Clause by Clause Based on the ISO 9001 - 2015

Based on the ISO 9001: 2015 the 309 requirements (verb shall) of clauses 4 to 10ISO 9001 : 2015 requirements Requirement No Clause PDCA cycle Quantity No 4 Context of the organization Plan 1 ÷ 24 24 5 Leadership Plan, Do, Check, Act 25 ÷ 50 26 6 Planning Plan 51 ÷ 77 27 7 Support Do 78 ÷ 120 43 8 Operation Do 121 ÷ 248 128 9 Performance evaluation Check 249 ÷ 291 43 10 Improvement Act 291 ÷ 309 18 Total 309 ISO 9001 2015 requirements The Deming PDCA cycle 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, No sub- Requirement Comment, link clause 4 Context of the organization Plan The organization and its 4.1 context 1 4.1 Determine external and internal Understand everything that can influence the issues purpose and strategic direction of the company (corporate culture, innovation, strategic direction, competition, market, compliance obligation) 2 4.1 Monitor and review information Issue: what one can gain or lose during an activity about issues (factors, conditions) Needs and expectations of 4.2 beginning interested parties 3 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 Each need and expectation is unique. Aim for a interested parties partnership in the long term 5 4.2 Monitor and review information Before accepting an order about interested parties and their requirements Scope of the quality 4.3 beginning management system 6 4.3 Define the scope of the QMS Geographic and organizational scope available to interested parties 7 4.3 a Take into account the external Cf. sub-clause 4.1 and internal issues 8 4.3 b Take into account the Cf. sub-clause 4.2 requirements of interested parties 9 4.3 c Take into account the products All products and services proposed by the and services company without exception 10 4.3 Apply any requirement of the ISO The requirements of the standard become internal 9001 standard applicable within requirements the scope of the QMS 11 4.3 Maintain the scope of the QMS Cf. sub-clause 7.5. Include all products and as documented information services 12 4.3 Include in the scope of the QMS Every requirement of the ISO 9001 standard which justification for any requirements cannot be applied in the company implies a which cannot be met justification Quality management system 4.4 beginning and its processes 13 4.4.1 Establish, implement, maintain The company is free to decide how to apply the and improve a process-based QMS without forgetting the issues (see sub- QMS clause 4.1) and requirements (see sub-clause 4.2) 14 4.4.1 Determine the needed processes "If you cannot describe what you are doing as a and their application process, you do not know what you're doing. Edwards Deming". Process map 15 4.4.1 a Determine process inputs and Process sheet outputs 16 4.4.1 b Determine the sequence and Flowchart interaction of processes 17 4.4.1 c Determine the criteria and Tools of the quality manager methods to control processes 18 4.4.1 d Determine and ensure the Needed to support processes. Cf. sub-clause 7.1 resources 19 4.4.1 e Assign process responsibilities Job description of process owners and authorities 20 4.4.1 f Take into account the risks and Plan and implement actions to address these risks, opportunities for each process cf. sub-clause 6.1 21 4.4.1 g Evaluate processes and if Identify methods to monitor, measure, check and necessary modify them modify processes. Cf. sub-clause 9.1.1 22 4.4.1 h Determine the improvement Cf. sub-clause 10.1 opportunities of processes and the QMS 23 4.4.2 Maintain documented information Cf. sub-clause 7.5. The bare essential is sufficient. on process operation Use process map 24 4.4.2 Retain documented information Cf. sub-clause 7.5. The goal is to ensure that on process operation processes' results are those planned 5 Leadership Plan , Do, Check, Act 5.1 Leadership and commitment 5.1.1 General beginning 25 5.1.1 a Assume responsibility for the "When you sweep the stairs, you start at the effectiveness of the QMS 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 The policy and the objectives are compatible with quality objectives strategic direction and context of the company 27 5.1.1 c Integrate QMS requirements in Cf. sub-clause 4.4 and sub-clause 7.1.4 the internal process requirements 28 5.1.1 d Raise awareness of the process Cf. sub-clause 0.3 (introduction) and sub- approach and risk-based clause 6.1 approach 29 5.1.1 e Provide the necessary resources Cf. sub-clause 7.1 for the QMS 30 5.1.1 f Raise awareness on the Third quality management principle (engagement importance of an effective and of people) conforming QMS 