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Attachment 8 - QEHSMS Clause By Clause Requirements

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Summary

This document details the clause-by-clause requirements for quality, environmental, and health and safety management systems, referencing ISO 9001:2015, 14001:2015, and 45001:2018 standards. It covers topics like process evaluation, improvement, and documented information.

Full Transcript

+-------------+-------------+-------------+-------------+-------------+ | | **ISO | **ISO | **ISO | | | | 9001:2015** | 14001:2015* | 45001:2018* | | | | | * | * | | +===========...

+-------------+-------------+-------------+-------------+-------------+ | | **ISO | **ISO | **ISO | | | | 9001:2015** | 14001:2015* | 45001:2018* | | | | | * | * | | +=============+=============+=============+=============+=============+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | 4.3 | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | the | When | | | | | organizatio | determining | | | | | n | this scope, | | | | | shall | the | | | | | consider: | organizatio | | | | | | n | | | | | | shall | | | | | | consider: | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | 4.4 | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | g. evaluate | | | | | | these | | | | | | processes | | | | | | and | | | | | | implement | | | | | | any changes | | | | | | needed to | | | | | | ensure that | | | | | | these | | | | | | processes | | | | | | achieve | | | | | | their | | | | | | intended | | | | | | results | | | | +-------------+-------------+-------------+-------------+-------------+ | | h. improve | | | | | | the | | | | | | processes | | | | | | and the | | | | | | quality | | | | | | management | | | | | | system | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | b\. retain | | | | | | documented | | | | | | information | | | | | | to have | | | | | | confidence | | | | | | that | | | | | | processes | | | | | | are | | | | | | carried | | | | | | out as | | | | | | planned | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | a\. taking | | | | | | overall | | | | | | responsibil | | | | | | ity | | | | | | and | | | | | | accountabil | | | | | | ity | | | | | | for the | | | | | | prevention | | | | | | of | | | | | | work-relate | | | | | | d | | | | | | injury | | | | | | and ill | | | | | | health, | | | | | | as well | | | | | | as the | | | | | | provision | | | | | | of safe | | | | | | and | | | | | | healthy | | | | | | workplaces | | | | | | and | | | | | | activities; | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | a. customer | | | | | | and | | | | | | applicable | | | | | | statutory | | | | | | and | | | | | | regulatory | | | | | | requirement | | | | | | s | | | | | | are | | | | | | determined, | | | | | | understood | | | | | | and | | | | | | consistentl | | | | | | y | | | | | | met | | | | +-------------+-------------+-------------+-------------+-------------+ | | b\. risks | | | | | | and | | | | | | opportuniti | | | | | | es | | | | | | that can | | | | | | affect | | | | | | conformity | | | | | | of | | | | | | products | | | | | | and | | | | | | services | | | | | | and the | | | | | | ability | | | | | | to | | | | | | enhance | | | | | | customer | | | | | | satisfactio | | | | | | n | | | | | | are | | | | | | determined | | | | | | and | | | | | | addressed | | | | +-------------+-------------+-------------+-------------+-------------+ | | c\. focus | | | | | | on | | | | | | enhancing | | | | | | customer | | | | | | satisfactio | | | | | | n | | | | | | is | | | | | | maintained | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | - be | | | | | | maintai | | | | | | ned | | | | | | as | | | | | | documen | | | | | | ted | | | | | | informa | | | | | | tion | | | +-------------+-------------+-------------+-------------+-------------+ | | | - be | | | | | | communi | | | | | | cated | | | | | | within | | | | | | the | | | | | | organiz | | | | | | ation | | | +-------------+-------------+-------------+-------------+-------------+ | | | - be | | | | | | availab | | | | | | le | | | | | | to | | | | | | interes | | | | | | ted | | | | | | parties | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. 2. 