. Cf. sub-clause 9.1 283 9.3.2 c 6 Take into account the information on the performance of the QMS and trends Audit results. Cf. sub-clause 9.2 284 9.3.2 c 7 Take into account the information on the performance of the QMS and trends Performance of external providers. Cf. sub-clause 8.4 285 9.3.2 d Take into account resources Availability of resources. Cf. sub-clause 7.1 286 9.3.2 e Take into account the effectiveness of actions Implemented to address risks and opportunities. Cf. sub-clause 6.1 287 9.3.2 f Take into account improvement opportunities Continual improvement. Cf. sub-clause 10.3 9.3.3

Management review outputs

288 9.3.3 a Include decisions regarding opportunities for continual improvement in the outputs of the management review Cf. sub-clause 10.3 289 9.3.3 b Include decisions regarding eventual changes to the QMS in the outputs of the management review Cf. sub-clause 6.3 290 9.3.3 c Include decisions regarding new resource needs in the outputs of the management review Cf. sub-clause 7.1 291 9.3.3 Retain the documented information on outputs of the review of management Cf. sub-clause 7.5 10

Improvement

Act 10.1

General

292 10.1 Find improvement opportunities and implement necessary actions In order to enhance customer satisfaction. "Where there is a problem, there is potential for improvement". Masaaki Imai 293 10.1 a Improve products and services Support innovation. In order to better meet current requirements and anticipate future requirements 294 10.1 b Reduce negative impacts Implementing corrective actions and global prevention (efficient QMS) 295 10.1 c Improve the results of the QMS To achieve the objectives of the QMS regarding performance 10.2

Nonconformity and corrective action

296 10.2.1 a 1 React to the nonconformity In order to reduce costs. Including all claims by processing, controlling, correcting. "One of the best ways to measure quality is to calculate the price of nonconformities". Philip Crosby 297 10.2.1 a 2 Take into account consequences Think risk-based approach 298 10.2.1 b 1 Examine the nonconformity And if necessary decide to carry out a corrective action 299 10.2.1 b 2 Investigate root causes So that the nonconformity does not happen again 300 10.2.1 b 3 Search for similar nonconformities In order to apply the same recipe (why reinvent the wheel?) 301 10.2.1 c Implement the necessary corrective actions In order to treat the nonconformity 302 10.2.1 d Review the effectiveness of any implemented corrective action In order to check whether the action is finalized 303 10.2.1 e Update risks and opportunities If necessary 304 10.2.1 f Make changes to the QMS If necessary 305 10.2.1 Respond proportionally to nonconformities consequences Do not make too much quality 306 10.2.2 a Retain documented information on the nature of nonconformities Cf. sub-clause 7.5 307 10.2.2 a Retain documented information on results of implemented actions Cf. sub-clause 7.5 10.3

Continual improvement

308 10.3 Improve continually the performance of the QMS In order to find improvement opportunities 309 10.3 Take into account the outputs of the analysis, evaluation and management review Cf. sub-clause 9.1.3 and sub-clause 9.3

What are the 7 main clauses of ISO 9001 2015?

ISO 9001 Clauses - DO.

7.1.1 General..

7.1.2 People..

Human Resources Procedure..

7.1.3 Infrastructure..

7.1.4 Environment for the operation of processes..

7.1.5 Monitoring and measuring resources..

7.1.6 organizational knowledge..

What are the 10 clauses of ISO 9001?

Top 10 Clauses in ISO 9001:2015.

Clause 0-3 – Introduction and scope of the standard..

Clause 4 – Context of the organization..

Clause 5 – Leadership..

Clause 6 – Planning..

Clause 7 – Support..

Clause 8 – Operation..

Clause 9 – Performance evaluation..

Clause 10 – Improvement..

How do you manage knowledge of the organization according to ISO 9001?

Determine the knowledge necessary for the operation of processes and for achieving conformity of products and services. Maintain knowledge and make it available to the extent necessary. Consider the current organizational knowledge and compare it to changing needs and trends.

What is monitoring and measurement results in ISO 9001?

The difference between monitoring and measurement in ISO 9001 is that monitoring is used to observe something closely so that you can record or detect, while measurement is used to determine the actual characteristics of something (e.g. sizes, volume, etc.)

The ISO 9001 standard requires an organization to identify, verify, protect and safeguard what

What are the 7 main clauses of ISO 9001 2015?

What are the 10 clauses of ISO 9001?

How do you manage knowledge of the organization according to ISO 9001?

What is monitoring and measurement results in ISO 9001?

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