31 5.1.1 g Ensure the achievement of Essential commitment of top management intended results of the QMS 32 5.1.1 h Support the staff contribution to "Employees first, customers second. Vineet the effectiveness of the QMS Nayar" 33 5.1.1 i Promote continual improvement Cf. sub-clause 10.3 34 5.1.1 j Support the leadership of Responsibility and authority of managers are managers backed at all times by top management 5.1.2 Customer focus beginning 35 5.1.2 a Determine and meet customer, Top management demonstrates statutory and regulatory leadership (assumes its responsibility and requirements commitment) permanently 36 5.1.2 b Determine and address the Any risk and opportunity that may influence the potential risks and opportunities conformity of products and services and customer satisfaction. Preserving the goal to always provide compliant products and services 37 5.1.2 c Maintain the objective of better First quality management principle (customer satisfying the customer focus) 5.2 Policy beginning 5.2.1 Establishing the quality policy 38 5.2.1 a Establish, implement and Top management applies a policy adapted to the maintain a suitable quality policy purpose, strategic direction, culture and business context 39 5.2.1 b Provide a framework to define Cf. sub-clause 6.2 and review the quality objectives 40 5.2.1 c Include meeting the applicable Cf. sub-clause 9.1.3 requirements 41 5.2.1 d Include a commitment to Cf. sub-clause 10.3 continuously improve the QMS Communicating the quality 5.2.2 beginning policy 42 5.2.2 a Maintain the quality policy as And make it available inside the company. Cf. sub- documented information 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 Roles, responsibilities, 5.3 beginning authorities 45 5.3 Define and communicate the Top management assigns all relevant roles in the responsibilities and authorities QMS 46 5.3 a Define and communicate the Top management assigns all relevant roles responsibilities and authorities according to the requirements of the ISO 9001 standard 47 5.3 b Define and communicate the Top management assigns all relevant roles so that responsibilities and authorities processes deliver expected results 48 5.3 c Define and communicate the Top management assigns all relevant roles so that responsibilities and authorities reporting on the performance of the QMS and improvement opportunities is done, cf. sub- clause 10.1 49 5.3 d Define and communicate the Top management assigns all relevant roles so that responsibilities and authorities customer focus is ensured (first quality management principle) 50 5.3 e Define and communicate the Top management assigns all relevant roles so that responsibilities and authorities implemented changes to the QMS do not affect its integrity 6 Planning Plan Actions to address risks and 6.1 beginning opportunities 51 6.1.1 a Take into account risks and In order to ensure that the QMS can achieve its opportunities 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) 53 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 In order to confirm the approach of continual opportunities improvement, cf. sub-clause 10.3 55 6.1.2 a Plan actions to address risks and Take into account risks in every process opportunities 56 6.1.2 b Plan the way to implement Define how to integrate actions in the QMS 1 actions processes, cf. sub-clause 4.4 57 6.1.2 b Plan the way to evaluate actions Follow the results of each action 2 58 6.1.2 Adapt actions to risks and Compared to the potential impact on the conformity opportunities of products and services 6.2 Quality objectives beginning 59 6.2.1 Establish quality objectives for "He who has no goals will not achieve them. processes Sun Tzu" 60 6.2.1 a Choose quality objectives Clarify criteria for setting objectives that are consistent with the quality policy 61 6.2.1 b Use measurable objectives And realistic 62 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 65 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 Cf. sub-clause 7.5 on the quality objectives 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 beginning 73 6.3 Plan the need for changes of the "The only person who likes change is a wet QMS baby". Cf. sub-clause 4.4 74 6.3 a Plan the changes Taking into account the purpose of the change and the possible consequences 75 6.3 b Plan the changes Taking into account the maintenance of the integrity of the QMS 76 6.3 c Plan the changes Taking into account the available resources 77 6.3 d Plan the changes Taking into account the assigned responsibilities and authorities 7 Support Do 7.1 Resources 7.1.1 General