3. | | | | | | assigning | | | | | | organiz | | | | | | ational | | | | | | roles, | | | | | | respons | | | | | | ibilities | | | | | | and | | | | | | authori | | | | | | ties, | | | | | | as | | | | | | applica | | | | | | ble | | | | | | (see | | | | | | 5.3); | | | | | | | | | | | | 4. determi | | | | | | ning | | | | | | how to | | | | | | fulfil | | | | | | legal | | | | | | require | | | | | | ments | | | | | | and | | | | | | other | | | | | | require | | | | | | ments | | | | | | (see | | | | | | \[6.1.3 | | | | | | ); | | | | | | | | | | | | 5. 6. det | | | | | | ermining | | | | | | applica | | | | | | ble | | | | | | control | | | | | | s | | | | | | for | | | | | | outsour | | | | | | cing, | | | | | | procure | | | | | | ment | | | | | | and | | | | | | contrac | | | | | | tors | | | | | | (see | | | | | | 8.1.4); | | | | | | | | | | | | 7. determi | | | | | | ning | | | | | | what | | | | | | needs | | | | | | to be | | | | | | monitor | | | | | | ed, | | | | | | measure | | | | | | d | | | | | | and | | | | | | evaluat | | | | | | ed | | | | | | (see | | | | | | 9.1); | | | | | | | | | | | | 8. plannin | | | | | | g, | | | | | | establi | | | | | | shing, | | | | | | impleme | | | | | | nting | | | | | | and | | | | | | maintai | | | | | | ning | | | | | | an | | | | | | audit | | | | | | program | | | | | | (s) | | | | | | (see | | | | | | 9.2.2); | | | | | | | | | | | | 9. ensurin | | | | | | g | | | | | | continu | | | | | | al | | | | | | improve | | | | | | ment | | | | | | (see | | | | | | 10.3); | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. determi | | | | | | ning | | | | | | the | | | | | | mechani | | | | | | sms | | | | | | for | | | | | | their | | | | | | consult | | | | | | ation | | | | | | and | | | | | | partici | | | | | | pation; | | | | | | | | | | | | 2. identif | | | | | | ying | | | | | | hazards | | | | | | and | | | | | | assessi | | | | | | ng | | | | | | risks | | | | | | and | | | | | | opportu | | | | | | nities | | | | | | (see | | | | | | 6.1.1 | | | | | | and | | | | | | 6.1.2); | | | | | | | | | | | | 3. 4. 5. | | | | | | determinin | | | | | | g | | | | | | what | | | | | | needs | | | | | | to be | | | | | | communi | | | | | | cated | | | | | | and how | | | | | | this | | | | | | will be | | | | | | done | | | | | | (see | | | | | | 7.4); | | | | | | | | | | | | 6. determi | | | | | | ning | | | | | | control | | | | | | measure | | | | | | s | | | | | | and | | | | | | their | | | | | | effecti | | | | | | ve | | | | | | | | | | | | | | | | | | | | | | | | 7. investi | | | | | | gating | | | | | | inciden | | | | | | ts | | | | | | and | | | | | | nonconf | | | | | | ormities | | | | | | and | | | | | | determi | | | | | | ning | | | | | | correct | | | | | | ive | | | | | | actions | | | | | | (see | | | | | | 10.2). | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | a. b. c. | a. the | a. b. c. | | | | d. | issues | | | | | | referre | | | | | | d | - hazards | | | | | to in | (see | | | | | 4.1 | 6.1.2.1 | | | | | | ); | | | | | b. the | | | | | | require | - OHS | | | | | ments | risks | | | | | referre | and | | | | | d | other | | | | | to in | risks | | | | | 4.2 | (see | | | | | | 6.1.2.2 | | | | | c. the | ); | | | | | scope | | | | | | of its | - OHS | | | | | environ | opportu | | | | | mental | nities | | | | | managem | and | | | | | ent | other | | | | | system | opportu | | | | | | nities | | | | | - - - | (see | | | | | | 6.1.2.3 | | | | | | ); | | | | | | | | | | | | - legal | | | | | | require | | | | | | ments | | | | | | and | | | | | | other | | | | | | require | | | | | | ments | | | | | | see | | | | | | 6.1.3). | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | - risks | | | | | | and | | | | | | opportu | | | | | | nities | | | | | | that | | | | | | need to | | | | | | be | | | | | | address | | | | | | ed | | | +-------------+-------------+-------------+-------------+-------------+ | | | - process | | | | | | (es) | | | | | | needed | | | | | | in | | | | | | 6.1.1 | | | | | | to | | | | | | 6.1.4, | | | | | | to the | | | | | | extent | | | | | | necessa | | | | | | ry | | | | | | to have | | | | | | confide | | | | | | nce | | | | | | they | | | | | | are | | | | | | carried | | | | | | out as | | | | | | planned | | | | | |. | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | - environ | | | | | | mental | | | | | | aspects | | | | | | and | | | | | | associa | | | | | | ted | | | | | | environ | | | | | | mental | | | | | | impacts | | | +-------------+-------------+-------------+-------------+-------------+ | | | - criteri | | | | | | a | | | | | | used to | | | | | | determi | | | | | | ne | | | | | | its | | | | | | signifi | | | | | | cant | | | | | | environ | | | | | | mental | | | | | | aspects | | | +-------------+-------------+-------------+-------------+-------------+ | | | - signifi | | | | | | cant | | | | | | environ | | | | | | mental | | | | | | aspects | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. infrast | | | | | | ructure, | | | | | | equipme | | | | | | nt, | | | | | | materia | | | | | | ls, | | | | | | substan | | | | | | ces | | | | | | and the | | | | | | physica | | | | | | l | | | | | | conditi | | | | | | ons | | | | | | of the | | | | | | workpla | | | | | | ce; | | | | | | | | | | | | 2. product | | | | | | and | | | | | | service | | | | | | design, | | | | | | researc | | | | | | h, | | | | | | develop | | | | | | ment, | | | | | | testing | | | | | | , | | | | | | product | | | | | | ion, | | | | | | assembl | | | | | | y, | | | | | | constru | | | | | | ction, | | | | | | service | | | | | | deliver | | | | | | y, | | | | | | mainten | | | | | | ance | | | | | | and | | | | | | disposa | | | | | | l; | | | | | | | | | | | | 3. human | | | | | | factors | | | | | | ; | | | | | | | | | | | | 4. how the | | | | | | work is | | | | | | perform | | | | | | ed; | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. those | | | | | | with | | | | | | access | | | | | | to the | | | | | | workpla | | | | | | ce | | | | | | and | | | | | | their | | | | | | activit | | | | | | ies, | | | | | | includi | | | | | | ng | | | | | | workers | | | | | | , | | | | | | contrac | | | | | | tors, | | | | | | visitor | | | | | | s | | | | | | and | | | | | | other | | | | | | person; | | | | | | | | | | | | 2. 3. wor | | | | | | kers | | | | | | at a | | | | | | locatio | | | | | | n | | | | | | not | | | | | | under | | | | | | the | | | | | | direct | | | | | | control | | | | | | of the | | | | | | organiz | | | | | | ation; | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. the | | | | | | design | | | | | | of work | | | | | | areas, | | | | | | process | | | | | | es, | | | | | | install | | | | | | ations, | | | | | | machine | | | | | | ry/equipmen | | | | | | t, | | | | | | operati | | | | | | ng | | | | | | procedu | | | | | | res | | | | | | and | | | | | | work | | | | | | organiz | | | | | | ation, | | | | | | includi | | | | | | ng | | | | | | their | | | | | | adaptat | | | | | | ion | | | | | | to the | | | | | | needs | | | | | | and | | | | | | capabil | | | | | | ities | | | | | | of the | | | | | | workers | | | | | | involve | | | | | | d; | | | | | | | | | | | | 2. situati | | | | | | ons | | | | | | occurri | | | | | | ng | | | | | | in the | | | | | | vicinit | | | | | | y | | | | | | of the | | | | | | workpla | | | | | | ce | | | | | | caused | | | | | | by | | | | | | work-re | | | | | | lated | | | | | | activit | | | | | | ies | | | | | | under | | | | | | the | | | | | | control | | | | | | of the | | | | | | organiz | | | | | | ation; | | | | | | | | | | | | 3. situati | | | | | | ons | | | | | | not | | | | | | control | | | | | | led | | | | | | by the | | | | | | organiz | | | | | | ation | | | | | | and | | | | | | occurri | | | | | | ng | | | | | | in the | | | | | | vicinit | | | | | | y | | | | | | of the | | | | | | workpla | | | | | | ce | | | | | | that | | | | | | can | | | | | | cause | | | | | | injury | | | | | | and ill | | | | | | health | | | | | | to | | | | | | persons | | | | | | in the | | | | | | workpla | | | | | | ce; | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | a. | | | | | | | | | | | | | | | | | | | | | | | | 1. opportu | | | | | | nities | | | | | | to | | | | | | adapt | | | | | | work, | | | | | | work | | | | | | organiz | | | | | | ation | | | | | | and | | | | | | work | | | | | | environ | | | | | | ment | | | | | | to | | | | | | workers | | | | | | ; | | | | | | | | | | | | 2. opportu | | | | | | nities | | | | | | to | | | | | | elimina | | | | | | te | | | | | | hazards | | | | | | and | | | | | | reduce | | | | | | OHS | | | | | | risks; | | | | | | | | | | | | | | | | | | | | | | | | b. | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | 1. applica | | | | | | ble | | | | | | require | | | | | | ments; | | | | | | | | | | | | 2. 