beginning 78 7.1.1 Provide the necessary resources In order to support the QMS 79 7.1.1 a Take into account existing And their capabilities and constrains resources 80 7.1.1 b Take into account the need for In order to provide necessary services not available the use of external providers inside the company 7.1.2 People beginning 81 7.1.2 Provide suitable people for the "But in the long run - and I emphasize this - no effective operation of the QMS matter how good or successful you are or how and its processes clever or crafty, your business and its future are in the hands of the people you hire. Akio Morita" 7.1.3 Infrastructure beginning 82 7.1.3 Provide and maintain the In order to achieve conformity of products and infrastructure necessary to the services. Examples: buildings, equipment, functioning of processes transportation, hardware, software 7.1.4 Process environment beginning 83 7.1.4 Provide and maintain the suitable In order to achieve conformity of products and environment necessary to the services. Examples: corporate culture, work functioning of processes atmosphere, temperature, ergonomics Monitoring and measuring 7.1.5 beginning resources 7.1.5.1 General 84 7.1.5.1 Provide suitable monitoring and In order to obtain expected inspection results measuring resources 85 7.1.5.1 Provide adequate resources to To inspect is to monitor and measure. Cf. sub- a the specific inspections clause 7.2 86 7.1.5.1 Maintain resources In order to ensure fitness for their purpose b 87 7.1.5.1 Retain documented information Cf. sub-clause 7.5 on the adequacy of inspection resources 7.1.5.2 Measurement traceability beginning 88 7.1.5.2 Verify or calibrate regularly the In order to have confidence in the measurement a measuring equipment results. When no such standards exist retain documented information on the reference used, cf. sub-clause 7.5 89 7.1.5.2 Identify the measuring equipment In order to monitor the validity of their calibration b (or verification) 90 7.1.5.2 Protect the measuring equipment Against activities that may invalidate the results of c the measurement (settings or deterioration) 91 7.1.5.2 Conduct corrective action on When the verification or calibration of a measuring previous measurement results instrument is not in conformity 7.1.6 Organizational knowledge beginning 92 7.1.6 Determine the necessary In order to control the processes and the knowledge conformity of products and services 93 7.1.6 Acquire, maintain and make In order to maintain the performance of the QMS organizational knowledge available to the extend necessary 94 7.1.6 Take into account the need for When needs and trends have changed additional knowledge 7.2 Competence beginning 95 7.2 a Determine the necessary Clarify quality competence requirements. Identify competence 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 Training, coaching, external providers the necessary competence and evaluate the effectiveness of these activities 98 7.2 d Retain documented information Cf. sub-clause 7.5 on staff competence 7.3 Awareness beginning 99 7.3 a Ensure the staff is aware of the Including people who carry out work under the quality policy company's control. Cf. sub-clause 5.2 100 7.3 b Ensure the staff is aware of the Cf. sub-clause 6.2 quality objectives 101 7.3 c Ensure the staff is aware of its In order to improve the performance of the QMS contribution 102 7.3 d Ensure the staff is aware of If QMS requirements are not met negative impacts 7.4 Communication beginning 103 7.4 a Define the subjects on which to Internally and externally. "Good news walk, bad communicate ones run. Swedish proverb" 104 7.4 b Define when to communicate Respond quickly to claims 105 7.4 c Define with whom to Communication goes both ways communicate 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 beginning 108 7.5.1 a Include the documented Documented information to maintain (documented information required by the ISO procedures) : 9001 standard  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 "Spoken words fly away, written one stay. Latin information deemed necessary to proverb" the effectiveness of the QMS 7.5.2 Creating and updating beginning 110 7.5.2 a Create, identify and describe the Codification, title, author, subject, product documented information 111 7.5.2 b Choose the format and the media Language, graphics; paper, electronic of the documented information 112 7.5.2 c Review and approve the Who writes, codifies, who approves adequacy of the documented information Control of documented 7.5.3 beginning information 113 7.5.3.1 Control the availability of the Where and when required in a form that is suitable a documented information for use 114 7.5.3.1 Control the protection of the Loss of confidentiality, loss of integrity, misuse b documented information 115 7.5.3.2 Control the distribution, access Who is in charge, method to use, rule to follow a and use of the documented information 116 7.5.3.2 Control the storage of the Including preservation, protection and readability b documented information 117 7.5.3.2 Control the changes of the Use of updated versions, restricted access to c documented information obsolete versions 118 7.5.3.2 Control the retention time and the Retention period, disposal method d removal of the documented information 119 7.5.3.2 Control the documented Unique codification, access, protection information of external origin 120 17.5.3.2 Protect the documented Who has the right to read, who has the right to information change 8 Operation Do Operational planning and 8.1 beginning control 121 8.1 a Plan and determine the By controlling processes. Cf. sub- requirements for the products and clauses 4.4 et 6.1 services 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 To have confidence that the process results are as the documented information on expected. Cf. sub-clause 7.5 process control 127 8.1 e 2 Determine, maintain and retain Meet applicable requirements. Cf. sub-clause 7.5 the documented information on product and service conformity 128 8.1 Control planned and unplanned Analyse the consequences of unplanned changes, changes actions to limit the effects 129 8.1 Control the outsourced processes Cf. sub-clause 8.4 Requirements for products and 8.2 services 8.2.1 Customer communication beginning 130 8.2.1 a Provide information to customers Related to products and services 131 8.2.1 b Control communication with Related to contracts, orders, changes and customers consultations 132 8.2.1 c Control communication with Regarding the perception, opinions, complaints and customers recommendations. "The most important thing in communication is hearing what is not said. Peter Drucker" 133 8.2.1 d Control communication with Regarding their property. Cf. sub-clause 8.5.3 customers 134 8.2.1 e Control communication with Regarding specific requirements for contingency customers actions Determining the requirements 8.2.2 related to products and beginning services 135 8.2.2 a Develop specific activities for In order to clarify statutory and regulatory 1 products and services requirements 136 8.2.2 a Define internal requirements Related to processes, products and services. And 2 check that the requirements can be met 137 8.2.2 b Be able to respond to claims In a relevant way (with facts) Review of requirements related 8.2.3 beginning 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 Review explicit customer Before order acceptance. Including delivery and a requirements post-delivery activities requirements 140 8.2.3.1 Review implicit customer Before order acceptance. Unformulated b requirements requirements but necessary for specified use or use intended by the customer 141 8.2.3.1 Review internal requirements Between requirements of an order and those c previously expressed 142 8.2.3.1 Review statutory and regulatory Applicable to the products and services d requirements 143 8.2.3.1 Review gaps Between requirements of an order (or contract) and e 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 When requirements are not documented accepting an order 146 8.2.3.2 Retain the documented Cf. sub-clause 7.5 a information on the results of the reviews of requirements 147 8.2.3.2 Retain the documented Cf. sub-clause 7.5 b information on any new or changed requirement for the products and services Changes to requirements for 8.2.4 beginning products and services 148 8.2.4 Communicate changes to After changing requirements in the documented relevant persons information Design and development of 8.3 products and services 8.3.1 General beginning 149 8.3.1 Establish, implement and When the product or service requirements are not maintain a process of design and yet defined. "I have not failed. I just found 10,000 development ways that will not work. Thomas Edison" Design and development 8.3.2 beginning planning 150 8.3.2 a Plan the design and development Taking into account the specificity of design and stages development activities 151 8.3.2 b Plan the design and development Taking into account the process requirements and stages applicable reviews 152 8.3.2 c Plan the design and development Taking into account the verification and validation stages activities 153 8.3.2 d Plan the