3. the | | | | | | results | | | | | | of | | | | | | consult | | | | | | ation | | | | | | with | | | | | | workers | | | | | | (see | | | | | | 5.4) | | | | | | and, | | | | | | where | | | | | | they | | | | | | exist, | | | | | | workers | | | | | | \' | | | | | | represe | | | | | | ntatives | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | **7 | **7 | **7 | | | | Support** | Support** | Support** | | +-------------+-------------+-------------+-------------+-------------+ | | RESOURCES | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.1 | | | | | | GENERAL | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine | | | | | | and provide | | | | | | resources | | | | | | needed for | | | | | | the | | | | | | establishme | | | | | | nt, | | | | | | implementat | | | | | | ion, | | | | | | maintenance | | | | | | and | | | | | | continual | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.2 | | | | | | PEOPLE | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine | | | | | | and provide | | | | | | the persons | | | | | | necessary | | | | | | for the | | | | | | effective | | | | | | implementat | | | | | | ion | | | | | | of the | | | | | | quality | | | | | | management | | | | | | system and | | | | | | for the | | | | | | operation | | | | | | and control | | | | | | of its | | | | | | processes | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.3 | | | | | | INFRASTRUCT | | | | | | URE | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine, | | | | | | provide and | | | | | | maintain | | | | | | the | | | | | | infrastruct | | | | | | ure | | | | | | necessary | | | | | | for the | | | | | | operation | | | | | | of its | | | | | | processes | | | | | | and achieve | | | | | | conformity | | | | | | of products | | | | | | and | | | | | | services. | | | | +-------------+-------------+-------------+-------------+-------------+ | | a. b. c. | | | | | | d. | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.4 | | | | | | ENVIRONMENT | | | | | | FOR THE | | | | | | OPERATION | | | | | | OF | | | | | | PROCESSES | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine, | | | | | | provide and | | | | | | maintain | | | | | | the | | | | | | environment | | | | | | necessary | | | | | | for the | | | | | | operation | | | | | | of its | | | | | | processes | | | | | | and achieve | | | | | | conformity | | | | | | of products | | | | | | and | | | | | | services. | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.5 | | | | | | MONITORING | | | | | | AND | | | | | | MEASURING | | | | | | RESOURCES | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.5.1 | | | | | | GENERAL | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine | | | | | | and provide | | | | | | the | | | | | | resources | | | | | | needed to | | | | | | ensure | | | | | | valid and | | | | | | reliable | | | | | | results | | | | | | when | | | | | | monitoring | | | | | | or | | | | | | measuring | | | | | | is used. It | | | | | | shall | | | | | | ensure that | | | | | | the | | | | | | resources | | | | | | provided: | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | retain | | | | | | appropriate | | | | | | documented | | | | | | information | | | | | | as evidence | | | | | | of fitness | | | | | | for purpose | | | | | | of the | | | | | | monitoring | | | | | | and | | | | | | measuring | | | | | | resources | | | | +-------------+-------------+-------------+-------------+-------------+ | | 7.1.5.2 | | | | | | MEASUREMENT | | | | | | TRACEABILIT | | | | | | Y | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine | | | | | | if the | | | | | | results has | | | | | | been | | | | | | adversely | | | | | | affected | | | | | | when | | | | | | measuring | | | | | | equipment | | | | | | is found to | | | | | | be unfit | | | | | | for the | | | | | | intended | | | | | | purpose, | | | | | | and shall | | | | | | take | | | | | | appropriate | | | | | | action as | | | | | | necessary. | | | | +-------------+-------------+-------------+-------------+-------------+ | | ORGANIZATIO | | | | | | NAL | | | | | | KNOWLEDGE | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall | | | | | | determine | | | | | | the | | | | | | knowledge | | | | | | necessary | | | | | | for the | | | | | | operation | | | | | | of | | | | | | processes | | | | | | and achieve | | | | | | conformity | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | a. | | | | | | determine | | | | | | the | | | | | | necessary | | | | | | competence | | | | | | of | | | | | | person(s) | | | | | | doing work | | | | | | under its | | | | | | control | | | | | | that | | | | | | affects its | | | | | | environment | | | | | | al | | | | | | performance | | | | | | and its | | | | | | ability to | | | | | | fulfil its | | | | | | compliance | | | | | | obligations | | | +-------------+-------------+-------------+-------------+-------------+ | | | b\. ensure | | | | | | that | | | | | | these | | | | | | persons | | | | | | are | | | | | | competent | | | | | | on the | | | | | | basis of | | | | | | appropriate | | | | | | education, | | | | | | training | | | | | | or | | | | | | experience | | | +-------------+-------------+-------------+-------------+-------------+ | | | c. | | | | | | determine | | | | | | training | | | | | | needs | | | | | | associated | | | | | | with its | | | | | | environment | | | | | | al | | | | | | aspects and | | | | | | its | | | | | | environment | | | | | | al | | | | | | management | | | | | | system | | | +-------------+-------------+-------------+-------------+-------------+ | | | d\. where | | | | | | applicable, | | | | | | take | | | | | | actions | | | | | | to | | | | | | acquire | | | | | | the | | | | | | necessary | | | | | | competence, | | | | | | and | | | | | | evaluate | | | | | | the | | | | | | effectivene | | | | | | ss | | | | | | of the | | | | | | actions | | | | | | taken | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | a. b. | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | c\. their | | | | | | contributio | | | | | | n | | | | | | to the | | | | | | effectivene | | | | | | ss | | | | | | of the | | | | | | environment | | | | | | al | | | | | | management | | | | | | system, | | | | | | including | | | | | | the | | | | | | benefits | | | | | | of | | | | | | enhanced | | | | | | environment | | | | | | al | | | | | | performance | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | b\. when | | | | | | to | | | | | | communicate | | | +-------------+-------------+-------------+-------------+-------------+ | | | c\. with | 1. 2. 3. | | | | | whom to | | | | | | communicate | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | DOCUMENTED | | | | | | INFORMATION | | | | +-------------+-------------+-------------+-------------+-------------+ | | GENERAL | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | - distrib | | | | | | ution, | | | | | | access, | | | | | | retriev | | | | | | al | | | | | | and use | | | +-------------+-------------+-------------+-------------+-------------+ | | | - storage | | | | | | and | | | | | | preserv | | | | | | ation, | | | | | | includi | | | | | | ng | | | | | | preserv | | | | | | ation | | | | | | of | | | | | | legibil | | | | | | ity | | | +-------------+-------------+-------------+-------------+-------------+ | | ISO | ISO | ISO | | | | 9001:2015 | 14001:2015 | 45001:2018 | | +-------------+-------------+-------------+-------------+-------------+ | | | - control | | | | | | of | | | | | | changes | | | | | | (versio | | | | | | n | | | | | | control | | | | | | ) | | | +-------------+-------------+-------------+-------------+-------------+ | | | - retenti | | | | | | on | | | | | | and | | | | | | disposi | | | | | | tion | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | | | | | +-------------+-------------+-------------+-------------+-------------+ | | **8 | **8 | **8 | | | | Operations* | Operations* | Operations* | | | | * | * | * | | +-------------+-------------+-------------+-------------+-------------+ | | OPERATIONAL | | | | | | PLANNING | | | | | | AND CONTROL | | | | +-------------+-------------+-------------+-------------+-------------+ | | shall plan, | - establi | a. establi | | | | implement | shing | shing | | | | and control | operati | criteri | | | | processes | ng | a | | | | needed to | criteri | for the | | | | meet the | a | process | | | | requirement | for the | es; | | | | s | process | | | | | for the | (es) | b. impleme | | | | provision | | nting | | | | of products | - impleme | control | | | | and | nting | of the | | | | services, | control | process | | | | and to | of the | es | | | | implement | process | in | | | | actions | (es), | accorda | | | | determined | in | nce | | | | during | accorda | with | | | | Planning | nce | the | | | | (as | with | criteri | | | | describe in | the | a; | | | | clause 6) | operati | | | | | by: | ng | c. d. ada | | | | | criteri | pting | | | | a. b. 1. | a. | work to | | | | the | | workers | | | | pro | |. | | | | cesses | | | | | | and | | | | | | | | | | | | 2. acc | | | | | | eptance | | | | | | of | | | | | | pro | | | | | | ducts | | | | | | and | | | | | | ser | | | | | | vices | | | | | | | | | | | | c.

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