design and development Taking into account the necessary responsibilities stages and authorities 154 8.3.2 e Plan the design and development Taking into account the needs of internal and stages external resources 155 8.3.2 f Plan the design and development Taking into account the relations between persons stages participating in the design and development 156 8.3.2 g Plan the design and development Taking into account the need for involvement of stages customers and users 157 8.3.2 h Plan the design and development Taking into account the requirements for stages subsequent products and services 158 8.3.2 i Plan the design and development Taking into account the level of control expected by stages interested parties 159 8.3.2 j Plan the design and development Taking into account the documented information stages meeting design and development requirements. Cf. sub-clauses 8.3.3, 8.3.5 and 8.3.6 Design and development 8.3.3 beginning 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 Taking into account also the performance requirements 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 In order to realize suitable design and development complete and unambiguous process 167 8.3.3 Resolve potential conflicts In order to obtain complete and unambiguous between inputs inputs 168 8.3.3 Retain the documented Cf. sub-clause 7.5 information on design and development inputs Design and development 8.3.4 beginning controls 169 8.3.4 a Define clearly the expected Regarding processes, products and services results 170 8.3.4 b Conduct reviews as planned Regarding processes, products and services 171 8.3.4 c Check that outputs meet input Cf. sub-clause 8.3.5 requirements 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 During reviews, verifications and validations identified problems 174 8.3.4 f Ensure that the documented Cf. sub-clause 7.5. Cf. sub- information is retained clauses 8.3.3, 8.3.5 and 8.3.6 Design and development 8.3.5 beginning outputs 175 8.3.5 a Ensure that outputs meet input Cf. sub-clause 8.3.3 requirements 176 8.3.5 b Ensure that outputs are in line Regarding the products and services with the subsequent processes 177 8.3.5 c Ensure that outputs include Including acceptance criteria monitoring and measuring requirements 178 8.3.5 d Ensure that outputs are suitable Proper use or planned by the customer in complete for their intended use safety 179 8.3.5 Retain the documented Cf. sub-clause 7.5 information on outputs Design and development 8.3.6 beginning changes 180 8.3.6 Identify, review and control the To ensure that the changes have no impact on changes made to inputs and meeting the requirements outputs 181 8.3.6 a Retain the documented Cf. sub-clause 7.5 information on changes 182 8.3.6 b Retain the documented Cf. sub-clause 7.5 information on results of reviews 183 8.3.6 c Retain the documented Cf. sub-clause 7.5 information on who authorized the changes 184 8.3.6 d Retain the documented In order to prevent negative impacts. Cf. sub- information on actions clause 7.5 8.4 External providers beginning 8.4.1 General 185 8.4.1 Ensure that the outputs of "You can outsource the activity, but you cannot external providers meet specified outsource risk. Michael Gallagher" requirements 186 8.4.1 a Apply the requirements for the When the products and services are integrated control of products and services internally provided by external providers 187 8.4.1 b Apply the requirements for the When the products and services are provided control of products and services directly to customers by external providers on behalf of the company 188 8.4.1 c Apply the requirements for the When a decision has been made to outsource the control of process done by process external providers 189 8.4.1 Establish and implement Including regular re-evaluation evaluation and selection criteria of external providers and monitor their performance 190 8.4.1 Retain the documented Cf. sub-clause 7.5 information on the results of the evaluation and monitoring 8.4.2 Type and extent of control beginning 191 8.4.2 Ensure the level of control of In order that the provision of external providers do external providers on meeting the not affect the conformity of products and services requirements delivered to the customer 192 8.4.2 a Ensure that the processes of In conformity with the external service provider external providers are controlled QMS. Any outsourced process is included in the scope of the QMS 193 8.4.2 b Define how to control the external The level of control (or influence) of an external provider and its process outputs service provider is sometimes a very sensitive area. Stay alert and caring! 194 8.4.2 c Take into account the potential On meeting the requirements of products and 1 impact of the outputs of the services delivered to the customer and on statutory external provider and regulatory requirements 195 8.4.2 c Take into account the control of And effectiveness of this control 2 the external provider 196 8.4.2 d Define how to control the outputs Verification and other activities necessary to of externally provided processes ensure that the provision of external providers does not affect the conformity of products and services delivered to the customer Information for external 8.4.3 beginning providers 197 8.4.3 Check the adequacy of the And only after communicate them to the external requirements provider 198 8.4.3 a Communicate the requirements Regarding the processes, products and services to to the external provider provide 199 8.4.3 b Communicate the requirements Regarding the approval of products and services 1 to the external provider 200 8.4.3 b Communicate the requirements Regarding the approval of methods, processes and 2 to the external provider equipment 201 8.4.3 b Communicate the requirements Regarding the approval of the release of products 3 to the external provider and services 202 8.4.3 c Communicate the requirements Regarding the competence (including required to the external provider qualifications) 203 8.4.3 d Communicate the requirements Regarding the relations between the external to the external provider provider and the company 204 8.4.3 e Communicate the requirements Regarding the control and monitoring of the to the external provider external provider's performance 205 8.4.3 f Communicate the requirements Regarding the verification or validation activities to the external provider that the company or its customer intends to realize at the external provider's premises Production and service 8.5 provision Control of production and 8.5.1 beginning service provision 206 8.5.1 Apply controlled conditions of Including delivery and post-delivery activities production and service provision 207 8.5.1 a Save documented information of Cf. sub-clause 7.5 1 specifications of products and services and the expected activities 208 8.5.1 a Save the documented information Cf. sub-clause 7.5. "A quality control that does 2 of results to be achieved not show results is no control. Kaoru Ishikawa" 209 8.5.1 b Include in the controlled Cf. sub-clause 7.1.5 conditions the inspection resources 210 8.5.1 c Include in the controlled To verify that the appropriate stages of the conditions the inspection processes' outputs meet the criteria activities 211 8.5.1 d Include in the controlled Cf. sub-clauses 7.1.3 et 7.1.4 conditions adequate infrastructure and environment 212 8.5.1 e Include in the controlled Including the necessary qualification, cf. sub- conditions the staff competence clause 7.2 213 8.5.1 f Include in the controlled Only in the case when the outputs cannot be conditions the validation of the checked a posteriori ability of a process to achieve the expected results 214 8.5.1 g Include in the controlled Use tools such as Poka-Yoke conditions the actions to prevent human error 215 8.5.1 h Include in the controlled Cf. sub-clause 8.6 and sub-clause 8.5.5 conditions the activities of release, delivery and post- delivery 8.5.2 Identification and traceability beginning 216 8.5.2 Use appropriate means to control In order to ensure the conformity of products and the unique identification of services when needed process outputs 217 8.5.2 Inspect processes throughout the In order to identify the status of process outputs production and service provision 218 8.5.2 Control the traceability of process When traceability is a requirement, the unique outputs identification is used 219 8.5.2 Retain the documented Cf. sub-clause 7.5. When traceability is a information on traceability requirement, the unique identification of outputs is used Property belonging to 8.5.3 customers or external beginning providers 220 8.5.3 Exercise care with property During its use or protection owned by customer or external provider 221 8.5.3 Identify, check, protect, monitor When used or incorporated with updated labels and safeguard customer or external provider property 222 8.5.3 Notify the customer or external Following incorrect or improper use. Cf. sub- provider when his property has clause 7.5. been damaged or lost and maintain the documented information on the situation 8.5.4 Preservation beginning 223 8.5.4 Preserve the process outputs Some examples of preservation methods: throughout production and identification, packaging, handling, storage, service provision activities transport, protection 8.5.5 Post-delivery activities beginning 224 8.5.5 Meet the requirements for post- Examples of post-delivery activities: exchange new delivery activities product, maintenance, recycling, final disposal 225 8.5.5 a Take into account statutory and Cf. sub-clause 4.2 regulatory requirements 226 8.5.5 b Take into account negative These are consequences of potential risks impacts related to products and services 227 8.5.5 c Take into account the nature, the When the extent of post-delivery activities has intended use and lifetime of been clarified products and services 228 8.5.5 d Take into account the And customers especially requirements of interested parties 229 8.5.5 e Take into account customer Of interested parties, when the extent of post- feedback delivery activities has been clarified 8.5.6 Control of changes beginning 230 8.5.6 Review and control unplanned Cf. sub-clause 6.3 (planned changes) changes 231 8.5.6 Retain the documented Cf. sub-clause 7.5. Include the results of reviews, information on unplanned the authorization of changes and actions changes implemented Release of products and 8.6 beginning services 232 8.6 Check products and services with "Inspection does not improve quality, nor activities at appropiate stages guarantee quality. Edwards Deming" 233 8.6 Release products and services Unless written approval (concession) by a after verification of conformity competent authority or client 234 8.6 Retain the documented Cf. sub-clause 7.5. information on the release of products and services 235 8.6 a Include in the documented These are the results of inspections compared to information evidence of the acceptance criteria conformity 236 8.6 b Include in the documented Including the person having authorized the release information the traceability of products and services Control of nonconforming 8.7 beginning outputs 237 8.7.1 Identify and treat nonconforming Marking and isolation to prevent unintended use or process, products and services mixing with conforming outputs outputs 238 8.7.1 Carry out corrective actions Including after delivery. Cf. sub-clause 10.2 commensurate to impacts 239 8.7.1 Carry out corrective actions on Cf. sub-clause 8.5.5 post-delivery activities 240 8.7.1 a Handle nonconforming outputs Repeat work, retouching, repair, recycling with corrections 241 8.7.1 b Handle nonconforming outputs by Including customer returns or products and segregation 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 To use in is (acceptance under concession) asking authorization 244 8.7.1 Check conformity after any After any correction go through the normal flow correction 245 8.7.2 a Retain the documented Cf. sub-clause 7.5. information on the description of nonconformities 246 8.7.2 b Retain the documented Cf. sub-clause 7.5. information on implemented actions 247 8.7.2 c Retain the documented Cf. sub-clause 7.5. information on approved concessions 248 8.7.2 d Retain the documented Cf. sub-clause 7.5 information on the person having decided the handling of the nonconformities 9 Performance evaluation Check Monitoring, measurement, 9.1 analysis and evaluation 9.1.1 General beginning 249 9.1.1 a Determine what is necessary to "If you can’t measure it, you can’t manage it. inspect Peter Drucker" 250 9.1.1 b Determine the methods for In order to ensure valid results inspection, analysis and evaluation 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 When that brings added value evaluate inspection results 253 9.1.1 Evaluate the performance and In order to ensure that specified requirements are effectiveness of the QMS met 254 9.1.1 Retain the documented Cf. sub-clause 7.5 information on the inspection results 9.1.2 Customer satisfaction beginning 255 9.1.2 Regularly monitor customer "The only measure of quality is customer perception about their level of satisfaction" satisfaction 256 9.1.2 Determine methods for obtaining Satisfaction surveys, claims, customer returns, and using customer information recommendations 9.1.3 Analysis and evaluation beginning 257 9.1.3 Analyse and evaluate inspection "Get the facts, analyze them and then do what data 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 beginning 265 9.2.1 a Conduct regularly planned In order to determine whether the QMS meets 1 internal audits internal company requirements. Cf. ISO 19011 266 9.2.1 a Conduct regularly planned In order to determine whether the QMS meets 2 internal audits requirements of the ISO 9001 standard 267 9.2.1 b Conduct regularly planned In order to determine whether the QMS is internal audits effectively implemented and maintained 268 9.2.2 a Plan, establish, implement and Include the frequency, methods, responsibilities, update an audit programme planning requirements (audit programme) and reporting requirements (audit report) 269 9.2.2 a Take into account in the audit Essentials points : programme essential 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 Limit the area to be audited; use specific and criteria 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 Cf. sub-clause 7.4 management concerned 273 9.2.2 e Undertake a correction quickly Cf. sub-clause 10.2 and corrective actions if necessary 274 9.2.2 f Retain the documented Cf. sub-clause 7.5 information on the audit programme and the audit reports 9.3 Management review beginning 9.3.1 General 275 9.3.1 Proceed at least once a year to In order to confirm that it is still relevant, review the QMS appropriate and effective. "No system is perfect" 9.3.2 Management review inputs 276 9.3.2 a Plan and carry out the Regarding the status of actions of the previous management review review 277 9.3.2 b Carry out the management Including strategic direction review taking into account the changes of external and internal issues for the QMS 278 9.3.2 c Take into account the information Customer satisfaction, feedback. Cf. sub- 1 on the performance of the QMS clauses 8.7 et 10.2 and trends 279 9.3.2 c Take into account the information The achievement of quality objectives, cf. sub- 2 on the performance of the QMS clause 6.2 and trends 280 9.3.2 c Take into account the information Process performance and conformity of outputs. 3 on the performance of the QMS Cf. sub-clause 9.1 and trends 281 9.3.2 c Take into account the information Nonconformities and corrective actions. Cf. sub- 4 on the performance of the QMS clause 10.2 and trends 282 9.3.2 c Take into account the information Inspection results. Cf. sub-clause 9.1 5 on the performance of the QMS and trends 283 9.3.2 c Take into account the information Audit results. Cf. sub-clause 9.2 6 on the performance of the QMS and trends 284 9.3.2 c Take into account the information Performance of external providers. Cf. sub- 7 on the performance of the QMS clause 8.4 and trends 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 Implemented to address risks and opportunities. effectiveness of actions Cf. sub-clause 6.1 287 9.3.2 f Take into account improvement Continual improvement. Cf. sub-clause 10.3 opportunities 9.3.3 Management review outputs beginning 288 9.3.3 a Include decisions regarding Cf. sub-clause 10.3 opportunities for continual improvement in the outputs of the management review 289 9.3.3 b Include decisions regarding Cf. sub-clause 6.3 eventual changes to the QMS in the outputs of the management review 290 9.3.3 c Include decisions regarding new Cf. sub-clause 7.1 resource needs in the outputs of the management review 291 9.3.3 Retain the documented Cf. sub-clause 7.5 information on outputs of the review of management 10 Improvement Act 10.1 General beginning 292 10.1 Find improvement opportunities In order to enhance customer satisfaction. "Where and implement necessary actions 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 Nonconformity and corrective 10.2 beginning action 296 10.2.1 a React to the nonconformity In order to reduce costs. Including all claims by 1 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 Take into account consequences Think risk-based approach 2 298 10.2.1 b Examine the nonconformity And if necessary decide to carry out a corrective 1 action 299 10.2.1 b Investigate root causes So that the nonconformity does not happen again 2 300 10.2.1 b Search for similar In order to apply the same recipe (why reinvent the 3 nonconformities wheel?) 301 10.2.1 c Implement the necessary In order to treat the nonconformity corrective actions 302 10.2.1 d Review the effectiveness of any In order to check whether the action is finalized implemented corrective action 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 Do not make too much quality nonconformities consequences 306 10.2.2 a Retain documented information Cf. sub-clause 7.5 on the nature of nonconformities 307 10.2.2 a Retain documented information Cf. sub-clause 7.5 on results of implemented actions 10.3 Continual improvement beginning 308 10.3 Improve continually the In order to find improvement opportunities performance of the QMS 309 10.3 Take into account the outputs of Cf. sub-clause 9.1.3 and sub-clause 9.3 the analysis, evaluation and management review